Federal Register Vol. 81, No.64,
Federal Register Volume 81, Issue 64 (April 4, 2016)
Federal Register Volume 81, Issue 64 (April 4, 2016)
| Page Range | 19021-19466 | |
| FR Document |
Document Created: 2015-12-31 23:05:12
Document Modified: 2015-12-31 23:05:12
| Page and Subject | |
|---|---|
| 81 FR 19136 - Certain Steel Nails From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2013-2014 | |
| 81 FR 19463 - Csar Chávez Day, 2016 | |
| 81 FR 19246 - Regular Board of Directors Meeting; Sunshine Act | |
| 81 FR 19239 - Notice of Intent To Reschedule Public Meetings for the Draft Programmatic Environmental Impact Statement for the Outer Continental Shelf (OCS) Oil and Gas Leasing Program: 2017-2022 | |
| 81 FR 19178 - Sunshine Act Notice | |
| 81 FR 19063 - Importation of Lemons From Chile Into the Continental United States | |
| 81 FR 19173 - Proposed Information Collection Request; Comment Request; Clean Water Act State Revolving Fund Program | |
| 81 FR 19234 - 60-Day Notice of Proposed Information Collection: Energy and Performance Information Center (EPIC) | |
| 81 FR 19233 - Request for Specific Policy Proposals and Methods of Research and Evaluation for MTW Demonstration Expansion | |
| 81 FR 19094 - Drawbridge Operation Regulation; Norwalk River, Norwalk, CT | |
| 81 FR 19040 - Drawbridge Operation Regulation; Three Mile Slough, Rio Vista, CA | |
| 81 FR 19097 - Safety Zone, Block Island Wind Farm; Rhode Island Sound, RI | |
| 81 FR 19216 - Prince William Sound Regional Citizens' Advisory Council Charter Renewal | |
| 81 FR 19041 - Safety Zone; Hudson River, Tarrytown, NY | |
| 81 FR 19041 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CA | |
| 81 FR 19171 - Pesticide Product Registration; Receipt of Applications for New Uses | |
| 81 FR 19188 - Administration on Disabilities, President's Committee for People With Intellectual Disabilities | |
| 81 FR 19060 - Importation of Fresh Cherimoya Fruit From Chile Into the United States | |
| 81 FR 19187 - Award of a Single Source Non-Competing Continuation Cooperative Agreement for One National Activities Grant Project Under Section 6 of the Assistive Technology Act of 1998, as Amended (ATAct) | |
| 81 FR 19282 - Louisiana Disaster Number LA-00062 | |
| 81 FR 19282 - Georgia Disaster Number GA-00066 | |
| 81 FR 19176 - Recommended Aquatic Life Ambient Water Quality Criteria for Cadmium-2016 | |
| 81 FR 19110 - Waste Prevention, Production Subject to Royalties, and Resource Conservation | |
| 81 FR 19162 - Proposed Subsequent Arrangement | |
| 81 FR 19098 - Approval and Promulgation of Implementation Plans; Kentucky; Infrastructure Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard | |
| 81 FR 19161 - Environmental Management Site-Specific Advisory Board Chairs | |
| 81 FR 19169 - Boulder Canyon Project | |
| 81 FR 19246 - Entergy Nuclear Operations, Inc.; James A. FitzPatrick Nuclear Power Plant | |
| 81 FR 19117 - Notice of Funds Availability: Inviting Applications for the Emerging Markets Program | |
| 81 FR 19113 - Notice of Funds Availability: Inviting Applications for the Foreign Market Development Cooperator Program | |
| 81 FR 19115 - Notice of Funds Availability: Inviting Applications for the Market Access Program | |
| 81 FR 19122 - Notice of Funds Availability: Inviting Applications for the Quality Samples Program | |
| 81 FR 19236 - Grant Availability to Federally Recognized Indian Tribes To Implement Traffic Safety Programs and Projects on Indian Reservations | |
| 81 FR 19120 - Notice of Funds Availability: Inviting Applications for the Technical Assistance for Specialty Crops Program | |
| 81 FR 19236 - Indian Gaming; Extension of Tribal-State Class III Gaming Compact (Flandreau Santee Sioux Tribe and the State of South Dakota) | |
| 81 FR 19185 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review | |
| 81 FR 19186 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review | |
| 81 FR 19186 - Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH) | |
| 81 FR 19137 - Takes of Marine Mammals Incidental to Specified Activities; Sand Quality Study Activities at the Children's Pool Beach, La Jolla, California | |
| 81 FR 19235 - Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of New Mexico | |
| 81 FR 19161 - Agency Information Collection Activities; Comment Request; Teacher Follow-Up Survey (TFS 2016-17) to the National Teacher and Principal Survey (NTPS 2015-16) | |
| 81 FR 19236 - Indian Gaming; Notice of Tribal-State Class III Gaming Compact Taking Effect in the State of New Mexico | |
| 81 FR 19285 - Shipping Coordinating Committee; Amended Notice of Public Meeting | |
| 81 FR 19021 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1; Corrections | |
| 81 FR 19285 - 60-Day Notice of Proposed Information Collection: Application for a U.S. Passport | |
| 81 FR 19112 - National Organic Standards Board (NOSB): Notice of Intent To Renew Charter and Call for Nominations | |
| 81 FR 19285 - Culturally Significant Objects Imported for Exhibition Determinations: “Court and Cosmos: The Great Age of the Seljuqs” Exhibition | |
| 81 FR 19058 - Fisheries of the Exclusive Economic Zone Off Alaska; Northern Rockfish in the Bering Sea and Aleutian Islands Management Area. | |
| 81 FR 19069 - Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications | |
| 81 FR 19194 - Labeling for Biosimilar Products; Draft Guidance for Industry; Availability | |
| 81 FR 19190 - Determination That PRONESTYL (Procainamide Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
| 81 FR 19242 - Agency Information Collection Activities; Proposed eCollection eComments Requested; National Institute of Justice Compliance Testing Program | |
| 81 FR 19241 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Report of Public Safety Officers Permanent and Total Disability | |
| 81 FR 19240 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Report of Public Safety Officers Death Benefits | |
| 81 FR 19240 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Claim for Death Benefits | |
| 81 FR 19283 - Texas Disaster Number TX-00465 | |
| 81 FR 19283 - Mississippi Disaster #MS-00084 | |
| 81 FR 19282 - Pennsylvania Disaster #PA-00069 | |
| 81 FR 19032 - Extension of the Workers' Compensation Offset From Age 65 to Full Retirement Age-Achieving a Better Life Experience (ABLE) Act | |
| 81 FR 19026 - Revisions to the Export Administration Regulations Based on the 2015 Missile Technology Control Regime Plenary Agreements | |
| 81 FR 19250 - Securities Investor Protection Corporation; Order Approving the Determination of the Board of Directors of the Securities Investor Protection Corporation Not To Adjust for Inflation the Standard Maximum Cash Advance Amount and Notice of the Standard Maximum Cash Advance Amount | |
| 81 FR 19059 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska | |
| 81 FR 19220 - Michigan; Amendment No. 1 to Notice of an Emergency Declaration | |
| 81 FR 19288 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Lending Limits | |
| 81 FR 19229 - Proposed Flood Hazard Determinations for Coconino County, Arizona and Incorporated Areas | |
| 81 FR 19221 - Final Flood Hazard Determinations | |
| 81 FR 19224 - Changes in Flood Hazard Determinations | |
| 81 FR 19205 - Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee | |
| 81 FR 19287 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Examination Questionnaire | |
| 81 FR 19289 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Community and Economic Development Entities, Community Development Projects, and Other Public Welfare Investments | |
| 81 FR 19216 - Agency Information Collection Activities: Administrative Rulings | |
| 81 FR 19036 - Special Local Regulation; Charleston Race Week, Charleston Harbor, Charleston, SC | |
| 81 FR 19038 - Special Local Regulation; Bucksport/Lake Murray Drag Boat Spring Nationals, Atlantic Intracoastal Waterway; Bucksport, SC | |
| 81 FR 19269 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Adopting Requirements for the Collection and Transmission of Data Pursuant to Appendices B and C of the Regulation NMS Plan to Implement a Tick Size Pilot Program | |
| 81 FR 19162 - Challenges and Opportunities for Pumped Storage Hydropower | |
| 81 FR 19283 - Agency Information Collection Activities: Proposed Request | |
| 81 FR 19044 - Fisheries of the Northeastern United States; Atlantic Herring Fishery; Framework Adjustment 4 | |
| 81 FR 19183 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 19195 - Comparability Protocols-Chemistry, Manufacturing, and Controls Information for New Animal Drugs; Guidance for Industry; Availability | |
| 81 FR 19125 - Ashley Resource Advisory Committee | |
| 81 FR 19108 - World Trade Center Health Program; Petition 010-Peripheral Neuropathy; Finding of Insufficient Evidence | |
| 81 FR 19286 - CSX Transportation, Inc.-Discontinuance of Service Exemption-in Greenbrier and Fayette Counties, W. Va. | |
| 81 FR 19136 - New England Fishery Management Council; Public Meeting | |
| 81 FR 19211 - Prospective Grant of Exclusive License: Development of 5T4 Antibodies in Human Cancer Therapeutics and Diagnostics | |
| 81 FR 19249 - New Postal Product | |
| 81 FR 19246 - Section 512 Study: Extension of Time To Submit Requests To Participate in Roundtable | |
| 81 FR 19214 - National Institute on Aging; Notice of Closed Meetings | |
| 81 FR 19208 - Center For Scientific Review; Notice of Closed Meetings | |
| 81 FR 19179 - Proposed Agency Information Collection Activities; Comment Request | |
| 81 FR 19178 - Proposed Agency Information Collection Activities; Comment Request | |
| 81 FR 19181 - Proposed Agency Information Collection Activities; Comment Request | |
| 81 FR 19208 - Office of the Director, National Institutes of Health; Notice of Meeting | |
| 81 FR 19169 - Review of Cost Submittals by Other Federal Agencies for Administering Part I of the Federal Power Act; Notice of Postponing Technical Conference | |
| 81 FR 19164 - Alaska Energy Authority; Notice of Availability of Draft Environmental Assessment | |
| 81 FR 19166 - Commission Information Collection Activities (FERC Form 6-Q); Comment Request; Extension | |
| 81 FR 19167 - PennEast Pipeline Company, LLC; Notice of Schedule for Environmental Review of the Penneast Pipeline Project | |
| 81 FR 19163 - Combined Notice of Filings #1 | |
| 81 FR 19168 - Energy Resources USA, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To Intervene | |
| 81 FR 19168 - City of Wadsworth, Ohio; Notice of Teleconference | |
| 81 FR 19164 - Notice of Technical Conference | |
| 81 FR 19165 - Energy Resources USA, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To Intervene | |
| 81 FR 19169 - Energy Resources USA, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To Intervene | |
| 81 FR 19186 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Health Disparities Subcommittee (HDS) | |
| 81 FR 19245 - Agricultural Worker Population Estimates for Basic Field-Migrant Grants | |
| 81 FR 19152 - Proposed Collection; Comment Request | |
| 81 FR 19066 - Administrative Actions for Noncompliance; Lesser Administrative Actions | |
| 81 FR 19033 - Administrative Actions for Noncompliance; Lesser Administrative Actions | |
| 81 FR 19250 - New Postal Product | |
| 81 FR 19247 - New Postal Product | |
| 81 FR 19248 - New Postal Product | |
| 81 FR 19153 - Annual Updates to the Income Contingent Repayment (ICR) Plan Formula for 2016-William D. Ford Federal Direct Loan Program | |
| 81 FR 19054 - Fisheries Off West Coast States; Comprehensive Ecosystem-Based Amendment 1; Amendments to the Fishery Management Plans for Coastal Pelagic Species, Pacific Coast Groundfish, U.S. West Coast Highly Migratory Species, and Pacific Coast Salmon | |
| 81 FR 19275 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Article 20, Rule 13 To Implement the Regulation NMS Plan To Implement a Tick Size Pilot Program (“Plan”) | |
| 81 FR 19260 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Instituting Proceedings To Determine Whether to Approve or Disapprove Proposed Rule Change To Adopt FINRA Rule 2030 and FINRA Rule 4580 to Establish “Pay-To-Play” and Related Rules | |
| 81 FR 19252 - Self-Regulatory Organizations; BATS Exchange, Inc., BATS Y-Exchange, Inc., EDGX Exchange, Inc., EDGA Exchange, Inc.; Order Approving Proposed Rule Changes To Amend and Restate the Certificate of Incorporation and Bylaws of the Exchanges' Ultimate Parent Company, BATS Global Markets, Inc. | |
| 81 FR 19255 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change, as Modified by Amendment Nos. 1, 2, 3, and 4 Thereto, To List and Trade Shares of the REX Gold Hedged S&P 500 ETF and the REX Gold Hedged FTSE Emerging Markets ETF Under NYSE Arca Equities Rule 8.600 | |
| 81 FR 19157 - Deadline Dates for Reports and Other Records Associated With the Free Application for Federal Student Aid (FAFSA®), the Federal Pell Grant Program, the William D. Ford Federal Direct Loan Program, the Teacher Education Assistance for College and Higher Education Grant Program, and the Iraq and Afghanistan Service Grant Program for the 2016-2017 Award Year | |
| 81 FR 19220 - Pennsylvania; Major Disaster and Related Determinations | |
| 81 FR 19228 - Georgia; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 81 FR 19233 - Mississippi; Major Disaster and Related Determinations | |
| 81 FR 19125 - Information Collection Activity; Comment Request | |
| 81 FR 19217 - Changes in Flood Hazard Determinations | |
| 81 FR 19228 - Proposed Flood Hazard Determinations | |
| 81 FR 19210 - National Human Genome Research Institute; Notice of Closed Meeting | |
| 81 FR 19214 - National Heart, Lung, and Blood Institute; Amended Notice of Meeting | |
| 81 FR 19210 - National Eye Institute; Notice of Closed Meeting | |
| 81 FR 19212 - National Institute on Aging Amended Notice of Meeting | |
| 81 FR 19209 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 81 FR 19207 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 81 FR 19213 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings | |
| 81 FR 19213 - Prospective Grant of Start-Up Exclusive License: Therapeutics for Multiple Sclerosis, Amyotrophic Lateral Sclerosis and Certain Other CNS Disorders | |
| 81 FR 19230 - Proposed Flood Hazard Determinations | |
| 81 FR 19222 - Proposed Flood Hazard Determinations | |
| 81 FR 19238 - Request for Nominations for the Preservation Technology and Training Board | |
| 81 FR 19175 - Proposed Consent Decree, Clean Air Act Citizen Suit | |
| 81 FR 19172 - Agency Information Collection Activities; Proposed Renewal of an Existing Collection (EPA ICR No. 0278.12); Comment Request | |
| 81 FR 19207 - Center for Scientific Review; Notice of Closed Meeting | |
| 81 FR 19207 - Proposed Collection; 60 Day Comment Request; Women's Health Initiative (NHLBI) | |
| 81 FR 19097 - Promulgation of Implementation Plans; Arkansas; Regional Haze and Interstate Visibility Transport Federal Implementation Plan; Reopening of Comment Period and Notice of Availability | |
| 81 FR 19212 - Center for Scientific Review; Notice of Closed Meeting | |
| 81 FR 19210 - National Cancer Institute; Notice of Meeting | |
| 81 FR 19211 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 19243 - MET Laboratories, Inc.: Grant of Expansion of Recognition and Modification to the NRTL Program's List of Appropriate Test Standards | |
| 81 FR 19209 - National Cancer Institute; Notice of Closed Meetings | |
| 81 FR 19213 - Center for Scientific Review; Amended Notice of Meeting | |
| 81 FR 19212 - National Institute on Deafness and Other Communication Disorders; Notice of Meeting | |
| 81 FR 19191 - Emergency Use Authorization of Medical Products and Related Authorities; Draft Guidance for Industry and Public Health Stakeholders; Availability | |
| 81 FR 19188 - Determination of Regulatory Review Period for Purposes of Patent Extension; BRINTELLIX | |
| 81 FR 19243 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; H-2A Temporary Employment Certification Program | |
| 81 FR 19183 - Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF) | |
| 81 FR 19131 - BE-150: Quarterly Survey of Payment Card and Bank Card Transactions Related to International Travel | |
| 81 FR 19135 - BE-185: Quarterly Survey of Financial Services Transactions Between U.S. Financial Services Providers and Foreign Persons | |
| 81 FR 19128 - BE-577: Quarterly Survey of U.S. Direct Investment Abroad-Transactions of U.S. Reporter With Foreign Affiliate | |
| 81 FR 19129 - BE-605: Quarterly Survey of Foreign Direct Investment in the United States-Transactions of U.S. Affiliate With Foreign Parent | |
| 81 FR 19128 - BE-125: Quarterly Survey of Transactions in Selected Services and Intellectual Property With Foreign Persons | |
| 81 FR 19132 - BE-45: Quarterly Survey of Insurance Transactions by U.S. Insurance Companies With Foreign Persons | |
| 81 FR 19127 - BE-37: Quarterly Survey of U.S. Airline Operators' Foreign Revenues and Expenses | |
| 81 FR 19196 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 041 | |
| 81 FR 19214 - Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies | |
| 81 FR 19130 - BE-30: Quarterly Survey of Ocean Freight Revenues and Foreign Expenses of U.S. Carriers | |
| 81 FR 19133 - BE-9: Quarterly Survey of Foreign Airline Operators' Revenues and Expenses in the United States | |
| 81 FR 19134 - BE-11: Annual Survey of U.S. Direct Investment Abroad | |
| 81 FR 19132 - BE-29: Annual Survey of Foreign Ocean Carriers' Expenses in the United States | |
| 81 FR 19126 - BE-15: Annual Survey of Foreign Direct Investment in the United States | |
| 81 FR 19291 - Proposed Information Collection (The Veterans Metrics Initiative: Linking Program Components to Post-Military Well-Being); Activity: Comment Request | |
| 81 FR 19290 - Proposed Information Collection (Complaint of Employment Discrimination, VA Form 4939; Information for Pre-Complaint Processing, VA Form 08-10192); Activity: Comment Request | |
| 81 FR 19293 - Agency Information Collection (Application for VA Education Benefits, Application for Family Member to Use Transferred Benefits, Application for VA Education Benefits Under the National Call to Service (NCS) Program and Application for Veterans Retraining Assistance Program) Activity Under OMB Review | |
| 81 FR 19291 - Proposed Information Collection-Department of Housing and Urban Development (HUD)/Department of Veterans Affairs (VA) Addendum to Uniform Residential Loan Application (VA Form 26-1802A); Activity: Comment Request | |
| 81 FR 19292 - Proposed Information Collection (Request for Determination of Loan Guaranty Eligibility-Unmarried Surviving Spouses); Activity: Comment Request | |
| 81 FR 19043 - Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Correction and Technical Amendments | |
| 81 FR 19022 - Airworthiness Directives; General Electric Company Turbofan Engines | |
| 81 FR 19024 - Airworthiness Directives; Technify Motors GmbH Reciprocating Engines | |
| 81 FR 19086 - Amendments to the Definition of Broker or Dealer in Securities | |
| 81 FR 19353 - Federal Agency Final Regulations Implementing Executive Order 13559: Fundamental Principles and Policymaking Criteria for Partnerships With Faith-Based and Other Neighborhood Organizations | |
| 81 FR 19325 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to a Pier Construction and Support Facilities Project, Port Angeles, WA | |
| 81 FR 19295 - Miscellaneous Changes to Trademark Trial and Appeal Board Rules of Practice | |
| 81 FR 19431 - Promoting Diversification of Ownership in the Broadcasting Services |
Issue
Agricultural Marketing Service
Animal and Plant Health Inspection Service
Commodity Credit Corporation
Forest Service
Rural Utilities Service
Economic Analysis Bureau
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Western Area Power Administration
Agency for Healthcare Research and Quality
Centers for Disease Control and Prevention
Community Living Administration
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Federal Emergency Management Agency
U.S. Customs and Border Protection
Indian Affairs Bureau
Land Management Bureau
National Park Service
Ocean Energy Management Bureau
Occupational Safety and Health Administration
Copyright Office, Library of Congress
Federal Aviation Administration
Comptroller of the Currency
Financial Crimes Enforcement Network
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Nuclear Regulatory Commission.
Correcting amendments.
The U.S. Nuclear Regulatory Commission (NRC) published a direct final rule in the
This rule is effective on April 4, 2016.
Please refer to Docket ID NRC-2015-0156 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Robert D. MacDougall, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-5175, email:
The NRC published a direct final rule in the
Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(B), the NRC finds good cause to waive notice and opportunity for comment on the amendments because it will have no substantive impact and is of a minor and administrative nature. Specifically, these amendments are to restore Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012) to CoC No. 1014. These amendments do not require action by any person or entity regulated by the NRC. Also, the final rule does not change the substantive responsibilities of any person or entity regulated by the NRC. Furthermore, for these reasons, the NRC finds, pursuant to 5 U.S.C. 553(d)(3), that good cause exists to make this rule effective upon publication of this document.
Administrative practice and procedure, Criminal penalties, Hazardous waste, Indians, Intergovernmental relations, Manpower training programs, Nuclear energy, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR part 72:
Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183,184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act
Certificate Number: 1014.
Initial Certificate Effective Date: May 31, 2000.
Amendment Number 1 Effective Date: July 15, 2002.
Amendment Number 2 Effective Date: June 7, 2005.
Amendment Number 3 Effective Date: May 29, 2007.
Amendment Number 4 Effective Date: January 8, 2008.
Amendment Number 5 Effective Date: July 14, 2008.
Amendment Number 6 Effective Date: August 17, 2009.
Amendment Number 7 Effective Date: December 28, 2009.
Amendment Number 8 Effective Date: May 2, 2012, as corrected on November 16, 2012 (ADAMS Accession No. ML12213A170); superseded by Amendment Number 8, Revision 1, on February 16, 2016.
Amendment Number 8, Revision 1, Effective Date: February 16, 2016.
Amendment Number 9 Effective Date: March 11, 2014, superseded by Amendment Number 9, Revision 1, on March 21, 2016.
Amendment Number 9, Revision 1, Effective Date: March 21, 2016.
Safety Analysis Report (SAR) Submitted by: Holtec International.
SAR Title: Final Safety Analysis Report for the HI-STORM 100 Cask System.
Docket Number: 72-1014.
Certificate Expiration Date: May 31, 2020.
Model Number: HI-STORM 100.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all General Electric Company (GE) CF6-80E1 turbofan engines with rotating compressor discharge pressure (CDP) seal, part number (P/N) 1669M73P02, installed. This AD was prompted by reports from the manufacturer of cracks in the teeth of two rotating CDP seals found during engine shop visits. This AD requires stripping of the coating, inspecting, and recoating the teeth of the affected rotating CDP seals. We are issuing this AD to prevent cracking of the CDP seal teeth, uncontained part release, damage to the engine, and damage to the airplane.
This AD is effective May 9, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of May 9, 2016.
For service information identified in this final rule, contact General Electric Company, GE Aviation, Room 285, 1 Neumann Way, Cincinnati, OH 45215; phone: 513-552-3272; email:
You may examine the AD docket on the Internet at
Herman Mak, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7147; fax: 781-238-7199; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all GE CF6-80E1 turbofan engines with rotating CDP seal, P/N 1669M73P02, installed. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 71747, November 17, 2015) (“the NPRM”) and the FAA's response to each comment.
Qantas, Air France, KLM Royal Dutch Airlines (KLM), and GE Aviation requested that the shop visit definition be clarified to allow for randomly occurring exemptions. Including exemptions would not increase the time between full shop visits.
We agree. We changed the shop visit definition to include specific conditions that do not qualify as shop visits.
KLM and Air France requested we clarify the phrase “separation of pairs of major mating engine flanges”.
We agree. We changed the definition for engine shop visit.
Qantas requested a more restrictive compliance time for engines that experience blade-out events and a less restrictive compliance time of next part
We disagree. The compliance times in the NPRM were derived from analysis that includes the risks associated with engines with and without blade-out events. We did not change this AD.
Qantas requested that we clarify the specific type of stationary CDP seal repair and that we clarify what is considered a replaced stationary CDP seal.
We agree. We modified the Compliance section to specify the repair as `honeycomb'. We also added a definition to define a replaced CDP seal.
KLM requested that the applicability be expanded to include spare parts.
We partially agree. We agree with the concern for accidental installation of borazon-nickel coated rotating CDP seals because the NPRM does not preclude this scenario. We disagree with expanding this AD to include spare parts because ADs address unsafe conditions of engines, not spare parts. We changed this AD by adding an installation prohibition paragraph to address this concern.
KLM requested the Credit for Previous Action paragraph allow for other approved original equipment manufacturer approved procedures for stripping and recoating rotating CDP seal teeth. KLM recoated two CDP seals using a procedure approved by GE.
We disagree. It is unknown whether previous recoating procedures are equivalent to the procedures specified in the Credit for Previous Action paragraph of this AD. Any party may submit a request for an Alternative Method of Compliance using the procedures listed in this AD. We did not change this AD.
We clarified paragraphs (e)(2)(i) and (e)(2)(ii) of this AD.
We updated the cost estimate. We changed the Costs of Compliance paragraph of this AD by increasing the number of affected engines by four and updating the costs accordingly.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed GE Service Bulletin (SB) CF6-80E1 S/B 72-0529, Revision 01, dated August 21, 2015. The SB describes procedures for stripping, inspecting, and replacing the seal tooth coating on the affected rotating CDP seals. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We reviewed GE CF6-80E1 (GEK99376) Engine Manual, Revision 42, dated March 15, 2014. The engine manual describes acceptable repair procedures for the seal teeth.
We estimate that this AD will affect 10 engines installed on airplanes of U.S. registry. We also estimate that it will take about 7.15 hours per engine to comply with this AD. The average labor rate is $85 per hour. Parts would cost about $7,835 per engine. Based on these figures, we estimate the total cost of this AD to U.S. operators to be $84,428.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective May 9, 2016.
None.
This AD applies to all General Electric Company (GE) CF6-80E1 turbofan engines with rotating compressor discharge pressure (CDP) seals, part number (P/N) 1669M73P02, installed.
This AD was prompted by reports from the manufacturer of cracks in the teeth of two rotating CDP seals found during engine shop visits. We are issuing this AD to prevent cracking of the CDP seal teeth, which can lead to uncontained part release, damage to the engine, and damage to the airplane.
(1) Comply with this AD within the compliance times specified, unless already done.
(2) Strip coating, inspect, and recoat the teeth of the rotating CDP seal, P/N 1669M73P02. Use paragraph 3.C.(2) of GE Service Bulletin (SB) CF6-80E1 S/B 72-0529, Revision 01, dated August 21, 2015 to do the strip coating, inspecting, and recoating, as follows:
(i) For engines that have had stationary CDP seal, P/N 1347M28G02, replaced or stationary CDP seal honeycomb repaired; strip coating, inspect, and recoat the teeth of the rotating CDP seal at the next engine shop visit.
(ii) For engines that have not had stationary CDP seal, P/N 1347M28G02, replaced or stationary CDP seal honeycomb repaired; strip coating, inspect, and recoat the teeth of the rotating CDP seal at the next part exposure of the rotating CDP seal.
After the effective date of this AD, do not install any rotating CDP seal, P/N 1669M73P02, that has not had its seal teeth recoated using procedures specified in ESM 72-31-10, REPAIR 002 of GE CF6-80E1 (GEK99376) Engine Manual, Revision 42, dated March 15, 2014, into any engine.
(1) For the purpose of this AD, exposure of the rotating CDP seal is defined as removal of the compressor rear frame from the high-pressure compressor (HPC) module.
(2) For the purpose of this AD, an engine shop visit is defined as the induction of an engine into the shop for maintenance involving the separation of any major mating engine flanges, except that the separation of engine flanges solely for the following purposes is not considered a shop visit:
(i) Transportation without subsequent engine maintenance.
(ii) Removing the turbine rear frame (TRF) for repair of TRF cracking.
(iii) Removing the top or bottom HPC case, or both, for HPC airfoil maintenance.
(iv) Removing only the accessory gearbox and/or transfer gearbox.
(v) Replacing the high-pressure turbine (HPT) stage 1 blades per CF6-80E1 SB 72-0504 “Quick-Turn Workscope Procedure to Replace CF6-80E1 Stage 1 HPT Blades”.
(3) For the purpose of this AD, a stationary CDP seal is replaced if at any previous shop visit, the seal has been removed and a different seal is installed.
You may take credit for the actions that are required by paragraph (e) of this AD if the actions were performed before the effective date of this AD using the procedures in ESM 72-31-10, REPAIR 002 of the GE CF6-80E1 (GEK99376) Engine Manual, Revision 42, dated March 15, 2014, or earlier versions.
The Manager, Engine Certification Office, FAA, may approve AMOCs to this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to:
(1) For more information about this AD, contact Herman Mak, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7147; fax: 781-238-7199; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) General Electric Company Service Bulletin CF6-80E1 S/B 72-0529, Revision 01, dated August 21, 2015.
(ii) Reserved.
(3) For GE service information identified in this AD, contact General Electric Company, GE Aviation, Room 285, 1 Neumann Way, Cincinnati, OH 45215; phone: 513-552-3272; email:
(4) You may view this service information at FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
(5) You may view this service information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain Technify Motors GmbH (type certificate previously held by Thielert Aircraft Engines GmbH) TAE 125-02-99 and TAE 125-02-114 reciprocating engines. This AD requires removal of affected fuel feed pumps. This AD was prompted by reports of in-flight shutdowns on TAE 125-02 engines. We are issuing this AD to prevent failure of the fuel feed pump, damage to the engine, and damage to the airplane.
This AD becomes effective May 9, 2016.
For service information identified in this AD, contact Technify Motors GmbH, Platanenstrasse 14, D-09356 Sankt Egidien, Germany; phone: +49-37204-696-0; fax: +49-37204-696-2912; email:
You may examine the AD docket on the Internet at
Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to the specified products. The NPRM was published in the
You may obtain further information by examining the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 27, January 4, 2016).
We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed.
Technify Motors GmbH has issued Operation & Maintenance Manual, CD-135/CD-155, OM-02-02, Issue 4, Revision No. 5, dated September 18, 2015. The service information describes procedures for removing and replacing the fuel feed pump.
We estimate that this AD affects 190 engines installed on airplanes of U.S. registry. We also estimate that it will take about 0.5 hours per engine to comply with this AD. The average labor rate is $85 per hour. Pro-rated cost of the life limit reduction is about $160 per part. Based on these figures, we estimate the cost of this AD on U.S. operators to be $38,475.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective May 9, 2016.
None.
This AD applies to all Technify Motors GmbH TAE 125-02-99 and TAE 125-02-114 reciprocating engines with a fuel feed pump, part number (P/N) 05-7312-K0073xx, or P/N 05-7312-K0133xx, where “xx” can be any number, installed.
This AD was prompted by reports of in-flight shutdowns on TAE 125-02 engines. We are issuing this AD to prevent failure of the fuel feed pump, damage to the engine, and damage to the airplane.
Comply with this AD within the compliance times specified, unless already done. Remove from service each affected fuel feed pump before it exceeds 600 operating hours (OH) time in service (TIS) or within 110 OH after the effective date of this AD, whichever occurs later.
After the effective date of this AD, do not install onto any engine, any fuel feed pump, P/N 05-7312-K0073xx or P/N 05-7312-K0133xx, where “xx” can be any number, if the fuel feed pump has 600 hours or more TIS. If TIS of a fuel feed pump is unknown or has exceeded 600 hours TIS, then the fuel feed pump is not eligible for installation. Rebuilt, overhauled, or repaired fuel feed pumps or fuel feed pumps that lack a serial number, are not eligible for installation.
(1) For more information about this AD, Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email:
(2) Refer to MCAI European Aviation Safety Agency AD 2015-0189, dated September 21, 2015, for more information. You may examine the MCAI in the AD docket on the Internet at
(3) For service information identified in this AD, contact Technify Motors GmbH, Platanenstrasse 14, D-09356 Sankt Egidien, Germany; phone: +49-37204-696-0; fax: +49-37204-696-2912; email:
(4) You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
None.
Bureau of Industry and Security, Commerce.
Final rule.
The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to reflect changes to the Missile Technology Control Regime (MTCR) Annex that were agreed to by MTCR member countries at the October 2015 Plenary in Rotterdam, Netherlands, and the April 2015 Technical Experts Meeting (TEM) in Bern, Switzerland. This final rule makes conforming changes to correlate the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) and other EAR provisions with the current MTCR Annex. This final rule revises six Export Control Classification Numbers (ECCNs) to implement the changes that were agreed to at the meetings and to better align the MT controls on the CCL with the MTCR Annex. In addition, this final rule makes a change to MT licensing policy to be consistent with the MTCR Annex
This rule is effective April 4, 2016.
Sharon Bragonje, Nuclear and Missile Technology Controls Division, Bureau of Industry and Security, Phone: (202) 482-0434; Email:
The Missile Technology Control Regime (MTCR) is an export control arrangement among 34 nations, including most of the world's suppliers of advanced missiles and missile-related equipment, materials, software and technology. The regime establishes a common list of controlled items (the Annex) and a common export control policy (the Guidelines) that member countries implement in accordance with their national export controls. The MTCR seeks to limit the risk of proliferation of weapons of mass destruction by controlling exports of goods and technologies that could make a contribution to delivery systems (other than manned aircraft) for such weapons.
In 1993, the MTCR's original focus on missiles for nuclear weapons delivery was expanded to include the proliferation of missiles for the delivery of all types of weapons of mass destruction (WMD),
This final rule revises the Export Administration Regulations (EAR) to reflect changes to the MTCR Annex agreed to at the October 2015 Plenary in Rotterdam, Netherlands, and changes resulting from the April 2015 Technical Experts Meeting (TEM) in Bern, Switzerland.
Corresponding MTCR Annex references are provided below for the MTCR Annex changes agreed to at the meetings. This rule also makes two conforming changes to correlate the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) and other EAR provisions with the current MTCR Annex. These conforming changes are made to better align the MT controls on the CCL and other parts of the EAR with the MTCR Annex. In the explanation below for the revisions made in this rule, BIS identifies these changes as follows: “Rotterdam 2015 Plenary,” “Bern 2015 TEM,” and “Conforming Change to MTCR Annex” to assist the public in understanding the origin of each change included in this final rule.
In § 742.5 (Missile technology), this final rule adds a new paragraph (b)(3), and redesignates paragraphs (b)(3) and (b)(4), as paragraphs (b)(4) and (b)(5). This paragraph specifies that BIS licenses for MT controlled items also authorize the minimum “software” and “technology” for MT controlled items authorized under the same license, unless such minimum “software” and “technology” are specifically excluded by BIS on the license. This final rule also amends § 750.7(c)(1), which identifies “non-material changes [to a license that] do not require submission of a `Replacement' license or any other notification to BIS.” BIS has determined that a license applicant who does not seek a license for minimum “software” or “technology” for an MT controlled item need not seek a “Replacement” license if the applicant subsequently wishes to export such software or technology under the authority of the previously issued license. Such a use of the license would amount to a non-material change because the basic purpose of the license would be substantially undermined if the exporter could not promptly provide minimum necessary software or technology for the previously licensed MT item, an outcome that would be especially problematic in view of the 2015 regime changes referred to above. Moreover, in many instances, such exports of minimum necessary software and technology may already be made pursuant to License Exception TSU, set forth at § 740.13(a) and (c) (referring to minimum necessary operation software and technology), and notwithstanding the general prohibition against the use of License Exceptions for MT controlled items in § 740.2(a)(5)(i), which excludes a substantial number of MT items from the general prohibition under specified circumstances. Because BIS has previously determined that many such exports can be made pursuant to a License Exception, it stands to reason that the substantially similar MT “minimum necessary” software and technology exports at issue in this rule should be eligible for “non-material” treatment under § 750.7(c)(1). Accordingly, in this rule BIS establishes a new paragraph (c)(1)(x) to § 750.7 that applies to all MT licenses, except when a condition is placed on the license that excludes such minimum “software” and “technology.” These changes are also consistent with the boilerplate text on BIS licenses, because the § 750.7(c)(1)(x) revision identifies the export, reexport or transfer (in-country) of minimum necessary MT controlled software and
BIS makes this change to MT licensing policy to be consistent with the MTCR Annex
BIS is presumptively including such minimum “software” and “technology” as part of the authorized scope for each license that includes MT controlled items. Therefore, applicants are not required to identify or provide any support documentation for such minimum “software” and “technology” on a license application for MT controlled items because such minimum “software” and “technology” is authorized within the scope of the license, pursuant to § 750.7(c)(1)(x), absent a license condition to the contrary. Applicants will be informed when such minimum “software” and/or “technology” in § 750.7(c)(1)(x) is excluded from the license by a BIS condition on the license, which will state the following: “This license does not authorize the export, reexport or transfer (in-country) of the minimum “software” and/or “technology” specified in paragraph (b)(3) of § 742.5.” Absent this condition on the license for MT controlled items, the licensee may assume, consistent with § 750.7(c)(1)(x) and the licensing policy in § 742.5, that the approved license also authorizes the export (or reexport, or transfer (in-country) as applicable) to the same ultimate consignee(s) and end user(s) specified on the license of the minimum “software,” excluding source code, controlled for MT reasons that is required for the installation, operation, maintenance or repair of the item and the “technology” required for the installation, operation, maintenance, or repair of the item in order to ensure the item's safe operation as originally intended. It is important to note that this licensing policy in paragraph (b)(3) of § 742.5 is only available for licensed exports (or reexports, or transfers (in-country)). For example, if an exporter wishes to export such minimum “software” and “technology” for a machine tool controlled for MT reasons, but there is not a license in place authorizing the export of the machine tool, then the export of such minimum “software” and “technology” would require a separate authorization under the EAR. This final rule adds a new Note to paragraph (b)(3), as described below, to make this clear.
This final rule also specifies in § 742.5, paragraph (b)(3) that a license for MT controlled items authorizes pursuant to § 750.7(c)(1)(x) the later export (or reexport, or transfer (in-country) as applicable) of “software” controlled for MT reasons intended to correct defects (bug fixes) in a previously legally exported item under a BIS license to the same ultimate consignee(s) and end user(s) specified on the license, provided that the capability and/or performance of the item are not otherwise enhanced and such “software” is not excluded from the license by a BIS condition on the license.
Lastly, for the changes to § 742.5, this final rule adds a Note to paragraph (b)(3) to clarify that for the limited number of ECCNs that are identified in § 740.2, paragraph (a)(5), License Exception TSU is available, and therefore exporters do not need to apply for a license from BIS for such minimum “software” or “technology.” License Exception TSU is available provided such minimum “software” or “technology” is for an end use specified in that paragraph and meets the requirements of License Exception TSU and is not otherwise restricted under § 740.2 of the EAR. This Note to paragraph (b)(3) also clarifies that the licensing policy in paragraph (b)(3) is only available for licensed exports (or reexports, or transfers (in-country)), as noted above in the example for what minimum “software” and “technology” would require a separate authorization under the EAR. BIS took into account that certain minimum “software” and “technology” was already eligible for License Exception TSU when deciding to add paragraph (b)(3) to § 742.5 for the MT licensing policy and paragraph (c)(1)(x) to § 750.7 to allow for such changes to a license for MT items.
In § 750.7(c) (Changes to the license), this rule adds a new paragraph (c)(1)(x), as referenced above in the description of the changes this final rule makes to § 742.5. This paragraph (c)(1)(x) specifies that the export, reexport or transfer (in-country) of missile technology (MT) controlled minimum “software” and/or “technology
Also in § 750.7, this final rule adds two notes to paragraph (c)(1)(x). The new Note 1 provides context for why BIS is implementing the MT licensing policy pursuant to § 750.7(c)(1)(x). Note 1 explains that the MT licensing policy is being implemented pursuant to paragraph (c)(1)(x) because it applies to all MT licenses. This new Note 1 also explains that this MT licensing policy does not apply when BIS places a condition on the specific license(s) which excludes the use of paragraph (c)(1)(x). This final rule also adds a Note 2 to paragraph (c)(1)(x) to provide guidance on the relationship between License Exception TSU and § 750.7(c)(1)(x), as well as § 742.5(b)(3). Note 2 is the same as the Note to paragraph (b)(3) to § 742.5, described above in this final rule, except for minor changes to reflect that the note is in § 750.7.
In addition, this final rule amends the Commerce Control List (CCL) to reflect changes to the MTCR Annex. Specifically, the following six ECCNs are affected by the changes set forth in this final rule:
This final rule revises paragraph b.4 to add the CAS Number (CAS 25265-19-4/CAS 68891-50-9) after the material “polybutadiene acrylic acid acrylonitrile (PBAN).” (MTCR Annex Change, Category II: Item 4.C.5.e., Rotterdam 2015 Plenary). This change is not expected to have any impact on the number of license applications received by BIS. This final rule revises paragraph d.9 to add the CAS Number (CAS 6068-98-0) after the material “ethylene dihydrazine.” (MTCR Annex Change, Category II: Item 4.C.2.b.8., Rotterdam 2015 Plenary). This change is not expected to have any impact on the number of license applications received by BIS.
This final rule revises paragraph d.12 to add the material “1,1-Dimethylhydrazinium azide (CAS 227955-52-4),” which is an alternative structure of the same chemical (Dimethylhydrazinium azide) classified under d.12. This final rule also revises paragraph d.12 to add “1,2-” before the material “Dimethylhydrazinium azide” and adds the CAS Number (CAS 299177-50-7) after the material “1,2-Dimethylhydrazinium azide.” These changes will aid exporters and licensing officers by making it clear that both structures of the chemical are caught under paragraph d.12. (MTCR Annex Change, Category II: Item 4.C.2.b.12., Rotterdam 2015 Plenary). These changes are not expected to have any impact on the number of license applications received by BIS.
Lastly, for the changes to ECCN 1C111, this final rule revises paragraph d.19, to add the material “1,1-Diethylhydrazine nitrate (DEHN),” which is an alternative structure of the same chemical (Diethylhydrazine nitrate (DEHN)) classified under d.19. This final rule also revises paragraph d.19 to add “1,2-” before the material “Diethylhydrazine nitrate (DEHN)” and adds the CAS Number (CAS 363453-17-2) after the material “1,2-Dimethylhydrazinium nitrate.” These changes will aid exporters and licensing officers and make clear that both structures of the chemical are caught under paragraph d.19. (MTCR Annex Change, Category II: Item 4.C.2.b.19., Rotterdam 2015 Plenary). These changes are not expected to have any impact on the number of license applications received by BIS.
This final rule also makes two conforming changes to ECCN 9A012 for the addition of paragraph 9A012.b.5. Specifically, this final rule is revising the “MT” paragraph in the License Requirements section to add an MT control for the new paragraph 9A012.b.5. This final rule is revising the Related Control Paragraph to include a reference to also see ECCN 9A610, because as noted above, similar types of systems and equipment are controlled under ECCN 9A610.w. This change is expected to result in an increase of 1-3 applications received annually by BIS.
Lastly, as a non-substantive formatting change, this final rule revises paragraph a.2 to move the comma inside of the single quotation marks for the term `bare table.' These changes are not expected to have any impact on the number of license applications received by BIS.
Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were on dock for loading, on lighter, laden aboard an exporting or reexporting carrier, or enroute aboard a carrier to a port of export or reexport, on April 4, 2016, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR) so long as they are exported or reexported before May 4, 2016. Any such items not actually exported or reexported before midnight, on May 4, 2016, require a license in accordance with this rule.
Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866.
2. Notwithstanding any other provision of law, no person may be required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.
4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Immediate implementation of these amendments fulfills the United States' international commitments to the MTCR. The MTCR contributes to international peace and security by promoting greater responsibility in transfers of missile technology items that could make a contribution to delivery systems (other than manned aircraft) for weapons of mass destruction. The MTCR consists of 34 member countries that act on a consensus basis and the changes set forth in this rule implement agreements reached by MTCR member countries at the October 2015 Plenary in Rotterdam, Netherlands and pursuant to the April 2015 Technical Experts Meeting in Bern, Switzerland. Since the United States is a significant exporter of the items in this rule, implementation of this provision is necessary for the MTCR to achieve its purpose. Moreover, it is in the public interest to waive the notice and comment requirements, as any delay in implementing this rule will disrupt the movement of affected items globally because of disharmony between export control measures implemented by MTCR members. Export controls work best when all countries implement the same export controls in a timely manner. If this rulemaking were delayed to allow for notice and comment and a 30 day delay in effectiveness, it would prevent the United States from fulfilling its commitment to the MTCR in a timely manner, would injure the credibility of the United States in this and other multilateral regimes, and may impair the international communities' ability to effectively control the export of certain potentially national- and international-security-threatening materials.
Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
Exports, Terrorism.
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.
Exports, Reporting and recordkeeping requirements.
Accordingly, parts 742, 750 and 774 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:
50 U.S.C. 4601
(b) * * *
(3)(i) Consistent with the MTCR Annex
(ii) Applicants are not required to identify or provide any support documentation for such minimum “software” or “technology” on a license application for MT controlled items because such minimum “software” or “technology” is authorized within the scope of the license, consistent with § 750.7(c)(1)(x). Applicants will be informed when such minimum “software” and/or “technology” in § 750.7(c)(1)(x) is excluded from the license by a BIS condition on the license, which will state the following: “
License Exception TSU under § 740.13 of the EAR is available for the ECCNs controlled for MT reasons specified in paragraph (a)(5) in § 740.2, provided the software or technology is for an end use specified in that paragraph and meets the requirements of License Exception TSU. (See §§ 740.2(a)(5) and 740.13). The licensing policy in paragraph (b)(3) is only available for licensed exports (or reexports, or transfers (in-country)).
50 U.S.C. 4601
(c) * * *
(1) * * *
(x) Export, reexport or transfer (in-country) of missile technology (MT) controlled minimum necessary “software” and/or “technology” permitted pursuant to the missile technology licensing policy in § 742.5(b)(3) of the EAR. (
This MT licensing policy is implemented pursuant to paragraph (c)(1)(x) of this section because it applies to all MT licenses, except when a condition is placed on the license which excludes the use of paragraph (c)(1)(x) of this section, as described in § 742.5(b)(3)(ii).
License Exception TSU under § 740.13 of the EAR is available for the ECCNs controlled for MT reasons specified in paragraph (a)(5) in § 740.2, provided the software or technology is for an end use specified in that paragraph and meets the requirements of License Exception TSU. (See §§ 740.2(a)(5) and 740.13). The licensing policy in § 742.5(b)(3) is only available for licensed exports (or reexports, or transfers (in-country)).
50 U.S.C. 4601
Items:
a. Filament winding machines or `fiber/tow-placement machines,' of which the motions for positioning, wrapping and winding fibers can be coordinated and programmed in three or more axes, designed to fabricate composite structures or laminates from fibrous or filamentary materials, and coordinating and programming controls;
b. `Tape-laying machines' of which the motions for positioning and laying tape can be coordinated and programmed in two or more axes, designed for the manufacture of composite airframe and missile structures;
For the purposes of 1B101.a. and 1B101.b., the following definitions apply:
1. `Fiber/tow-placement machines' and `tape-laying machines' are machines that perform similar processes that use computer-guided heads to lay one or several `filament bands' onto a mold to create a part or a structure. These machines have the ability to cut and restart individual `filament band' courses during the laying process.
2. A `filament band' is a single continuous width of fully or partially resin-impregnated tape, tow, or fiber. Fully or partially resin-impregnated `filament bands' include those coated with dry powder that tacks upon heating.
3. `Fiber/tow-placement machines' have the ability to place one or more `filament bands' having widths less than or equal to 25.4 mm. This refers to the minimum width of material the machine can place, regardless of the upper capability of the machine.
4. `Tape-laying machines' have the ability to place one or more `filament bands' having widths less than or equal to 304.8 mm, but cannot place `filament bands' with a width equal to or less than 25.4 mm. This refers to the minimum width of material the machine can place, regardless of the upper capability of the machine.
Items:
b. * * *
b.4. Polybutadiene acrylic acid acrylonitrile (PBAN) (CAS 25265-19-4/CAS 68891-50-9);
d. * * *
d.9. Ethylene dihydrazine (CAS 6068-98-0);
d.12. 1,1-Dimethylhydrazinium azide (CAS 227955-52-4)/1,2-Dimethylhydrazinium azide (CAS 299177-50-7);
d.19. 1,1-Diethylhydrazine nitrate (DEHN)/1,2-Diethylhydrazine nitrate (DEHN) (CAS 363453-17-2);
Items:
b. * * *
b.5. Pneumatic, hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by ECCN 9A012., and capable of delivering at least 500 kilograms payload to a range of at least 300 km.
w. Pneumatic, hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., and capable of delivering at least 500 kilograms payload to a range of at least 300 km.
a. Environmental chambers having all of the following characteristics:
a.1. Capable of simulating any of the following flight conditions:
a.1.a. Altitude equal to or greater than 15,000 m; or
a.1.b. Temperature range from below −50 °C to above 125 °C; and
a.2. Incorporating, or designed or modified to incorporate, a shaker unit or other vibration test equipment to produce vibration environments equal to or greater than 10 g rms, measured `bare table,' between 20 Hz and 2 kHz while imparting forces equal to or greater than 5 kN;
Social Security Administration.
Final rule.
This final rule adopts, with one additional change, the notice of proposed rulemaking (NPRM) that we published in the
This final rule is effective April 4, 2016.
Dean Dwight, Office of Income Security Programs, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401, (410) 966-7161. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at
This final rule adopts, with one additional change discussed below, the NPRM that we published in the
We explained our reasons for proposing the rule that we are now adopting as a final rule in the preamble to the NPRM (81 FR at 41), and we incorporate that discussion here.
In addition to the changes we proposed in the NPRM, we are making one additional change to our rules. The fourth sentence of current section 404.317 states, “Your monthly benefit amount may be reduced if you receive workers' compensation or public disability payments before you become 65 years old as described in § 404.408.” For consistency with the other changes we are making to our rules, we are also revising the reference to “before you become 65 years old” in section 404.317 to “before you attain full retirement age.”
In the NPRM, we provided a 30-day comment period, which ended on February 3, 2016. We received one comment. The comment came from a member of the public. After carefully considering the comment, we are adopting our proposed rule (81 FR 41-42) as a final rule.
We find good cause for dispensing with the 30-day delay in the effective date of this final rule. 5 U.S.C. 553(d)(3). For the reasons discussed above and in the preamble to the NPRM (81 FR at 41), we are making minor changes to our current rules to incorporate changes made by section 201 of the ABLE Act
We consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the criteria for a significant regulatory action under Executive Order 12866 as supplemented by Executive Order 13563. Thus, OMB did not review the final rule.
We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it applies to individuals only. Thus, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.
These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.
Administrative practice and procedure; Blind; Disability benefits; Government employees; Old-age, Survivors and Disability Insurance; Reporting and recordkeeping requirements; Social security.
For the reasons set forth in the preamble, we amend subparts D and E of part 404 of title 20 of the Code of Federal Regulations as set forth below:
Secs. 202, 203(a) and (b), 205(a), 216, 223, 225, 228(a)-(e), and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 403(a) and (b), 405(a), 416, 423, 425, 428(a)-(e), and 902(a)(5)).
* * * Your monthly benefit amount may be reduced if you receive workers' compensation or public disability payments before you attain full retirement age (as defined in § 404.409) (see § 404.408). * * *
Secs. 202, 203, 204(a) and (e), 205(a) and (c), 216(l), 222(c), 223(e), 224, 225, 702(a)(5), and 1129A of the Social Security Act (42 U.S.C. 402, 403, 404(a) and (e), 405(a) and (c), 416(l), 422(c), 423(e), 424a, 425, 902(a)(5), and 1320a-8a); 48 U.S.C. 1801.
(a) * * *
(4) An individual under full retirement age (see § 404.409) is concurrently entitled to disability insurance benefits and to certain public disability benefits (see § 404.408);
(a) * * *
(2) * * *
(ii) The individual has not attained full retirement age as defined in § 404.409.
Food and Drug Administration, HHS.
Direct final rule.
The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.
This rule is effective August 17, 2016. Submit electronic or written comments on this direct final rule or its companion proposed rule by June 20, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Sheila Brown, Office of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-6563.
FDA is amending § 56.120(b) (21 CFR 56.120(b)), which describes lesser administrative actions that the Agency may impose on an IRB until the IRB takes appropriate action to correct the IRB's noncompliance. We are publishing this direct final rule because it is intended to clarify an existing regulation, and we do not anticipate any significant adverse comment regarding this amendment to § 56.120(b). Specifically, this direct final rule would amend § 56.120(b) by clarifying that FDA has authority to require the IRB to withhold approval of new FDA-regulated studies conducted at the institution or reviewed by the IRB, direct that no new subjects be added to ongoing studies, and terminate ongoing studies provided that doing so would not endanger study subjects.
This amendment also renumbers current paragraphs (b)(4) and (c) as paragraphs (c) and (d), respectively, and inserts “FDA may” into newly designated paragraph (c) so that it is a complete sentence.
FDA first proposed requirements for the composition and operations of institutional review committees in the “Proposed Investigational Device Exemptions,” published in the
Subsequently, FDA published “Standards for Institutional Review Boards for Clinical Investigations” on August 8, 1978 (43 FR 35186; “Proposed IRB Standards”). Comments on implementing institutional review requirements received in response to the Proposed IDE Rule were reviewed and utilized in preparing the Proposed IRB Standards (43 FR 35186 at 35187). In the Proposed IRB Standards, FDA proposed that disqualification would be used only if the Commissioner of Food and Drugs finds that: (1) The IRB failed to comply with one or more of the standards for IRBs in part 56 or other supplemental requirements in the investigational new drug or investigational device exemptions (IDE) regulations; (2) the noncompliance adversely affects the validity of the data or the rights or safety of the human subjects; and (3) other lesser regulatory actions (
FDA received numerous comments to the Proposed IRB Standards, and addressed those comments in the
This direct final rule amends § 56.120(b) to read, in addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to withhold approval of new studies, direct that no new subjects be added to ongoing studies, or terminate ongoing studies. This will ensure that those activities are suspended until the IRB takes appropriate corrective action to address its noncompliance. We believe revising § 56.120(b) as described in this document will improve the clarity and accuracy of the regulations. We are also renumbering § 56.120(b)(4) as § 56.120(c), and § 56.120(c) as § 56.120(d). We are inserting “FDA may” into newly designated § 56.120(c) so that it is a complete sentence.
FDA may notify relevant State and Federal regulatory Agencies when warranted to assure that organizations with a need to know about the IRB's apparent noncompliance are appropriately informed. The revision would eliminate confusion by stating clearly that FDA is authorized to notify others about the IRB's noncompliance. We believe these changes will ensure clarity and improve the accuracy of the regulations.
In the
Consistent with FDA's direct final rulemaking procedures, we are publishing a companion proposed rule elsewhere in this issue of the
If FDA receives any significant adverse comment, we will withdraw this direct final rule before its effective date by publishing a notice in the
If we withdraw this direct final rule, FDA will consider all comments that we received regarding the companion proposed rule as we develop a final rule through the usual notice-and-comment procedures of the APA. If we receive no significant adverse comment during the specified comment period regarding this direct final rule, we intend to publish a confirmation notice in the
This rule, if finalized, would amend § 56.120(b). FDA's authority to modify § 56.120(b) arises from the same authority under which FDA initially issued this regulation, the IRB regulations, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262).
We have determined under 21 CFR 25.30(h) and 25.34(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule does not add any additional regulatory burdens, we certify that this final rule will not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
The purpose of this final rule is to affirm FDA's longstanding interpretation of § 56.120(b), that FDA may impose these administrative actions on a noncompliant IRB until the IRB takes appropriate corrective action. The amendment will improve the clarity and accuracy of the regulations. Because this final rule is a clarification and would impose no additional regulatory burdens, this regulation is not anticipated to result in any compliance costs, and the economic impact is expected to be minimal.
This direct final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
Human research subjects, Reporting and recordkeeping requirements, Safety.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 56 is amended as follows:
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262.
(b) On the basis of the IRB's or the institution's response, FDA may schedule a reinspection to confirm the adequacy of corrective actions. In addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to:
(1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB;
(2) Direct that no new subjects be added to ongoing studies subject to this part; or
(3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects.
(c) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, FDA may notify relevant State and Federal regulatory agencies and other parties with a direct interest in the Agency's action of the deficiencies in the operation of the IRB.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a special local regulation on the waters of Charleston Harbor in Charleston, SC during the Charleston Race Week from April 15, 2016 through April 17, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.
This rule is effective from April 15, 2016 through April 17, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email Lieutenant John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone(843)740-3184, email
On November 18, 2015, the Charleston Ocean Racing Association notified the Coast Guard that it will sponsor a series of sailboat races in the Charleston Harbor, Charleston, SC. from 8:30 a.m. to 5 p.m. April 15, 2016 through April 17, 2016. In response, on February 5, 2016, the Coast Guard published a notice of proposed rulemaking titled Charleston Race Week. There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this special local regulation. During the comment period that ended March 7, 2016, we received no comments.
Under good cause provisions in 5 U.S.C. 553(d)(3), we are making this rule effective less than 30 days after its publication in the
The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to insure safety of life on navigable waters of the United States during three Charleston Race Week sailboat races. It was determined that potential hazards are associated with the areas used in the Charleston Race Week sailboat races that can be alleviated by prohibiting access to the regulated areas.
As noted above, we received no comments on our NPRM published February 5, 2016. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
From April 15, 2016 through April 17, 2016, Charleston Ocean Racing Association will host three sailboat races on Charleston Harbor in Charleston, South Carolina during Charleston Race Week. Approximately 300 sailboats will participate in the three races. This rule establishes a special local regulation on certain waters of Charleston Harbor in Charleston, South Carolina. The special local regulation will be enforced daily from 8:30 a.m. until 5 p.m. on April 15, 2016 through April 17, 2016. The special local regulation consists of the following three race areas.
1.
2.
3.
Except for those persons and vessels participating in the sailboat races, persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the race areas unless specifically authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels desiring to enter, transit through, anchor in, or remain within any of the race areas may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the race areas is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.
The economic impact of this rule is not significant for the following reasons: (1) Non-participant persons and vessels may enter, transit through, anchor in, or remain within the regulated area during the enforcement periods if authorized by the Captain of the Port Charleston or a designated representative; (2) vessels not able to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port Charleston or a designated representative may operate in the surrounding areas during the enforcement period; and (3) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners; (4) the safety zone will impact only 3 small designated areas of Charleston Harbor for less than 9 hours per day for 3 days over the weekend of April 15, to 17, 2016, and thus is limited in time and scope.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small entities: The owner or operators of vessels intending to enter, transit through, anchor in, or remain within the regulated area during the enforcement period. For the reasons discussed in Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction.
An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233
(a)
(1)
(2)
(3)
(b)
(c)
(2) The Coast Guard will provide notice of the regulated area by Marine Safety Information Bulletins, Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a special local regulation on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Lake Murray Drag Boat Spring Nationals, on June 4 and June 5, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.
This rule is effective from June 4, 2016 through June 5, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email Lieutenant John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone (843) 740-3184, email
On December 27, 2015, the Bucksport Marina notified the Coast Guard that it will sponsor a series of drag boat races from 1 p.m. to 7 p.m. on June 4 and June 5, 2016. In response, on February 5, 2016, the Coast Guard published a notice of proposed rulemaking titled Bucksport/Lake Murray Drag Boat Spring Nationals, Atlantic Intracoastal Waterway; Bucksport, SC. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this special local regulation. During the comment period that ended March 7, 2016, we received no comments.
The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to insure safety of life on navigable waters of the United States during the two days of drag boat races.
As noted above, we received no comments on our NPRM published February 5, 2016. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM. From June 4, 2016 through June 5, 2016, Bucksport Marina will host a series of drag boat races on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Lake Murray Drag Boat Spring Nationals. Approximately 50 powerboats are anticipated to participate in the races and approximately 35 spectator vessels are expected to attend the event. This rule establishes a special local regulation on certain waters on the Atlantic
Except for those persons and vessels participating in the drag boat races, persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the race areas unless specifically authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels desiring to enter, transit through, anchor in, or remain within any of the race areas may contact the Captain of the Port Charleston by telephone at (843)740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the race areas is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.
The economic impact of this rule is not significant for the following reasons: (1) Non-participant persons and vessels may enter, transit through, anchor in, or remain within the regulated area during the enforcement periods if authorized by the Captain of the Port Charleston or a designated representative; (2) vessels not able to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port Charleston or a designated representative may operate in the surrounding areas during the enforcement period; and (3) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners. (4) the safety zone will impact only a small designated area of the Atlantic Intracoastal Waterway for the 2 days of June 4, and 5, from 1p.m. to 7 p.m., and thus is limited in time and scope.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small entities: The owner or operators of vessels intending to enter, transit through, anchor in, or remain within the regulated area during the enforcement period. For the reasons discussed in Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure,
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction.
An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(c)
(2) The Coast Guard will provide notice of the regulated area by Marine Safety Information Bulletins, Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
(d)
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Highway 160 drawbridge across Three Mile Slough, mile 0.1, at Rio Vista, CA. The deviation is necessary to allow the bridge owner to complete the necessary sand blasting and painting rehabilitation. This deviation allows the bridge to be secured in the closed-to-navigation position during the deviation period.
This deviation is effective from 12:01 a.m. on April 11, 2016 to 11:59 p.m. on April 17, 2016.
The docket for this deviation, [USCG-2016-0239], is available at
If you have questions on this temporary deviation, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email
The California Department of Transportation has requested a temporary change to the operation of the Highway 160 drawbridge, mile 0.1, over Three Mile Slough, at Rio Vista, CA. The drawbridge navigation span provides 12 feet vertical clearance above Mean High Water in the closed-to-navigation position. In accordance with 33 CFR 117.5, the draw opens on signal. Navigation on the waterway is commercial, search and rescue, law enforcement, and recreational.
The drawbridge will be secured in the closed-to-navigation position from 12:01 a.m. on April 11, 2016 to 11:59 p.m. on April 17, 2016, to allow the bridge owner to complete the necessary sand blasting and painting rehabilitation after unforeseen events have caused project delays. A containment scaffolding system has been installed below low steel of the entire length of the bridge structure, reducing vertical clearance for navigation by not more than 4 feet, and is lighted at night with red lights. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.
Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies. The confluence of the San Joaquin and Sacramento rivers can be used as an alternate route
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the community to participate in the Pony Express Marathon.
This deviation is effective from 6:30 a.m. to 11 a.m. on May 1, 2016.
The docket for this deviation, [USCG-2016-0225] is available at
If you have questions on this temporary deviation, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email
California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The vertical lift bridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.
The drawspan will be secured in the closed-to-navigation position from 6:30 a.m. to 11 a.m. on May 1, 2016, to allow the community to participate in the Pony Express Marathon. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.
Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary moving safety zone for navigable waters of the Hudson River, in the vicinity of the Tappan Zee Bridge around a 100-yard radius of DECK BARGE WITTE 1406. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by salvage operations on the sunken vessel TUG SPECIALIST. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port New York.
This rule is effective without actual notice from April 4, 2016 through May 17, 2016. For the purposes of enforcement, actual notice will be used from March 17, 2016 through April 4, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email MST1 Kristina Pundt, Waterways Management Division, U.S. Coast Guard; telephone 718-354-4352, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because immediate action is needed to respond to the potential safety hazards associated with the salvage operations of TUG SPECIALIST that sank in the Hudson River on March 12, 2016. Delaying the effective date of this rule would be contrary to the public interest of ensuring the safety of salvage workers, DECK BARGE WITTE 1406, other vessels, and mariners from the hazards associated with the salvage of TUG SPECIALIST.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port New York (COTP) has determined that potential hazards associated with emergency salvage operations starting March 17, 2016, will be a safety concern for anyone within a 100-yard radius of DECK BARGE WITTE 1406. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while DECK BARGE WITTE 1406 conducts salvage operations on the sunken vessel.
This rule establishes a safety zone from March 17, 2016 through May 17, 2016. The safety zone will cover all navigable waters within 100 yards of DECK BARGE WITTE 1406 to salvage the sunken tug vessel. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while salvage operations are conducted. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and Executive order related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Hudson River in the vicinity of the Tappan Zee Bridge for 60 days and during a time of year when vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves: A safety zone lasting approximately 62 that will prohibit entry within 100 yards of DECK BARGE WITTE 1406 being used by personnel to salvage the sunken tug vessel. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) To seek permission to enter, contact the COTP or the COTP's representative via VHF channel 16 or by phone at (718) 354-4353 (Sector New York Command Center). Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Department of Health and Human Services.
Interim final rule; correction and technical amendments.
The Department of Health and Human Services published a document containing technical amendments in the
Effective on April 4, 2016.
Audrey E. Clarke, Ph.D., Division of Grants, Office of Grants and Acquisition Policy and Accountability, Office of the Assistant Secretary for Financial Resources, U.S. Department of Health and Human Services, email:
HHS is correcting its regulations in line with FR Doc. 2014-28697, published on December 19, 2014 (79 FR 75871), entitled “Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards”, the “Guidance for Reporting and Use of Information Concerning Recipient Integrity and Performance” to 2 CFR part 200, published on July 22, 2015 (80 FR 43301), and “Universal Identifier and System of Award Management; Corrections”, published on September 10, 2015 (80 FR 54407), made by the Office of Management and Budget (OMB). HHS adopts the correcting amendments made by OMB. HHS is also making amendments to address citation or grammatical inconsistencies, to amend incomplete statements in the regulation, and to update existing HHS regulations to incorporate 45 CFR part 75. The correcting amendments will go into effect at the time of publication.
This is the second set of corrections. The first set of corrections was published in the
In the
On page 3018, in the third column, remove amendatory instruction 197c.
Accounting, Auditing, Administrative practice and procedure, Colleges and universities, Cost principles, Grant programs, Grant programs-health, Grants administration, Hospitals, Indians, Nonprofit organizations, Reporting and recordkeeping requirements, and State and local governments.
Accordingly, HHS makes the following technical amendments to 45 CFR part 75:
5 U.S.C. 301.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS implements approved measures in Framework 4 to the Atlantic Herring Fishery Management Plan. The New England Fishery Management Council developed Framework 4 to further enhance catch monitoring and address discarding in the herring fishery. The approved measures include: A requirement that vessels report slippage (
Effective May 4, 2016.
The New England Fishery Management Council (Council) developed an environmental assessment (EA) for this action that describes the proposed action and other considered alternatives and provides a thorough analysis of the impacts of the proposed measures and alternatives. Copies of the framework, the EA, and the Regulatory Impact Review (RIR)/Initial Regulatory Flexibility Analysis (IRFA), are available upon request from Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Newburyport, MA 01950. The EA/RIR/IRFA is accessible via the Internet at
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted to NMFS, Greater Atlantic Regional Fisheries Office and by email to
Carrie Nordeen, Fishery Policy Analyst, phone 978-281-9272, fax 978-281-9135.
The Council adopted Framework Adjustment 4 to the Atlantic Herring Fishery Management Plan at its April 22, 2014, meeting. The Council submitted Framework 4 to NMFS for review on July 18, 2014, and resubmitted it to NMFS on February 27, 2015, and April 30, 2015. The proposed rule for Framework 4 published in the
NMFS implements approved measures in Framework 4 to the Atlantic Herring Fishery Management Plan (Herring FMP) and minor corrections to existing regulations in this final rule. The Council developed Framework 4 to build on catch monitoring improvements implemented in Amendment 5 to the Herring FMP (79 FR 8786, February 13, 2014) by further enhancing catch monitoring and addressing discarding in the herring fishery. The approved measures in Framework 4 clarify the slippage definition, require limited access herring vessels to report slippage events on the daily vessel monitoring system (VMS) catch report, and establish slippage consequences. Slippage consequence measures require vessels with All Areas (Category A) or Areas 2/3 (Category B) Limited Access Herring Permits to move 15 nautical miles (27.78 km) following an allowable slippage event (
NMFS disapproved two measures recommended by the Council in Framework 4. Those measures would have required: Herring vessel fish holds to be certified and observers to collect volumetric catch estimates on herring trips as a cross-check of vessel and dealer data; and herring vessel fish holds to be empty of fish before leaving port, unless a waiver is issued by an authorized law enforcement officer. During the development of Framework 4, NMFS expressed its concern with the lack of support for these two measures in Framework 4. Specifically, NMFS commented that these measures are not likely to improve catch monitoring, but they would result in compliance and enforcement costs. Despite NMFS urging, the Council did not include sufficient support for these two measures in Framework 4. Framework 4 does not provide evidence of specific problems with catch monitoring or discarding that need to be addressed, nor does it demonstrate how these
NMFS approves the following measures because it believes they will further enhance catch monitoring and address discarding in the herring fishery.
Framework 4 maintains the existing requirements that prohibit operational discards (
Framework 4 clarifies that a slippage event due to safety, mechanical failure, or excess catch of spiny dogfish is categorized as an “allowable” slippage event and clarifies that slippage for any other reason is categorized as a “non-allowable” slippage event. The Council recommended these categories to help distinguish between slippage types and the triggers for slippage consequence measures.
Framework 4 clarifies that catch not brought on board due to gear damage would be categorized as mechanical failure and, therefore, as an allowable slippage event. Although a gear failure that results in the release of catch from a codend is often beyond the control of the vessel operator, instances of catch released due to gear damage are similar to instances of catch released due to mechanical failure. Therefore, the Council and NMFS believe that catch released due to gear damage should be categorized as mechanical failure and an allowable slippage event. As an allowable slippage event, catch not brought on board due to gear damage would be subject to a slippage consequence measure.
Framework 4 clarifies that when catch that falls out of or off of gear and is not brought on board, the event would not be categorized as a slippage event. In general, only small amounts of catch fall out or off of gear during fishing and/or when catch is being brought aboard the vessel, unlike the potential for catch loss due to mechanical failure. Therefore, the Council and NMFS believe that fish that fall out of the gear should be categorized as discarded catch, but not slippage. For these reasons, instances of catch falling out or off of gear during fishing and/or when catch is being brought aboard the vessel would not be subject to existing slippage requirements or any slippage consequence measures.
Building on the slippage restrictions established in Amendment 5, Framework 4 requires vessels to move following an allowable slippage event before resuming fishing. Specifically, vessels with Category A or B herring permits slipping catch due to safety, mechanical failure, or excess catch of spiny dogfish, are required to move at least 15 nautical miles (27.78 km) away from the slippage event location. The vessel is allowed to move 15 nautical miles (27.78 km) away in any direction, but it is prohibited from resuming fishing until it is at least 15 nautical miles (27.78 km) from the location of the allowable slippage event. Additionally, the vessel is required to remain at least 15 nautical miles (27.78 km) from the slippage event location for the duration of that fishing trip. In addition to moving and remaining at least 15 nautical miles (27.78 km) away from an allowable slippage event, vessels with Category A or B herring permits fishing with midwater trawl gear in the Groundfish Closed Areas must leave the Groundfish Closed Areas and remain outside of the Groundfish Closed Areas for the remainder of the fishing trip following an allowable slippage event.
Framework 4 also requires trip termination for non-allowable slippage events. Specifically, vessels with Category A or B herring permits, including those fishing with midwater trawl gear in the Groundfish Closed Areas, that slip catch for any reason other than safety, mechanical failure, or excess catch of spiny dogfish, are required to immediately stop fishing and return to port. After having returned to port and terminated the fishing trip, vessels are allowed to initiate another fishing trip, consistent with the existing pre-trip notification requirements (
NMFS is implementing slippage consequences for both allowable and non-allowable slippage events to further discourage slippage in the herring fishery and enhance the catch monitoring program established through Amendment 5. The herring fishery is a relatively high-volume fishery capable of catching large quantities of fish in a single tow. Therefore, even a few slippage events have the potential to substantially affect species composition data, especially extrapolations of incidental catch. Additionally, slippage is a significant concern for many stakeholders because they believe it undermines the ability to collect unbiased estimates of herring catch, as well as other species, in the herring fishery. Stakeholders expressed support for the slippage consequence measures in Framework 4 to further ensure accountability for all catch in the herring fishery.
NMFS expects the requirement for vessels to move following slippage events will provide sufficient incentive for herring vessels to minimize slippage, while still promoting safety at sea and providing opportunities to utilize the herring optimum yield (OY). The requirement for vessels to move 15 nautical miles (27.78 km) following an allowable slippage event applies uniformly to all vessels that slip catch, unlike other considered alternatives (
The Mid-Atlantic Fishery Management Council recommended these same slippage consequences for allowable and non-allowable slippage events in the Atlantic mackerel fishery as part of Framework 9 to the Atlantic Mackerel, Squid, and Butterfish FMP. Many vessels participate in both the herring and mackerel fisheries, and NMFS expects that implementing consistent slippage consequences across these fisheries will improve compliance and enforcement of slippage requirements.
Framework 4 requires vessels with limited access herring permits to report slippage events, including the reason for the slippage event, via the herring daily VMS catch report. NMFS expects that this VMS report, in combination with observer data, will help enhance the enforceability of existing slippage requirements, such as completing a released catch affidavit, as well as the slippage consequences.
This final rule also contains minor clarifications and corrections to existing regulations. NMFS implements these adjustments under the authority of section 305(d) to the Magnuson-Stevens Act, which provides that the Secretary of Commerce may promulgate regulations necessary to ensure that framework adjustments to a FMPs are carried out in accordance with the FMP and the Magnuson-Stevens Act. These adjustments, identified and described below, are necessary to clarify current regulations and do not change the intent of any regulations.
NMFS is implementing a transiting provision for herring management areas with seasonal sub-ACLs. This provision allows vessels to transit herring management areas during periods when zero percent of the sub-ACL for those areas is available for harvest, with herring harvested from other herring management areas aboard, provided gear is stowed and not available for use. NMFS overlooked this provision during rulemaking for Framework Adjustment 2 to the Herring FMP and the provision is consistent with the intent of that action and the Herring FMP. NMFS is removing regulations at § 648.80(d)(7) describing requirements for midwater trawl vessels fishing in Groundfish Closed Area I because they are redundant with regulations at § 648.202(b) describing requirements for midwater trawl vessels fishing in any of the Groundfish Closed Areas. NMFS is adding the definition of operational discards at § 648.2 and clarifying that operational discards are not permitted aboard midwater trawl vessels fishing in Groundfish Closed Areas, unless those fish have first been made available to an observer for sampling. NMFS is revising references to individual years in regulations for carryover at § 648.201 to more correctly describe the timing of carryover. Lastly, NMFS is correcting coordinates for Herring Management Area 2 at § 648.200(f)(2).
NMFS disapproved the following measures because it determined they are inconsistent with the Magnuson-Stevens Act, APA, and PRA.
Framework 4 would have required vessels with limited access herring permits to have their fish holds certified and NEFOP observers to collect volumetric estimates of total catch by measuring the volume of the fish in hold prior to offloading. Observers would have converted the volumetric estimate to a weight and submitted the estimated weight to the Greater Atlantic Region Fisheries Office (GARFO) for a cross-check of vessel trip reports (VTRs) and dealer reports. The requirement for observers to estimate the amount of catch in the fish hold was intended to enhance catch monitoring in the herring fishery by providing an independent estimate of total catch.
This measure was developed to address stakeholder concerns with NMFS's reliance on industry-reported catch data to monitor the herring fishery. Specifically, some stakeholders, including environmental organizations, the groundfish industry, and recreational fishing groups, believe that herring catch is not accurately reported by the industry and that large discrepancies exist between vessel and dealer reports. The herring industry, in general, does not believe that herring catch is being misreported but, in an effort to address stakeholder concerns, supports the requirement for observers to collect an estimate of total catch.
Framework 4 does not provide evidence of misreporting by the herring industry, but it does highlight past differences, that have since been minimized, between the amount of herring reported by vessels and dealers. In past years, discrepancies between VTRs and dealer data have been as large as 54 percent. But recently, GARFO staff has improved the process for cross-checking and resolving differences between VTRs and dealer data. Now discrepancies between VTRs and dealer data are minimal, with differences averaging 1 percent. Because discrepancies between VTRs and dealer data are now minimal, NMFS does not believe that the proposed measure requiring volumetric estimates of total catch is necessary to help resolve discrepancies between VTR and dealer data.
Vessels and dealers report catch by species. VTRs, in combination with observer data, are used in herring stock assessments, while a combination of dealer data, VTR, and VMS, and observer data are used to track catch against herring annual catch limits and catch caps in the herring fishery. The measure requiring volumetric catch estimates would have provided an estimate of total catch, but would not have differentiated catch by species. Because the volumetric estimate would not have provided catch by species, it could not have been used to replace VTRs or dealer data nor could it have been used for catch monitoring or stock assessments.
Additionally, Framework 4 cautions whether the proposed measure would be more accurate than methods currently used by vessel operators or dealers to estimate catch. The volumetric conversion proposed in Framework 4 is based on herring harvested in other parts of the world. Using a volumetric conversion assumes consistency in the size, weight, and density of the catch, but there can be substantial variability in the catch composition of the herring fishery, depending on the area and season. Additionally, the proposed 5 percent deduction from total weight to account for water in the tanks is based on industry practices, but the Council did not rigorously evaluate the amount of the deduction. For these reasons, Framework 4 explains that converting a volume of total fish to pounds based on the proposed conversion could produce less accurate catch estimates than current vessel or dealer estimates.
The measure requiring a volumetric catch estimate is unlikely to improve catch monitoring in the herring fishery because that estimate cannot be used to
For these reasons, NMFS concluded that the measure requiring fish holds to be certified and observers to collect volumetric catch estimates is inconsistent with the requirements of the Magnuson-Stevens Act, APA, and PRA. The measure is inconsistent with the APA because there is insufficient support in Framework 4 documenting the need for this measure and how this measure would address the purported need. The measure is inconsistent with the requirements of Magnuson-Stevens Act National Standard 7 and the PRA because the benefit of the volumetric catch estimate is dubious and does not outweigh the additional burden on vessel owners of certifying their fish holds and making available a measuring stick for observers. The measure is inconsistent with Magnuson-Stevens Act National Standard 2 because the quality of the volumetric catch estimate is not sufficient for monitoring the fishery, facilitating inseason management, or judging the performance of the management regime. Finally, the measure is inconsistent with Magnuson-Stevens Act National Standard 5 because it does not allow the fishery to operate at the lowest possible administrative costs relative to any additional monitoring benefit provided by the measure.
Framework 4 would have required fish holds of vessels with Category A or B Limited Access Herring Permits to be empty of fish before leaving the dock on a herring trip. A waiver may have been issued by an authorized law enforcement officer when fish have been reported as caught but cannot be sold due to the condition of fish.
The Council recommended this measure to enhance catch monitoring and discourage wasteful fishing practices in the herring fishery. Some stakeholders are concerned that vessels are harvesting more fish than they can sell and then discarding the unsold fish on subsequent fishing trips. These stakeholders are also concerned that fish not purchased by a dealer, and discarded on subsequent trips, may not be reported on the VTR. The Council intended this measure to discourage the discarding of unreported fish, provide a mechanism to document when harvested fish become unmarketable, and prevent vessel operators from mixing fish from multiple trips in the hold, potentially biasing catch data.
While prohibiting the disposal of unsold fish at sea may discourage wasteful fishing practices, there is insufficient support in the record to conclude that herring vessels are harvesting excess fish and discarding unsold fish at sea. The costs associated with a herring trip, including fuel, crew wages, and insurance, are substantial, so it is unlikely that vessel operators are making herring trips to harvest fish that will ultimately be discarded. Additionally, if discarding of unsold fish at sea is occurring, Framework 4 explains that it is unclear whether unsold catch disposed of at sea on a subsequent trip is reported.
Initially, this measure requiring empty fish holds simply required that fish holds be empty of fish at the beginning of a herring trip. But recognizing that there may be unforeseen events making it difficult to sell fish (
Part of the justification for the waiver provision is to provide a way to verify that fish have been reported and to document the extent to which vessels are departing on trips with fish in their fish holds. However, Framework 4's proposed waiver provides no way of verifying the amount of fish reported relative to the amount of fish left in the hold. Therefore, NMFS does not believe that this measure contains a viable mechanism to verify whether harvested fish that are left in the hold were reported by the vessel.
Because the measure lacks a mechanism to verify or correct the amount of fish reported on the VTR, the measure is unlikely to improve catch monitoring in the herring fishery. In contrast, the compliance and enforcement costs associated with the measure may be high. For example, vessel operators needing to dispose of fish at sea may lose time and money waiting for an authorized law enforcement officer to travel to their vessel, inspect the fish in the fish hold, and issue a waiver. Additionally, it would likely be time consuming for authorized officers to issue waivers and would divert resources from other law enforcement duties.
This measure is also intended to prevent vessel operators from mixing catch from multiple trips in the hold and biasing catch data. NEFOP observers sample the catch while it is on the deck, before it is placed in the fish hold, so there would be no chance that observers would be sampling fish from multiple trips that were mixed in the hold. The herring fishery is also sampled portside by the Massachusetts Department of Marine Fisheries (MA DMF) and Maine's Department of Marine Resources. Mixing of catch from multiple fishing trips, although unlikely, may have the potential to bias landings data used to inform herring stock assessments, state management spawning closures, and the river herring avoidance program operated by the University of Massachusetts' School of Marine Fisheries and MA DMF.
The Atlantic States Marine Fisheries Commission recently adopted a requirement that vessel fish holds be empty of fish before vessels depart on a herring trip, contingent on adoption in Federal waters, in Amendment 3 to the Interstate FMP for Atlantic Herring. Establishing a similar provision in this action would have promoted coordination between Federal and state management, but, for the reasons described above, it is unlikely to improve catch monitoring in the herring fishery.
For these reasons, NMFS concluded that the measure requiring fish holds to be empty of fish before leaving port, unless a waiver is issued by an authorized officer, is inconsistent with the requirements of the Magnuson-Stevens Act, APA, and PRA. The measure is inconsistent with the APA because there is insufficient support in Framework 4 documenting the need for this measure and how this measure would address the purported need. The measure is inconsistent with Magnuson-Stevens Act National Standard 7 and the PRA because the benefit of requiring
NMFS received four comment letters on the proposed rule. Two letters were from environmental advocacy groups (Herring Alliance and CHOIR (Coalition for the Atlantic Herring Fishery's Orderly, Informed, and Responsible Long Term Development)) and two letters were from herring industry groups (Seafreeze Ltd. and the Sustainable Fisheries Coalition).
Framework 4 maintains the existing requirements that prohibit operational discards aboard midwater trawl vessels fishing in the Groundfish Closed Areas, but allows operational discards to occur on board herring vessels fishing outside the Groundfish Closed Areas. Framework 4 clarifies that operational discards are small amounts of fish that cannot be pumped on board and remain in the codend or seine at the end of pumping operations. Current observer protocols include estimating the amount and composition of operational discards. Because the fish cannot be pumped, it can be time and labor intensive to bring these small amounts of fish on board the vessel. There is no evidence in Framework 4 to suggest that continuing to allow operational discards would increase the discarding of unsampled catch. Rather, Framework 4 concludes that the compliance costs associated with requiring herring vessels fishing outside the Groundfish Closed Areas to bring operational discards on board would likely outweigh any benefits to the catch monitoring program and the herring resource.
Framework 4 clarifies that catch that falls out of or off of gear and is not brought on board would be categorized as discarded catch, but not slippage. In general, only small amounts of catch fall out or off of gear during fishing and/or when catch is being brought aboard the vessel, unlike the potential for catch loss due to mechanical failure. It would be very difficult for vessels to retrieve the small amounts of fish that fall out of or off gear and bring those fish on board the vessel. Again, there is no evidence in Framework 4 suggesting that this measure would increase the discarding of unsampled catch and the compliance costs associated with requiring these fish be brought on board the vessel for sampling would likely outweigh any benefit to herring catch monitoring.
Seafreeze Ltd. and the Sustainable Fisheries Coalition commented that because no scientific analysis supports the requirement to move 15 nautical miles (27.78 km), the measure is inconsistent with the requirement that measures be based on the best available
Seafreeze Ltd. noted that as spiny dogfish populations continue to increase, herring fishery interactions with dogfish will also likely increase. Seafreze Ltd. also noted that vessels typically move from an area following interactions with dogfish, but they do not move as far as 15 nautical miles (27.78 km).
Seafreeze Ltd. and the Sustainable Fisheries Coalition commented that needing to slip catch for safety or mechanical failure is often beyond the control of the vessel operator. Seafreeze Ltd. also commented that requiring vessels to move 15 nautical miles (27.78 km) following allowable slippage events may pressure vessel operators to possibly engage in unsafe fishing practices to avoid a penalty. Additionally, Seafreeze Ltd. commented that penalizing a vessel for safety concerns violates National Standard 10.
Lastly, Seafreeze Ltd. commented that its bottom trawl vessels have higher observer coverage rates than other gear types participating in the herring fishery and would, therefore, be disproportionately impacted by the proposed slippage consequence measure following an allowable slippage event.
NMFS anticipates this slippage consequence measure will address concerns about bycatch and slippage by discouraging the occurrence of slippage throughout the fishery, while continuing to promote safe and efficient fishing practices on vessels participating in the herring fishery. Safety is an important consideration for all fishery management plans and Framework 4 acknowledges that slippage events due to safety concerns or mechanical failure may be beyond the control of the vessel operator. NMFS expects the requirement to move 15 nautical miles (27.78 km) following an allowable slippage event will accommodate any safety concerns because it allows vessels to continue fishing, when it is safe to do so, rather than requiring trip termination.
NMFS also expects that this slippage consequence measure will enhance the catch monitoring program established through Amendment 5 by further discouraging slippage in the herring fishery. The requirement for a vessel to move following an allowable slippage event is not based on the biology or distribution of a fish species, like the Groundfish Closed Areas, nor is it intended to rectify mechanical failures, unsafe weather conditions, or encounters with spiny dogfish. Instead, the measure was based on an analysis evaluating the distances vessels move during fishing operations and is intended to provide sufficient incentive (
Framework 4 describes the impact of this slippage consequence measure as a low negative for the herring industry. This impact is not related to safety concerns, but to the potential for lost time and money associated with moving following an allowable slippage event. Analyses in Framework 4 show that midwater trawl and purse seine vessels participating in the herring fishery have the potential to be most affected by the requirement to move following an allowable slippage event. Small mesh bottom trawl vessels are expected to be least affected by the move requirement because documented slippage events by those vessels are low.
NMFS implemented this same slippage consequence measure in the mackerel fishery as part of the measures recommended by the Mid-Atlantic Fishery Management Council in Framework 9 to the MSB FMP. Many vessels participate in both the herring and mackerel fisheries, and NMFS expects that implementing consistent slippage consequences across these fisheries will improve compliance and enforcement of slippage measures.
Vessels and dealers report catch by species. VTRs, in combination with observer data, are used in herring stock assessments, while a combination of dealer data, VTR, and VMS, and observer data are used to track catch against herring annual catch limits and catch caps in the herring fishery. The proposed measure would provide an estimate of total catch, but not catch by species. Therefore, the volumetric estimate could not be used to replace either VTRs or dealer data and it could not be used for catch monitoring or stock assessments.
Framework 4 does not provide evidence of misreporting by the herring industry, but it does highlight past differences, that have since been minimized, between the amount of herring reported by vessels and dealers. In recent years, discrepancies between VTRs and dealer data have been minimal. VTRs were higher than dealer reports in 2009 (2 percent), 2010 (1.3 percent), 2011 (1.2 percent), and 2013 (0.1 percent) and less than dealer reports in 2012 (0.1 percent). GARFO staff use a rigorous process to match vessel and dealer reported data and make corrections to the appropriate data set. Given that discrepancies between VTR and dealer data are minimal as well as investigated and resolved, NMFS does not consider the proposed volumetric catch estimate necessary to help identify or resolve discrepancies between VTR and dealer data.
NMFS disapproved the requirement for volumetric catch estimates because it considers the measure inconsistent with the Magnusson-Stevens Act, APA, and PRA.
NMFS agrees with Seafreeze Ltd. that requiring observers to collect volumetric catch estimates would increase observer workload and that discrepancies between vessel and dealer reports are minimal. As described previously, volumetric estimates could not be used to replace either VTRs or dealer data and it could not be used for catch monitoring or stock assessments. Increasing observer workload with duties that are unlikely to improve herring catch monitoring is not an effective use of NMFS resources. As described previously, NMFS does not consider the proposed volumetric catch estimate necessary to help identify or resolve the minimal discrepancies between VTR and dealer data.
Lastly, the measure, as proposed, would have required all vessels with limited access herring permits to have their fish holds certified and observers to collect volumetric catch estimates. Limiting the measure to only apply to vessels whose fish holds had already been certified would have meant substantially revising the measure. NMFS can only approve or disapprove a proposed measure; therefore, NMFS cannot revise the measure to only apply to vessels whose fish holds have already been certified.
Part of the justification for the waiver provision is to provide a way to verify that fish have been reported and document the extent to which vessels are departing on trips with fish in their fish holds. However, Framework 4's proposed waiver provides no way of verifying the amount of fish reported relative to the amount of fish left in the hold. Therefore, NMFS does not believe this measure contains a viable mechanism to verify whether harvested fish that are left in the hold were reported by the vessel and is unlikely to improve catch monitoring in the herring fishery.
NMFS disapproved the requirement for empty fish holds because it considers the measure inconsistent with the Magnusson-Stevens Act, APA, and PRA.
The proposed rule for Framework 4 contained all the measures in that were adopted by the Council in April 2014. As described previously, NMFS disapproved the measures requiring fish holds to be certified and observers to collect volumetric catch estimates, and fish holds to be empty of fish before leaving port, unless a waiver is issued by an authorized law enforcement officer. Thus, the regulatory requirements associated with those two measures are not included in this final rule. Specifically, the following sections from the proposed rule have been removed: §§ 648.4(a)(10)(iv)(P), 648.11 (m)(5), 648.14(r)(1)(ii)(D), 648.14(r)(2)(xiii), and 648.204(c) are not being implemented in this rule. Additionally, proposed § 648.11(m)(3)(ii) was revised to remove provisions related to providing an observer with a NMFS-approved measuring stick when requested.
This final rule also contains minor clarifications to the slippage definition, slippage reporting requirements, and slippage consequence measures to ensure consistency with slippage requirements for the Atlantic mackerel fishery. Specifically, the following sections have been revised: §§ 648.2, 648.11(m)(4)(C)(iv), and 648.14(r)(2)(vii), (xi), and (xii). Many vessels participate in both the herring and mackerel fisheries and NMFS expects that implementing consistent requirements across these fisheries will improve compliance and enforcement of slippage requirements. NMFS is revising the regulations under the authority of section 305(d) to the Magnuson-Stevens Act, which provides that the Secretary of Commerce may promulgate regulations necessary to ensure that framework adjustments to FMPs are carried out in accordance with the FMP and the Magnuson-Stevens Act.
The Assistant Administrator for Fisheries, NOAA, has determined that this rule is consistent with the national standards and other provisions of the Magnuson-Stevens Act and other applicable laws.
The Office of Management and Budget has determined that this rule is not significant according to Executive Order 12866.
This final rule does not contain policies with federalism or “takings” implications, as those terms are defined in E.O. 13132 and E.O. 12630, respectively.
NMFS, pursuant to section 604 of the Regulatory Flexibility Act (RFA), has completed a final regulatory flexibility analysis (FRFA) in support of Framework 4 in this final rule. The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, NMFS responses to those comments, a summary of the analyses completed in the Framework 4 EA, and this portion of the preamble. A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in Framework 4 and in the preamble to the proposed and this final rule, and is not repeated here. All of the documents that constitute the FRFA are available from NMFS and a copy of the IRFA, the RIR, and the EA are available upon request (see
NMFS received four comment letters on the proposed rule. Those comments, and NMFS' responses, are contained in the Comments and Responses section of this final rule and are not repeated here. None of the comments addressed the IRFA and NMFS did not make any changes in the final rule based on public comment.
This action regulates the activity of vessels with limited access herring permits and vessels with Category A or B limited access herring permits. Therefore, the regulated entity is the business that owns at least one limited access herring permit.
In 2013, the most recent full year of fishery permit data, 93 fishing vessels were issued a limited access herring permit. Vessels and/or permits may be owned by entities affiliated by stock ownership, common management, identity of interest, contractual relationships, or economic dependency. For the purposes of this analysis, ownership entities are defined as those entities with common ownership personnel as listed on permit application documentation. Only
Based on this ownership criterion, NMFS dealer data for recent years (2010-2013), and the size standards for finfish and shellfish firms, there are 68 regulated fishing firms with a limited access herring permit. Of those 68 firms, there are 61 small entities and 7 large entities. Not all of these permitted firms are active: Only 32 small entities and 5 large entities were actively fishing for herring during the last 3 years. Additionally, there are 32 regulated fishing firms that hold Category A or B herring permits. Of those 32 firms, there are 27 small entities and 5 large entities. Not all of these permitted firms are active: Only 19 small entities and 5 large entities holding Category A or B herring permits were actively fishing for herring during the last 3 years.
This final rule contains collection-of-information requirements subject to the PRA that have been approved by the OMB under Control Number 0648-0202.
This action requires all limited access vessels to report slippage events via the daily VMS herring catch report. This information is intended to improve catch monitoring in the herring fishery. All limited access herring vessels are currently required to submit daily VMS catch reports, therefore, reporting slippage via VMS is not expected to cause any additional time or cost burden above that which was previously approved under OMB Control Number 0648-0202. Time burdens that were previously approved through OMB Control Number 0648-0202 include an estimated burden of 5 minutes to complete daily catch reports, with an additional 2 minutes if the vessel is also reporting all fish kept, and a total burden of 429 hours. Cost burdens that were previously approved through OMB Control Number 0648-0202 include an estimated burden of $0.60 per transmission of daily catch reports and a total burden of $2,323. In a given fishing year, NMFS estimates that the additional reporting requirements included in Framework 4 will not cause any additional time or cost burden from that which was previously approved. Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see
Notwithstanding any other provisions of the law, no person is required to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at:
NMFS disapproved two measures in Framework 4 because it determined the measures were inconsistent with the Magnuson-Stevens Act, APA, and PRA.
One of the disapproved measures in Framework 4 would have required owners of vessels with limited access herring permits to certify the capacity of their fish holds and purchase and carry a NMFS-approved measuring stick to estimate the volume of fish in the fish hold. Each fish hold certification done by a certified marine surveyor is estimated to cost $300-$400. The cost of the NMFS-approved measuring stick is unknown at this time, but expected to be minimal. Ninety-three vessels were issued a limited access herring permit in 2013. Therefore, an estimated 93 vessels would have been required to submit a fish hold certification at the time of permit issuance in 2016 and obtain and carry on board a NMFS-approved measuring stick. By disapproving this measure, vessel owners will not incur the costs associated with this measure.
The other disapproved measure in Framework 4 would have required vessels with Category A or B herring permits to have fish holds empty of fish prior to departing on a herring trip. A waiver may have been issued by an authorized law enforcement officer when fish had been reported as caught but could not be sold due to condition. Forty-three vessels were issued a Category A or B herring permit in 2013. Therefore, an estimated 43 vessels would have been required to obtain a waiver from an authorized officer prior to leaving the dock on a herring trip with fish in the hold. The burden to the vessel operator/owner associated with obtaining a waiver would be any loss of time and/or money waiting for an authorized officer to travel to their vessel, inspect the fish hold, and issue a waiver. By disapproving this measure, vessel owners will not incur the burden associated with this measure.
NMFS is implementing slippage consequence measures for vessels with Category A and B herring permits in this rule, including requirements to move 15 nautical miles (27.78 km) following an allowable slippage event and terminate a trip following a non-allowable slippage event. Because non-allowable slippage events are already prohibited in the herring fishery, NMFS expects that instances of vessels terminating a trip and returning to port following a non-allowable slippage event will be rare. Therefore, the requirement to terminate a trip following a non-allowable slippage event will not have a significant economic impact on vessels with Category A and B herring permits. NMFS also expects that the requirement to move 15 nautical miles (27.78 km) following an allowable slippage event will also not have a significant economic impact on Category A and B vessels. The measure is based on an analysis evaluating the distances vessels move during fishing operations and is intended to provide sufficient incentive (
This rule also implements clarifications and minor corrections to existing regulations. These clarifications and minor corrections are intended to clarify existing slippage measures; allow vessels to transit herring management areas during periods when zero percent of the sub-ACL for those areas is available for harvest, provided gear was stowed and not available for use; and correcting coordinates for Herring
Fisheries, Fishing, Recordkeeping and reporting requirements.
For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:
16 U.S.C. 1801
(m) * * *
(4)
(A) The vessel operator has determined, and the preponderance of available evidence indicates that, there is a compelling safety reason; or
(B) A mechanical failure, including gear damage, precludes bringing some or all of the catch on board the vessel for inspection; or,
(C) The vessel operator determines that pumping becomes impossible as a result of spiny dogfish clogging the pump intake. The vessel operator shall take reasonable measures, such as strapping and splitting the net, to remove all fish which can be pumped from the net prior to release.
(ii) Vessels may make test tows without pumping catch on board if the net is re-set without releasing its contents provided that all catch from test tows is available to the observer to sample when the next tow is brought on board for sampling.
(iii) If a vessel issued any limited access herring permit slips catch, the vessel operator must report the slippage event on the Atlantic herring daily VMS catch report and indicate the reason for slipping catch. Additionally, the vessel operator must complete and sign a Released Catch Affidavit detailing: The vessel name and permit number; the VTR serial number; where, when, and the reason for slipping catch; the estimated weight of each species brought on board or slipped on that tow. A completed affidavit must be submitted to NMFS within 48 hr of the end of the trip.
(iv) If a vessel issued an All Areas or Areas 2/3 Limited Access Herring permit slips catch for any of the reasons described in paragraph (m)(4)(i) of this section, the vessel operator must move at least 15 nm (27.78 km) from the location of the slippage event before deploying any gear again, and must stay at least 15 nm (27.78 km) away from the slippage event location for the remainder of the fishing trip.
(v) If catch is slipped by a vessel issued an All Areas or Areas 2/3 Limited Access Herring permit for any reason not described in paragraph (m)(4)(i) of this section, the vessel operator must immediately terminate the trip and return to port. No fishing activity may occur during the return to port.
(r) * * *
(1) * * *
(vii) * * *
(F) Transit or be in an area that has zero percent sub-ACL available for harvest specified at § 648.201(d) with herring on board, unless such herring were caught in an area or areas with an available sub-ACL specified at § 648.201(d), all fishing gear is stowed and not available for immediate use as defined in § 648.2, and the vessel is issued a vessel permit that authorizes the amount of herring on board for the area where the herring was harvested.
(2) * * *
(v) Fish with midwater trawl gear in any Northeast Multispecies Closed Area, as defined in § 648.81(a) through (e), without a NMFS-approved observer on board, if the vessel has been issued an Atlantic herring permit.
(vi) Slip or operationally discard catch, as defined at § 648.2, unless for one of the reasons specified at § 648.202(b)(2), if fishing any part of a tow inside the Northeast Multispecies Closed Areas, as defined at § 648.81(a) through (e).
(vii) Fail to immediately leave the Northeast Multispecies Closed Areas or comply with reporting requirements after slipping catch or operationally discarding catch, as required by § 648.202(b)(4).
(viii) Slip catch, as defined at § 648.2, unless for one the reasons specified at § 648.11(m)(4)(i).
(ix) For vessels with All Areas or Areas 2/3 Limited Access Herring Permits, fail to move 15 nm (27.78 km), as required by § 648.11(m)(4)(iv) and § 648.202(b)(4)(iv).
(x) For vessels with All Areas or Areas 2/3 Limited Access Herring Permits, fail to immediately return to port, as required by § 648.11(m)(4)(v) and § 648.202(b)(4)(iv).
(xi) Fail to complete, sign, and submit a Released Catch Affidavit as required by § 648.11(m)(4)(iii) and § 648.202(b)(4)(ii).
(xii) Fail to report or fail to accurately report a slippage event on the Atlantic
(f) * * *
(2)
(e) A vessel may transit an area that has zero percent sub-ACL available for harvest specified in paragraph (d) of this section with herring on board, provided such herring were caught in an area or areas with sub-ACL available specified in paragraph (d) of this section, that all fishing gear is stowed and not available for immediate use as defined in § 648.2, and the vessel is issued a permit that authorizes the amount of herring on board for the area where the herring was harvested.
(f) Up to 500 mt of the Area 1A sub-ACL shall be allocated for the fixed gear fisheries in Area 1A (weirs and stop seines) that occur west of 67°16.8′ W. long (Cutler, Maine). This set-aside shall be available for harvest by fixed gear within the specified area until November 1 of each fishing year. Any portion of this allocation that has not been utilized by November 1 shall be restored to the sub-ACL allocation for Area 1A.
(g)
8. In § 648.202, paragraphs (b)(2) introductory text, (b)(2)(ii), (b)(4) introductory text, and (b)(4)(ii) are revised, and paragraphs (b)(4)(iii) and (iv) are added to read as follows:
(b) * * *
(2) No vessel issued an Atlantic herring permit and fishing with midwater trawl gear, when fishing any part of a midwater trawl tow in the Closed Areas, may slip or operationally discard catch, as defined at § 648.2, except in the following circumstances:
(ii) A mechanical failure, including gear damage, precludes bringing some or all of the catch on board the vessel for inspection; or,
(4) If catch is slipped or operational discarded by a vessel, the vessel operator must:
(ii) Complete and sign a Released Catch Affidavit detailing: The vessel name and permit number; the VTR serial number; where, when, and for what reason the catch was released; the estimated weight of each species brought on board or released on that tow. A completed affidavit must be submitted to NMFS within 48 hr of the end of the trip.
(iii) Report slippage events on the Atlantic herring daily VMS catch report and indicate the reason for slipping catch if the vessel was issued a limited access herring permit.
(iv) Comply with the measures to address slippage specified in § 648.11(m)(4)(iv) and (v) if the vessel was issued an All Areas or Areas 2/3 Limited Access Herring Permit.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues regulations to implement Comprehensive Ecosystem-Based Amendment 1 (CEBA 1), which includes amendments to the Pacific Fishery Management Council's (Council's) four fishery management plans (FMPs): the Coastal Pelagic Species (CPS) FMP, the Pacific Coast Groundfish FMP, the FMP for U.S. West Coast Highly Migratory Species (HMS), and the Pacific Coast Salmon FMP. CEBA 1 amended the Council's FMPs to bring new ecosystem component species (collectively, “Shared EC Species”) into each of those FMPs, and prohibits directed commercial fisheries for Shared EC Species within the U.S. West Coast Exclusive Economic Zone (EEZ). This final rule defines and prohibits directed commercial fishing for Shared EC Species, and prohibits, with limited exceptions, at-sea processing of Shared EC Species.
Effective May 4, 2016.
Electronic copies of CEBA 1 may be obtained from the Council Web site at
Yvonne deReynier, 206-526-6129,
NMFS published a notice of availability of CEBA 1 in the
CEBA 1, through its implementing FMP amendments and regulations, prohibits the development of fisheries for a suite of ecosystem component species (collectively, “Shared EC Species”) within the U.S. West Coast EEZ until the Council has had an adequate opportunity to both assess the scientific information relating to any proposed directed fishery and consider potential impacts to existing fisheries, fishing communities, and the greater marine ecosystem. CEBA 1 includes these FMP amendments: Amendment 15 to the CPS FMP, Amendment 25 to the Pacific Coast Groundfish FMP, Amendment 3 to the FMP for U.S. West Coast HMS, and Amendment 19 to the Pacific Coast Salmon FMP. CEBA 1 adds the following species as Shared EC Species to each of the four West Coast FMPs: round herring (
This final rule revises 50 CFR 660.1(a) to clarify that the regulations in Part 660 of Title 50 of the Code of Federal Regulations are not limited to fishing for management unit species, but are applicable generally to vessels fishing within the U.S. West Coast EEZ. This rule also adds new regulations at 50 CFR part 660, subpart B, that: 1) identify Shared EC Species as including the unfished forage species listed earlier in the preamble to this rule; 2) define what is meant by “directed commercial fishing” for Shared EC Species within the U.S. West Coast EEZ; 3) prohibit directed commercial fishing for Shared EC Species; and 4) prohibit at-sea processing of Shared EC Species, except while otherwise lawfully processing groundfish in accordance with 50 CFR part 600, subpart D. This action is needed to proactively protect unmanaged, unfished forage fish of the U.S. West Coast EEZ, in recognition of the importance of these forage fish to the species managed under the Council's FMPs and to the larger California Current Ecosystem. Shared EC Species have not historically been targeted or processed in EEZ fisheries, and the limits provided in this final rule are intended to recognize that low levels of incidental catch of Shared EC Species may continue to occur. This action does not supersede tribal or state fishery management for these species.
NMFS received 63 letters and emails supporting the finalization of CEBA 1 and its implementing regulations during the public comment period. Within the letters of support, NMFS received a letter from the U.S. Department of the Interior requesting clarification on whether essential fish habitat (EFH) would be defined for Shared EC Species. Several letters from environmental organizations included petitions supporting the action, with signatures or comments from 91,966 people supporting the action. Two of the letters of support were received from organizations of fishermen and vessel owners asking for clarifications of or revisions to the regulations language. In addition to the letters and emails supporting the action, NMFS also received a letter from an organization of fishermen and vessel owners recommending clarifications to the final rule. NMFS appreciates the broad public interest in this rulemaking and has taken the strong public support it received during the comment period into account in its approval of this final rule. Comments requesting clarification on regulatory issues, or suggesting revisions to regulatory language implementing this action are summarized below, with NMFS's responses to those comments.
In the analysis that NMFS conducted to review potential limits for allowable incidental landings levels of Shared EC Species, NMFS noted that the highest daily landing level for the 2005-2014 period of groups of species that were predominantly Shared EC Species, but which could also have included Humboldt squid, was 52 mt. NMFS also noted that a daily incidental landing level of 10 mt would account for 99 percent of all historic daily landings levels. For annual total landings of species groups that were predominantly Shared EC Species, but which could also have included Humboldt squid, the highest historic annual landing level was 225 mt, while an annual limit of 30 mt would account for 97 percent of all historic annual landings levels. Between approximately 2006 and 2010 and peaking in 2008, the waters off the U.S. West Coast were inundated with large schools of Humboldt squid, which is not a Shared EC Species. Due to the somewhat surprising nature of this mass squid migration and population explosion, West Coast fisheries data collection programs were not initially equipped to separately identify Humboldt squid from other squid species on fish landings tickets. For these regulations, the Council recommended a Shared EC Species daily incidental landing limit of 10 mt and an annual cumulative landing limit of 30 mt, knowing that historic landings at those levels could possibly have included some Humboldt squid, also known as “jumbo” squid for its large size. NMFS believes that the limits recommended by the Council, provided in the proposed rule for this action, and finalized with this final rule, strike an appropriate balance between being high enough to account for unique historic incidental catch of Shared EC Species, without being so high as to allow or encourage targeting of those species. The NMFS analysis of historic West Coast landings of Shared EC Species, including discussions explaining the constraints of the fisheries landings data, is available on the Council's Web site for its September 2015 meeting:
The Council can schedule a review of these regulations and their effects at any time. Regulations at 50 CFR part 660 govern the actions of fishermen, fishing vessel owners, and fisheries participants operating in the U.S. West Coast EEZ. The scope of this action did not include the activities of the Council itself, and therefore this final rule does not include any provisions governing the actions of the Council.
There are no changes to the regulatory text from the proposed rule, except for a minor and non-substantive grammatical correction to 50 CFR 660.1(a), changing the word “of” to “by,” when referring to fishing activity by vessels of the United States.
The Administrator, West Coast Region, NMFS, determined that the FMP amendments implementing CEBA 1 are necessary for conservation and management of West Coast fisheries, and that they are consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
A final regulatory flexibility analysis (FRFA) was prepared pursuant to 5 U.S.C. 604(a), and incorporates the Initial Regulatory Flexibility Analysis (IRFA), and NMFS's responses to comments received on the IRFA, if any. NMFS did not receive any comments from the public on the IRFA for this action. The preamble to the proposed rule for this action included a detailed summary of the analyses contained in IRFA, and that discussion is not repeated here.
This rule prohibits new directed commercial fishing in Federal waters on unmanaged, unfished forage fish species until the Council has had an adequate opportunity to both assess the scientific information relating to any proposed directed fishery and consider potential impacts to existing fisheries, fishing communities, and the greater marine ecosystem. This action is needed to proactively protect unmanaged, unfished forage fish of the U.S. West Coast EEZ in recognition of the importance of these forage fish to the species managed under the Council's FMPs and to the larger CCE. This action is not intended to supersede tribal or state fishery management for these species, and coordination would still occur through the existing Council process. CEBA 1 brings new ecosystem component species into each of the Council's four FMPs through amendments to those FMPs, and protects those species by prohibiting the future development of new directed commercial fisheries for Shared EC Species within the U.S. West Coast EEZ. No existing fisheries will be eliminated by this action. Under this rulemaking, existing levels of incidental catch of Shared EC Species in current fisheries will be allowed to continue into the future.
No public comments were received by NMFS in response to the IRFA or the economic analyses summarized in the IRFA, and no changes were required to be made as a result of the public comments. A summary of the comments received, and our responses, can be found above in the “Comments and Responses” section of this rule's preamble.
The Small Business Administration did not provide any comments on the proposed rule for this action.
This rule will have no direct impact on any small entities.
This action does not contain any Federal reporting, record keeping, or any other compliance requirements for either small or large entities.
Alternative 2, the selected alternative for this rule, accomplishes the stated objectives of applicable statutes without any significant economic impact on small entities. Alternative 1, the no-action alternative, also would not have had any direct economic impact on small entities, but did not accomplish the state objectives of applicable statutes. Alternative 3 was expected to have moderate, indirect and negative effects on coastal pelagic species, shrimp, bottom trawl, and whiting fisheries and fishery management practices and was thus rejected in favor of the selected alternative in order to minimize economic impact on small entities consistent with the stated objectives of applicable statutes. A copy of this analysis is available from NMFS (see
This final rule was developed after meaningful collaboration, through the Council process, with the tribal representative on the Council. NMFS is not aware of any Treaty Indian tribe or subsistence fisheries in the EEZ other than those listed in 50 CFR 600.725(v). This action does not supersede or otherwise affect exemptions that exist for Treaty Indian fisheries.
Administrative practice and procedure, Fisheries, Fishing.
For the reasons set out in the preamble, 50 CFR part 660 is amended as follows:
16 U.S.C. 1801
(a) The regulations in this part govern fishing activity by vessels of the United States that fish or support fishing inside the outer boundary of the EEZ off the states of Washington, Oregon, and California.
(a)
(1) Round herring (
(2) Mesopelagic fishes of the families
(3) Pacific sand lance (
(4) Pacific saury (
(5) Silversides (family
(6) Smelts of the family
(7) Pelagic squids (families:
(b)
(1) 10 mt combined weight of all Shared EC Species from any fishing trip; or
(2) 30 mt combined weight of all Shared EC Species in any calendar year.
In addition to the general prohibitions specified in § 600.725 of this chapter, and the other prohibitions specified in this part, it is unlawful for any person to:
(a)
(1) Fishing authorized by the Hoh, Makah, or Quileute Indian Tribes, or by the Quinault Indian Nation, or
(2) Fishing trips conducted entirely within state marine waters.
(b)
(d) * * *
(16) Retain and process more than 1 mt of Shared EC Species other than squid species in any calendar year; or, retain and process more than 40 mt of any Shared EC squid species in any calendar year.
(e) * * *
(10) Retain and process more than 1 mt of Shared EC Species other than squid species in any calendar year; or, retain and process more than 40 mt of any Shared EC squid species in any calendar year.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; modification of closure.
NMFS is opening directed fishing for northern rockfish in the Bering Sea and Aleutian Islands Management Area (BSAI). This action is necessary to fully use the 2016 total allowable catch (TAC) of northern rockfish in the BSAI.
Effective 1200 hrs, Alaska local time (A.l.t.), March 30, 2016, through 2400 hrs, A.l.t., December 31, 2016. Comments must be received at the following address no later than 4:30 p.m., A.l.t., April 19, 2016.
You may submit comments on this document, identified by
•
•
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
Pursuant to the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016), NMFS closed the directed fishery for northern rockfish under § 679.20(d)(1)(iii).
As of March 28, 2016, NMFS has determined that approximately 3,200 metric tons of northern rockfish initial TAC remains unharvested in the BSAI. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully utilize the 2016 TAC of northern rockfish in the BSAI, NMFS is terminating the previous closure and is opening directed fishing for northern rockfish in the BSAI. This will enhance the socioeconomic well-being of harvesters in this area. The Administrator, Alaska Region (Regional Administrator) considered the following factors in reaching this decision: (1) The current catch of northern rockfish in the BSAI and, (2) the harvest capacity and stated intent on future harvesting patterns of vessels in participating in this fishery.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) and § 679.25(c)(1)(ii) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of northern rockfish in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent,
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
Without this inseason adjustment, NMFS could not allow the fishery for northern rockfish in the BSAI to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until April 19, 2016.
This action is required by §§ 679.20 and 679.25 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2016 Pacific cod total allowable catch apportioned to vessels using pot gear in the Central Regulatory Area of the GOA.
Effective 1200 hours, Alaska local time (A.l.t.), March 31, 2016, through 1200 hours, A.l.t., June 10, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.
The A season allowance of the 2016 Pacific cod total allowable catch (TAC) apportioned to vessels using pot gear in the Central Regulatory Area of the GOA is 8,028 metric tons (mt), as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016) and reallocation (81 FR 15650, March 24, 2016).
In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2016 Pacific cod TAC apportioned to vessels using pot gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 8,018 mt and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of Pacific cod for vessels using pot gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 29, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend the regulations to allow the importation of fresh cherimoya fruit from Chile into the continental United States, provided that fruit is produced in accordance with a systems approach, as an alternative to the currently required treatment. Commercial consignments of fresh cherimoya fruit are currently authorized entry into all ports of the United States from Chile subject to a mandatory soapy water and wax treatment. The proposed systems approach would include requirements for production site registration, low pest prevalence area certification, post-harvest processing, and fruit cutting and inspection at the packinghouse. The fruit would also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization of Chile with an additional declaration stating that the consignment was produced in accordance with the regulations. Fresh cherimoya fruit that does not meet the conditions of the systems approach would continue to be allowed to be imported into the United States subject to treatment. This action would allow for the importation of fresh cherimoya fruit from Chile while continuing to provide protection against the introduction of plant pests into the continental United States.
We will consider all comments that we receive on or before June 3, 2016.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Ms. Claudia Ferguson, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, Imports, Regulations, and Manuals, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2352.
Under the regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-74, referred to below as the regulations or the fruits and vegetables regulations), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.
Pursuant to 7 CFR 319.56-4(a), fresh cherimoya (
The national plant protection organization (NPPO) of Chile has requested that APHIS amend the regulations in order to allow fresh cherimoya fruit that has been produced in accordance with an approved systems approach to be imported into the continental United States as an alternative option to the currently approved treatment.
As part of our evaluation of Chile's request, we prepared a pest risk assessment (PRA), “Importation of Fresh Cherimoya (
The PRA identifies the false red mite as the one quarantine pest that could be introduced into the United States in consignments of fresh cherimoya fruit from Chile. A quarantine pest is defined in § 319.56-2 as “a pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled.” In the PRA, the likelihood and consequences of introducing this pest to the United States are considered, and the false red mite is rated as having a medium pest risk potential. Pests receiving a rating within the medium range may necessitate specific phytosanitary measures in addition to standard port-of-entry inspection of the commodity being imported into the continental United States.
We also prepared a commodity import evaluation document (CIED) to determine what phytosanitary measures should be applied to mitigate the pest risk associated with the importation of fresh cherimoya fruit from Chile into the continental United States. Copies of the PRA and CIED may be obtained from the person listed under
In the CIED, entitled, “Importation of Fresh Cherimoya (
Based on the findings of the CIED and the PRA, we are proposing to add the systems approach to the regulations in a new § 319.56-75.
Only commercial consignments of fresh cherimoya fruit from Chile would be allowed to be imported into the continental United States. Produce grown commercially is less likely to be infested with plant pests than noncommercial consignments. Noncommercial consignments are more prone to infestations because the commodity is often ripe to overripe, could be of a variety with unknown susceptibility to pests, and is often grown with little or no pest control. Commercial consignments, as defined in § 319.56-2, are consignments that an inspector identifies as having been imported for sale and distribution. Such identification is based on a variety of indicators, including, but not limited to: Quantity of produce, type of packing, identification of grower or packinghouse on the packaging, and documents consigning the fruits or vegetables to a wholesaler or retailer.
Under this proposed rule, the production site where the fruit is grown would be required to be registered with the NPPO of Chile. The official registration number of the production site would be marked on all field cartons and containers of harvested fresh cherimoya fruit. Production sites would be required to renew their registration annually.
Registration of production sites with the NPPO of Chile and marking of field cartons or containers with the registration numbers would allow traceback to the production site if pest problems were found on fruit shipped to the United States. Problem production sites could then be suspended until further mitigation measures were taken to address the pest populations.
Between 1 and 30 days prior to harvest, random samples of leaves would have to be collected from each registered production site under the direction of the NPPO of Chile. These samples would have to undergo a pest detection and evaluation method as follows: The leaves would have to be washed using a flushing method, placed in a 20-mesh sieve on top of a 200-mesh sieve, sprinkled with a liquid soap and water solution, washed with water at high pressure, and washed with water at low pressure. The process would then be repeated. The contents of the 200-mesh sieve would then be placed on a petri dish and analyzed for the presence of live false red mites. If a single live false red mite were found, the production site would not qualify for certification as a low-prevalence production site and would only be eligible to export fruit to the continental United States if the fruit is subsequently treated with an APHIS-approved quarantine treatment in Chile. Each production site would have only one opportunity per season to qualify as a low-prevalence production site, and certification of low prevalence would be valid for one harvest season only. The NPPO of Chile would be required to present a list of certified production sites to APHIS.
Production site low-prevalence certification would identify problem production sites and prevent the shipment of fruit with false red mites from such sites. This mite sampling method has been tested in Chile and found to be successful in identifying grape, citrus, baby kiwi, and pomegranate production areas with high and low populations of mites.
After harvest, all damaged or diseased fruits would have to be culled at the packinghouse, and the remaining fruit would have to be packed into new, clean boxes, crates, or other APHIS-approved packing containers.
Post-harvest processing procedures, such as culling damaged fruit and sampling for mites, would remove fruit that could contain pests from consignments being shipped to the United States. Culling is a standard procedure to remove fruit that may contain pests or otherwise be of poor quality.
The fruit would have to be inspected in Chile at an APHIS-approved inspection site under the direction of APHIS inspectors in coordination with the NPPO of Chile following any post-harvest processing. In order to be eligible for shipment to the continental United States, the fruit in the consignment would have to pass inspection by meeting the following requirements:
• Fruit presented for inspection would have to be identified in the shipping documents accompanying each lot of fruit to specify the production site(s) where the fruit was produced and the packing shed(s) where the fruit was processed. This identification would have to be maintained until the fruit is released for entry into the United States.
• A biometric sample would have to be drawn from each consignment and examined for false red mite. If a single live false red mite were found during the inspection process, the certified low-prevalence production site where the fruit was grown would lose its certification for the remainder of the harvest season. Rejected consignments of fruit would still be eligible for export to all ports of the United States only after application of an APHIS-approved quarantine treatment in Chile as long as the fruit is imported in commercial consignments only and accompanied by documentation to validate foreign site preclearance inspection after the required treatment is completed.
The proposed requirements for the identification in shipping documents of the fresh cherimoya fruit to their production sites and packing sheds would aid in traceback if pests were discovered. The proposed requirements for visual inspection and biometric sampling of the fruit would provide additional layers of protection against the possibility of fresh cherimoya fruit infested with quarantine pests being shipped from Chile to the United States. These methods have proved effective when employed to inspect consignments of citrus, baby kiwi, and pomegranates from Chile.
Each consignment of fruit would have to be accompanied by a phytosanitary certificate issued by the NPPO of Chile that contains an additional declaration stating that the fruit in the consignment was inspected and found free of false red mite based on field and packinghouse inspections and was
Requiring a phytosanitary certificate would ensure that the NPPO of Chile has inspected the fruit and certified that the fruit meets the conditions in the section for export to the United States.
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under
APHIS is proposing to allow the importation of fresh cherimoya fruit from Chile into the continental United States under a systems approach, in response to a January 2013 request from Chile's NPPO. This proposed rule provides the public with the opportunity to comment on APHIS' PRA and CIED that are the basis for this action. Currently, commercial consignments of fresh cherimoya are allowed into all of the United States subject to mandatory soapy water and wax treatment for
Over 80 percent of Chile's cherimoya exports are to the United States. APHIS welcomes information regarding cherimoya production within the United States. Regardless of the number of U.S. producers or their size, any impact of this proposed rule would be minor because the volume of cherimoya imported from Chile is not expected to change significantly.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.
This proposed rule would allow fresh cherimoya fruit to be imported into the continental United States from Chile under a systems approach. If this proposed rule is adopted, State and local laws and regulations regarding fresh cherimoya fruit imported under this rule would be preempted while the fruit is in foreign commerce. Fresh fruits are generally imported for immediate distribution and sale to the consuming public and would remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. If this proposed rule is adopted, no retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
We are proposing to amend the regulations to allow the importation of fresh cherimoya fruit from Chile into the continental United States, provided that fruit is produced in accordance with a systems approach, as an alternative to the currently required treatment. Commercial consignments of fresh cherimoya fruit are currently authorized entry into all ports of the United States from Chile subject to a mandatory soapy water and wax treatment.
The proposed systems approach would include requirements for production site registration, low pest prevalence area certification, post-harvest processing, and fruit cutting and inspection at the packinghouse. The fruit would also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the NPPO of Chile with an additional declaration stating that the consignment was produced in accordance with the regulations. Fresh cherimoya fruit that does not meet the conditions of the systems approach would continue to be allowed to be imported into the United States subject to treatment. This action would allow for the importation of fresh cherimoya fruit from Chile while continuing to provide protection against the introduction of plant pests into the continental United States.
Implementing this rule will require pre-clearance documentation, production site registration with low-prevalence level certification option, inspections, box markings, and phytosanitary certificates.
We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology;
Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
The Animal and Plant Health Inspection Service is committed to compliance with the EGovernment Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms.
Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Rice, Vegetables.
Accordingly, we propose to amend 7 CFR part 319 as follows:
7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Fresh cherimoya (
(a)
(b) The risks presented by
(1) The fresh cherimoya fruit are subject to treatment and certification consisting of:
(i) A soapy water and wax treatment.
(ii) Each consignment of fresh cherimoya fruit must be accompanied by documentation to validate foreign site preclearance inspection after soapy water and wax treatment completed in Chile; or
(2) The fresh cherimoya fruit are subject to a systems approach consisting of the following:
(i)
(ii)
(iii)
(iv)
(A) Fruit presented for inspection must be identified in the shipping documents accompanying each lot of fruit to specify the production site or sites in which the fruit was produced and the packing shed or sheds in which the fruit was processed. This identification must be maintained until the fruit is released for entry into the United States.
(B) A biometric sample of the boxes, crates, or other APHIS-approved packing containers from each consignment will be selected by the NPPO of Chile, and the fruit from these boxes, crates, or other APHIS-approved packing containers will be visually inspected for quarantine pests. If a single live
(v)
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend the fruits and vegetables regulations to list lemon (
We will consider all comments that we receive on or before June 3, 2016.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Mr. George Balady, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, Plant Health Programs, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 851-2240.
Under the regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-74, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.
The regulations in § 319.56-4(a) provide that fruits and vegetables that can be imported using one or more of the designated phytosanitary measures in § 319.56-4(b) to mitigate risk will be listed, along with the applicable requirements for their importation, on the Internet (currently in the Fruits and Vegetables Import Requirements [FAVIR] database at
The regulations in § 319.56-4(a) also provide that commodities that require phytosanitary measures other than those measures cited in § 319.56-4(b) may only be imported in accordance with applicable requirements in § 319.56-3 and commodity-specific requirements contained elsewhere in the subpart. Under those provisions, other citrus fruits, including clementines (
In this document, we are proposing to amend § 319.56-38 to include lemons that are currently enterable into the United States subject to treatment, thereby making the lemons eligible for importation under the same systems approach as other citrus from Chile.
Our review of the information supporting the safe importation into the United States of citrus from Chile under the listed phytosanitary measures is examined in a commodity import evaluation document (CIED) titled “Importation of Fresh Lemons (
In June 2010, APHIS recognized all of Chile as a pest-free area with respect to
Based on the findings of our CIED, we are proposing to allow the importation of fresh lemons from Chile into the United States subject to the same systems approach in place for other citrus from Chile. Under a systems approach, a set of phytosanitary conditions, at least two of which have an independent effect in mitigating the pest risk associated with the movement of commodities, is specified, whereby fruits and vegetables may be imported into the United States from countries that are not free of certain plant pests. The systems approach for lemons from Chile would require the fruit to be grown in a place of production that is registered with the national plant protection organization (NPPO) of Chile. The fruit would have to undergo pre-harvest sampling at the registered production site under the direction of the NPPO of Chile. The NPPO of Chile would present a list of production sites certified as having a low prevalence of
The production site where the lemons are grown would have to be registered with the NPPO of Chile. To register, the production site must provide the NPPO of Chile with the following information: Production site name, grower name, municipality, province, region, area planted to each species, number of plants/hectares/species, and approximate date of harvest. Registration would have to be renewed annually.
Registration of production sites is required to manage production site requirements and to control access to
Between 1 and 30 days prior to harvest, random samples of fruit would have to be collected from each registered production site under the direction of the NPPO of Chile. These samples would have to undergo a pest detection and evaluation method as follows: The fruit would have to be washed using a flushing method, placed in a 20-mesh sieve on top of a 200-mesh sieve, sprinkled with a liquid soap and water solution, washed with water at high pressure, and washed with water at low pressure. The washing process would then be repeated immediately after the first washing. The contents of the 200-mesh sieve would then be placed on a petri dish and analyzed for the presence of live
After harvest and before packing, the fruit would have to be washed, rinsed in a potable water bath, washed with detergent with brushing using bristle rollers, rinsed with a hot water shower with brushing using bristle rollers, predried at room temperature, waxed, and dried with hot air. These mitigations aid in removing any pests from the fruit.
The fruit would have to be inspected in Chile at an APHIS-approved inspection site under the direction of APHIS inspectors in coordination with the NPPO of Chile following any post-harvest processing. A biometric sample would be drawn from each consignment, which may represent multiple grower lots from different packing sheds. Consignments with mites will be rejected from the systems approach. Rejected lots may still be exported to the United States but would require fumigation with methyl bromide either in Chile or at the port of first arrival in the United States in accordance with § 305.5 of the regulations.
Each consignment of fruit would have to be accompanied by a phytosanitary certificate issued by the NPPO of Chile that contains an additional declaration stating that the lemons in the consignment meet the conditions of the systems approach and are free of
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under
The Government of Chile submitted a market access request for lemon fruit to be approved for import into the continental United States using a systems approach as an alternative to methyl bromide fumigation, to mitigate the risk of introduction of the Chilean false red mite.
The United States is a net exporter of fresh lemon; over 5 seasons (2009/10-2013/14), annual exports averaged about 102,410 metric tons (MT) (19 percent of production), compared to annual imports that averaged about 46,270 MT. Based on the Small Business Administration small-entity standards, the majority of entities that comprise industries that may be affected by this rule are small. These entities include lemon producers, packers, wholesalers, retailers, and importers.
Chile supplies about one-third of U.S. fresh lemon imports. Chile's Ministry of Agriculture estimates that approximately 60 percent of their lemon consignments to the United States will switch from methyl bromide treatment to the systems approach. Chile currently exports about 15,000 MT per year to the United States, of which the systems approach is expected to be used for 8,500 to 9,000 MT. For this reason, the proposed rule is not expected to result in a significant increase in Chilean lemon exports to the United States or their competitiveness.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.
This proposed rule would allow lemon fruit to be imported into the continental United States from Chile. If this proposed rule is adopted, State and local laws and regulations regarding lemon fruit imported under this rule would be preempted while the fruit is in foreign commerce. Fresh fruits are generally imported for immediate distribution and sale to the consuming public and would remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. If this proposed rule is adopted, no retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
APHIS is proposing to amend the fruits and vegetables regulations to list lemon (
Implementing this rule will require permits, production site registration with low-prevalence level certification option, phytosanitary inspections, phytosanitary certificates, and chemical treatment procedures.
We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology;
Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Rice, Vegetables.
Accordingly, we propose to amend 7 CFR part 319 as follows:
7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions, until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.
Submit electronic or written comments on this proposed rule or its companion direct final rule by June 20, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the
Submit written/paper comments as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Sheila Brown, Office of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-6563.
FDA is proposing to amend the text of § 56.120(b) (21 CFR 56.120(b)), which describes lesser administrative actions that the Agency may impose on an IRB until the IRB takes appropriate action to correct the IRB's noncompliance. FDA is proposing this revision to clarify the language and improve the accuracy of the regulations. Specifically, this proposed rule would propose to amend § 56.120(b) by clarifying that FDA has authority to require the IRB to withhold approval of new FDA-regulated studies conducted at the institution or reviewed by the IRB, direct that no new subjects be added to ongoing studies, and terminate ongoing studies provided that doing so would not endanger study subjects.
This amendment also proposes to renumber current paragraphs (b)(4) and (c) as paragraphs (c) and (d), respectively, and inserts “FDA may” into newly designated paragraph (c) so that it is a complete sentence.
FDA first proposed requirements for the composition and operations of institutional review committees in the “Proposed Investigational Device Exemptions,” published in the
Subsequently, FDA published “Standards for Institutional Review Boards for Clinical Investigations” on August 8, 1978 (43 FR 35186; “Proposed IRB Standards”). Comments on implementing institutional review requirements received in response to the Proposed IDE Rule were reviewed and utilized in preparing the Proposed IRB Standards (43 FR 35186 at 35187). In the Proposed IRB Standards, FDA proposed that disqualification would be used only if the Commissioner of Food and Drugs finds that: (1) The IRB failed to comply with one or more of the standards for IRBs in part 56 or other supplemental requirements in the investigational new drugs or investigational device exemptions (IDE) regulations; (2) the noncompliance adversely affects the validity of the data or the rights or safety of the human subjects; and (3) other lesser regulatory actions (
FDA received numerous comments to the Proposed IRB Standards, and addressed those comments in the
This proposed rule would amend § 56.120(b) to read that, in addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to withhold approval of new studies, direct that no new subjects be added to ongoing studies, or terminate ongoing studies. This will ensure that those activities are suspended until the IRB takes appropriate corrective action to address
FDA may notify relevant State and Federal regulatory Agencies when warranted to assure that organizations with a need to know about the IRB's apparent noncompliance are appropriately informed. The revision would eliminate confusion by stating clearly that FDA is authorized to notify others about the IRB's noncompliance. We believe these changes will ensure clarity and improve the accuracy of the regulations.
This proposed rule is a companion to a direct final rule affirming FDA's longstanding interpretation of § 56.120(b),
If FDA receives any significant adverse comment regarding the direct final rule, we will publish a notice of significant adverse comment and withdraw the direct final rule within 30 days after the comment period ends. We will then proceed to final rulemaking using our usual notice-and-comment rulemaking procedures under the Administrative Procedure Act (APA). The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period. We will consider any comments that we receive in response to this companion proposed rule to be comments also regarding the direct final rule and vice versa. We do not intend to provide additional opportunity for comment.
A significant adverse comment is one that explains why the rule would be inappropriate (including challenges to the rule's underlying premise or approach), or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rule, we consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the APA (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered adverse. A comment recommending a rule change in addition to the rule would not be considered a significant adverse comment, unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of a rule and that part can be severed from the remainder of the rule, we may adopt as final those parts of the rule that are not the subject of a significant adverse comment.
You can find additional information about FDA's direct final rulemaking procedures in the guidance document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,”
This proposed rule, if finalized, would amend § 56.120(b). FDA's authority to modify § 56.120(b) arises from the same authority under which FDA initially issued this regulation, the IRB regulations, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262).
We have determined under 21 CFR 25.30(h) and 25.34(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would not add any additional regulatory burdens, we propose to certify that this proposed rule will not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
The purpose of this proposed rule is to affirm FDA's longstanding interpretation of § 56.120(b), that FDA may impose these restrictions on a noncompliant IRB until the IRB takes appropriate corrective action. The amendment will improve the clarity and accuracy of the regulations. Because this proposed rule is a clarification and would impose no additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.
FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
Human research subjects, Reporting and recordkeeping requirements, Safety.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 56 is amended as follows:
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262.
(b) On the basis of the IRB's or the institution's response, FDA may schedule a reinspection to confirm the adequacy of corrective actions. In addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to:
(1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB;
(2) Direct that no new subjects be added to ongoing studies subject to this part; or
(3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects.
(c) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, FDA may notify relevant State and Federal regulatory agencies and other parties with a direct interest in the Agency's action of the deficiencies in the operation of the IRB.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA or Agency) is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). We are also proposing other changes to make the TEA process more efficient.
Submit either electronic or written comments on the proposed rule by June 3, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by June 3, 2016, (see the “Paperwork Reduction Act of 1995” section of this document).
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Submit comments on information collection issues to the Office of Management and Budget in the following ways:
• Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
This proposed rule is intended to implement part of the Sunscreen Innovation Act (SIA) (21 U.S.C. Ch. 9 sub. 5 part I, enacted November 26, 2014). Among other provisions, the SIA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 586F to the FD&C Act. Section 586F(b) directs FDA to issue regulations establishing timelines and related performance metrics for the review of certain submissions under FDA's regulation governing TEAs, which is codified at 21 CFR 330.14. The TEA regulation sets forth criteria and procedures by which OTC drugs initially marketed in the United States after the OTC Drug Review began in 1972 and OTC drugs without any U.S. marketing experience can be considered in the OTC drug monograph system. If a drug meets each of the conditions contained in any applicable OTC drug monograph, and other applicable regulations, it is considered generally recognized as safe and effective (GRASE) and not misbranded, and is not required by FDA to be approved in a new drug application (NDA) under section 505 of the FD&C Act. Drugs determined to be not GRASE (or non-monograph) must be approved under section 505 of the FD&C Act before being marketed in the United States (see section II.A. for more detail on the OTC Drug Review and the TEA process).
Section 586F(b) of the FD&C Act specifically requires FDA to issue regulations providing for the timely and efficient review of submissions under the TEA regulation, including establishing (1) reasonable timelines for reviewing and acting on such submissions for non-sunscreen OTC active ingredients and other conditions (non-sunscreen TEA conditions) and (2) measurable metrics for tracking the extent to which such timelines are met.
FDA is also proposing to amend the TEA regulation to make the TEA process more efficient and predictable for both product sponsors and FDA by adding filing determination requirements and criteria and by addressing the withdrawal of consideration of TEA and safety and effectiveness data submissions.
The timelines and metrics in this proposed rule would apply to non-sunscreen TEA conditions (see section V.A for more detail). FDA is addressing timelines for review of sunscreen active ingredients and other related topics regarding sunscreens separately, under other provisions of the SIA (see section II.B for more detail).
The proposed rule implements the SIA requirements for non-sunscreen TEAs by adding proposed new § 330.15 to FDA's OTC drug monograph regulations (21 CFR part 330). The proposed new section has two major provisions regarding actions to be taken by FDA, consistent with requirements in the SIA. In particular, proposed § 330.15(c) establishes timelines for FDA to review and take action on non-sunscreen TEA conditions, and proposed § 330.15(b) describes measurable metrics that FDA will use for tracking the extent to which the timelines set forth in the regulations are met. Proposed § 330.15(a) generally limits the applicability of these timelines to non-sunscreen TEAs submitted after the enactment of the SIA, with one exception.
We are proposing to amend § 330.14 to:
• Add provisions concerning filing determinations regarding safety and effectiveness data submissions for eligible TEA conditions (
• add provisions regarding the withdrawal of consideration of TEAs and safety and effectiveness data submissions (§ 330.14(k)),
• add certain definitions (§ 330.14(a)), and
• make minor conforming and clarifying changes.
This rule is proposed under FDA's authority to regulate OTC drug products under the FD&C Act (see sections 201, 501, 502, 503, 505, 510, 586F, and 701(a) of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6, and 371(a))). As stated in the
In addition, section 586F of the FD&C Act requires FDA to issue regulations providing for the timely and efficient review of certain submissions under the TEA regulation at 21 CFR 330.14. Section 586F of the FD&C Act specifically requires these regulations to include timelines and metrics associated with the review of those submissions under the TEA regulation. Proposed § 330.15 would add timeline and metrics provisions that are intended to implement section 586F of the FD&C Act.
We expect that the proposed rule would make the TEA process more efficient and predictable, and improve communication between FDA and sponsors. Sponsors may benefit from knowing if additional data is needed and what optimal steps to take to receive a GRASE determination, and we would be able to bring resolution to TEA conditions. However, we do not know the monetary value of added predictability to sponsors.
We expect the rule would create a minimal burden on sponsors, primarily when they send a letter to request a meeting with us. Thus, we anticipate no increase in annual recurring costs for either small or large sponsors. We expect the six current sponsors of non-sunscreen TEAs covering conditions that have been found eligible to be considered for inclusion in the OTC drug monograph system would incur one-time costs to read and understand the proposed rule. We also estimate sponsors will submit two additional TEAs annually, and each of these sponsors would also spend time reading and understanding the proposed rule. The present value of the total costs over 10 years ranges from about $17,000 to $35,000 with a 7 percent discount rate and from about $19,000 to $38,000 with a 3 percent discount rate. With a discount rate of 7 percent and 3 percent, we estimate that on average affected sponsors would incur less than $150 of annualized costs per year.
The OTC drug monograph system was established to evaluate the safety and effectiveness of all OTC drug products marketed in the United States before May 11, 1972, that were not covered by new drug applications (NDAs) and all OTC drug products covered by “safety” NDAs that were marketed in the United States before enactment of the 1962 drug amendments to the FD&C Act. In 1972, FDA began its OTC Drug Review to evaluate OTC drugs by categories or classes (
FDA publishes these conditions in the
Initially, OTC drug conditions not marketed in the U.S. prior to the inception of the OTC Drug Review were not eligible for review under the OTC drug monograph process. The TEA process, established by regulations finalized in 2002 (21 CFR 330.14), expanded the scope of the OTC Drug Review. A “condition,” for purposes of the TEA regulation, is an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration marketed for a specific OTC use. The TEA process provides a potential pathway for OTC conditions, including newer active ingredients that previously had no U.S. marketing history or that were marketed in the United States after the OTC Drug Review began, to be marketed under an OTC drug monograph.
Active ingredients and other conditions that satisfy the TEA eligibility requirements are subject to the same safety, effectiveness, and labeling standards that apply to other conditions under the OTC monograph process (see 21 CFR 330.14(g)). The TEA regulation requires multi-step, notice-and-comment rulemaking procedures before an active ingredient or other condition is added to an OTC drug monograph.
The TEA process begins with the submission of a TEA containing data documenting the OTC marketing history of the active ingredient, combination of active ingredients, or other condition(s) (
We note that although a TEA is the application regarding the time and extent of marketing, which leads to an eligibility determination (resulting in publication of an NOE or a letter of ineligibility), references to TEAs or applications under section 330.14 (including in the SIA) sometimes encompass FDA's review of the condition's eligibility and the GRASE determination for the condition. Thus, these references may be used to mean the TEA itself, the safety and
If, after FDA reviews the safety and effectiveness data, the Agency initially determines that the active ingredient or other condition is GRASE, it will publish a proposed rule to include the condition in an appropriate OTC drug monograph.
If the condition is initially determined not to be GRASE, FDA will inform the sponsor and other interested parties that submitted data of its decision by letter, and will include the letter in the relevant public docket (§ 330.14(g)(4)). The Agency will also publish a notice of proposed rulemaking to include the condition in § 310.502. The sponsor and other interested parties will have an opportunity to submit comments and new data on FDA's initial determination and proposed rule (§ 330.14(g)(5)). After evaluation of any additional data submitted, FDA will either issue a final rule or a new proposed rule, if necessary, in the
In November 2014, Congress passed the SIA to supplement the TEA process with regard to both sunscreen and non-sunscreen OTC drug products. Proposed § 330.15 addresses section 586F of the FD&C Act, which was added by the SIA and only applies to TEAs for drugs other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients (see sections 586 and 586F of the FD&C Act, as amended by the SIA). For FDA review of non-sunscreen TEA conditions, section 586F includes two main requirements, one regarding timelines for review of eligible TEA conditions pending before the date of enactment of the SIA, and the other regarding timelines and performance metrics for the TEA process going forward.
The first general requirement (see FD&C Act section 586F(a)) is that FDA provide the option of selecting one of four frameworks for review to each non-sunscreen TEA sponsor who (1) had submitted a TEA for a condition that had been deemed eligible to be considered for inclusion in the OTC monograph system before the date of enactment of the SIA, and (2) requested the framework option within 180 days after enactment. FDA was required to provide the framework options to requesting sponsors by no later than one year after enactment of the SIA (by November 26, 2015). Before the date of SIA enactment, there were six non-sunscreen TEAs for conditions that had been found eligible to be considered for inclusion in the OTC drug monograph system: (1) Piroctone olamine (for dandruff control) (69 FR 7652, 2/18/04; Docket 2004N-0050 (FDA-2004-N-0037)); (2) triclosan (for oral healthcare) (69 FR 40640, 7/6/04; Docket 1981N-0033P (FDA-1981-N-0015)); (3) triclosan (for acne treatment) (70 FR 72447, 12/5/05; Docket 2005N-0445 (FDA-2005-N-0454)); (4) climbazole (for dandruff control) (70 FR 72448, 12/5/05; Docket 2005N-0444 (FDA-2005-N-0021)); (5) sodium picosulfate (for laxative use) (71 FR 35917, 6/22/06; Docket 2006O-0232 (FDA-2006-O-0057)); and (6) sodium shale oil sulfonate (for dandruff control) (74 FR 15741, 4/7/09; Docket FDA-2009-N-0146).
The sponsors of three of those TEAs requested that FDA provide a review framework by the deadline established in section 586F(a) of the FD&C Act. The three TEAs are for: (1) Piroctone olamine (for dandruff control) (69 FR 7652, 2/18/04; Docket 2004N-0050 (FDA-2004-N-0037)); (2) sodium picosulfate (for laxative use) (71 FR 35917, 6/22/06; Docket 2006O-0232 (FDA-2006-O-0057)); and (3) sodium shale oil sulfonate (for dandruff control) (74 FR 15741, 4/7/09; Docket FDA-2009-N-0146). FDA provided the review framework options to the requesting sponsors on November 24, 2015. With regard to the three sponsors who did not request or elect a framework in accordance with section 586F(a) of the FD&C Act, the eligible conditions addressed by their TEAs will be reviewed under the timelines set forth in proposed § 330.15 (if finalized as proposed).
The second general requirement (see FD&C Act section 586F(b)) is that FDA issue a regulation that includes (1) timelines for review of non-sunscreen TEA conditions and (2) measurable metrics for tracking the extent to which the timelines are met. This proposed rule includes both timelines and metrics, as required by the SIA.
FDA has determined that with regard to non-sunscreen TEAs, the best way to both address the statutory requirements of the SIA and to make certain FDA-initiated modifications to the TEA process set forth in § 330.14 is to (1) establish a new section (proposed § 330.15) that is specific to non-sunscreen TEA conditions, and (2) amend § 330.14 with regard to process improvements for TEAs for all OTC drugs (such as providing format and content criteria for a filing determination and addressing withdrawal of consideration).
In addition to developing new § 330.15, which implements SIA requirements with regard to the TEA process for non-sunscreens, FDA proposes to make certain changes to the process set forth in § 330.14 that we believe will make the TEA process more clear and efficient for both sponsors and FDA. These proposed changes to § 330.14 are discussed in more detail in this document, but notably include provisions that address filing determination requirements with regard to safety and effectiveness data submissions (to allow FDA to determine, and sponsors to know, early on whether a submission is sufficiently complete to permit a substantive review) and provisions regarding withdrawal of consideration of a TEA or safety and effectiveness data submission.
This rule is being proposed under FDA's authority to regulate OTC drug products under the FD&C Act (see sections 201, 501, 502, 503, 505, 586F, and 701(a) of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 355, 360fff-6, and 371(a))). As stated in the
In addition, section 586F of the FD&C Act requires FDA to issue regulations providing for the timely and efficient review of certain submissions under the TEA regulation at 21 CFR 330.14. Section 586F of the FD&C Act specifically requires these regulations to
In this rule, we are proposing to establish new § 330.15 and to amend current § 330.14. In particular, we are proposing to: (1) Establish timelines and metrics for review of non-sunscreen TEA conditions, (2) add provisions concerning filing determination requirements with regard to the content and format of safety and effectiveness data submissions under § 330.14(f), (3) address withdrawal of consideration of TEAs and safety and effectiveness data submissions, (4v) add related definitions, and (5) make clarifying and conforming changes to the TEA regulation. These proposed changes are discussed in detail in this section.
The SIA mandates that FDA issue regulations to establish timelines and metrics regarding the review of non-sunscreen TEA conditions, and provides that the proposed timelines may vary based on the content, complexity, and format of the submission, and that they must (1) reflect FDA's public health priorities, including the potential public health benefits posed by the inclusion of additional drugs in the OTC drug monograph system, (2) take into consideration the availability of FDA resources for carrying out such priorities and the relevant review processes and procedures, and (3) be reasonable, taking into account the required consideration of priorities and resources (FD&C Act section 586F(b)(2)). Proposed § 330.15 is intended to implement these requirements.
As a general matter, the timeline provisions in proposed § 330.15 apply to FDA and are triggered by specific actions by sponsors, such as submission of a TEA or submission of a safety and effectiveness data submission (as defined in proposed § 330.14(a)) and, in some cases, FDA (
Proposed § 330.15(a) describes which TEA conditions are subject to the timelines for FDA review and action in this section and which are not. We invite comment on the proposed applicability of this section. In particular, FDA is proposing that the review of an active ingredient or other condition in a TEA submitted under § 330.14 for consideration in the OTC drug monograph system would be subject to the proposed timelines, with two exceptions.
First, in § 330.15(a)(1), FDA proposes that § 330.15 does not apply to a sunscreen active ingredient or a combination of sunscreen active ingredients or other conditions for such ingredients. Section 586F(b) of the FD&C Act directs the Agency to issue regulations establishing timelines for drugs other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients. The SIA recognizes that active ingredients can only be GRASE under specified conditions. For example, section 586A of the FD&C Act, which was added by the SIA to provide an alternative route for inclusion in the sunscreen monograph, states that a person may submit a request to FDA for a determination of whether a nonprescription sunscreen active ingredient or combination of ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dosage strength, and route of administration) is GRASE. Because the TEA regulation addresses active ingredients and other conditions, including dosage forms, and an active ingredient can only be GRASE under specified conditions, we understand the reference to TEAs for drugs other than sunscreen active ingredients in section 586F(b) of the FD&C Act to be distinguishing sunscreen active ingredients and related conditions from non-sunscreen active ingredients and related conditions. Furthermore, “pending requests” for sunscreen active ingredients under the SIA are subject to the provisions of section 586C(b) of the FD&C Act, as amended by the SIA (21 U.S.C. 360fff-3(b)), which include timeframes for FDA review and action. Therefore, under proposed § 330.15(a), § 330.15 would not apply to sunscreen active ingredients and related conditions.
Second, in § 330.15(a)(2), FDA proposes that § 330.15 generally does not apply to non-sunscreen active ingredients or other conditions submitted in TEAs under § 330.14 on or before the date of enactment of the SIA. Section 586F(b)(1) of the FD&C Act directs the Agency to issue regulations establishing timelines for the review of TEA conditions submitted after the date of enactment of the SIA. However, as provided in the SIA, any non-sunscreen TEA conditions determined to be eligible to be considered for inclusion in the OTC drug monograph system before the date of enactment of the SIA, for which the sponsor did not request a framework for review under section 586F(a)(1), will also be reviewed under the timelines set forth in § 330.15(c) of this proposed rule (see FD&C Act section 586F(a)(1)(C)) (if finalized as proposed). Accordingly, the scope of the exclusion in proposed § 330.15(a)(2) references section 586F(a)(1)(C) of the FD&C Act to account for such TEA conditions.
For sponsors of TEAs covering conditions that had been found eligible to be considered for inclusion in the OTC drug monograph system before the date of enactment of the SIA who elected to choose a framework for review, FDA was required to provide four optional frameworks that set forth timelines for FDA review (FD&C Act section 586F(a)((2)). The frameworks included timelines for review if the sponsors choose an order process with or without a filing determination, or a rulemaking process with or without a filing determination. A notification of optional frameworks was provided to each requesting sponsor on November 24, 2015. Before the date of enactment of the SIA, there were six non-sunscreen TEA conditions that were found by FDA to be eligible to be considered for inclusion in the OTC drug monograph system (listed in section II.B). Of these, three sponsors elected a framework for review, and three did not (listed in section II.B).
As discussed in the introduction to section V.A, section 586F(b) of the FD&C Act, as amended by the SIA, directs FDA to establish timelines for the review of certain TEA conditions. As also discussed in section V.A.1, in addition to applying to new non-sunscreen TEAs, these timelines would apply to certain non-sunscreen TEA conditions that were found to be eligible before November 26, 2014. Section 586F(b) of the FD&C Act also requires timelines for internal procedures related to the review of safety and effectiveness data submissions.
FDA is proposing to establish the timelines described in this section of the document for FDA review and action, as described in proposed new § 330.15(c).
Note that terms for certain actions that begin review timelines for FDA are defined in proposed amendments to
The proposed timelines are:
• FDA will issue a notice of eligibility or post to the docket a letter of ineligibility, in accordance with § 330.14(d) and (e), within 180 days of submission of a TEA under § 330.14(c).
• FDA will issue a filing determination in accordance with § 330.14(j) within 90 days of receipt by FDA of a safety and effectiveness data submission from the sponsor under § 330.14(f). Under proposed § 330.14(a)(5), a safety and effectiveness data submission is defined as a data package submitted by a sponsor that includes safety and effectiveness data and information under § 330.14(f) and that is represented by the sponsor as being a complete submission. Therefore, FDA will not start the 90-day filing determination period until the sponsor has confirmed that it considers the submission to contain all data and information required under § 330.14(f) by providing a statement that the submission is a complete safety and effectiveness data submission. If the sponsor submitted such a safety and effectiveness data submission at the same time as the sponsor submitted the TEA, and the condition addressed in the TEA is deemed eligible for consideration, FDA will issue a filing determination within 90 days after issuing the notice of eligibility.
• If the active ingredient or other condition is initially determined not to be GRASE, FDA will inform the sponsor and other interested parties who have submitted data of its determination by feedback letter in accordance with § 330.14(g)(4), within 730 days (generally 24 months) from the date of filing. FDA is considering whether to add a codified provision to address sponsor requests for additional time in response to a feedback letter and how that would affect the timeline for review. We welcome comments on this issue.
• FDA will issue a notice of proposed rulemaking within 1,095 days (generally 36 months) from the date of filing to either:
○ Include the active ingredient or other condition in an appropriate OTC monograph(s), either by amending an existing monograph(s) or establishing a new monograph(s), if necessary; or
○ Include the active ingredient or other condition in § 310.502 (which would require the sponsor to seek approval under section 505 of the FD&C Act before marketing).
• FDA will issue a final rule within 912 days (generally 30 months) of the closing of the docket of the proposed rulemaking under § 330.15(c)(4). If the docket is reopened, the final rule will be issued within 912 days of the closing of the re-opened docket.
For non-sunscreen TEA conditions that were found to be eligible before enactment of the SIA and that would be subject to the timelines in proposed § 330.15, FDA intends to treat the date of publication of the final rule for § 330.15 to be the date of filing for purposes of §§ 330.14 and 330.15. Therefore, upon the publication of the final rule, the timelines in proposed § 330.15(c)(3), if applicable, and § 330.15(c)(4) would begin for these eligible TEA conditions.
As required by the SIA (section 586F(b)(2) of the FD&C Act), FDA considered specific factors in developing the timelines in proposed new § 330.15(c). In particular, the SIA provides that the timelines for the review of non-sunscreen TEA conditions
FDA is allowed (for the “may” factors) or required (for the “shall” factors) to take these factors into account in the timelines for review of non-sunscreen TEAs and related submissions. These SIA provisions recognized factors that could possibly affect how long it may take FDA to complete review of a particular TEA and related submissions. The timelines proposed in § 330.15 factored in the considerations that are required under the SIA; they reflect the projected time necessary for FDA to complete its review of marketing, filing, and scientific data and other information, as well as to make tentative and final determinations about the adequacy of the submissions to ultimately support a finding that the active ingredient or other condition is or is not GRASE and not misbranded for nonprescription use, based on the Agency's public health priorities and the resources available to carry them out. The timelines also include the projected time necessary to draft and finalize the letters or rules (proposed and final), and when applicable, prepare the document for publication in the
Under section 586F(b)(2)(B)(i) of the FD&C Act, the timelines must reflect FDA's public health priorities, including the potential public health benefits posed by the inclusion of additional drugs in the OTC drug monograph system. FDA has a very broad mandate and multiple public health priorities, with limited resources to address these priorities.
FDA's Center for Drug Evaluation and Research (CDER) is responsible for regulating the safety and efficacy of both prescription and nonprescription human drugs. Like FDA as a whole, CDER must continually balance multiple important public health priorities, of which the OTC Drug Review is one. CDER does, and will continue to, consider the OTC Drug Review among its priorities as it endeavors to appropriately allocate staff and resources within the context of all CDER responsibilities.
Examples of how FDA public health priorities may affect the time required for the review of non-sunscreen TEA conditions under the proposed timelines include situations such as a public health emergency or competing high priority work that requires diversion of the staff assigned to a TEA or safety and effectiveness data submission.
Under section 586F(b)(2)(B)(ii), the timelines must take into consideration Agency resources available for carrying out its public health priorities and the processes and procedures related to the review of TEA conditions. Examples of resource constraints that may affect the time required for review include, but are
In developing the timelines set forth in proposed new § 330.15(c), FDA has attempted to set reasonable timelines that will be achievable in most circumstances, given our experience to date with TEAs and related safety and effectiveness data submissions. While FDA expects that the filing determination requirements we propose adding to § 330.14(j) will help to avoid major content and format deficiencies in incoming safety and effectiveness data submissions, there is likely still to be some variation in the formatting of incoming TEAs and safety and effectiveness data submissions, and a related variation in the ease and efficiency of review.
In determining reasonable timelines, FDA also considered the potential effect on stakeholders, including TEA sponsors and the public. In addition to considering the benefits that the proposed timelines and related metrics would provide to sponsors (
With respect to the eligibility determination (§ 330.15(c)(1)), FDA is proposing to review and issue a notice of eligibility or post to the docket a letter of ineligibility within 180 days of receipt of a TEA, which FDA considers to be a reasonable timeline, taking into consideration Agency priorities and resources. As stated previously, in a 2011 final guidance to industry, FDA previously estimated a 1-year timeframe for taking this action (Ref. 1).
FDA is proposing to issue a filing determination within 90 days of submission by the sponsor of a safety and effectiveness data submission, which is defined in proposed § 330.14(a), in part, as a submission that the sponsor has confirmed it considers to be complete (
Notice and comment rulemaking is generally a lengthy and multistep process (Ref. 2). The timelines in this proposed rule are consistent with the length of time typically required for other rulemaking, and reflect the amount of time FDA anticipates will be required for the reviews of safety and effectiveness data submissions and related rulemaking.
Major steps for FDA rulemaking generally include determination that a rule is needed and what the rule should say; drafting, reviewing, and finalizing the proposed rule; publishing the proposed rule; a public comment period and review of the comments; revising the proposed rule as appropriate; reviewing the draft final rule and finalizing it, and publishing the final rule in the
As noted previously, rulemaking is often a lengthy process, and the OTC Drug Review process (of which the TEA process is a part) offers additional rulemaking challenges, such as were discussed in a public meeting on OTC process reform held by FDA in 2014 (“Over-The-Counter Drug Monograph System—Past, Present and Future; Public Hearing,” 79 FR 10168, February 24, 2014; Docket No. FDA-2014-N-0202). Additional information, such as the hearing transcript, is available at
If the active ingredient or other condition is initially determined not to be GRASE for OTC use in the United States, FDA will also issue a feedback letter within this 730-day (generally 24-month) timeline. The feedback letter may identify the specific gaps in the data or information necessary to make a GRASE determination, and it provides the sponsor with time before the NPRM is published that could be used to begin collecting the data or information required for potential inclusion in a monograph. We note that a feedback letter reflects the Agency's initial determination. If FDA does not issue a feedback letter, it does not guarantee that we will ultimately determine that an ingredient is GRASE and not misbranded.
FDA proposes to issue an NPRM within 1,095 days (generally 36 months) from the date of filing (as defined in proposed § 330.15(a)(6)). For an active ingredient or other condition that is initially determined to be GRASE, FDA would issue a proposed rule to include the condition in the appropriate OTC monograph. For an active ingredient or other condition that is initially determined not to be GRASE, FDA would issue a proposed rule to include the condition in 21 CFR 310.502 (the regulation listing drugs that have been accorded new drug status through rulemaking and must be approved under section 505 of the FD&C Act before marketing). In general, FDA intends to close the public comment period for the proposed rule at 90 days,
FDA is proposing to issue a final rule within 912 days (generally 30 months) of the closing of the comment period for the proposed rule. During this 912-day time period, FDA will review and consider any new data, information, and public comments submitted to the docket and draft and publish a final regulation.
Timelines for FDA review and action for sunscreen active ingredients under sections 586B and 586C of the FD&C Act, as amended by the SIA, are generally shorter than those in this proposed rule. The most notable differences are the timelines for proposed and final GRASE determinations which, under the SIA requirements for sunscreen active ingredients, are made through an order process rather than a rulemaking process. The order process eliminates some of the requirements of rulemaking that are time-consuming and resource intensive.
A 2009 Government Accountability Office (GAO) report (Ref. 3) examined, among other things, how long agencies, including FDA, take to issue rules. For the 16 case studies, the report found significant variation in time to complete rulemaking, with an average of about four years and a range of one to nearly 14 years. Factors that influenced the time needed to issue a rule included the complexity of the issues, Agency priorities, and the amount of internal and external review required (Ref. 3 at p. 19).
In summary, based on the type of data typically submitted in a TEA, along with the potential variability in the content and formatting of that submission, and because of the complex scientific review required to determine if an active ingredient or other condition is GRASE for OTC use, the possible use of an advisory committee, and the requirements for the rulemaking process itself, FDA considers the timelines put forth in this proposed rule to be reasonable, taking into consideration Agency priorities and resources. As described in further detail in the paragraphs that follow, if a TEA and the related safety and effectiveness data submission are straightforward, well-organized, and complete, FDA may be able to take action within shorter timeframes than proposed in this rule.
As stated previously, under section 586F(b)(2)(A) of the FD&C Act, the timelines established in the regulations required under that section could vary based on the content, complexity, and format of the submission. FDA considered a number of timeline options. Ultimately, FDA determined that instead of setting multiple proposed timelines for submissions of varying content, complexity, and format, it would be more efficient and sensible to set one general timeline for the review of non-sunscreen TEA conditions that accommodates anticipated variation among submissions. There is likely to be some variation in how quickly each submission is reviewed, because each will present a unique set of data and each review will occur in the context of multiple ongoing FDA activities and priorities. This may result in a review step taking less time than proposed in § 330.15(c) (for example, if a submission is well-organized, complete when submitted, and straightforward). In unusual circumstances, a review or rulemaking step may require a longer time than proposed in § 330.15(c) (
The quantity and quality of submitted data can generally impact FDA's review. If a TEA or safety and effectiveness data submission includes all the information that is required and all information that the sponsor wishes to have considered in the initial submission to FDA, it is likely possible to complete review of the TEA or safety and effectiveness data submission more quickly than if it has poor quality data, if FDA finds that clarification or additional data is needed, or if the sponsor submits additional spontaneous data supplements during the substantive review.
Complexity, including, among other things, the nature of the active ingredient or other condition that is the subject of the TEA and the status of the monograph for the therapeutic category (
The OTC monograph status for the therapeutic category (final, tentative, or new) and the U.S. Pharmacopeia (USP) monograph status (whether establishment of a USP monograph is required or not) may each affect the time required for review and rulemaking, in that addition of an active ingredient or other condition to a final OTC monograph once the GRASE determination is made would generally be faster than working with a tentative or new OTC monograph. Also, because a USP monograph for the ingredient is required before FDA can issue a final rule adding an active ingredient to an OTC monograph (§ 330.14(i)), the USP monograph status may lengthen the review and rulemaking time.
Finally, if FDA determines that an advisory committee or an advisory review panel is appropriate (
The format including, among other things, whether a TEA or safety and effectiveness data submission is well-organized or poorly-organized, whether some or all of the information is submitted in electronic format, etc., could also impact FDA's review. We note that FDA recently issued draft guidance for industry regarding the format and content of data submissions for nonprescription sunscreen active ingredients (Ref. 4). A well-formatted TEA can generally be reviewed more quickly and efficiently than a poorly-organized TEA. In addition, review could take longer (or result in a refusal to file) if a safety and effectiveness data submission is disorganized with a structure that does not facilitate review for completeness, if there are electronic submissions that cannot be opened or that cannot be readily navigated (
Section 586F(b) of the FD&C Act requires FDA to establish measurable metrics for tracking the extent to which the timelines set forth in the regulations are met (see proposed timelines under § 330.15(c)). FDA is proposing to maintain a publicly available posting of metrics for the review of TEAs and safety and effectiveness data submissions submitted under § 330.14 that are subject to the timelines under proposed § 330.15(a), and update the posting annually. The posting will contain the metrics listed in this section, as proposed in § 330.15(b), for submissions received during the previous calendar year.
• Number and percent of eligibility notices or ineligibility letters issued within 180 days of submission of a TEA (
• Number and percent of filing determinations issued within 90 days of submission of a safety and effectiveness data submission (
• If applicable, number and percent of feedback letters issued within 730 days (generally 24 months) from the date of filing (
• Number and percent of notices for proposed rulemaking issued within 1,095 days (generally 36 months) from the date of filing (
• Number and percent of final rules issued within 912 days (generally 30 months) of closing of the docket of the proposed rulemaking (
• Total number of TEAs submitted under § 330.14; FDA may also post a total number of TEAs that have been submitted in all previous years.
For purposes of the metrics, a lack of FDA action in response to a triggering event in the previous calendar year will not be factored in unless the response was due in the previous calendar year. In other words, if a sponsor submits a TEA in October of the previous calendar year, and FDA has not yet issued a notice of eligibility or letter of ineligibility because 180 days has not elapsed by the end of the calendar year, under the proposed metrics, FDA would not consider the lack of response as missing the timeline. Whether FDA met the timeline or not would be reflected in the next year's metrics.
FDA intends to track these metrics and post them publically on the FDA Internet site. The Agency routinely uses its Internet site to post information and track progress and performance metrics on various initiatives (Ref. 5).
The Agency anticipates that the proposed metrics web posting will improve transparency by providing sponsors and the public with information that will enable them to quickly ascertain the number of TEAs that have been submitted to FDA, and the Agency's performance in meeting the proposed timelines. Over time, these measurements may also assist the Agency with resource planning and utilization.
FDA is proposing to revise § 330.14 to add new definitions and requirements. The new proposed definitions are primarily meant to clarify the beginning or ending of the timelines for FDA review and action as proposed in new § 330.15. The new proposed requirements include filing determination provisions under proposed new § 330.14(j) and “withdrawal of consideration” provisions under proposed new § 330.14(k), which are intended to make the TEA process more efficient for both sponsors and FDA.
FDA is proposing new definitions that, in general, are intended to clarify the beginning or ending of the timelines for FDA review and action as proposed in § 330.15. FDA is adding these definitions to § 330.14 instead of proposed new § 330.15 because § 330.14 describes the TEA process to which these definitions apply. The definitions for “condition” and “botanical drug substance,” proposed under § 330.14(a)(1) and (2) respectfully, are unchanged from the current definitions under § 330.14(a). FDA is proposing to add the following new definitions of terms that apply to § 330.14.
• FDA is proposing that the term “sponsor” mean the person (as defined in section 201(e) of the FD&C Act) that submitted a TEA under § 330.14(c). Because the TEA process involves a public rulemaking process, comments from other interested parties, such as additional safety and effectiveness data, may be submitted to the docket for a TEA condition. FDA is proposing this definition to make clear that the sponsor is the person that submitted the TEA and related safety and effectiveness data submission, and will be the recipient of certain letters communicating FDA decisions. Because this is a public process, such letters will also be posted publicly to the relevant docket.
• FDA is proposing that the term “time and extent application (TEA)” mean a submission by a sponsor under § 330.14(c), which will be evaluated by the Agency to determine eligibility of a condition for consideration in the OTC drug monograph system. FDA is proposing this definition to make clear the difference between a submission to FDA for the purposes of establishing that the condition has been marketed for a material time and to a material extent versus a submission to FDA for the purposes of establishing that the condition is GRASE.
• FDA is proposing that the phrase “safety and effectiveness data submission” mean a data package submitted by a sponsor that includes safety and effectiveness data and information under § 330.14(f) and that is represented by the sponsor as being a complete submission. FDA is proposing this definition to differentiate this type of submission from the TEA. It also clarifies that FDA will not begin its filing determination under § 330.14(j) unless the sponsor first asserts that the submission is complete.
• FDA is proposing that the phrase “date of filing” mean the date of the notice from FDA informing the sponsor that FDA has made a threshold determination that the safety and effectiveness data submission is sufficiently complete to permit a substantive review. For submissions filed over protest in accordance with § 330.14(j)(3), the date of filing is the date of the notice from FDA informing the sponsor that FDA has filed the submission over protest. This date will be no later than 30 days after the sponsor's request that FDA file the submission over protest. FDA is
• FDA is proposing that the term “feedback letter” mean a letter issued by the Agency in accordance with § 330.14(g)(4) that informs the sponsor and other interested parties who have submitted data under paragraph (f) of this section that a condition is initially determined not to be GRASE. FDA is proposing this definition to clarify the FDA action under § 330.14(g)(4) and the timeframe for such action under § 330.15(c)(3).
FDA is proposing new requirements that specify certain filing determination requirements that are intended, in part, to help improve the content and format of a safety and effectiveness data submission. FDA is also proposing timelines related to these proposed new requirements. For example, submission criteria include factors such as whether the submission includes all required information, whether the submission is organized and formatted in a manner that allows FDA to readily determine if it is sufficiently complete to permit a substantive review, and whether the submission includes all required certifications.
The proposed new section also sets forth processes that apply whether the submission is accepted for filing, refused, or filed over protest. If the submission is filed, the date of filing, as defined in proposed § 330.14(a), represents the start of FDA's initial review for a GRASE determination, and triggers the start of timelines under proposed §§ 330.15(c)(3) and (4).
FDA believes that these proposed requirements would benefit both TEA sponsors and FDA, as well as potentially benefitting other interested parties. In FDA's experience, TEA-related submissions vary widely in their content and format and are sometimes difficult or extremely time-consuming and resource-intensive to review as submitted (
We note that while the SIA did not require FDA to issue a regulation regarding filing determination criteria for safety and effectiveness data submissions under § 330.14, it did require FDA to issue draft and final guidance on the format and content of information submitted by a sponsor in support of a “request” under section 586A of the FD&C Act and a “pending request,” which are related to sunscreens (see FD&C Act section 586D(a)(1)(A) and (B)). A notice of availability of the draft guidance on this topic was published in the
As stated earlier in this section, proposed § 330.14(j) sets forth criteria FDA would use in making a filing determination for a safety and effectiveness data submission, as well as timing and processes related to the determination. In particular, in § 330.14(j)(1), FDA proposes that after FDA receives a safety and effectiveness data submission, the Agency will determine whether the submission may be filed. The determination would be whether or not to accept the submission for filing, after an initial review of the submission regarding whether the submission contains the data and information required under § 330.14(f) in an acceptable format, and satisfies the other filing criteria under § 330.14(j)(4). The filing of a submission under proposed § 330.14(j)(2) would mean that FDA has made a threshold determination that the submission is sufficiently complete to permit a substantive review.
In § 330.14(j)(2), FDA proposes that the date of filing will begin the FDA timelines described in § 330.15(c)(3) and (4).
In § 330.14(j)(3), FDA proposes to describe the process for cases in which FDA refuses to file the safety and effectiveness data submission. If this happens, the Agency would notify the sponsor in writing and state the reason for the refusal under proposed § 330.14(j)(4). Proposed § 330.14(j)(3) provides the sponsor 30 days in which to request an informal conference with the Agency about whether the Agency should file the submission and sets forth the procedures if the sponsor wishes to file the submission over protest following the informal conference. Proposed § 330.14(j)(3) further provides that FDA will convene the informal conference within 30 days of the request from the sponsor. It also provides that if, within 120 days after the informal conference, the sponsor requests that FDA file the submission (with or without correcting the deficiencies), the Agency will file the safety and effectiveness data submission over protest under § 330.14(j)(2), notify the sponsor in writing, and review it as filed. The sponsor need not resubmit a copy of a safety and effectiveness data submission that is filed over protest.
In proposed § 330.14(j)(4), FDA describes the conditions under which FDA may refuse to file a safety and effectiveness data submission. These include a submission that:
○ Is incomplete because it does not contain information required under § 330.14(f) (if such information is not provided because it is not relevant, the submission must clearly identify and explain the omission);
○ Is not organized or formatted in a manner to enable the Agency to readily determine if it is sufficiently complete to permit a substantive review;
○ Does not contain a signed statement that the submission represents a complete safety and effectiveness data submission and that the submission includes all the safety and effectiveness data and information available to the sponsor at the time of the submission, whether positive or negative;
○ Does not contain an analysis and summary of the data and other supporting information, organized by clinical or nonclinical area;
○ Does not contain a supporting document summarizing the strategy used for literature searches, including search terms, sources, dates accessed and years reviewed;
○ Does not contain a reference list and copy of supporting information; or
○ Includes data or information relevant to the GRASE determination that is marked as confidential without a statement that the information may be released to the public (if the relevant data was produced and marked confidential by a third party, the sponsor would need to include a statement that the sponsor is authorized to make the information publicly available or include an authorization from the third party permitting the information to be publicly disclosed).
In addition, the following four filing determination factors relate to requirements under other sections of the regulations. FDA may refuse to file a safety and effectiveness data submission if the submission:
○ Does not contain either a complete environmental assessment or information supporting a categorical exclusion under part 25 (see 21 CFR part 25, “Environmental impact considerations”);
○ Does not contain a statement for each nonclinical laboratory study that it was conducted in compliance with part 58 requirements (see 21 CFR part 58, “Good laboratory practice for nonclinical laboratory studies”) (or a statement of reasons for the noncompliance);
○ Does not contain a statement for each clinical investigation involving human subjects that it was conducted in compliance with part 56 institutional review board regulations (see 21 CFR part 56, “Institutional Review Boards”) or was not subject to those regulations, and that it was conducted in compliance with part 50 informed consent regulations (see 21 CFR part 50, “Protection of human subjects”); or
○ Does not include required part 54 financial certification and disclosure statements (see 21 CFR part 54, “Financial disclosure by clinical investigators”).
The Agency is also proposing to add withdrawal provisions to new § 330.14(k). These proposed provisions acknowledge that a sponsor may request withdrawal of consideration of a TEA or safety and effectiveness data submission. In addition, inaction by a sponsor in certain circumstances may be deemed by FDA as a request for withdrawal of consideration (
The Agency believes that the proposed provisions on withdrawal of consideration would allow the Agency to better allocate resources for the review of TEA conditions than the current process. Based on past experience with the OTC monograph process, FDA has found that following an Agency action, a sponsor may not respond to a request for data from FDA. For example, the Agency issued an NOE and request for safety and effectiveness data in 2005 for a TEA active ingredient (70 FR 72447, December 5, 2005) and to date, FDA has not received data or a response from the sponsor. Without an established deadline for submitting data or otherwise responding to an Agency request, a sponsor may never submit the requested data and a TEA condition may remain unresolved. To better utilize FDA resources as well as to address the withdrawal of consideration of a TEA or a safety and effectiveness data submission, the Agency is proposing to amend § 330.14 to add paragraph (k) to address such withdrawal of consideration.
In § 330.14(k)(1), we propose that FDA may withdraw consideration of a TEA or safety and effectiveness data submission if: (1) The sponsor requests that its submission be withdrawn from consideration, or (2) FDA deems the submission to be withdrawn from consideration due to the sponsor's failure to act on the submission or failure to respond to communications from FDA. For purposes of this provision, withdrawal of consideration of a TEA would include the withdrawal of consideration of a TEA condition that had been found to be eligible, but for which a safety and effectiveness data submission is not received by the Agency. If a sponsor requests withdrawal of consideration for its TEA or safety and effectiveness data submission, FDA generally intends to stop its review. However, we note that while FDA may withdraw consideration of a TEA or safety and effectiveness determination, we may determine not to do so in some cases. For example, if FDA has already issued a proposed rule that tentatively determines that the active ingredient or other condition is GRASE for OTC use, or is not GRASE for OTC use, FDA may continue to rely on the information submitted to the docket and proceed to issue a final rule.
In § 330.14(k)(2), we propose that FDA will notify the sponsor of a submission that FDA intends to deem withdrawn under paragraph (k)(1)(ii), and that the sponsor will then have 30 days from the date of the notice to request that FDA not withdraw consideration of the TEA or safety and effectiveness data submission and request additional time needed to submit relevant data and information. For example, a sponsor may request that FDA not withdraw consideration of a safety and effectiveness data submission to allow the submission of new safety or effectiveness data to the record if the sponsor needs additional time to conduct a study and submit the data. If, within 30 days of FDA's notice, the sponsor requests that FDA not withdraw consideration under proposed § 330.14(k)(1)(ii), we will continue to consider the submission. If we continue to consider the submission, that does not preclude the possibility of withdrawing consideration under § 330.14(k)(1) at a later time. FDA recommends that sponsors keep FDA apprised of the anticipated timing for submission of requested data to facilitate the review process and better utilize FDA resources.
In § 330.14(k)(3), FDA proposes to clarify that if consideration of a TEA or safety and effectiveness data submission is withdrawn, information that has been posted to the public docket for the TEA at the time of the withdrawal (such as an NOE or a safety and effectiveness data submission that has been accepted for filing and posted to the docket) will remain on the public docket. The TEA process is primarily a public process and withdrawal of consideration of a TEA or safety and effectiveness data submission will not cause previously public information to be removed from
In § 330.14(k)(4), FDA proposes that if a TEA or safety and effectiveness data submission being reviewed in accordance with § 330.15 is withdrawn, the timelines under § 330.15(c) and the metrics under § 330.15(b) no longer apply.
FDA is proposing to reorganize paragraph (a) of § 330.14 to create an introductory paragraph that includes the current text under § 330.14(a), except for the definitions of “condition” and “botanical drug substance,” which would be moved to the proposed definitions section in § 330.14(a). FDA is proposing to eliminate the paragraph heading “introduction,” and in its place, propose the paragraph heading “definitions” and a statement that the definitions that follow apply to this section and § 330.15. Under this new heading, FDA is proposing to include the definitions and current text for the terms “condition” and “botanical drug substance.” FDA is also proposing to add to the end of the introductory paragraph of § 330.14 a sentence stating that § 330.15 sets forth timelines for FDA review and action.
FDA is proposing several minor amendments to § 330.14(f) for clarity and for consistency with the OTC monograph regulations under § 330.10.
• FDA is proposing to revise paragraph (f) to use terminology consistent with the new definition in § 330.14(a)(5) for “safety and effectiveness data submission” when referring to the data package submitted by the sponsor.
• FDA is proposing to revise the first sentence and add the second sentence to differentiate between, in the NOE, requesting the safety and effectiveness data submission from the sponsor, and requesting data and views from other interested parties.
• FDA is proposing to add a sentence that references the new filing determination requirements at proposed new § 330.14(j) and makes clear that the safety and effectiveness data submission must be sufficiently complete to be filed by the Agency under proposed paragraph (j)(2).
• FDA is proposing to add a sentence that references the requirements for compliance with good laboratory practices, institutional review board, informed consent, and financial certification or disclosure statement requirements, under § 330.10(c), (e), and (f), and makes clear that those requirements also apply to the safety and effectiveness data and information submitted under this paragraph. This proposed sentence does not impose new requirements. The sentence was added for clarity and consistency with § 330.10.
FDA is proposing to add the word “feedback” prior to the word “letter” in the first sentence of § 330.14(g)(4) to use terminology consistent with the proposed new definition for “feedback letter” in § 330.14(a)(7).
The SIA directs the Agency to issue a final rule regarding the timelines and metrics described in section 586F(b) of the FD&C Act within 27 months after the enactment of the SIA (by February 26, 2017). The SIA also requires that the final rule be published not less than 30 calendar days before the effective date of the regulation. Consequently, the final rule implementing the timeline and metrics provisions of section 586F(b) will become effective 30 calendar days after the date of the final rule's publication in the
Beginning on that date, the timelines and metrics set forth in the regulation will apply to the review of TEAs and safety and effectiveness data submissions to which that regulation is applicable, and any amended provisions of § 330.14 will apply to the TEA process under that regulation.
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule does not impose significant new economic burdens on any entity, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
In table 1, we provide the Regulatory Information Service Center/Office of Information and Regulatory Affairs Consolidated Information System accounting information.
We regulate nonprescription drug products under two primary pathways: (1) The new drug application (NDA) process, described in 21 CFR part 314; or (2) the nonprescription (over-the-counter or OTC) drug monograph process, described in part 330. There are important differences between these two pathways. Under the NDA process, the sponsor of an application must submit to us nonclinical and clinical data that supports the safety and effectiveness of its drug product, and we must review and approve the application before the sponsor can market such product. By contrast, OTC drug monographs are regulations describing conditions (§ 330.14 defines condition as an active ingredient or botanical drug substance (or combination of both), dosage form, dosage strength, or route of administration marketed for a particular specific OTC use) that certain OTC drugs (such as antacids) must meet to be considered as GRASE and not misbranded. In contrast with the application pathway, once a sponsor submits safety and effectiveness data to amend a monograph (which is posted to a public docket), the data are public. Drug products that comply with an applicable OTC drug monograph and other applicable regulations may be marketed without an NDA.
Initially, active ingredients and other conditions that were not marketed in the United States before the inception of the OTC Drug Review in 1972 were not eligible for review under the OTC drug monograph process. However, the TEA process, established by regulations finalized in 2002 (21 CFR 330.14), expanded the scope of this OTC drug review. The TEA process offers a pathway for OTC conditions to be marketed under an OTC drug monograph. OTC conditions can include newer active ingredients that previously had no U.S. marketing history, or that were marketed in the United States after the OTC drug review began. Active ingredients and other conditions that satisfy the TEA eligibility requirements are subject to the same safety, effectiveness, and labeling standards that apply to other conditions under the OTC monograph process.
The TEA process requires multi-step, notice-and-comment rulemaking procedures before a new active ingredient or other condition is added to an OTC drug monograph. After determining that an active ingredient or other condition is eligible for consideration under the OTC monograph process, we issue a notice in the
Although our multi-step TEA process allows sponsors to learn about the progress of our review of an application (for example when an NOE is issued, and if a feedback letter is issued), there are no established timelines to review applications or for sponsors to submit data. The lack of timelines can create unpredictability for interested parties because they may lack key information. For example, they may not know: (1) Whether the safety and effectiveness data submitted is sufficient or in the right format for us to conduct a substantive review; (2) when they need to submit new information; or (3) when to expect our determinations regarding eligibility or other feedback. The unpredictability in the process could result in sponsors not performing a required action within reasonable time for our review, performing unnecessary actions (examples of unnecessary actions may include collecting unnecessary or inadequate data, performing tests or studies that do not contribute to data needed by us to make a GRASE determination), or creating unnecessary effort for us and for them. For example, if a TEA remains inactive for a significant amount of time, scientific knowledge may evolve thus creating the need to amend the original TEA. Without specific timelines sponsors may not know whether their initial data submission was insufficient to review, was sufficient but is under review, or whether we require additional information. In addition, without specific timelines, we don't know if sponsors intend to submit additional data or whether they do not intend to pursue their application any further.
This proposed rule complies with certain mandates of the Sunscreen Innovation Act (Pub. L. 113-195), enacted in November 2014. In particular, the proposed rule would establish timelines and metrics for review of TEAs for non-sunscreen OTC drug products. Specific timelines applicable to non-sunscreen TEA conditions would be added in a new section to Title 21 of the CFR, § 330.15. The first proposed timeline is to issue a Notice of Eligibility or a post a letter of ineligibility to the TEA docket within 180 days of submission of a TEA. The second proposed timeline is to issue a filing determination within 90 days of receipt of a complete safety and effectiveness data submission from the sponsor once such sponsor has confirmed that it considers the submission to be complete. If we initially determine the active ingredient or other condition not to be GRASE, we will inform sponsors and interested parties within 730 days from the date of filing as defined in proposed § 330.14(a). The next proposed timeline is to issue a notice of proposed rulemaking (NPRM) within 1,095 days from the date of filing. Lastly, we propose to issue a final rule within 912 days of the closing of the docket of the proposed rulemaking.
The proposed rule would also amend the existing § 330.14 by: (1) Setting forth clear filing determination requirements with regard to the content and format of safety and effectiveness data submissions for TEAs, and by (2) addressing withdrawal of consideration of a TEA or safety and effectiveness data submission. These amendments would apply to all TEAs, and their goal is to provide early notification to sponsors whether their applications meet the filing requirements and to provide more clarity regarding withdrawal of a TEA-related submissions. The proposed amendments are intended to provide us with feedback from sponsors whether they intend to actively pursue their applications, and specify that we may withdraw consideration of a TEA or safety and effectiveness data submission in certain circumstances (such as at a sponsor's request or after prolonged inaction and lack of response to FDA communications). Finally, the proposed rule would also add definitions and make clarifying changes to the TEA regulation in § 330.14.
The proposed clarifications and establishment of timelines for the TEA process seek to dissipate uncertainties that may be preventing interested parties from submitting all the necessary data for us to grant final GRASE determination to existing TEA conditions that have been found to be eligible to be considered for inclusion in the OTC drug monograph system. Since the TEA review process became effective in 2002 (67 FR 3060 at 3074, January 23, 2002), we have received six TEAs for non-sunscreen active ingredients, including applications for dandruff, laxative, anti-gingivitis, and anti-acne products. However, we have not yet issued a proposed rule regarding whether any of these ingredients are GRASE under specified conditions of use. In fact, as of December 2015, the sponsor of one of these TEAs has not yet submitted safety and effectiveness data for our review.
We lack data to quantify the potential benefits of the proposed rule. With the proposed rule, we expect the proposed timelines and data submission clarifications would make the TEA process, including establishing a new OTC drug monograph, more efficient and predictable, and improve communication between us and sponsors. Sponsors may benefit from knowing if additional data is needed and what optimal steps to take to receive a GRASE determination, and we would be able to bring resolution to TEA conditions. However, we do not know the monetary value of added predictability to sponsors. Also, because we have not yet issued tentative GRASE determinations for any of the non-sunscreen TEA conditions under review, as of December 2015, and because we do not know the increase in the probability of granting tentative GRASE determinations resulting from the proposed rule, we request comment on the potential benefits of the proposed rule.
This proposed rule supplements the TEA process. We expect the rule would create a minimal burden on sponsors from the possible cost associated with sending a meeting request letter to us in the event that we refuse to file a safety and effectiveness data submission and the sponsor would like to meet with us to discuss the decision, or the possible cost of calling or writing FDA to request that we not withdraw consideration of a submission in the event that we deem a submission withdrawn under proposed 330.14(k)(ii). Therefore, we anticipate no increase in annual recurring costs for either small or large sponsors.
We expect the six current sponsors would spend time reading and understanding the proposed rule, and this would take from about 6.5 hours to 13 hours. With an hourly wage rate of $133 including 100 percent overhead, each sponsor would incur one-time costs ranging from about $865 to $1,730. We also estimate that we would receive two additional TEAs annually, and thus during a 10-year horizon we estimate potentially twenty additional applicants would spend the time to read and understand the proposed rule. The present value of the total costs over 10 years ranges from about $17,000 to $35,000 with a 7 percent discount rate and from about $19,000 to $38,000 with a 3 percent discount rate. With a discount rate of 7 percent and 3 percent, we estimate that on average sponsors would incur less than $150 of annualized costs per year.
The Regulatory Flexibility Act requires a Regulatory Flexibility Analysis (RFA) unless the Agency can certify that the proposed rule would have no significant impact on a substantial number of small entities. The proposed rule would affect few entities. Moreover, we estimate one-time costs under $2,000 per entity, costs well below 0.01 percent of annual revenues for the smallest entities, and we propose to certify that the rule would not have a significant economic impact on a substantial number of small entities.
We invite comments on this analysis.
We have determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection are given under this section with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
We invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
FDA has OMB approval (Control Number 0910-0688) for the information collection in 21 CFR 330.14, which specifies additional criteria and procedures by which OTC drugs that were initially marketed in the United States after the OTC Drug Review began and OTC drugs without any U.S. marketing experience may become eligible for consideration in the OTC drug monograph system.
The proposed rule would amend the TEA regulations in § 330.14 to make the process more efficient and to make conforming and clarifying changes. Proposed § 330.14(j) would clarify the requirements on content and format criteria for a safety and effectiveness data submission, and would provide procedures for FDA's review of the submissions and determination of whether a submission is sufficiently complete to permit a substantive review. Proposed § 330.14(j)(3) would describe the process for cases in which FDA refuses to file the safety and effectiveness data submission. Under proposed § 330.14(j)(3), if FDA refuses to file the submission, the Agency will notify the sponsor in writing, state the reason(s) for the refusal, and provide the sponsor with 30 days in which to submit a written request for an informal conference with the Agency about whether the Agency should file the submission. A sponsor's submission of a written request for an informal conference is not already approved under OMB Control Number 0910-0688. We estimate that approximately one sponsor (“number of respondents” in table 2, row 1) will annually submit to FDA approximately one request for an informal conference (“total annual responses” in table 2, row 1), and that preparing and submitting each request will take approximately one hour for each sponsor (“average burden per response” in table 2, row 1).
Under proposed § 330.14(j)(4)(iii), the safety and effectiveness data submission must contain a signed statement that the submission represents a complete safety and effectiveness data submission and that the submission includes all the safety and effectiveness data and information available to the sponsor at the time of the submission, whether positive or negative. A sponsor's signed statement is not already approved under OMB Control Number 0910-0688. We estimate that approximately two sponsors (“number of respondents” in table 2, row 2) will annually submit to FDA approximately two signed statements as described previously (“total annual responses” in table 2, row 2), and that preparing and submitting each signed statement will take approximately one hour for each sponsor (“average burden per response” in table 2, row 2).
Under proposed § 330.14(k)(1), FDA, in response to a written request from a sponsor, may withdraw consideration of a TEA submitted under § 330.14(c) or a safety and effectiveness data submission submitted under § 330.14(f). A sponsor's request that FDA withdraw consideration of a TEA or safety and effectiveness data submission is not already approved under OMB Control Number 0910-0688. We estimate that approximately one sponsor (“number of respondents” in table 2, row 3) will annually submit to FDA approximately one request (“total annual responses” in table 2, row 3), and that preparing and submitting each request will take approximately one hour for each sponsor (“average burden per response” in table 2, row 3).
Under proposed § 330.14(k)(2), a sponsor may request that FDA not withdraw consideration of a TEA or safety and effectiveness data submission. A sponsor's request for FDA to not deem its submission withdrawn from consideration is not already approved under OMB Control Number 0910-0688. We estimate that approximately one sponsor (“number of respondents” in table 2, row 4) will annually submit to FDA approximately one request (“total annual responses” in table 2, row 4), and that preparing and submitting each request will take approximately two hours for each sponsor (“average burden per response” in table 2, row 4).
FDA estimates the burden of this information collection as follows:
In compliance with the PRA (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this proposed rule to OMB for review. Interested persons are requested to send comments on this information collection to the Office of Information and Regulatory Affairs, OMB (see
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” The sole statutory provision giving preemptive effect to the proposed rule is section 751 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379r).
We believe that the preemptive effect of this proposed rule, if finalized, would be consistent with Executive Order 13132. Through the publication of this proposed rule, we are providing notice and an opportunity for State and local officials to comment on this rulemaking.
The following references are on display in the Division of Dockets Management (see
1. FDA, Guidance for Industry, “Time and Extent Applications for Nonprescription Drug Products,” September 2011, available at
2. Office of the Federal Register, “A Guide to the Rulemaking Process,” 2011, available at
3. GAO, “Federal Rulemaking, Improvements Needed to Monitoring and Evaluation of Rules Development as Well as to the Transparency of OMB Regulatory Reviews,” April 2009 (GAO-09-205), available at
4. FDA, Draft Guidance for Industry, “Nonprescription Sunscreen Drug Products: Content and Format of Data Submissions To Support a GRASE Determination Under the Sunscreen Innovation Act,” November 2015, available at
5. Examples of FDA internet pages that include progress reports or other metrics include: FDA's FDA-TRACK Web page,
Over-the-counter drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 330 be amended as follows:
21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6, 371.
The revisions and additions read as follows:
This section sets forth additional criteria and procedures by which over-the-counter (OTC) drugs initially marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered in the OTC drug monograph system. This section also addresses conditions regulated as a cosmetic or dietary supplement in a foreign country that would be regulated as OTC drugs in the United States. Section 330.15 sets forth timelines for FDA review and action.
(a)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(f)
(g) * * *
(4) If the condition is initially determined not to be GRASE for OTC use in the United States, the agency will inform the sponsor and other interested parties who have submitted data of its determination by feedback letter, a copy of which will be placed on public display in the docket established in the Division of Dockets Management. The agency will publish a notice of proposed rulemaking to include the condition in § 310.502 of this chapter.
(j)
(2) If FDA finds that none of the reasons in paragraph (j)(4) of this section for refusing to file the safety and effectiveness data submission apply, the agency will file the submission and notify the sponsor in writing. The date of filing begins the FDA timelines described in § 330.15(c)(3) and (4).
(3) If FDA refuses to file the safety and effectiveness data submission, the agency will notify the sponsor in writing and state the reason(s) under paragraph (j)(4) of this section for the refusal. The sponsor may request in writing, within 30 days of the date of the agency's notification, an informal conference with the agency about whether the agency should file the submission, and FDA will convene the meeting within 30 days of the request. If, within 120 days after the informal conference, the sponsor requests that FDA file the submission (with or without correcting the deficiencies), the agency will file the safety and effectiveness data submission over protest under paragraph (j)(2) of this section, notify the sponsor in writing, and review it as filed. The sponsor need not resubmit a copy of a safety and effectiveness data submission that is filed over protest.
(4) FDA may refuse to file a safety and effectiveness data submission if any of the following applies:
(i) The submission is incomplete because it does not contain information required under paragraph (f) of this section. If the submission does not contain required information because such information or data are not relevant to the condition, the submission must clearly identify and provide an explanation for the omission.
(ii) The submission is not organized or formatted in a manner to enable the agency to readily determine if it is sufficiently complete to permit a substantive review.
(iii) The submission does not contain a signed statement that the submission represents a complete safety and effectiveness data submission and that the submission includes all the safety and effectiveness data and information available to the sponsor at the time of the submission, whether positive or negative.
(iv) The submission does not contain an analysis and summary of the data and other supporting information, organized by clinical or nonclinical area, such as clinical efficacy data, clinical safety data, clinical pharmacology, adverse event reports, animal toxicology, chemistry data, and compendial status.
(v) The submission does not contain a supporting document summarizing the strategy used for literature searches, including search terms, sources, dates accessed and years reviewed.
(vi) The submission does not contain a reference list of supporting information, such as published literature, unpublished information, abstracts and case reports, and a copy of the supporting information.
(vii) The submission includes data or information relevant for making a GRASE determination marked as confidential without a statement that the information may be released to the public.
(viii) The submission does not contain a complete environmental assessment under § 25.40 of this chapter or fails to provide sufficient information to establish that the requested action is subject to categorical exclusion under § 25.30 or § 25.31 of this chapter.
(ix) The submission does not contain a statement for each nonclinical laboratory study that it was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if it
(x) The submission does not contain a statement for each clinical investigation involving human subjects that it was conducted in compliance with the institutional review board regulations in part 56 of this chapter, or was not subject to those regulations, and that it was conducted in compliance with the informed consent regulations in part 50 of this chapter.
(xi) The submission does not include financial certification or disclosure statements, or both, as required by part 54 of this chapter, accompanying any clinical data submitted.
(k)
(i) The sponsor requests that its submission be withdrawn from consideration, or
(ii) FDA deems the submission to be withdrawn from consideration due to the sponsor's failure to act on the submission or failure to respond to communications from FDA.
(2) Before FDA deems a submission withdrawn under paragraph (k)(1)(ii) of this section, FDA will notify the sponsor of the submission. If, within 30 days from the date of the notice from FDA, the sponsor requests that FDA not withdraw consideration of the submission, FDA will not deem the submission to be withdrawn.
(3) If FDA withdraws consideration of a submission under paragraph (k)(1) of this section, FDA will post a notice of withdrawal to the docket. Information that has been posted to the public docket for the TEA at the time of the withdrawal (such as a notice of eligibility or a safety and effectiveness data submission that has been accepted for filing and posted to the docket) will remain on the public docket.
(4) If FDA withdraws consideration of a submission under paragraph (k)(1) of this section, the timelines under § 330.15(c) will no longer apply as of the date of withdrawal, and the submission will not be included in the metrics under § 330.15(b).
(a)
(1) A sunscreen active ingredient or combination of sunscreen active ingredients, and other conditions for such ingredients, or
(2) A non-sunscreen active ingredient or combination of non-sunscreen active ingredients and other conditions for such ingredients submitted in a TEA under § 330.14 prior to November 27, 2014, subject to section 586F(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act.
(b)
(1) Number and percent of eligibility notices or ineligibility letters issued within 180 days of submission of a TEA;
(2) Number and percent of filing determinations issued within 90 days of submission of a safety and effectiveness data submission;
(3) If applicable, number and percent of feedback letters issued within 730 days from the date of filing;
(4) Number and percent of notices for proposed rulemaking issued within 1,095 days from the date of filing;
(5) Number and percent of final rules issued within 912 days of closing of the docket of the proposed rulemaking; and
(6) Total number of TEAs submitted under § 330.14.
(c)
(1) Within 180 days of submission of a TEA under § 330.14(c), FDA will issue a notice of eligibility or post to the docket a letter of ineligibility, in accordance with § 330.14(d) and (e).
(2) Within 90 days of submission by the sponsor of a safety and effectiveness data submission, FDA will issue a filing determination in accordance with § 330.14(j). The date of filing begins the FDA timelines in paragraphs (c)(3) and (4) of this section.
(3) Within 730 days from the date of filing, if the condition is initially determined not to be GRASE for OTC use in the United States, FDA will inform the sponsor and other interested parties who have submitted data of its determination by feedback letter in accordance with § 330.14(g)(4).
(4) Within 1,095 days from the date of filing of a safety and effectiveness data submission, FDA will issue a notice of proposed rulemaking to either:
(i) Include the condition in an appropriate OTC monograph(s), either by amending an existing monograph(s) or establishing a new monograph(s), if necessary; or
(ii) Include the condition in § 310.502 of this chapter.
(5) Within 912 days of the closing of the docket of the proposed rulemaking under paragraph (c)(4) of this section, FDA will issue a final rule.
Financial Crimes Enforcement Network (“FinCEN”), Treasury.
Notice of proposed rulemaking.
FinCEN, a bureau of the Department of the Treasury, is proposing amendments to the definitions of “broker or dealer in securities” and “broker-dealer” under the regulations implementing the Bank Secrecy Act. This rulemaking would amend those definitions explicitly to include funding portals that are involved in the offering or selling of crowdfunding securities pursuant to section 4(a)(6) of the Securities Act of 1933. The consequence of those amendments would be that funding portals would be required to implement policies and procedures reasonably designed to achieve compliance with the Bank Secrecy Act requirements currently applicable to brokers or dealers in securities. The proposal to specifically require funding portals to comply with the Bank Secrecy Act regulations is intended to help prevent money laundering, terrorist financing, and other financial crimes.
Written comments on this Notice of Proposed Rulemaking (“NPRM”) must be submitted on or before June 3, 2016.
Comments may be submitted, identified by Regulatory Identification Number (RIN) 1506-AB29, by any of the following methods:
•
•
Please submit comments by one method only. Comments submitted in response to this NPRM will become a matter of public record. Therefore, you should submit only information that you wish to make publicly available.
FinCEN Resource Center at 1-800-767-2825 or 1-703-905-3591 (not a toll free number) and select option 3 for regulatory questions. Email inquiries can be sent to
The Currency and Foreign Transactions Reporting Act of 1970, as amended by the Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (Public Law 107-56) (“USA PATRIOT Act”) and other legislation, which legislative framework is commonly referred to as the Bank Secrecy Act (“BSA”),
The BSA was amended by the Annunzio-Wylie Anti-Money Laundering Act of 1992 (Pub. L. 102-550) (“Annunzio-Wylie”).
The Jumpstart Our Business Startups Act (the “JOBS Act”), enacted on April 5, 2012, establishes the foundation for a regulatory structure for startups and small businesses to raise funds by offering and selling securities through crowdfunding
Title III of the JOBS Act amends the Securities Act of 1933 and the Securities Exchange Act of 1934 to create a new exemption for offerings of crowdfunded securities.
The JOBS Act also amends the Securities Exchange Act of 1934 to include a definition of funding portals in section 3(a)(80).
In addition, the JOBS Act adds new section 3(h) to the Securities Exchange Act of 1934, which requires the SEC to exempt, by rule, conditionally or unconditionally, a registered funding portal from the requirement to register with the SEC as a broker.
Current BSA regulations at Part 1023 of Chapter X of Title 31 of the CFR (the Part that imposes the specific requirements to maintain an anti-money laundering program and to file suspicious activity reports) define “broker-dealers” by reference to persons “registered, or required to be registered, as a broker or dealer with the Commission under the Securities Exchange Act of 1934.”
There are good reasons to ensure that funding portals are subject to BSA regulations. As the SEC has recognized, funding portals would continue to function as brokers regardless of the statutory provisions exempting them from registering as brokers under the Exchange Act.
Moreover, as the SEC noted in its November 5, 2013 Crowdfunding NPRM, there is reason to “expect that funding portals would often facilitate offerings of microcap or low-priced securities, which may be more susceptible to fraud and market manipulation. We believe that imposing the monitoring and reporting requirements of the BSA on funding portals would establish a valuable oversight, prevention and detection mechanism.”
These securities pose a money laundering risk because they are often used to generate illicit assets through market manipulation, insider trading, and fraud.
FinCEN believes that funding portals could play a critical role in detecting, preventing, and reporting money laundering and other illicit financing, such as market manipulation and fraud. As described above, funding portals should be subject to normal BSA obligations. A funding portal, like an introducing broker, is in the best position to know its customers, and to identify and monitor for suspicious and potentially illicit activity at the individual customer level, as compared to other required participants in the transaction such as the qualified third
For all of these reasons, in addition to the provisions finalized in the SEC's Crowdfunding rulemaking, FinCEN believes that it is further appropriate, in response to changes in the registration requirement in the JOBS Act, to amend the BSA definitions of a broker or dealer in securities and broker-dealer to explicitly include funding portals, registered or required to be registered as such, with the SEC. Explicitly requiring funding portals to comply with the BSA's requirements, consistent with registered brokers or dealers in securities, helps ensure consistent regulation of brokers or dealers in securities with fewer opportunities for regulatory gaps, which could be exploited by financial criminals. Because the BSA and its implementing rules are risk-based, we expect that funding portals would design programs commensurate with their limited business model and not the more comprehensive programs established by full service broker-dealers.
On October 26, 2001, the President signed into law the USA PATRIOT Act of 2001. Title III of the USA PATRIOT Act makes a number of amendments to the anti-money laundering provisions of the BSA to promote the prevention, detection, and prosecution of international money laundering and the financing of terrorism. The statutory mandate that all financial institutions, which include brokers or dealers in securities, establish an AML program and comply with the BSA regulations is a key element in the nation's effort to detect and prevent money laundering and the financing of terrorism. If implemented, this proposal would explicitly incorporate a funding portal's activities within the existing definition of brokers or dealers in securities, and require funding portals to comply with the full range of requirements outlined in 31 CFR 1023 applicable to broker-dealers, including: (1) AML program; (2) Suspicious Activity Report; (3) Customer Identification Program; (4) Currency Transaction Report; (5) Recordkeeping and Travel rules; (6) Information Sharing (section 314); (7) Due Diligence for Correspondent Accounts for Foreign Financial Institutions and Private Banking Accounts; (8) Prohibition on Correspondent Accounts for Foreign Shell Banks; and (9) Special Measures (section 311).
Section 352(a) of the USA PATRIOT Act amended section 5318(h) of the BSA. Section 5318(h)(1) requires every financial institution defined in 31 U.S.C. 5312(a)(2), which are also covered in 31 CFR, to establish an AML program that includes, at minimum, (1) the development of internal policies, procedures, and controls; (2) the designation of a compliance officer; (3) an ongoing employee training program; and (4) an independent audit function to test programs.
FinCEN has promulgated Suspicious Activity Report (“SAR”) regulations for a number of financial institutions. These include banks, casinos, money services businesses, brokers or dealers in securities, mutual funds, insurance companies, and futures commission merchants and introducing brokers in commodities.
The Secretary was granted authority in 1970, with the enactment of 31 U.S.C. 5313, to require financial institutions to report currency transactions exceeding $10,000. The information collected on the Currency Transaction Report is required to be provided pursuant to 31 U.S.C. 5313. The implementing regulation for brokers or dealers in securities can be found at 31 CFR 1023.310.
On January 3, 1995, FinCEN and the Board of Governors of the Federal Reserve System (“the Board”) jointly issued a rule that requires banks and nonbank financial institutions to collect and retain information on certain funds transfers and transmittals of funds (the “recordkeeping rule”).
The recordkeeping and travel rules provide uniform recordkeeping and transmittal requirements for financial institutions, and are intended to help law enforcement and regulatory authorities detect, investigate, and prosecute money laundering and other financial crimes by preserving an information trail about persons sending and receiving funds through the funds transfer system.
In general, the recordkeeping rule requires financial institutions to retain certain information on transmittals of funds of $3,000 or more, which must be retrievable and available upon request to FinCEN, to law enforcement, and to regulators to whom FinCEN has delegated the BSA compliance examination authority. Under the travel rule, a financial institution acting as the transmittor's financial institution must obtain and include in the transmittal order certain information on transmittals of funds of $3,000 or more.
31 CFR 1023.220 sets forth the customer identification program (“CIP”) requirements for brokers or dealers in securities, which would include funding portals with the proposed amendments. Under the rule published jointly with the SEC,
31 CFR 1023.500 states generally that brokers or dealers in securities are covered by the special information procedures to detect money laundering and terrorist activity requirements.
Under the section 314(a) requirements, brokers or dealers in securities must respond to requests for information made by FinCEN on behalf of Federal, state, and local law enforcement agencies, or a similar request from FinCEN on its own behalf, on behalf of certain components of Treasury, or on behalf of certain foreign law enforcement agencies.
31 CFR 1023.600 generally states that brokers or dealers in securities are subject to the special standards of diligence, prohibitions, and special measures requirements.
Section 313 of the USA PATRIOT Act amended the BSA by adding subsection (j) to 31 U.S.C. 5318. Sections 1010.630 and 1023.630 implement this provision and set forth the requirements for brokers and dealers in securities. The regulations prohibit covered financial institutions from providing correspondent accounts in the United States to foreign shell banks (
Section 319(b) of the USA PATRIOT Act amended the BSA by adding subsection (k) to 31 U.S.C. 5318, which requires any covered financial institution that provides a
Section 311 of the USA PATRIOT Act (“section 311”) added section 5318A to the BSA, granting FinCEN the authority to require domestic financial institutions and financial agencies to take certain “special measures” upon finding that reasonable grounds exist for concluding that a foreign jurisdiction, institution, class of transaction, or type of account is of “primary money laundering concern.” To address the specific money laundering risks, section 311 provides a range of special measures that can be imposed individually, jointly, in any combination, and in any sequence.
Under 31 CFR 1010.810(a), “[o]verall authority for enforcement and compliance, including coordination and direction of procedures and activities of all other agencies exercising delegated authority under this chapter, is delegated [by the Secretary] to the Director, FinCEN.” In turn, Federal functional regulators have been delegated authority to examine certain financial institutions they oversee for compliance with FinCEN's regulations. FinCEN has delegated to the SEC the authority to examine brokers or dealers in securities, which would include funding portals, for compliance with FinCEN regulations.
This NPRM proposes to revise the regulations implementing the BSA by amending the definition of “broker or dealer in securities” and its synonymous term “broker-dealer” to specifically include funding portals that are involved in the offering or selling of crowdfunding securities pursuant to section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6)). These terms are defined in three different places, and phrased slightly differently for each, but are substantively the same:
• In 31 CFR 1010.100(h), a “broker or dealer in securities” is defined as “[a] broker or dealer in securities, registered or required to be registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934, except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934.”
• 31 CFR 1010.605(e)(1)(viii) and (e)(2)(viii) refer to “[a] broker or dealer in securities registered, or required to be registered, with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
• In 31 CFR 1023.100(b), a “broker-dealer” is defined to mean “a person registered or required to be registered as a broker or dealer with the Commission under the Securities Exchange Act of 1934 (15 U.S.C. 77a
FinCEN proposes to amend these definitions by adding to each the phrase “a person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6)).” FinCEN further proposes to make technical amendments to each definition to create one standard definition of the terms “broker or dealer in securities” and “broker-dealer” to be used throughout the regulations.
FinCEN invites comment on any and all aspects of the NPRM, and specifically seeks comments on the following questions:
• Is the application of all BSA regulations currently covering brokers or dealers in securities to funding portals appropriate?
• Are there exceptions to the regulations that should be granted to funding portals? If so, why would any such exceptions be appropriate?
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this proposed rule is a significant regulatory action, although not economically significant, for purposes of Executive Orders 12866 and 13563.
Section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), Public Law 104-4 (March 22, 1995), requires that an agency prepare a budgetary impact statement before promulgating a rule that may result in expenditure by the state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 202 of the Unfunded Mandates Act also requires an agency to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. Since there is no change to the requirements imposed under existing regulations, FinCEN has determined that it is not required to prepare a written statement under section 202.
The Regulatory Flexibility Act (“RFA”) (5 U.S.C. 601
Section 601(3) of the RFA states that the term “small business” has the same meaning as the term “small business concern” under section 3 of the Small Business Act, unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate for the activities of the agency and publishes such definition(s) in the
Relying on the SEC's definition has the benefit of ensuring consistency in the categorization of small entities for SEC examiners, as well as providing the broker or dealer industry with a uniform standard. In addition, FinCEN's proposed use of the SEC's definition of small entity will have no material impact upon the application of these proposed rules to the broker or dealer industry. FinCEN requests comment on the appropriateness of using the SEC's definition of small entity.
The proposed changes are intended to amend the regulatory definition of broker or dealer in securities to include funding portals in light of the JOBS Act and the Final SEC Crowdfunding Rules. While these amendments do not alter a broker or dealer in securities existing obligations, they will expand the BSA regulations to create obligations for funding portals. Accordingly, FinCEN has prepared an initial regulatory flexibility analysis pursuant to the Regulatory Flexibility Act. A final regulatory flexibility analysis will be conducted after consideration of comments received during the public comment period.
The JOBS Act creates a comprehensive regulatory structure for startups and small businesses to raise capital through securities offerings using the Internet through crowdfunding. It also establishes the regulation of registered funding portals and brokers that are required to act as intermediaries in the offer and sale of crowdfunded securities. The JOBS Act amends the Federal securities laws to include certain funding portals, defined as any person acting as an intermediary in a transaction involving the offer or sale of securities for the account of others solely pursuant to section 4(a)(6) of the Securities Act, but that is exempted from the requirement to register as a broker-dealer with the SEC, and is instead required to be registered as a funding portal with the SEC. This proposed regulation is necessary to expand the scope of the regulatory definition of broker or dealer in securities to incorporate funding portals, to ensure consistent applicability of the BSA regulations to all brokers in securities.
While the proposed BSA requirements would impose burdens on funding portals, the proposed rules would not impose any burden on funding portals in addition to those already imposed on broker-dealers. Consequently, we do not discuss those burdens here, and we would not be requesting any separate approval from OMB to impose the burdens associated with the information collection requirements to comply with the requirements of 31 CFR 1023, including the BSA/AML program, CTR, SAR, CIP, Recordkeeping and travel rules, Due Diligence Programs for Correspondent Accounts for Foreign Financial Institutions and Private Bank accounts, Prohibition on Correspondent Account for Shell Banks, section 311, and section 314 requirements.
The requirements of this proposed regulation, which are consistent with the existing requirements for brokers or dealers in securities, would include funding portals regardless of size. Based on SEC analysis of the estimated 50 funding portals in the first year expected to register with the SEC, as a result of the JOBS Act and implementing regulations, 30 would be classified as “small” entities for purposes of the Regulatory Flexibility Act.
Upon finalization of this proposal, registered funding portals would be required to comply with all of the requirements of the BSA, including the reporting, recordkeeping, and record retention requirements that apply to entities currently defined as brokers or dealers in securities. We recognize that the proposed rules would impose costs on funding portals to implement AML procedures, but we believe that the proposed amendments and requirements provide important benefits. As noted in the SEC NPRM, low-priced and privately-placed securities pose a money laundering risk because they are susceptible to market manipulation and fraud.
The proposed regulations would require funding portals to develop programs reasonably designed to comply with the BSA and to collect and keep certain information, as well as report suspicious activity, among other reports. While the proposed regulations would not change the scope of compliance with the BSA requirements for brokers or dealers in securities that are not funding portals, the reporting, recordkeeping, and other compliance requirements of the proposed regulation would impact small entities that decide to register as funding portals. While the majority of these requirements would be performed by the funding portal's internal compliance personnel, some funding portals may choose to hire outside counsel and third-party service providers to assist in meeting the compliance requirements.
FinCEN believes that there are no Federal rules that duplicate, overlap, or conflict with the proposed regulations or the proposed amendments.
FinCEN considered whether it would be appropriate to establish different compliance or reporting obligations for small funding portals in the proposal, or whether small funding portals should be exempt from any parts of the proposed rules or even from the rules in their entirety. While the proposed rules are based on existing compliance requirements applicable to registered brokers or dealers in securities, FinCEN believes that it would not be necessary, nor would it be advisable, to establish different requirements for small funding portals that engage in crowdfunding. Eliminating or issuing different requirements for smaller funding portals would not be the most effective means of addressing the money laundering risk associated with securities crowdfunding as it would create a loophole and a path of least resistance that money launderers could exploit. The number of small funding portals that would be affected by the proposed rules would be limited. According to the SEC, an industry survey of crowdfunding platforms reported that 191 platforms were estimated to be operating in the United States as of 2012.
FinCEN welcomes comment on any significant alternatives that would minimize the impact of the proposal on small funding portal entities.
The collection of information requirements have been reviewed and approved by the Office of Management and Budget (“OMB”) under section 3507 of the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3507(d). (OMB Control Number 1506-0004 for the CTR requirement, the OMB Control Number for the CTR report itself is 1506-0064, OMB Control Number 1506-0019 for the SAR regulatory requirement, the OMB Control Number for the BSA SAR report itself is 1506-0065, OMB Control Number 1506-0034 for the CIP requirement, OMB Control Number 1506-0043 for the Prohibitions on Correspondent Accounts for Foreign Shell Banks requirement, OMB Control Number 1506-0049 for the section 314 requirement, and OMB Control Number 1506-0053 for the Recordkeeping and travel rules requirements). Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Certain provisions of the proposed rules contain “collection of information” requirements within the meaning of the PRA. This proposal intends to expand the scope of financial institutions subject to the BSA regulations FinCEN issued for brokers or dealers in securities to include funding portals. The collections of information included under OMB Control Number 1506-0004 for the CTR requirement, OMB Control Number 1506-0019 for the SAR requirement, OMB Control Number 1506-0034 for the CIP requirement, OMB Control Number 1506-0043 for the Prohibitions on Correspondent Accounts for Shell Banks requirement, OMB Control Number 1506-0049 for the section 314 requirement, and OMB control number 1506-0053 for the Recordkeeping and travel rules requirements, respectively would be amended to reflect related burdens under the proposed rules.
Funding portals registered or required to be registered with the SEC.
According to the SEC, as of 2014, there are approximately 200 U.S.-based crowdfunding portals in existence. Approximately 15% of these crowdfunding portals would participate in securities-based crowdfunding. The SEC estimates that the number of crowdfunding portals would grow at 60% per year over the next three years and that approximately 50 entities would register as funding portals annually.
For purposes of this analysis it should be noted that the actual number of funding portals that would participate in securities-based crowdfunding transactions is uncertain, as the rules governing securities-based crowdfunding transactions through funding portals have only recently been passed. Based on registration information currently available, the SEC estimates that approximately 10
As this is a new requirement, the estimated average burden associated with the recordkeeping requirement in this proposed rule is three hours for development of a written program. A one hour per year burden is recognized for annual maintenance and update. FinCEN believes funding portals would establish policies and procedures to achieve compliance with the BSA requirements at the same time as it is establishing policies and procedures to comply with the JOBS Act. This would reduce the overall burden on funding portals as all issues concerning the establishment of policies and procedures could be addressed simultaneously. Nevertheless, the proposed rules would not impose any additional burden on funding portals to those currently imposed on brokers or dealers. Therefore, the burden on funding portals would be the same as the existing burden for broker-dealers, and would be included within those estimates FinCEN provided to OMB for brokers or dealers.
Authority delegations (Government agencies), Banks and banking, Currency, Investigations, Law enforcement, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, parts 1010 and 1023 of Chapter X of title 31 of the Code of Federal Regulations are proposed to be amended as follows:
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314, 5316-5332; title III, section 314, Pub. L. 107-56, 115 Stat. 307.
(h)
(1) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(2) A person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6));
(e) * * *
(1) * * *
(viii) A broker or dealer in securities means:
(A) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(B) A person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6));
(2) * * *
(viii) A broker or dealer in securities means:
(A) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(B) A person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6)).
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314, 5316-5332; title III, section 314, Pub. L. 107-56, 115 Stat. 307.
(b)
(1) A person registered, or required to be registered, as a broker or dealer with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(2) A person registered, or required to be registered, as a funding portal with the Securities and Exchange Commission under section 4(a)(6) of the Securities Act of 1933 (15 U.S.C. 77d(a)(6)).
Coast Guard, DHS.
Supplemental Notice of proposed rulemaking.
The Coast Guard proposes to modify the operating schedule that governs the Metro-North WALK Bridge across the Norwalk River, mile 0.1, at Norwalk, Connecticut. The bridge owner submitted a request to require a greater advance notice for bridge openings and to increase time periods the bridge remains in the closed position during the weekday morning and evening rush hours. It is expected that this change to the regulations will create efficiency in drawbridge operations while continuing to meet the reasonable needs of navigation.
Comments and related material must reach the Coast Guard on or before May 4, 2016.
You may submit comments identified by docket number USCG-2014-1057 using Federal eRulemaking Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this supplemental proposed rule, call or email Mr. Chris Bisignano, Project officer, First Coast Guard District, telephone 212-514-4331, email
On August 31, 2015, we published a notice of proposed rulemaking (NPRM) entitled, Drawbridge Operation Regulation; Norwalk River, Norwalk, CT, in the
The Metro-North WALK Bridge, mile 0.1, across the Norwalk River at Norwalk, Connecticut, has a vertical clearance in the closed position of 16 feet at mean high water and 23 feet at mean low water. The drawbridge operation regulations are listed at 33 CFR 117.217(b). The waterway users are seasonal recreational vessels and commercial vessels of various sizes.
The owner of the bridge, Connecticut Department of Transportation (CDOT), requested a change to the Drawbridge Operation Regulations because the volume of train traffic across the bridge during the peak commuting hours makes bridge openings impractical under the current schedule. As a result, bridge openings that occur during peak commuter train hours cause significant delays to commuter rail traffic.
The NPRM published in August 2015 would have permanently changed the operating hours during the Monday-Friday, excluding holidays, timeframes to operate as follows:
(1) The draw shall open on signal between 4:30 a.m. and 9 p.m. after at least a two hour advance notice is given; except that, from 4:30 a.m. through 9:30 a.m. and from 4 p.m. through 9 p.m., Monday through Friday excluding holidays, the draw need not open for the passage of vessel traffic unless an emergency exists.
(2) From 9 p.m. through 4:30 a.m. the draw shall open on signal after at least a four hour advance notice is given.
In response to the comments received and after further review of bridge logs and train schedules, the Coast Guard now proposes to modify the NPRM by adjusting when the draw will be available to open Monday through Friday, excluding holidays as follows:
(1) The draw shall open on signal between 4:30 a.m. and 9 p.m. after at least a two hour advance notice is given; except that, from 5:45 a.m. through 9:45 a.m. and from 4 p.m. through 8 p.m., Monday through Friday excluding holidays, the draw need not open for the passage of vessel traffic unless an emergency exists.
(2) From 9 p.m. through 4:30 a.m. the draw shall open on signal after at least a four hour advance notice is given.
We received four submissions commenting on the NPRM. Three submissions opposed and one submission supported the proposed changes. Some submissions commented on multiple aspects of the proposed regulation. The Coast Guard considered all comments and the responses from CDOT in creation of this supplemental alternative proposal.
One comment suggested a meeting to deliberate the changes proposed in this rulemaking. The Coast Guard met with all parties that expressed interest in this rulemaking on May 11, 2015. The Coast Guard does not see a need to hold additional public meetings at this time.
One comment requested that any modification to the existing rule should not be extended past the initiation of construction of a new replacement bridge. The Coast Guard disagrees. A replacement bridge is only in the planning stage at CDOT. Design and construction of a replacement project for a bridge of this scale typically takes several years. As the timeline of a potential bridge replacement is uncertain, the Coast Guard cannot consider it within this rulemaking.
One comment suggested that any change in the operating regulations for the Metro-North WALK bridge should take into consideration the operating rule of the downstream SR136 (Washington Street) Bridge to facilitate the movement of waterborne commerce. The Coast Guard agrees that the operating schedule of the SR136 Bridge is relevant and considered the operating schedule for SR136 when drafting this supplemental rulemaking.
One comment recommended that the Coast Guard consider revising the 4:30 a.m. to 9:30 a.m. opening schedule, Monday through Friday, as only two trains cross the bridge from 9 a.m. to 9:30 a.m. In response to this comment, the Coast Guard expanded its analysis of train traffic densities; this analysis contributed to the adjustments made in this supplemental rule compared to the proposed rule. These adjustments shorten from five to four hours the a.m. and p.m. periods provided for in the “except that” language in paragraph (b)(1) of the regulation, but also shifts the a.m. period to end later in the day.
Two commenters noted that the added restrictions to opening times of the bridge would negatively impact aggregate deliveries and require alternative deliveries by truck, thereby stressing the road system in the area. Even under the more restrictive test deviation conducted from January 1, 2015, to June 28, 2015, as discussed in the NPRM, Metro-North was able to accommodate all of the requests for bridge openings. Further, review of the bridge logs revealed that in 2014, prior to the aforementioned test deviation and NPRM, as compared to 2015 during the test deviation and the NPRM, the difference in the number of requested bridge openings was negligible. The Coast Guard also reviewed tidal data for this area in consideration of the types of commercial traffic known to use this waterway. The combination of these factors contributed to the adjustments made in this supplemental rule compared to the proposed rule.
The Coast Guard believes the supplemental changes balance the needs of rail and vessel traffic. The proposed changes enhance rail traffic without significantly affecting vessel traffic.
In review of the proposed rule and stakeholder comments, the Coast Guard noted that the term “emergency,” as used within the existing and proposed regulation, was not specifically discussed. The term and associated required actions by the bridge owner are as defined within 33 CFR 117.31. This proposed rule makes no changes to regulations under that section. However, the Coast Guard notes that there may be
Based on further review of bridge logs and scheduled train crossings, the Coast Guard now proposes to modify the NPRM, specifically changing the “except that” language in paragraph (b)(1) of the regulation as indicated above in Section II. This slight modification would better serve the freedom of navigation without significantly impacted rail traffic.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders and discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the proposed rule has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the fact that vessels can still transit the bridge given advanced notice. The vertical clearance under the bridge in the closed position is relatively high enough to accommodate most vessel traffic during the time periods the draw is closed during the morning and evening commuter rush hours.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This proposed rule simply promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters.
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice, and all public comments, are in our online docket at
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(b) The draw of the Metro-North “WALK” Bridge, mile 0.1, at Norwalk, shall operate as follows:
(1) The draw shall open on signal between 4:30 a.m. and 9 p.m. after at least a two hour advance notice is given; except that, from 5:45 a.m. through 9:45 a.m. and from 4 p.m. through 8 p.m., Monday through Friday excluding holidays, the draw need not open for the passage of vessel traffic unless an emergency exists.
(2) From 9 p.m. through 4:30 a.m. the draw shall open on signal after at least a four hour advance notice is given.
(3) A delay in opening the draw not to exceed 10 minutes may occur when a train scheduled to cross the bridge without stopping has entered the drawbridge lock.
(4) Requests for bridge openings may be made by calling the bridge via marine radio VHF FM Channel 13 or the telephone number posted at the bridge.
Coast Guard, DHS.
Proposed rule; reopening of comment period.
The Coast Guard is extending the comment period for the proposed safety zone. In response to public requests, the Coast Guard is extending the comment period until April 17, 2016.
The comment period for the proposed rule published in the
You may submit comments identified by docket number USCG-2016-0026 using the
If you have questions about this rule, call or email Mr. Edward G. LeBlanc, Chief of the Waterways Management Division at Coast Guard Sector Southeastern New England, telephone 401-435-2351, email
On February 16, 2016, the Coast Guard published the proposed rule “Safety Zone, Block Island Wind Farm” in the
The original deadline to submit comments was March 17, 2016. This action extends the deadline for 30 days. Written comments must now be received by April 17, 2016.
Environmental Protection Agency (EPA).
Proposed rule; reopening of comment period; availability of supplemental information.
The Environmental Protection Agency (EPA) is reopening the comment period for a proposed rule to establish a Clean Air Act (CAA) Federal Implementation Plan (FIP) to address regional haze and visibility transport requirements for the State of Arkansas. The reopening of the comment period is strictly limited to EPA's calculations of revised RPGs for Arkansas' Class I areas, which are presented in a supporting document being made available at this time in the docket. EPA is reopening the public comment period until May 4, 2016.
The comment period for the proposed rule published on April 8, 2015 (80 FR 18944), extended at 80 FR 24872 (July 15, 2015), and reopened at 80 FR 43661 (July 23, 2015), is again reopened. Written comments must be received on or before May 4, 2016.
Submit your comments, identified by Docket No. EPA-R06-OAR-2015-0189, at
Dayana Medina, (214) 665-7241;
On April 8, 2015, we published in the
We are announcing the availability in the docket of supplemental information we relied on in our Arkansas FIP proposal, but which was inadvertently omitted from the docket at the time we proposed the FIP. In our proposed rule published on April 8, 2015, we proposed revised RPGs for the 20% worst days for Arkansas' Class I areas, the Caney Creek and Upper Buffalo Wilderness Areas (80 FR at 18998). Our revised RPGs and our methodology for calculating the revised RPGs were discussed in detail in our proposal and in our technical support documentation,
Environmental protection, Air pollution control, Best available control technology, Incorporation by reference, Intergovernmental relations, Interstate transport of pollution, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping, requirements, Sulfur dioxides, Regional haze, Visibility.
42 U.S.C. 7401
Environmental Protection Agency.
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve portions of the State Implementation Plan (SIP) submission, submitted by the Commonwealth of Kentucky, Energy and Environment Cabinet, Department for Environmental Protection, through the Kentucky Division for Air Quality (KDAQ), on April 26, 2013, to demonstrate that the Commonwealth meets the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 1-hour sulfur dioxide (SO
Written comments must be received on or before May 4, 2016.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2014-0426 at
Michele Notarianni, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Notarianni can be reached via electronic mail at
On June 22, 2010 (75 FR 35520), EPA revised the primary SO
Today's action is proposing to approve Kentucky's infrastructure SIP submission for the applicable requirements of the 2010 1-hour SO
Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains.
More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As mentioned above, these requirements include basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. The requirements that are the subject of this proposed rulemaking are summarized below and in EPA's September 13, 2013, memorandum entitled “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2).”
EPA is acting upon the SIP submission from Kentucky that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2010 1-hour SO
EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review (NNSR) permit program submissions to address the permit requirements of CAA, title I, part D.
Section 110(a)(1) addresses the timing and general requirements for infrastructure SIP submissions, and section 110(a)(2) provides more details concerning the required contents of these submissions. The list of required elements provided in section 110(a)(2) contains a wide variety of disparate provisions, some of which pertain to required legal authority, some of which pertain to required substantive program provisions, and some of which pertain to requirements for both authority and substantive program provisions.
The following examples of ambiguities illustrate the need for EPA to interpret some section 110(a)(1) and section 110(a)(2) requirements with respect to infrastructure SIP submissions for a given new or revised NAAQS. One example of ambiguity is that section 110(a)(2) requires that “each” SIP submission must meet the list of requirements therein, while EPA has long noted that this literal reading of the statute is internally inconsistent and would create a conflict with the nonattainment provisions in part D of title I of the Act, which specifically address nonattainment SIP requirements.
Another example of ambiguity within sections 110(a)(1) and 110(a)(2) with respect to infrastructure SIPs pertains to whether states must meet all of the infrastructure SIP requirements in a single SIP submission, and whether EPA must act upon such SIP submission in a single action. Although section 110(a)(1) directs states to submit “a plan” to meet these requirements, EPA interprets the CAA to allow states to make multiple SIP submissions separately addressing infrastructure SIP elements for the same NAAQS. If states elect to make such multiple SIP submissions to meet the infrastructure SIP requirements, EPA can elect to act on such submissions either individually or in a larger combined action.
Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise with respect to infrastructure SIP submission requirements for different NAAQS. Thus, EPA notes that not every element of section 110(a)(2) would be relevant,
EPA notes that interpretation of section 110(a)(2) is also necessary when EPA reviews other types of SIP submissions required under the CAA. Therefore, as with infrastructure SIP submissions, EPA also has to identify and interpret the relevant elements of section 110(a)(2) that logically apply to these other types of SIP submissions. For example, section 172(c)(7) requires that attainment plan SIP submissions required by part D have to meet the “applicable requirements” of section 110(a)(2). Thus, for example, attainment plan SIP submissions must meet the requirements of section 110(a)(2)(A) regarding enforceable emission limits and control measures and section 110(a)(2)(E)(i) regarding air agency resources and authority. By contrast, it is clear that attainment plan SIP submissions required by part D would not need to meet the portion of section 110(a)(2)(C) that pertains to the PSD program required in part C of title I of the CAA, because PSD does not apply to a pollutant for which an area is designated nonattainment and thus subject to part D planning requirements. As this example illustrates, each type of SIP submission may implicate some elements of section 110(a)(2) but not others.
Given the potential for ambiguity in some of the statutory language of section 110(a)(1) and section 110(a)(2), EPA believes that it is appropriate to interpret the ambiguous portions of section 110(a)(1) and section 110(a)(2) in the context of acting on a particular SIP submission. In other words, EPA assumes that Congress could not have intended that each and every SIP submission, regardless of the NAAQS in question or the history of SIP development for the relevant pollutant, would meet each of the requirements, or meet each of them in the same way. Therefore, EPA has adopted an approach under which it reviews infrastructure SIP submissions against the list of elements in section 110(a)(2), but only to the extent each element applies for that particular NAAQS.
Historically, EPA has elected to use guidance documents to make recommendations to states for infrastructure SIPs, in some cases conveying needed interpretations on newly arising issues and in some cases conveying interpretations that have already been developed and applied to individual SIP submissions for particular elements.
As an example, section 110(a)(2)(E)(ii) is a required element of section 110(a)(2) for infrastructure SIP submissions. Under this element, a state must meet the substantive requirements of section 128, which pertain to state boards that approve permits or enforcement orders and heads of executive agencies with similar powers. Thus, EPA reviews infrastructure SIP submissions to ensure that the state's implementation plan appropriately addresses the requirements of section 110(a)(2)(E)(ii) and section 128. The 2013 Guidance explains EPA's interpretation that there may be a variety of ways by which states can appropriately address these substantive statutory requirements, depending on the structure of an individual state's permitting or enforcement program (
As another example, EPA's review of infrastructure SIP submissions with respect to the PSD program requirements in sections 110(a)(2)(C), (D)(i)(II), and (J) focuses upon the structural PSD program requirements contained in part C and EPA's PSD regulations. Structural PSD program requirements include provisions necessary for the PSD program to address all regulated sources and new source review (NSR) pollutants, including greenhouse gases (GHGs). By contrast, structural PSD program requirements do not include provisions that are not required under EPA's regulations at 40 CFR 51.166 but are merely available as an option for the state, such as the option to provide grandfathering of complete permit applications with respect to the 2012 fine particulate matter (PM
For other section 110(a)(2) elements, however, EPA's review of a state's infrastructure SIP submission focuses on assuring that the state's SIP meets basic structural requirements. For example, section 110(a)(2)(C) includes, among other things, the requirement that states have a program to regulate minor new sources. Thus, EPA evaluates whether the state has an EPA-approved minor NSR program and
With respect to certain other issues, EPA does not believe that an action on a state's infrastructure SIP submission is necessarily the appropriate type of action in which to address possible deficiencies in a state's existing SIP. These issues include: (i) Existing provisions related to excess emissions from sources during periods of startup, shutdown, or malfunction that may be contrary to the CAA and EPA's policies addressing such excess emissions (“SSM”); (ii) existing provisions related to “director's variance” or “director's discretion” that may be contrary to the CAA because they purport to allow revisions to SIP-approved emissions limits while limiting public process or not requiring further approval by EPA; and (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Thus, EPA believes it may approve an infrastructure SIP submission without scrutinizing the totality of the existing SIP for such potentially deficient provisions and may approve the submission even if it is aware of such existing provisions.
EPA's approach to review of infrastructure SIP submissions is to identify the CAA requirements that are logically applicable to that submission. EPA believes that this approach to the review of a particular infrastructure SIP submission is appropriate, because it would not be reasonable to read the general requirements of section 110(a)(1) and the list of elements in 110(a)(2) as requiring review of each and every provision of a state's existing SIP against all requirements in the CAA and EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. Because SIPs have grown by accretion over the decades as statutory and regulatory requirements under the CAA have evolved, they may include some outmoded provisions and historical artifacts. These provisions, while not fully up to date, nevertheless may not pose a significant problem for the purposes of “implementation, maintenance, and enforcement” of a new or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP submission. EPA believes that a better approach is for states and EPA to focus attention on those elements of section 110(a)(2) of the CAA most likely to warrant a specific SIP revision due to the promulgation of a new or revised NAAQS or other factors.
For example, EPA's 2013 Guidance gives simpler recommendations with respect to carbon monoxide than other NAAQS pollutants to meet the visibility requirements of section 110(a)(2)(D)(i)(II), because carbon monoxide does not affect visibility. As a result, an infrastructure SIP submission for any future new or revised NAAQS for carbon monoxide need only state this fact in order to address the visibility prong of section 110(a)(2)(D)(i)(II).
Finally, EPA believes that its approach with respect to infrastructure SIP requirements is based on a reasonable reading of sections 110(a)(1) and 110(a)(2) because the CAA provides other avenues and mechanisms to address specific substantive deficiencies in existing SIPs. These other statutory tools allow EPA to take appropriately tailored action, depending upon the nature and severity of the alleged SIP deficiency. Section 110(k)(5) authorizes EPA to issue a “SIP call” whenever the Agency determines that a state's SIP is substantially inadequate to attain or maintain the NAAQS, to mitigate interstate transport, or to otherwise comply with the CAA.
Kentucky's April 26, 2013, infrastructure submission addresses the provisions of sections 110(a)(1) and (2) as described below.
1. 110(a)(2)(A)
KDAQ cited to chapters and associated Kentucky Administrative Regulations (KAR) under Title 401 to demonstrate that the Commonwealth meets the requirements of this element, including the following:
• Chapter 50
• Chapter 51
• Chapter 52 Permits, Registrations, and Prohibitory Rules: 401 KAR 52:001. Definitions for 401 KAR Chapter 52; 401 KAR 52:020. Title V permits;
Collectively these regulations establish enforceable emissions limitations and other control measures, means or techniques, for activities that contribute to SO
In this action, EPA is not proposing to approve or disapprove any existing Commonwealth provisions with regard to excess emissions during SSM operations at a facility. EPA believes that a number of states have SSM provisions which are contrary to the CAA and existing EPA guidance, “State Implementation Plans: Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown” (September 20, 1999), and the Agency is addressing such state regulations in a separate action.
Additionally, in this action, EPA is not proposing to approve or disapprove any existing state rules with regard to director's discretion or variance provisions. EPA believes that a number of states have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109 (November 24, 1987)), and the Agency plans to take action in the future to address such state regulations. In the meantime, EPA encourages any state having a director's discretion or variance provision which is contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.
2. 110(a)(2)(B)
KDAQ cites the following regulations to demonstrate that the Commonwealth meets the requirements of this element: 401 KAR 50:050.
These SIP-approved rules and Kentucky's statute, along with Kentucky's Ambient Air Monitoring Network Plan, provide for the establishment and operation of ambient air quality monitors, the compilation and analysis of ambient air quality data, and the submission of these data to EPA upon request. Annually, states develop and submit to EPA for approval statewide ambient monitoring network plans consistent with the requirements of 40 CFR parts 50, 53, and 58. The annual network plan involves an evaluation of any proposed changes to the monitoring network, includes the annual ambient monitoring network design plan and a certified evaluation of the agency's ambient monitors and auxiliary support equipment.
3. 110(a)(2)(C)
Kentucky's infrastructure SIP submission demonstrates that new major sources and major modifications in areas of the Commonwealth designated attainment or unclassifiable for the specified NAAQS are subject to a federally-approved PSD permitting program meeting all the current structural requirements of part C of title I of the CAA to satisfy the infrastructure SIP PSD elements.
4. 110(a)(2)(D)(i)(I) and (II)
110(a)(2)(D)(i)(I)—prongs 1 and 2: EPA is not proposing any action in this rulemaking related to the interstate transport provisions pertaining to the contribution to nonattainment or interference with maintenance in other states of section 110(a)(2)(D)(i)(I) (prongs 1 and 2) because Kentucky's 2010 1-hour SO
110(a)(2)(D)(i)(II)—prong 3: With regard to section 110(a)(2)(D)(i)(II), the PSD element, referred to as prong 3, this requirement may be met by a state's confirmation in an infrastructure SIP submission that new major sources and major modifications in the state are subject to: A PSD program meeting all the current structural requirements of part C of title I of the CAA, or (if the state contains a nonattainment area that has the potential to impact PSD in another state) to a NNSR program. As discussed in more detail above under section 110(a)(2)(C), Kentucky's SIP contains the relevant SIP revisions necessary to satisfy the structural PSD requirements of prong 3. Kentucky's SIP-approved NNSR program is found at 401 KAR 51:052.
110(a)(2)(D)(i)(II)—prong 4: EPA is not proposing any action in this rulemaking related to the interstate transport provisions pertaining to visibility protection in other states of section 110(a)(2)(D)(i)(II) (prong 4) and will consider these requirements in relation to Kentucky's 2010 1-hour SO
5. 110(a)(2)(D)(ii)
6. 110(a)(2)(E)
In support of EPA's proposal to approve elements 110(a)(2)(E)(i) and (iii), KDAQ's infrastructure submission demonstrates that it is responsible for promulgating rules and regulations for the NAAQS, emissions standards, general policies, a system of permits, fee schedules for the review of plans, and other planning needs. With respect to having the necessary funding and authority to implement the Kentucky SIP, Kentucky regulation, 401 KAR 50:038.
Section 110(a)(2)(E)(ii) requires that Kentucky comply with section 128 of the CAA. Section 128 requires at 128(a)(1) the majority of members of the state board or body which approves permits or enforcement orders represent the public interest and do not derive any significant portion of their income from persons subject to permitting or enforcement orders under the CAA; and 128(a)(2) any potential conflicts of interest by such board or body, or the head of an executive agency with similar, powers be adequately disclosed. For purposes of section 128(a)(1), Kentucky has no boards or bodies with authority over air pollution permits or enforcement actions. Such matters are instead handled by the Director of the KDAQ. As such, a “board or body” is not responsible for approving permits or enforcement orders in Kentucky, and the requirements of section 128(a)(1) are not applicable. For purposes of section 128(a)(2), KDAQ's SIP has been updated. On October 3, 2012, EPA took final action to approve incorporation of KRS Chapters 11A.020, 11A.030, 11A.040 and Chapters 224.10-020 and 224.10-100 into the SIP to address the conflict of interest requirements of section 128.
7. 110(a)(2)(F)
Additionally, Kentucky is required to submit emissions data to EPA for purposes of the National Emissions Inventory (NEI). The NEI is EPA's central repository for air emissions data. EPA published the Air Emissions
8. 110(a)(2)(G)
In addition, KRS 224.10-100
9. 110(a)(2)(H)
KDAQ is responsible for adopting air quality rules and revising SIPs as needed to attain or maintain the NAAQS in Kentucky. 401 KAR Chapter 53
10. 110(a)(2)(J)
11. 110(a)(2)(K)
12. 110(a)(2)(L)
Kentucky regulation, 401 KAR 50:038
13. 110(a)(2)(M)
With the exception of interstate transport provisions pertaining to the contribution to nonattainment or interference with maintenance in other states and visibility protection requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4) and the minor source program requirements of section 110(a)(2)(C), EPA is proposing to approve Kentucky's April 26, 2013, infrastructure SIP submission for the 2010 1-hour SO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Centers for Disease Control and Prevention, HHS.
Denial of petition for addition of a health condition.
On January 5, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 010) to add peripheral neuropathy to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add peripheral neuropathy to the List. The Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
The Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of April 4, 2016.
Rachel Weiss, Program Analyst, 1090 Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629 (this is a toll-free number); email
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act) Public Law 111-347, as amended by Public Law 114-113, added Title XXXIII to the Public Health Service Act (PHS Act)
All references to the Administrator of the WTC Health Program (Administrator) in this notice mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his or her designee.
Pursuant to section 3312(a)(6)(B) of the PHS Act, interested parties may petition the Administrator to add a health condition to the List in 42 CFR 88.1. After receipt of a petition to add a condition to the List, the Administrator must take one of the following four actions described in PHS Act, section 3312(a)(6)(B) and 42 CFR 88.17: (i) Request a recommendation of the STAC; (ii) publish a proposed rule in the
The Secretary, HHS, or her designee, the Director, Centers for Disease Control and Prevention (CDC) and Administrator, Agency for Toxic Substances and Disease Registry (ATSDR), authorized the undersigned, the Administrator of the WTC Health Program, to sign and submit the document to the Office of the Federal Register for publication as an official document of the WTC Health Program. Thomas R. Frieden, M.D., M.P.H., Director, CDC, and Administrator, ATSDR, approved this document on March 24, 2016, for publication.
On January 5, 2016, the Administrator received a petition to add “peripheral neuropathy” to the List (Petition 010).
The Administrator has established a policy for evaluating whether to add non-cancer health conditions to the List of WTC-Related Health Conditions, published online in the Policies and Procedures section of the WTC Health Program Web site.
In accordance with section 3312(a)(6)(B) of the PHS Act, 42 CFR 88.17, and the policy for the addition of non-cancer health conditions to the List, the Administrator reviewed the evidence presented in Petition 010. The WTC Health Program conducted a systematic literature search of the published scientific and medical literature
The first study cited by the petitioner, “Analysis of Short-Term Effects of World Trade Center Dust on Rat Sciatic Nerve,” by Stecker
The systematic literature search identified only one epidemiologic study regarding peripheral neuropathy in 9/11-exposed populations, which was the second study cited by the petitioner, “Neuropathic Symptoms in World Trade Center Disaster Survivors and Responders,” by Wilkenfeld
Due to the substantial limitations inherent in the only available study, the Administrator has concluded that the available evidence does not have the potential to provide a basis for a decision on whether to add peripheral neuropathy to the List.
The findings described above led the Administrator to determine that insufficient evidence exists to take further action, including either proposing the addition of peripheral neuropathy to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 88.17(a)(2)(ii)) or publishing a determination not to publish a proposed rule in the
For the reasons discussed above, the request made in Petition 010 to add peripheral neuropathy to the List of WTC-Related Health Conditions is denied.
Bureau of Land Management, Interior.
Proposed rule; extension of public comment period.
On February 8, 2016, the Bureau of Land Management (BLM) published in the
The comment period for the proposed rule published on February 8, 2016 (81 FR 6616) is extended. Send your comments on this proposed rule to the BLM on or before April 22, 2016. The BLM need not consider, or include in the administrative record for the final rule, comments that the BLM receives after the close of the comment period or comments delivered to an address other than those listed below (see
Eric Jones at the BLM Moab Field Office, 82 East Dogwood Ave., Moab, UT 84532, or by telephone at 435-259-2117; or Timothy Spisak at the BLM Washington Office, 20 M Street SE., Room 2134LM, Washington, DC 20003, or by telephone at 202-912-7311. For questions relating to regulatory process issues, please contact Faith Bremner, BLM Washington Office, at 202-912-7441. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individuals during normal business hours. FIRS is available 24 hours a day, 7 days a week to leave a message or question with the above individuals. You will receive a reply during normal business hours.
If you wish to comment, you may submit your comments by any one of the methods listed in the
1. Those supported by quantitative information or studies; and
2. Those that include citations to, and analyses of, the applicable laws and regulations.
The BLM is not obligated to consider or include in the Administrative Record for the rule comments received after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the address listed under
Before including your address, telephone number, email address, or other personal identifying information in your comment, be advised that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask in your comment to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so.
The proposed rule was published on February 8, 2016 (81 FR 6616), with a 60-day comment period closing on April 8, 2016. Since publication, the BLM has received requests to extend the comment period on the proposed rule, as well as requests not to extend the comment period. Commenters requesting an extension cited the technical nature and complexity of the proposed rule; its potential interaction with the BLM's proposals to update and replace oil and gas production measurement rules currently found in Onshore Orders 3, 4, and 5; and the Environmental Protection Agency's proposed rule to establish standards for control of emissions of methane and volatile organic compounds (VOCs) from certain oil and gas production activities, which would be codified as 40 CFR part 60 subpart OOOOa.
After considering these requests, the BLM has determined that it is appropriate to grant the requests to extend the comment period for a limited time. The BLM is hereby extending the comment period on the proposed rule for 14 days. The closing date of the extended comment period is April 22, 2016.
Agricultural Marketing Service, USDA.
Notice: Intent to renew Charter and call for nominations.
The National Organic Standards Board (NOSB) was established to assist in the development of standards for substances to be used in organic production and to advise the Secretary on the implementation of the Organic Foods Production Act of 1990 (OFPA). Through this Notice, USDA is announcing the following: its intent to renew the Charter of the NOSB, which expires on May 8, 2016; its call for nominations to fill five (5) upcoming vacancies for appointments in 2017, and its call for nominations for a pool of candidates to fill future unexpected vacancies in any of the position categories should that occur.
The current NOSB Charter expires on May 8, 2016. Written nominations must be postmarked on or before June 3, 2016.
Nomination applications can be sent via email to Michelle Arsenault at
Michelle Arsenault, (202) 720-0081; Email:
The OFPA of 1990, as amended (7 U.S.C. Section 6501
Pursuant to the FACA, notice is hereby given that the Secretary of Agriculture intends to renew the NOSB Charter for two years. The NOSB is of a continuing nature due to the changes in organic production and marketing brought about through advancements in science and technology.
The NOSB is composed of 15 members including; four individuals who own or operate an organic farming operation, two individuals who own or operate an organic handling operation; one individual who owns or operates a retail establishment with significant trade in organic products; three individuals with expertise in areas of environmental protection and resource conservation; three individuals who represent public interest or consumer interest groups; one scientist with expertise in the fields of toxicology, ecology, or biochemistry; and one individual who is a certifying agent. Through this Notice, the USDA seeks to fulfill two goals: Firstly, it is seeking nominations to fill five (5) upcoming vacancies for the following positions: One (1) organic producer; one (1) individual with expertise in areas of environmental protection and resource conservation; one (1) representative of a public or consumer interest group; one (1) organic handler or processor; and one (1) scientist (toxicology, ecology or biochemistry). The Secretary of Agriculture will appoint one person to each of these five positions to serve a 5-year term of office beginning January 24, 2017, and ending January 23, 2022. Secondly, the USDA is seeking nominations to fill future unexpected vacancies in any of the position categories. These nominations will be held as a pool of candidates that the Secretary of Agriculture can draw upon as replacement appointees if unexpected vacancies occur. A person appointed to fill a vacancy will serve for the remainder of the 5-year term of the vacant position.
As per the OFPA, individuals seeking appointment to the NOSB must meet the definition of the position that they seek as identified under section 6518 of this title, as well as satisfy the selection criteria for an NOSB member.
Selection criteria include the following: An understanding of organic principles and practical experience in the organic community; demonstrated experience and interest in organic production and organic certification; demonstrated experience with respect to agricultural products produced and handled on certified organic farms; a commitment to the integrity of the organic food and fiber industry; demonstrated experience in the development of public policy such as participation on public or private advisory boards, boards of directors or other comparable organizations; support of consumer and public interest organizations; participation in standards development or involvement in educational outreach activities; the ability to evaluate technical information and to fully participate in Board deliberation and recommendations; the willingness to commit the time and energy necessary to assume Board duties; and other such factors as may be appropriate for specific positions.
To nominate yourself or someone else, please submit the following: a resume (required), Form AD-755 (required), which can be accessed at:
If USDA receives a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552), for records relating to NOSB nominations, your application materials may be released to the requester. Prior to the release of the information, personally identifiable information protected by the FOIA Privacy Act will be redacted.
Nominations are open to all individuals without regard to race, color, religion, gender, national origin, age, mental or physical disability,
The information collection requirements concerning the nomination process have been previously cleared by the Office of Management and Budget (OMB) under OMB Control No. 0505-0001.
The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2017 Foreign Market Development Cooperator (Cooperator) program. The intended effect of this notice is to solicit applications from eligible applicants for fiscal year 2017 and to set out criteria for the award of funds under the program in October 2016. The Cooperator program is administered by personnel of the Foreign Agricultural Service (FAS).
All applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Applications received after this date will not be considered.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service
FAS allocates funds in a manner that effectively supports the strategic decision-making initiatives of the Government Performance and Results Act (GPRA) of 1993. In deciding whether a proposed project will contribute to the effective creation, expansion, or maintenance of foreign markets, FAS considers whether the applicant provides a clear, long-term agricultural trade strategy and a program effectiveness time line against which results can be measured at specific intervals using quantifiable product or country goals. FAS also considers the extent to which a proposed project targets markets with the greatest growth potential. These factors are part of the FAS resource allocation strategy to fund applicants who can demonstrate performance and address the objectives of the GPRA.
Under the Cooperator program, FAS enters into agreements with eligible nonprofit U.S. trade organizations to share the cost of certain overseas marketing and promotion activities. Funding priority is given to organizations that have the broadest possible producer representation of the commodity being promoted and that are nationwide in membership and scope. Cooperators may receive assistance only for generic activities that do not involve promotions targeted directly to consumers. The program generally operates on a reimbursement basis.
The degree of commitment of an applicant to the promotional strategies contained in its application, as represented by the cost-share contributions specified therein, is considered by FAS when determining which applications will be approved for funding. Cost-share may be actual cash invested or in-kind contributions, such as professional staff time spent on design and execution of activities. The Cooperator program regulations, including sections 1484.50 and 1484.51, provide detailed discussion of eligible and ineligible cost-share contributions.
Applicants planning to use the web-based application must contact FAS' Program Operations Division to obtain site access information. The web-based application may be found at the following URL address:
FAS highly recommends applying via the web-based application as this format virtually eliminates paperwork and expedites the FAS processing and review cycle. However, applicants also have the option of submitting an electronic version of their application to FAS at
In addition, in accordance with 2 CFR part 25, each entity that applies to the Cooperator program and does not qualify for an exemption under 2 CFR 25.110 must:
(i) Provide a valid DUNS number in each application or plan it submits to CCC;
(ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and
(iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.
Similarly, in accordance with 2 CFR part 170, each entity that applies to the Cooperator program and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive funding under the Cooperator program. Incomplete applications and applications that do not otherwise conform to this announcement or the Cooperator program regulations will not be accepted for review.
FAS administers various other agricultural export assistance programs, including the Market Access Program (MAP), the Emerging Markets Program, the Quality Samples Program, and the Technical Assistance for Specialty Crops program. Any organization that is not interested in applying for the Cooperator program, but would like to request assistance through one of the other programs mentioned, should contact the Program Operations Division.
Applications received by the closing date will be reviewed by FAS to determine the eligibility of the applicants and the completeness of the applications. These requirements appear in sections 1484.14 and 1484.20 of the Cooperator program regulations as well as in this Notice. Applications that meet the requirements then will be further evaluated by the appropriate Commodity Branch office of FAS' Cooperator Programs Division. The Commodity Branch will review each application against the criteria listed in section 1484.21 of the Cooperator program regulations. The purpose of this review is to identify meritorious proposals. The Commodity Branch then recommends an appropriate funding level for each application for consideration by the Office of the Deputy Administrator, Office of Trade Programs.
Meritorious applications are passed on to the Office of the Deputy Administrator, Office of Trade Programs, for the purpose of allocating available funds among those applicants. Applicants will compete for funds on the basis of the following allocation criteria as appropriate (the number in parentheses represents a percentage weight factor):
• The applicant's 6-year average share (2012-2017) of all contributions under the Cooperator program (contributions may include cash and goods and services provided by U.S. entities in support of foreign market development activities) compared to the applicant's 6-year average share (2012-2017) of the funding level for all Cooperator program participants.
• The 6-year average share (2011-2016) of the value of exports promoted by the applicant compared to the applicant's 6-year average share (2011-2016) of the funding level for all Cooperator participants plus, for those groups participating in the MAP program, a 6-year average share (2011-2016) of all MAP budgets.
• The 6-year average share (2011-2016) of the total value of world trade of the commodities promoted by the applicant compared to the applicant's 6-year average share (2011-2016) of all Cooperator program expenditures plus, for those groups participating in the MAP program, a 6-year average share (2011-2016) of all MAP expenditures.
• The projected total dollar value of world trade of the commodities being promoted by the applicant for the year 2022 compared to the applicant's requested funding level.
• The actual dollar value share of world trade of the commodities being promoted by the applicant for the year 2015 compared to the applicant's past projected share of world trade of the commodities being promoted by the applicant for the year 2015, as specified in the applicant's 2012 Cooperator program application.
The Commodity Branches' recommended funding levels for each applicant are converted to percentages of the total Cooperator program funds available and then multiplied by each weight factor to determine the amount of funds allocated to each applicant.
For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture
The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2017 Market Access Program (MAP). The intended effect of this notice is to solicit applications from eligible applicants for fiscal year 2017 and to set out criteria for the award of funds under the program in October 2016. The MAP is administered by personnel of the Foreign Agricultural Service (FAS).
All applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Applications received after this date will not be considered.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service
FAS allocates funds in a manner that effectively supports the strategic decision-making initiatives of the Government Performance and Results Act (GPRA) of 1993. In deciding whether a proposed project will contribute to the effective creation, expansion, or maintenance of foreign markets, FAS considers whether the applicant provides a clear, long-term agricultural trade strategy and a program effectiveness time line against which results can be measured at specific intervals using quantifiable product or country goals. FAS also considers the extent to which a proposed project targets markets with the greatest growth potential. These factors are part of the FAS resource allocation strategy to fund applicants who can demonstrate performance and address the objectives of the GPRA.
Under the MAP, the CCC enters into agreements with eligible Participants to share the cost of certain overseas marketing and promotion activities. MAP Participants may receive assistance for generic or brand promotion activities. For generic activities, funding priority is given to organizations that have the broadest possible producer representation of the commodity being promoted and that are nationwide in membership and scope. For branded activities, only nonprofit U.S. agricultural trade organizations, nonprofit state regional trade groups (SRTGs), U.S. agricultural cooperatives, and state government agencies can participate directly in the brand program. The MAP generally operates on a reimbursement basis.
The degree of commitment of an applicant to the promotional strategies contained in its application, as represented by the cost-share contributions specified therein, is considered by FAS when determining which applications will be approved for funding. Cost-share may be actual cash invested or in-kind contributions, such as professional staff time spent on design and execution of activities. The MAP regulations, in section 1485.16, provide a detailed discussion of eligible and ineligible cost-share contributions.
FAS highly recommends applying via the web-based application, as this format virtually eliminates paperwork and expedites the FAS processing and review cycle. However, applicants also have the option of submitting an electronic version of their application to FAS at
In addition, in accordance with 2 CFR part 25, each entity that applies to the MAP and does not qualify for an exemption under 2 CFR 25.110 must:
(i) Provide a valid DUNS number in each application or plan it submits to CCC;
(ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and
(iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.
Similarly, in accordance with 2 CFR part 170, each entity that applies to MAP and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive MAP funding.
Incomplete applications and applications that do not otherwise conform to this announcement and the MAP regulations will not be accepted for review.
FAS administers various other agricultural export assistance programs including the Foreign Market Development Cooperator (Cooperator) program, the Emerging Markets Program, the Quality Samples Program, and the Technical Assistance for Specialty Crops program. Any organization that is not interested in applying for the MAP, but would like to request assistance through one of the other programs mentioned, should contact the Program Operations Division.
(1) Phase 1—Sufficiency Review and FAS Divisional Review:
Applications received by the closing date will be reviewed by FAS to determine the eligibility of the applicants and the completeness of the applications. These requirements appear in sections 1485.12 and 1485.13 of the MAP regulations. Applications that meet the requirements then will be further evaluated by the appropriate Commodity Branch office of FAS' Cooperator Programs Division. The Commodity Branch will review each application against the criteria listed in section 1485.14(b) and (c) of the MAP regulations as well as in this Notice. The purpose of this review is to identify meritorious proposals and to recommend an appropriate funding level for each application based upon these criteria.
(2) Phase 2—Competitive Review:
Meritorious applications then will be passed on to the Office of the Deputy Administrator, Office of Trade Programs, for the purpose of allocating available funds among the applicants. Applicants will compete for funds on the basis of the following allocation criteria as applicable (the number in parentheses represents a percentage weight factor):
• The applicant's 4-year average share (2014-2017) of all contributions under the MAP (cash and goods and services provided by U.S. entities in support of overseas marketing and promotion activities) compared to the applicant's 4-year average share (2014-2017) of the funding level for all MAP Participants.
• The 3-year average share (2013-2015) of the value of exports promoted by the applicant compared to the applicant's 2-year average share (2015-2016) of the funding level for all MAP Participants plus, for those groups participating in the Cooperator program, the 2-year average share (2015-2016) of all Cooperator program budgets.
• The total dollar value of projected exports promoted by the applicant for 2017 compared to the applicant's requested funding level.
• Actual exports for 2015 as reported in the 2017 MAP application compared to past projections of exports for 2015 as specified in the 2015 MAP application.
The Commodity Branches' recommended funding levels for each applicant are converted to percentages of the total MAP funds available and then multiplied by each weight factor as described above to determine the amount of funds allocated to each applicant.
For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture
The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2017 Emerging Markets Program (EMP). The intended effect of this notice is to solicit applications from the private sector and from government agencies for fiscal year 2017 and to set out criteria for the award of funds under the program in October 2016. The EMP is administered by personnel of the Foreign Agricultural Service (FAS).
To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Any applications received after this time will be considered only if funds are still available.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service
All U.S. agricultural commodities, except tobacco, are eligible for consideration. Agricultural product(s) should be comprised of at least 50 percent U.S. origin content by weight, exclusive of added water, to be eligible for funding. Proposals that seek support for multiple commodities are also eligible. EMP funding may only be used to develop, maintain, or expand emerging markets for U.S. agricultural commodities and products through generic activities. EMP funding may not be used to support the export of another country's products to the United States, or to promote the development of a foreign economy as a primary objective.
(a) Assistance to teams consisting primarily of U.S. individuals expert in assessing the food and rural business systems of other countries. This type of EMP project must include all three of the following:
• Conduct an assessment of the food and rural business system needs of an emerging market;
• Make recommendations on measures necessary to enhance the effectiveness of these systems; and
• Identify opportunities and projects to enhance the effectiveness of the emerging market's food and rural business systems.
To be eligible, such proposals must clearly demonstrate that experts are primarily agricultural consultants, farmers, and other persons from the private sector and government officials, and that they have expertise in assessing the food and rural business systems of other countries.
(b) Assistance to enable individuals from emerging markets to travel to the United States so that these individuals can, for the purpose of enhancing the food and rural business systems in their countries, become familiar with U.S. technology and agribusiness and rural enterprise operations by consulting with food and rural business system experts in the United States.
(c) Assistance to enable U.S. agricultural producers and other individuals knowledgeable in agricultural and agribusiness matters to travel to emerging markets to assist in transferring their knowledge and expertise to entities in emerging markets. Such travel must be to emerging markets. Travel to developed markets is not eligible under the program even if the traveler's targeted market is an emerging market.
(d) Technical assistance to implement the recommendations, projects, and/or opportunities identified under 2(a) above. Technical assistance that does not implement the recommendations, projects, and/or opportunities identified by assistance under 2(a) above is not eligible under the EMP.
Proposals that do not fall into one or more of the four categories above, regardless of previous guidance provided regarding the EMP, are not eligible for consideration under the program.
EMP funds may not be used to support normal operating costs of individual organizations, nor as a source to recover pre-award costs or prior expenses from previous or ongoing projects. Proposals that counter national strategies or duplicate activities planned or already underway by U.S. non-profit agricultural commodity or trade associations (“cooperators”) will not be considered. Other ineligible expenditures include: branded product promotions (
(a) Is taking steps toward developing a market-oriented economy through the food, agriculture, or rural business sectors of the economy of the country; and
(b) Has the potential to provide a viable and significant market for U.S. agricultural commodities or products of U.S. agricultural commodities.
Because EMP funds are limited and the range of potential emerging market countries is worldwide, consideration will be given only to proposals that target countries or regional groups with per capita income of less than $12,736 (the current ceiling on upper middle income economies as determined by the World Bank [World Development Indicators; July 2015,
Income limits and their calculation can change from year to year with the result that a given country may qualify under the legislative and administrative criteria one year, but not the next. Therefore, CCC has not established a fixed list of emerging market countries.
A few countries technically qualify as emerging markets but may require a separate determination before funding can be considered because of political sensitivities.
In general, all qualified proposals received before the application deadline will compete for EMP funding. The applicant's willingness to contribute resources, including cash, goods, and services, will be a critical factor in determining which proposals are funded under the EMP. Each proposal will also be judged on the potential benefits to the industry represented by the applicant and the degree to which the proposal demonstrates industry support.
The limited funds and the range of eligible emerging markets worldwide generally preclude CCC from approving large budgets for individual projects. While there is no minimum or maximum amount set for EMP-funded projects, most projects are funded at a level of less than $500,000 and for a duration of approximately one year. Private entities may submit multi-year proposals requesting higher levels of funding that may be considered in the context of a detailed strategic implementation plan. Funding in such cases is generally limited to three years and provided one year at a time with commitments beyond the first year subject to interim evaluations and funding availability. Proposals from government entities are not eligible for multi-year funding.
Funding for successful proposals will be provided through specific agreements. The CCC, through FAS, will be kept informed of the implementation of approved projects through the requirement to provide interim progress reports and final performance reports. Changes in the original project timelines and adjustments within project budgets must be approved in advance by FAS.
EMP funds awarded to government agencies must be expended or otherwise obligated by close of business, September 30, 2017.
U.S. export market development cooperators and SRTGs may seek funding to address priority, market specific issues and to undertake technical assistance activities supported by an approved EMP assessment.
Cost-sharing is not required for proposals from government agencies, but is mandatory for all other eligible entities, even when they may be party to a joint proposal with a government agency. Contributions from USDA or other government agencies or programs may not be counted toward the stated cost-share requirement of other applicants. Similarly, contributions from foreign (non-U.S.) organizations may not be counted toward the cost-share requirement, but may be counted in the total cost of the project.
Applicants are strongly encouraged to submit their applications to FAS through the web-based UES application. The Internet-based format reduces paperwork and expedites FAS' processing and review cycle. Applicants planning to use the on-line UES system must contact the Program Operations Division to obtain site access information. The Internet-based application is located at the following URL address:
Although FAS highly recommends applying via the UES, applicants also have the option of submitting an electronic application to FAS at
In addition, in accordance with the Office of Management and Budget's issuance of a final policy (68 FR 38402 (June 27, 2003)) regarding the need to identify entities that are receiving government awards, all applicants must submit a Dun and Bradstreet Data Universal Numbering System (DUNS) number. An applicant may request a DUNS number at no cost by calling the dedicated toll-free DUNS number request line at (866) 705-5711.
In addition, in accordance with 2 CFR part 25, each entity that applies to the EMP and does not qualify for an exemption under 2 CFR 25.110 must:
(i) Provide a valid DUNS number in each application or plan it submits to CCC;
(ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and
(iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.
Similarly, in accordance with 2 CFR part 170, each entity that applies to the EMP and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive EMP funding.
Applications should be no longer than ten (10) pages and include the following information:
(a) Date of proposal;
(b) Name of organization submitting proposal;
(c) Organization address, telephone, and fax;
(d) Tax ID number;
(e) DUNS number;
(f) Primary contact person;
(g) Full title of proposal;
(h) Target market(s);
(i) Specific description of activity/activities to be undertaken;
(j) Clear demonstration that successful implementation will benefit an emerging market's food and rural business system and/or reduce potential trade barriers, and will benefit a particular industry as a whole, not just the applicant(s);
(k) Current conditions in the target market(s) affecting the intended commodity or product;
(l) Description of the need to assess the food and rural business systems of the emerging market, or of the recommendations, projects, and/or opportunities previously identified by an approved EMP assessment that are to be addressed by the project;
(m) Project objectives;
(n) Performance measures: Benchmarks for quantifying progress in meeting the objectives;
(o) Rationale: Explanation of the underlying reasons for the project proposal and its approach, the anticipated benefits, and any additional pertinent analysis;
(p) Explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance;
(q) Timeline(s) for implementation of activity, including start and end dates;
(r) Information on whether similar activities are or have previously been funded with USDA resources in the target country or countries (
(s) Detailed line item activity budgets:
• Cost items should be allocated separately to each participating organization;
• Individual expense items constituting a proposed activity's overall budget (
(1) Which items are to be covered by EMP funding;
(2) Which are to be covered by the participating U.S. organization(s); and
(3) Which are to be covered by foreign third parties (if applicable);
• Cost line items for consultant fees should show the calculation of the daily rate and the number of days;
• Cost line items for travel expenses should show the number of trips and the destination, cost, and objective for each trip; and
(t) Qualifications of applicant(s) should be included as an attachment.
• Proposals received by 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered for funding with other proposals received by that date;
• Proposals not approved for funding during the review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;
• Proposals received after 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered in the order received for funding only if funding remains available.
5.
• Appropriateness of the Activity, including the ability of the applicant to provide an experienced U.S.-based staff with knowledge and expertise to ensure adequate development, supervision, and execution of the proposed project; the entity's willingness to contribute resources, including cash and goods and services of the U.S. industry, with greater weight given to cash contributions (for private sector proposals only); and the conditions or constraints affecting the level of U.S. exports and market share for the agricultural commodity/product (30%);
• Market Impact, including the degree to which the proposed project is likely to contribute to the development, maintenance, or expansion of U.S. agricultural exports to emerging markets; demonstration of how a proposed project will benefit a particular industry as a whole; and the quality of the project's proposed performance measures (50%); and
• Completeness and Viability of the proposal along with past program results and evaluations, if applicable (20%).
Please see 7 CFR part 1486 for additional evaluation criteria.
For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture
The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2017 Technical Assistance for Specialty Crops (TASC) program. The intended effect of this notice is to solicit applications from the private sector and from government agencies for fiscal year 2017 and to set out criteria for the award of funds in October 2016. The TASC program is administered by personnel of the Foreign Agricultural Service (FAS).
To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Any applications received after this time will be considered only if funds are still available.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service
Prior to the enactment of the Agricultural Act of 2014 (Act) on February 7, 2014, the TASC program was not available to address technical barriers to trade except for those that were related to sanitary or phytosanitary issues. The Act amended the statute authorizing the TASC program to allow the program to be used to address technical barriers to trade regardless of whether the barriers are related to a sanitary or phytosanitary barrier. The TASC regulations have been amended to reflect the recent statutory change.
As a general matter, TASC program projects should be designed to address the following criteria:
• Projects should identify and address a sanitary, phytosanitary, or technical barrier that prohibits or threatens the export of U.S. specialty crops;
• Projects should demonstrably benefit the represented industry rather than a specific company or brand;
• Projects must address barriers to exports of commercially-available U.S. specialty crops for which barrier removal would predominantly benefit U.S. exports; and
• Projects should include an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance.
Examples of expenses that CCC may agree to reimburse under the TASC program include, but are not limited to: Initial pre-clearance programs, export protocol and work plan support, seminars and workshops, study tours, field surveys, development of pest lists, pest and disease research, reasonable logistical and administrative support, and travel and per diem expenses.
In general, all qualified proposals received before the specified application deadline will compete for funding. The limited funds and the range of barriers affecting the exports of U.S. specialty crops worldwide preclude CCC from approving large budgets for individual projects. Proposals requesting more than $500,000 in any given year will not be considered. Additionally, private entities may submit multi-year proposals that may be considered in the context of a detailed strategic implementation plan. The maximum duration of an activity is five years. Funding in such cases may, at FAS' discretion, be provided one year at a time with commitments beyond the first year subject to interim evaluations and funding availability. In order to validate funding eligibility, proposals must specify previous years of TASC funding for each proposed activity/title/market/constraint combination. Government
Applicants may submit multiple proposals, and applicants with previously approved TASC proposals may apply for additional funding. The number of approved projects that a TASC participant can have underway at any given time is five. Please see 7 CFR part 1487 for additional restrictions.
FAS will consider providing either grant funds as direct assistance to U.S. organizations or technical assistance on behalf of U.S. organizations, provided that the organization submits timely and qualified proposals. FAS will review all proposals against the evaluation criteria contained in the program regulations.
Funding for successful proposals will be provided through specific agreements. These agreements will incorporate the proposal as approved by FAS. FAS must approve in advance any subsequent changes to the project. FAS or another Federal agency may be involved in the implementation of approved projects.
Foreign organizations, whether government or private, may participate as third parties in activities carried out by U.S. organizations, but are not eligible for direct funding assistance from the program.
Although FAS highly recommends applying via the web-based UES application, applicants have the option of submitting an electronic version to FAS at
In addition, in accordance with 2 CFR part 25, each entity that applies to the TASC and does not qualify for an exemption under 2 CFR 25.110 must:
(i) Provide a valid DUNS number in each application or plan it submits to CCC;
(ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and
(iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.
Similarly, in accordance with 2 CFR part 170, each entity that applies to the TASC program and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive TASC funding.
Incomplete applications and applications that do not otherwise conform to this announcement will not be accepted for review.
• Proposals received by 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered for funding with other proposals received by that date;
• Proposals not approved for funding during the review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;
• Proposals received after 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered in the order received for funding only if funding remains available.
Notwithstanding the foregoing, a proposal may be submitted for expedited consideration under the TASC Quick Response process if, in addition to meeting all requirements of the TASC program, a proposal clearly identifies a time-sensitive activity. In these cases, a proposal may be submitted at any time for an expedited evaluation. Such a proposal must include a specific request for expedited evaluation.
FAS will track the time and date of receipt of all proposals.
Certain types of expenses are not eligible for reimbursement by the program, such as the costs of market research, advertising, or other promotional expenses, and will be set forth in the written program agreement between CCC and the participant. CCC will also not reimburse unreasonable expenditures or any expenditure made prior to approval of a proposal.
(1) The nature of the specific export barrier and the extent to which the proposal is likely to successfully remove, resolve, or mitigate that barrier (12.5%);
(2) The potential trade impact of the proposed project on market retention, market access, and market expansion, including the potential for expanding commercial sales in the targeted market (12.5%);
(3) The completeness and viability of the proposal. Among other things, this can include the cost of the project and the amount of other resources dedicated to the project, including cash, goods, and services of the U.S. industry and foreign third parties (15%);
(4) The ability of the organization to provide an experienced staff with the requisite technical and trade experience to execute the proposal (15%);
(5) The extent to which the proposal is targeted to a market in which the United States is generally competitive (17.5%);
(6) The degree to which time is essential to addressing specific export barriers (5%);
(7) The ability of the applicant to provide a broad base of producer representation (12.5%);
(8) The effectiveness and potential of the performance measures (10%);
For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture
The Commodity Credit Corporation (CCC) announces it is inviting proposals for the 2017 Quality Samples Program (QSP). The intended effect of this notice is to solicit applications from eligible applicants for fiscal year 2017 and to set out the criteria for the award of funds under the program in October 2016. QSP is administered by personnel of the Foreign Agricultural Service (FAS).
To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, June 3, 2016. Any applications received after this time will be considered only if funds are still available.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service
QSP participants will be responsible for procuring (or arranging for the procurement of) commodity samples, exporting the samples, and providing the on-site technical assistance necessary to facilitate successful use of the samples by importers. Participants that are funded under this announcement may seek reimbursement from QSP for the sample purchase price and for the cost of transporting the samples domestically to the port of export and then to the foreign port or point of entry. Transportation costs from the foreign port or point of entry to the final destination are not eligible for reimbursement. CCC will not reimburse the costs incidental to purchasing and transporting samples, such as: Inspection or documentation fees, certificates of any kind, tariffs, etc. Although providing technical assistance is required for all projects, QSP will not reimburse the costs of providing technical assistance. A QSP participant will be reimbursed after CCC reviews its reimbursement claim and determines that the claim is complete.
As a general matter, QSP projects should conform to the following guidelines:
• Projects should benefit the represented U.S. industry and not a specific company or brand;
• Projects should develop a new market for a U.S. product, promote a new U.S. product, or promote a new use for a U.S. product rather than promote the substitution of one established U.S. product for another;
• Commodities provided under a QSP project must be available on a commercial basis and in sufficient supply;
• The QSP project must either subject the commodity sample to further processing or substantial transformation in the importing country, or the sample must be used in technical seminars in the importing country designed to demonstrate to an appropriate target audience the proper preparation or use of the sample in the creation of an end product;
• Samples provided in a QSP project shall not be directly used as part of a retail promotion or supplied directly to consumers. However, the end product (that is, the product resulting from further processing, substantial transformation, or a technical preparation seminar) may be provided to end-use consumers to demonstrate to importers consumer preference for that end product;
• Samples shall be in quantities less than a typical commercial sale and limited to the amount sufficient to achieve the project goal (
• Projects should be completed within one year of CCC approval.
QSP projects shall target foreign importers and audiences who:
• Have not previously purchased the U.S. commodity that will be transported under QSP;
• Are unfamiliar with the variety, quality attributes, or end-use characteristics of the U.S. commodity;
• Have been unsuccessful in previous attempts to import, process, and market the U.S. commodity (
• Are interested in testing or demonstrating the benefits of the U.S. commodity; or
• Need technical assistance in processing or using the U.S. commodity.
Under this announcement, the number of projects per participant will not be limited. However, individual projects will be limited to $75,000 of QSP reimbursement. Projects comprised only of technical preparation seminars (that is, projects that do not include further processing or substantial transformation of the sample) will be limited to $15,000 of QSP reimbursement due to the need for smaller samples. Financial assistance will be made available on a reimbursement basis only; cash advances will not be made available to any QSP participant.
All proposals will be reviewed against the evaluation criteria contained herein and funds will be awarded on a competitive basis. Funding for successful proposals will be provided through specific agreements between the applicant and CCC. These agreements will incorporate the proposal as approved by FAS. FAS must approve in advance any subsequent changes to the project.
3. Proposals should include a justification for funding assistance from the program—an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance. Applicants may submit more than one proposal.
1.
Applicants must contact FAS' Program Operations Division to obtain UES Web site access information. The Internet-based application may be found at the following URL address:
In addition, in accordance with 2 CFR part 25, each entity that applies to the QSP and does not qualify for an exemption under 2 CFR 25.110 must:
(i) Provide a valid DUNS number in each application or plan it submits to CCC;
(ii) Be registered in the System for Award Management (SAM) prior to submitting an application or plan; and
(iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by CCC.
Similarly, in accordance with 2 CFR part 170, each entity that applies to the QSP and does not qualify for an exception under 2 CFR 170.110(b) must ensure it has the necessary processes and systems in place to comply with the applicable reporting requirements of 2 CFR part 170 should it receive QSP funding.
Incomplete applications and applications that do not otherwise conform to this announcement will not be accepted for review.
Proposals should contain, at a minimum, the following:
(a) Organizational information, including:
• Organization's name, address, Chief Executive Officer (or designee), Federal Tax Identification Number (TIN), and DUNS number;
• Type of organization;
• Name, telephone number, fax number, and email address of the primary contact person;
• A description of the organization and its membership;
• A description of the organization's prior export promotion experience; and
• A description of the organization's experience in implementing an appropriate trade/technical assistance component.
(b) Market information, including:
• An assessment of the market;
• A long-term strategy in the market; and
• U.S. export value/volume and market share (historic and goals) for 2010-2016.
(c) Project information, including:
• A brief project title;
• The amount of funding requested;
• The beginning and end dates for the proposed project;
• A brief description of the specific market development trade constraint or opportunity to be addressed by the project;
• A description of the activities planned to address the constraint or opportunity, including how the sample will be used in the end-use performance trial, the attributes of the sample to be demonstrated and its end-use benefit, and details of the trade/technical servicing component (including who will provide and fund this component);
• The performance measures that will be used to benchmark performance and measure the effectiveness of the project, the long-term sales to the market, and the benefits to the represented industry;
• A description of the sample to be provided (
• An itemized list of all estimated costs associated with the project for which reimbursement will be sought;
• The importer's role in the project regarding handling and processing the commodity sample; and
• An explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance;
(d) Information indicating all funding sources and amounts to be contributed by each entity that will supplement implementation of the proposed project. This may include the organization that submitted the proposal, private industry entities, host governments, foreign third parties, CCC, FAS, or other Federal agencies. Contributed resources may include cash, goods, or services.
• Proposals received by 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered for funding with other proposals received by that date;
• Proposals not approved for funding during this review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;
• Proposals received after 5 p.m. Eastern Daylight Time, June 3, 2016, will be considered in the order received for funding only if funding remains available.
• The income, population, or market share growth potential in the proposed market;
• Benefits of project would accrue to entire industry, not a single company;
• The proposed sample size is appropriate to the project;
• The ability of the organization to provide an experienced staff with the requisite technical and trade experience to execute the proposal;
• The extent to which the proposal is targeted to a market in which the United States is generally competitive;
• The potential for expanding commercial sales in the proposed market;
• The nature of the specific market constraint or opportunity identified and how well it is addressed by the proposal;
• The extent to which the importer's contribution in terms of handling and processing enhances the potential outcome of the project;
• The amount of reimbursement requested and the organization's willingness to contribute resources, including cash, goods, and services of the U.S. industry and foreign third parties; and
• How well the proposed technical assistance component assures that performance trials will effectively demonstrate the intended end-use benefit.
FAS will also review and evaluate how well the following unweighted criteria are addressed in the proposal:
• The quality of the performance measures and how effective they will be in demonstrating the impact of the project;
• The assessment of the market;
• The long-term strategy in the market; and
• Export goals in each country.
Proposals will be evaluated by the appropriate Commodity Branch in FAS' Cooperator Programs Division. The Commodity Branches will review each proposal against the factors described above. The purpose of this review is to identify meritorious proposals, recommend an appropriate funding level for each proposal based upon these factors, and submit proposals and funding recommendations to the Deputy Administrator, Office of Trade Programs.
1.
2.
QSP projects are subject to review and verification by FAS' Compliance, Security and Emergency Planning Division. Upon request, a QSP participant shall provide to CCC the original documents that support the participant's reimbursement claims. CCC may deny a claim for reimbursement if the claim is not supported by adequate documentation.
3.
For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture
Forest Service, USDA.
Notice of meeting.
The Ashley Resource Advisory Committee (RAC) will meet in Vernal, Utah. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site:
Meeting will be held from 6:00 p.m. to 8:00 p.m. on April 20, 2016.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at Ashley National Forest (NF) Supervisor's Office, 355 North Vernal Avenue, Vernal, Utah.
Written comments may be submitted as described under
Louis Haynes, RAC Coordinator, by phone at 435-781-5105 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to:
1. Conduct a final evaluation and roll call;
2. Vote on each submitted project; and
3. Finalize recommendations for funding of project long forms for the Designated Federal Officer's approval.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by April 6, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Attention: Louis Haynes, RAC Coordinator, Ashley NF Supervisor's Office, 355 North Vernal Avenue, Vernal, Utah 84078; by email to
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS) invites comments on this information collection for which approval from the Office of Management and Budget (OMB) will be requested.
Comments on this notice must be received by June 3, 2016.
Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, Rural Development, United States Department of Agriculture, 1400 Independence Avenue SW., STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-4492. FAX: (202) 720-8435. Email:
The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB for extension.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c)
For a distribution system, a lien on the borrower's assets generally represents adequate security. However, since most G&T revenues flow from its distribution members, RUS requires, as a condition of a loan or loan guarantee to a G&T the long-term requirements wholesale power contract to purchase their power from the G&T at rates that cover all the G&T's expenses, including debt service and margins. RUS Form 444 is the standard form of the wholesale power contract. The Form is used by RUS G&T borrowers to enter into agreement with their distribution members for purchase of power from the G&T. Most borrowers adapt this form to meet their specific needs. The contract is prepared and executed by the G&T and each member and by RUS and the information allows RUS to determine credit quality and credit worthiness to determine repayment ability for loans and loan guarantees.
Copies of this information collection can be obtained from Rebecca Hunt, RUS Program Development and Regulatory Analysis, at (202) 205-3660; Facsimile: (202) 720-8435 or Email:
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Annual Survey of Foreign Direct Investment in the United States (BE-15). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-15. A completed report covering a reporting company's fiscal year ending during the previous calendar year is due by May 31 (or by June 30 for reporting companies that use BEA's eFile system). This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0034.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 18.2 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of U.S. Airline Operators' Foreign Revenues and Expenses (BE-37). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-37. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0011. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 4 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of U.S. Direct Investment Abroad—Transactions of U.S. Reporter with Foreign Affiliate (BE-577). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-577. Reports are due 30 days after the close of each calendar or fiscal quarter; 45 days if the report is for the final quarter of the financial reporting year. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0004. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 1 hour per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of Reporting Requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons (BE-125). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0067. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 18 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Foreign Direct Investment in the United States—Transactions of U.S. Affiliate with Foreign Parent (BE-605). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-605. Reports are due 30 days after the close of each calendar or fiscal quarter; 45 days if the report is for the final quarter of the financial reporting year. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0009. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 1 hour per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Ocean Freight Revenues and Foreign Expenses of U.S. Carriers (BE-30). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-30. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0011. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 4 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Payment Card and Bank Card Transactions Related to International Travel (BE-150). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-150. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0072. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 16 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Insurance Transactions by U.S. Insurance Companies with Foreign Persons (BE-45). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-45. Reports are due 60 days after the end of each calendar quarter, or 90 days after the close of the calendar year. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0066. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 8 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Annual Survey of Foreign Ocean Carriers' Expenses in the United States (BE-29). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-29. Reports are due 90 days after the end of each calendar year. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0012. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 3 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Foreign Airline Operators' Revenues and Expenses in the United States (BE-9). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-9. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0068. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 6 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Annual Survey of U.S. Direct Investment Abroad (BE-11). This survey is authorized by the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-11. A completed report covering a reporting company's fiscal year ending during the previous calendar year is due by May 31. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to those required to complete this survey.
(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0053. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 138 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons (BE-185). This survey is authorized by the International Investment and Trade in Services Survey Act and by Section 5408 of the Omnibus Trade and Competitiveness Act of 1988.
This Notice constitutes legal notification to all U.S. persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the BE-185. Reports are due 45 days after the end of each fiscal quarter, except for the final quarter of the U.S. person's fiscal year when reports must be filed within 90 days. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Additional information about BEA's collection of data on international trade in services and direct investment can be found in the 2012 rule, the International Investment and Trade in Services Survey Act (22 U.S.C. 3101
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(b) Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.
This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 0608-0065. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Public reporting burden for this collection of information is estimated to average 10 hours per response. Additional information regarding this burden estimate may be viewed at
22 U.S.C. 3101-3108 and 15 U.S.C. 4908(b).
In notice document 2016-05994 beginning on page 14092 in the issue of Wednesday, March 16, 2016, make the following correction:
Due to numerous errors, the table on page 14094 is being reprinted in its entirety to read as follows:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).
The meeting will be held on Tuesday, Wednesday and Thursday, April 19, 20, and 21, 2016. It will start at 9 a.m. on April 19, and at 8:30 a.m. on both April 20 and 21.
The meeting will be held at the Mystic Hilton Hotel, 20 Coogan Boulevard, Mystic, CT 06355; telephone: (860) 572-0731, or online at
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492, ext. 113.
After introductions and any announcements, the Council meeting will open with brief reports from the NEFMC Chairman and Executive Director, the NOAA Regional Administrator for the Greater Atlantic Region (GAR), Northeast Fisheries Science Center and Mid-Atlantic Fishery Management Council liaisons, NOAA General Counsel and Office of Law Enforcement representatives, and staff from the Atlantic States Marine Fisheries Commission and the U.S Coast Guard. Following these reports, the Council will receive two others from representatives of the Northeast Fisheries Science Center; the first is on the status of the Northeast continental shelf ecosystem; and a second will cover scientific efforts to assess the vulnerability of fish stocks to climate change. Next, the NEFMC's Ecosystem-Based Fisheries Management Committee will provide an update on its progress to develop a working example of a fisheries ecosystem plan. After a lunch break, the Council will discuss and prepare comments on NOAA Fisheries draft National Bycatch Strategy and the agency's proposed draft Standardized Bycatch Reporting Methodology.
The second day of the meeting will begin with an overview of progress to develop Amendment 22 to the Northeast Multispecies Fishery Management Plan.
The final meeting day will begin with a report from the Council's Habitat Committee Chair. After a review of work to date, the committee will ask for Council approval of the Omnibus Deep-Sea Coral Amendment management alternatives for the purpose of further development and analyses. A presentation is then scheduled on the draft Northeast Regional Ocean Plan. The next report will address plans for a peer review (fall 2016) of the in-season discard methodology to be used by NOAA Fisheries. The report will include a discussion of the terms of reference approved by the Northeast Regional Coordinating Committee. Following a mid-day lunch break, and under the auspices of the Groundfish Committee, there will be: a progress report on work to evaluate the groundfish monitoring program, and an update on other groundfish priorities for 2016, including windowpane flounder management measures and improving the process to develop recreational fishery management measures. The Council will adjourn after it addresses any other outstanding business during the afternoon of April 21st.
Although other non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided that the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed Incidental Harassment Authorization (IHA); request for comments.
NMFS has received an application from the City of San Diego for an IHA to take small numbers of marine mammals, by Level B harassment, incidental to the conduct of sand quality study activities at the Children's Pool Beach in La Jolla, California. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to the City of San Diego to take, by Level B harassment only, three species of marine mammals during the specified activities.
Comments and information must be received no later than May 4, 2016.
Comments on the IHA application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments is
All comments received are a part of the public record and will generally be posted to
An electronic copy of the IHA application containing a list of the references used in this document may be obtained by visiting the Internet at:
Dale Youngkin, Office of Protected Resources, NMFS, 301-427-8401.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for the incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”
Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the United States can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) of the MMPA establishes a 45-day time limit for NMFS's review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of small numbers of marine mammals. Within 45 days of the close of the public comment period, NMFS must either issue or deny the authorization.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].
On December 14, 2015, NMFS received an application from the City of San Diego, Transportation & Storm Water Department, Storm Water Division, requesting an IHA for the taking of marine mammals incidental to the conduct of sand quality study activities. NMFS determined that the IHA application was adequate and complete on February 25, 2016.
The City of San Diego would undertake the proposed sand quality sampling activities between June 1, 2016 and December 14, 2016 at the Children's Pool Beach in La Jolla, California. Visual stimuli due to the presence of technicians on the beach and their sand sample collection activities during the study has the potential to result in the take of marine mammals through behavioral disturbance. The requested IHA would authorize the take, by Level B (behavioral) harassment, of small numbers of Pacific harbor seals (
The City of San Diego plans to conduct a sand quality study at the Children's Pool Beach in La Jolla, CA in order to fulfill a special condition that was part of a permit issued by the California Coastal Commission (Commission). The special provision required a feasibility study to analyze the sand quality, and methods for improving sand quality, at Children's Pool Beach. Children's Pool Beach is currently listed on the Clean Water Act Section 303(d) list as impaired for Fecal Indicator Bacteria (FIB). Additionally, researchers have identified pinniped molting and excrement as a potential source of mercury to the environment (McHuron, Harvey et al. 2014, Cossaboon, Ganguli et al. 2015). The sand quality study will analyze the current extent and magnitude of FIB and mercury contamination in the beach sand at Children's Pool Beach, and will assess several possible variable effects including tidal cycles, wave regimes, sand depth, and seasonal variability during the effective dates of the IHA.
The California Coastal Commission's permit certified the City's request to amend its Land Use Plan. Specifically, the City's amendment included revisions to allow seasonal closure at Children's Pool Beach during the Pacific harbor seal pupping season, generally from December 15 to May 15 of every year. The amendment applies only to Children's Pool Beach, and is intended to allow special protection of the harbor seals at Children's Pool Beach during the vulnerable months of their pupping season.
The sand quality sampling activities would involve teams of two to three people collecting sand samples for approximately four hours along transects parallel to the shoreline between the water line and the seawall/bluff railing. Sixteen sampling events are proposed for the sand quality study period between June 1 and December 14, 2016. Sand sample collection would involve grab samples of surface layer sand (surface up to 20 cm of sand to be collected with a sterilized spoon). A small subset of samples per event would be collected from the subsurface via narrow plastic cores (approximately 5 centimeters [cm] by 60 cm) driven into the sand by hand to the extent possible, and then sunk to the desired depth with a small rubber mallet. Approximately 21 samples would be collected per event. Visual stimuli due to the presence of researchers on the beach collecting sand samples would potentially result in behavioral disturbance of pinnipeds hauled out on the beach, which would equate to a take under the MMPA.
The City of San Diego is planning to begin the project at the Children's Pool in La Jolla, CA after the beach is opened to the public in May, with completion of the sand sampling activities to be completed prior to closure of the beach to the public in December, 2016. The City of San Diego and NMFS are requiring a moratorium on all sand sampling activities during harbor seal pupping and weaning (
Proposed sand sampling activities would occur during daylight hours only, as stipulated in the IHA application. In addition, prior to sand sampling events, the beach would be surveyed for the presence of northern fur seals and/or Guadalupe fur seals. If either of these species are observed hauled out or in the water at Children's Pool Beach, sand sampling would not commence. This precaution is included due to the unusually high number of strandings of fur seals along the entire California coast beginning in January, 2015, which has resulted in the declaration of an Unusual Mortality Event (UME) for Guadalupe fur seal (
The La Jolla Children's Pool Beach is located at 850 Coast Boulevard, La Jolla, CA 92037 (32°50′51.18″ North, 117°16′41.94″ West). All sand quality sampling events will take place at Children's Pool Beach. The locations of the beach and the study area can be found in the City of San Diego's IHA application.
The Children's Pool was created in 1931 by building a breakwater wall which created a protected pool for swimming. Although partially filled with sand, the Children's Pool still has open water for swimming and a beach for sunbathing and beachcombing. The Children's Pool and nearby shore areas (
All sand sampling activities will take place on the sandy beach area. Samples will be collected along transects parallel to the shoreline between the water's edge and the bluff/railing, while ensuring a distance of at least three meters (m) from any pinnipeds on the beach. Samples would consist of grab samples from the surface, with a subset of samples collected approximately 25 to 50 cm below the sand surface by using a hollow tube (approximately 5 cm by 60 cm) driven into the sand by hand and/or with a small rubber mallet with minimal digging.
All sand sampling events will be conducted during daylight hours, and each sampling event would be approximately four hours in duration. Sampling events will be scheduled to the maximum extent practicable to occur during the daily period of lowest haul out occurrence (generally 8:30 a.m.-3:30 p.m.). Because the City of San Diego already closes the Children's Pool Beach during harbor seal pupping season (December 15 through May 15), work on this project will be performed between June 1 and December 14, 2016, and up to 16 sampling events would be conducted during this timeframe. The first six sand sampling events are planned to occur soon after June 1, 2016. The first three sampling events (Phase 1a) are designed to maximize sampling area and to capture critical conditions when FIB may be at their highest concentrations. During each Phase 1a event, three transects parallel to the shoreline at the swash zone, the high-tide line, and the supralittoral zone will be established relative to the seawall railing and three surface sand (SS) FIB samples (top 2 centimeters) will be collected across each of the transects at approximately left, middle, and right beach. In addition, subsurface sand (SbS) FIB samples will also be collected at three of the nine SS sampling location during each event at approximately 25-50 centimeters below the surface. A maximum of 21 FIB samples, including field replicates, will be collected for each Phase 1a monitoring event, for an approximate maximum Phase 1a total of 63 FIB samples. The remaining three sampling events (Phase 1b) will consist of biased sampling based on Phase 1a preliminary findings. The study design for Phase 1b will be finalized in consultation with the City. A maximum of 21 FIB samples, including field replicates, will be collected for each Phase 1b monitoring event, for an approximate maximum Phase 1b total of 63 FIB samples. These early test results can then be compared with additional test results from up to 10 additional sampling events that could be collected during the warmer, high-public-use summer and fall months.
Information on marine mammal species for which take would be authorized is included below. Further information on the biology and local distribution of these marine mammal species and others in the region can be found in the NMFS Marine Mammal Stock Assessment Reports, which are available online at:
Three species of pinnipeds are known to occur in the Children's Pool proposed action area and off the Pacific coastline (see Table 1 below). Pacific harbor seals are the most common species likely to be found within the immediate vicinity of the activity area. California sea lions and northern elephant seals may also be found within the immediate vicinity of the activity area, but are more rare occurrences than harbor seals. Northern fur seals and Guadalupe fur seals are even more rarely observed at this location (Northern and Guadalupe fur seals have been seen observed at nearby beaches on rare occasions, and a northern fur seal was observed hauled out at La Jolla Cove, which is less than a mile from Children's Pool, per a personal communication with Dr. Hanan [February 4, 2016], a scientist with extensive knowledge of the area and the species occurring there). Fur seals are not known to haul out in such urban mainland beaches, and their presence would likely be attributed to sickness or injury if they were observed in this location. Therefore, only three species are considered to be potentially exposed to effects of the proposed sand sampling activities, as sand sampling activities would not be conducted if fur seals were present and coordination with the stranding network would commence. A variety of other marine mammal species have on occasion been reported in the coastal waters off southern California. However, none of these species have been reported to occur in the immediate proposed action area of the Children's Pool Beach. Therefore, NMFS does not expect, and does not propose to authorize, incidental take of marine mammal species other than Pacific harbor seals, California sea lions, and northern elephant seals from the proposed specified activities. Table 1 below provides information on these marine mammal species, their habitat, and conservation status in the nearshore area of the general region of the proposed project area.
Harbor seals are widely distributed in the North Atlantic and North Pacific. Two subspecies exist in the Pacific Ocean:
In California, approximately 400 to 600 harbor seal haul-out sites are distributed along the mainland coast and on offshore islands, including intertidal sandbars and ledges, rocky shores and islets, and beaches (Harvey
The Children's Pool area is the only rookery in San Diego County and the only mainland rookery on the U.S. west coast between the border of Mexico and Point Mugu in Ventura County, CA (321.9 km [200 miles]). The number of harbor seals in this area has increased since 1979, and they have been documented giving birth at the Children's Pool since the 1990's (Yochem and Stewart, 1998; Hanan & Associates, 2004). Pacific harbor seals haul-out year-round on beaches and rocks (
Children's Pool is one of the three known haul-out sites for this species in San Diego County. These animals have been observed in this area moving to/from the Children's Pool, exchanging with the rocky reef directly west of and adjacent to the breakwater and with Seal Rock, which is about 150 m (492 ft) west of the Children's Pool. Harbor seals have also been reported on the sandy beach just southwest of the Children's Pool. At low tide, additional space for hauling-out is available on the rocky reef areas outside the retaining wall and on beaches immediately southward. Haul-out times vary by time of year, from less than an hour to many hours. There have been no foraging studies at this site, but harbor seals have been observed in nearshore waters and kelp beds nearby, including La Jolla Cove.
In southern California, a considerable amount of information is known about the movements and ecology of harbor seals, but population structure in the region is not as well known (Stewart and Yochem, 1994, 2000; Keper
Radio-tagging and photographic studies have revealed that only a portion of seals utilizing a hauling-out site are present at any specific moment or day (Hanan, 1996, 2005; Gilbert
The City of San Diego has fitted a polynomial curve to the number of expected harbor seals hauling-out at the Children's Pool by month (see Figure 2 of the IHA application and Figure 1 below) based on counts at the Children's Pool by Hanan (2004), Hanan & Associates (2011), Yochem and Stewart (1998), and the Children's Pool docents (Hanan, 2004).
A complete count of all harbor seals in California is impossible because some are always away from the haul-out sites. A complete pup count (as is done for other pinnipeds in California) is also not possible because harbor seals are precocial, with pups entering the water almost immediately after birth. Population size is estimated by counting the number of seals ashore during the peak haul-out period (May to July) and by multiplying this count by a correction factor equal to the inverse of the estimated fraction of seals on land. Based on the most recent harbor seal counts (2009) and including a revised correction factor, the estimated population of harbor seals in California is 30,196 individuals (NMFS, 2011), with an estimated minimum population of 26,667 for the California stock of harbor seals. Counts of harbor seals in California increased from 1981 to 2004. The harbor seal is not listed under the ESA and the California stock is not considered depleted or strategic under the MMPA (Carretta
The California sea lion is a separate species from the Galapagos sea lion (
The entire California sea lion population cannot be counted because all age and sex classes are never ashore at the same time. In lieu of counting all sea lions, pups are counted during the breeding season (because this is the only age class that is ashore in its entirety), and the numbers of births is estimated from the pup count. The size of the population is then estimated from the number of births and the proportion of pups in the population. Censuses are conducted in July after all pups have been born. There are no rookeries at or
The rocks and beaches at or near the Children's Pool in La Jolla, CA, are almost exclusively Pacific harbor seal hauling-out sites. On infrequent occasions, one or two California sea lions have been observed on the sand or rocks at or near the Children's Pool (
Northern elephant seals breed and give birth in California (U.S.) and Baja California (Mexico), primarily on offshore islands (Stewart
Populations of northern elephant seals in the U.S. and Mexico have recovered after being nearly hunted to extinction (Stewart
A complete population count of elephant seals is not possible because all age classes are not ashore simultaneously. Elephant seal population size is typically estimated by counting the number of pups produced and multiplying by the inverse of the expected ratio of pups to total animals (McCann, 1985). Based on counts of elephant seals at U.S. rookeries in 2010, Lowry
The rocks and beaches at or near the Children's Pool in La Jolla, CA, are almost exclusively Pacific harbor seal hauling-out sites. On infrequent occasions, juvenile northern elephant seal have been observed on the sand or rocks at or near the Children's Pool (
A significant body of monitoring data exists for pinnipeds at Children's Pool. In addition, pinnipeds have co-existed with heavy public use at this location, and are likely habituated to human presence and activity. Nevertheless, the City of San Diego's sand sampling activities have the potential to disturb pinnipeds present on the beach. Past monitoring at this location has revealed that some or all of the seals present may move or flush from the beach in response to the presence of humans or their pets as well as crew and equipment associated with construction, though some may remain hauled-out. No stampeding of seals—a potentially dangerous occurrence in which large numbers of animals succumb to mass panic and rush away from a stimulus—has been documented. While it is likely impossible to conduct the proposed sand sampling activities without provoking some response in hauled-out animals, precautionary mitigation measures, described later in this document, help ensure that this type of disturbance would be minimized. Under these conditions, it is anticipated that seals would exhibit a continuum of responses, beginning with alert movements (
In the absence of appropriate mitigation measures, it is possible that pinnipeds could be subject to injury, serious injury, or mortality, likely through abandonment of pups. However, based on a significant body of site-specific data, harbor seals are unlikely to sustain any harassment that may be considered biologically significant. Individual animals would, at most, flush into the water in response to the sand sampling activities, but may also simply become alert or move across the beach away from the sand sampling crew.
California sea lions and northern elephant seals have been observed as less sensitive to stimulus than harbor seals during monitoring at numerous
Children's Pool is a rookery for harbor seals, so we have evaluated the potential for injury, serious injury, or mortality to pups. Pup injury or mortality would be most likely to occur in the event of extended separation of a mother and pup, or trampling in a stampede. As discussed previously, no stampedes have been recorded at Children's Pool. Any California sea lions or northern elephant seals present would be independent juveniles or adults; therefore, analysis of impacts on pups is not relevant for those species.
The period of mother-pup bonding, a critical time needed to ensure pup survival and maximize pup health, is not expected to be impacted by the sand sampling activities. Harbor seal pups are extremely precocious, swimming and diving immediately after birth and throughout the lactation period, unlike most other phocids which normally enter the sea only after weaning (Lawson and Renouf, 1985; Cottrell
In summary, and based on extensive monitoring data, we believe that impacts to hauled-out pinnipeds during estuary management activities would be behavioral harassment of limited duration (
Harbor seals have been observed hauling-out and documented giving birth at the Children's Pool since the 1990's (Yochem and Stewart, 1998; Hanan & Associates, 2004). It is one of the three known haul-out sites for this species in San Diego County and is the only rookery in San Diego County and the only mainland rookery on the U.S. west coast between the border of Mexico and Point Mugu in Ventura County, CA. In addition to Pacific harbor seals, California sea lions and northern elephant seals have also been observed at Children's Pool Beach occasionally (Yochem and Stewart 1998; Hanan 2004; Hanan & Associates 2014). More information on this population of Pacific harbor seals can be found in the “Description of Marine Mammals in the Specified Geographic Area of the Proposed Specified Activity.”
The primary anticipated adverse impact upon habitat consists of the removal of sand from the beach. This change is minor, temporary, and limited in duration to the period of the sand sampling activities. All sand sampling activities will take place on the sand beach area normally occupied by hauled out seals. Although sand will be collected from the beach, the total volume removed over the course of the study is estimated to be less than one cubic foot. Additionally, a subset of samples will be collected approximately 25 to 50 centimeters (cm) below the sand surface. Because of the mechanism of collection (use of a hollow plastic tube and rubber mallet with minimal digging), only transient sand displacement is anticipated. Therefore, we do not anticipate impacts to habitat.
The area of habitat affected is small and the effects are localized and temporary; thus there is no reason to expect any significant reduction in habitat available for other habitat uses. No aspect of the project is anticipated to have any permanent effect on the location or use of pinniped haul-outs or related habitat features in the area. Further, the site is already very disturbed by members of the public who come to the area during the day and night to view the pinnipeds. The City of San Diego and NMFS do not project any loss or modification of physical habitat for these species. Any potential temporary loss or modification of habitat due to the presence of the sand sampling technicians and their activities during the proposed sand quality study is expected by the City of San Diego and NMFS to be quickly restored after the sand sampling activities end.
For these reasons, NMFS anticipates that the proposed action would result in no impacts to marine mammal habitat beyond rendering the areas of Children's Pool Beach immediately around the sand sampling activities less desirable. These sampling activities would be temporary and would occur relatively infrequently, as they are anticipated to occur up to 16 times over the months of May to December for approximately four hours at a time. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.
In order to issue an Incidental Take Authorization (ITA) under section 101(a)(5)(D) of the MMPA, NMFS must prescribe, where applicable, the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).
The City of San Diego has established the Children's Pool as a shared beach for pinnipeds and people except during pupping season, when the beach has been closed to the public in order to protect the seals. In the past, during the pupping season, a rope was placed along the upper part of the beach with signage to inform and designate how close people can come to the haul-out area and the pinnipeds. The timeframe for the rope has been extended so that it is now present year-round.
The activities proposed by the applicant include a variety of measures to minimize potential impacts on marine mammals, including:
Sand sampling activities shall be prohibited during the Pacific harbor seal pupping season (December 15th to May 15th), and for an additional two weeks thereafter to accommodate lactation and weaning of late season pups. Thus, sand quality study activities shall be prohibited until June 1, 2016 and would
Sand sampling activities shall be conducted during daylight hours only. As Protected Species Observers (PSOs) will be required to monitor the sand sampling activities (see discussion below), conducting the sampling events during daylight hours with adequate visibility will allow observers to adequately observe and record activities.
Sand sampling activities shall be scheduled, to the maximum extent practicable, during the daily period of lowest haul-out occurrence, from approximately 8:30 a.m. to 3:30 p.m., as harbor seals typically have the highest daily or hourly haul-out period during the afternoon from 3 p.m. to 6 p.m. However, sand sampling activities may be extended from 7 a.m. to 7 p.m. to help assure that the project can be completed at a time with low numbers of seals hauled out.
As stated above, per Dr. Doyle Hanan, ongoing observations of harbor seals at Children's Pool have indicated a habituation to the presence of people and therefore, generally show signs of disturbance when people are very close to them on the beach (generally less than two to three meters). Sand sampling activities will be conducted such that humans remain at least three meters from hauled out pinnipeds at all times. While the study calls for taking samples along transects, there is enough flexibility to allow for variation from the transect line to collect samples and still allow for minimizing approach to pinnipeds on the beach. Therefore, hauled out pinnipeds will be minimized or avoided, and efforts will be made to avoid disturbing/alerting/flushing them.
Trained PSOs would be used to detect, document, and minimize impacts to marine mammals. More information about this measure is contained in the “Proposed Monitoring” section (below).
NMFS has carefully evaluated the applicant's mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. NMFS's evaluation of potential measures included consideration of the following factors in relation to one another:
• The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;
• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and
• The practicability of the measure for applicant implementation, including consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the activity.
Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:
(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).
(2) A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to visual or auditory stimuli associated with the proposed sand quality study, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
(3) A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to visual or auditory stimuli associated with the proposed sand quality study, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
(4) A reduction in the intensity of exposures (either total number or number at biologically important time or location) to visual or auditory stimuli associated with the proposed sand quality study, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).
(5) Avoidance of minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.
(6) For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on NMFS's evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must, where applicable, set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) require that requests for ITAs include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.
Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:
(1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;
(2) An increase in our understanding of how many marine mammals are likely to be exposed to visual or auditory stimuli associated with the proposed sand quality study that we associate with specific adverse effects, such as behavioral harassment;
(3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:
• Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict distance from source, and other pertinent information);
• Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict distance from the source, and other pertinent information);
• Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;
(4) An increased knowledge of the affected species;
(5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures; and
(6) An increase in our level of knowledge regarding the overall health of the monitored species, particularly in light of recent local UMEs and observations of malnutrition increases in the area.
The City of San Diego has developed a monitoring plan based on discussions between the City of San Diego and NMFS, as well as review of past IHAs granted to the City of San Diego. The plan is also included as an Appendix to our draft Environmental Assessment (EA) for issuance of the IHA for the sand quality study activities (see National Environmental Policy Act section below), which is available for public review along with the draft EA.
The monitoring plan involves PSOs surveying and conducting hourly visual counts beginning prior to sand sampling activities (beginning at least 30 minutes prior to sampling activities), monitoring during sampling activities, and post-sand sampling monitoring (continuing for at least 30 minutes after sand sampling activities have ended). During each sample collection event, the PSO will conduct continuous monitoring from a vantage point along the seawall (weather permitting) or along the bluff above the beach, such that the full study area is in view. During the proposed sand sampling activities, monitoring shall assess behavior and potential behavioral responses to noise and visual stimuli due to the proposed activities. As noted above, if northern fur seals or Guadalupe fur seals are observed prior to commencement of activities, the activities will not occur and coordination with the stranding network will be initiated.
Counts will be performed by species for three zones: Pinnipeds hauled out on the sandy beach area, pinnipeds observed in the water within approximately 30 meters of the beach, and pinnipeds hauled out on the reef/rocks just off the beach (including Seal Rock). Total counts, counts of juveniles (yearlings and pups), and counts of males/females (when possible) will be recorded. In addition to counts, continuous behavioral monitoring will be conducted for the duration of the sampling event to document any behavioral responses to visual (or other) stimuli, as noted in Table 2 below. When responses are observed, the type of take (
Additional parameters will be recorded during the first and last count of each sampling event including Beaufort sea state; atmospheric conditions; cloud cover; visibility conditions; air and water temperature; tide height; and number of public visitors present by location at Children's Pool.
Field observations will be documented on Field Monitoring Forms, and all observations and associated data, including daily monitoring reports, would be maintained on City of San Diego computers. A report summarizing mitigation and monitoring for the duration of the Children's Pool Beach sand quality study will be prepared and submitted by the City of San Diego to NMFS following completion of sand sampling activities for the 2016 sampling season.
The following marine mammal monitoring and reporting shall be performed for the proposed action:
(1) The PSO shall be selected prior to sand sampling activities.
(2) The NMFS-approved PSO shall attend the project site prior to, during, and after sand sampling activities cease each day that the sand sampling activities occur.
(3) The PSO shall search for marine mammals within the Children's Pool area.
(4) The PSO shall be present during sand sampling activities to observe for the presence of marine mammals in the vicinity of the specified activity. All such activity would occur during daylight hours (
(5) If marine mammals are sighted by the PSO, the PSO shall record the number of marine mammals and the duration of their presence while the sand sampling activity is occurring. The PSO would also note whether the marine mammals appeared to respond to the noise/visual stimuli and, if so, the nature of that response. The PSO shall record the following information: Date and time of initial sighting, tidal stage, weather conditions, Beaufort sea state, species, behavior (activity, group cohesiveness, direction and speed of travel, etc.), number, group composition, distance between sampling personnel and pinniped(s), number of animals impacted, sampling activities occurring at time of sighting (walking, taking surface sample, or pounding core sampler), and monitoring and mitigation measures implemented (or not implemented). The observations would be reported to NMFS.
(6) To avoid takes of Guadalupe fur seals, if fur seals are observed to be hauled out on the beach, or in the water/rocks at the Children's Pool Beach prior to the initiation of sand collection activities, sand sampling activities will not commence. PSOs will alert the stranding network, as the occurrence of these species would typically indicate a sick/injured animal. Recommendations of the stranding coordinator will be followed, which may include a 24-hour or 48-hour waiting and observation period, and sand sampling would not commence until the animal(s) either vacated the area on its own, or was collected by the stranding network
(7) A final report would be submitted summarizing all effects from sand sampling activities and marine mammal monitoring during the time of the authorization.
A written log of dates and times of monitoring activity will be kept. The log shall report the following information:
• Time of observer arrival on site;
• Time of the commencement of sand sampling activities;
• Distances to all marine mammals relative to the stimuli;
• For harbor seal, northern elephant seal, and California sea lion observations, notes on behavior during sand sampling activity, as described above, and on the number and distribution observed in the project vicinity;
• For observations of all marine mammals other than harbor seals, northern elephant seals, and California sea lions, the time and duration of each animal's presence in the project vicinity; the number of animals observed; the behavior of each animal, including any response to sand sampling activities;
• Time of the cessation of sand sampling activities; and
• Time of observer departure from site.
All monitoring data collected during sand sampling events would be included in the biological monitoring notes to be submitted. A final report summarizing the sand sampling monitoring and any general trends observed would also be submitted to NMFS within 90 days after monitoring has ended during the period of the sand quality study or 45 days prior to the date by which any subsequent IHA is requested by the City of San Diego, whichever comes first.
A draft final report must be submitted to NMFS within 90 days after the conclusion of the final sand sampling activities of the Children's Pool Beach. The report would include a summary of the information gathered pursuant to the monitoring requirements set forth in the IHA, including dates and times of operations and all marine mammal sightings (dates, times, locations, species, behavioral observations [activity, group cohesiveness, direction and speed of travel, etc.], tidal stage, weather conditions, Beaufort sea state and wind force, associated sand sampling activities). A final report must be submitted within 30 days after receiving comments from NMFS on the draft final report. If no comments are received from NMFS, the draft final report would be considered to be the final report.
While the IHA does not authorize injury (
In the unanticipated event that the City of San Diego discovers a live stranded marine mammal (sick and/or injured, or if any fur seals are observed) at Children's Pool, they shall immediately contact Sea World's stranded animal hotline at 1-800-541-7235. Sea World shall also be notified if a dead stranded pinniped is found so that a necropsy can be performed. In all cases, NMFS stranding coordinator shall be notified as well, but for immediate response purposes, Sea World shall be contacted first.
• Time, date, and location (latitude/longitude) of the incident;
• The type of activity involved;
• Description of the circumstances during and leading up to the incident;
• Water depth; environmental conditions (
• Description of marine mammal observations in the 24 hours preceding the incident; species identification or description of the animal(s) involved;
• The fate of the animal(s); and photographs or video footage of the animal (if equipment is available).
Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with the City of San Diego to determine the action necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The City of San Diego may not resume its activities until notified by NMFS via letter, email, or telephone.
Hanan & Associates, Inc., on behalf of the City of San Diego, conducted marine mammal and in-air sound monitoring at six locations during demolition and construction activities at the Children's Pool Lifeguard Station in La Jolla, California from June 3, 2013 to February 12, 2014. Demolition and construction activities began on July 10, 2013 and were halted for the Pacific harbor seal pupping season (December 15, 2013 to May 30, 2014). During 115 days of visual and acoustic observations, Hanan & Associates counted a total of 61,631 Pacific harbor seals and 26,037 people. During the 2013 demolition and construction activities, Hanan & Associates observed a total of 15,673 takes by Level B harassment (
Hanan & Associates, Inc., on behalf of the City of San Diego, conducted marine mammal monitoring at seven locations during demolition and construction activities at the Children's Pool Lifeguard Station in La Jolla, California from August 6, 2014 to March 15, 2015. Construction activities began on August 6, 2014 and were halted for the Pacific harbor seal pupping season (December 15, 2014 to May 30, 2015). During 127 days of visual and acoustic observations, Hanan & Associates counted a total of 63,598 Pacific harbor seals and 27,844 people. During the 2014 demolition and construction activities, Hanan & Associates observed a total of 20,259 takes by Level B harassment (
More information on the monitoring results from the City of San Diego's previous demolition and construction activities at the La Jolla Children's Pool Lifeguard Station can be found in the final monitoring reports. The 2013 to 2014 and 2014 to 2015 monitoring reports can be found online at:
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].
The City of San Diego and NMFS anticipate takes of Pacific harbor seals, California sea lions, and northern elephant seals by Level B (behavioral) harassment only incidental to visual disturbance associated with the sand quality study sand sampling activities at the Children's Pool Beach. No takes by injury (Level A harassment), serious injury, or mortality are expected. NMFS will consider pinnipeds behaviorally reacting to the sand sampling activities by flushing into the water, moving more than twice the animal's body length but not into the water; becoming alert and moving more than twice its body length; and changing direction of current movements by individuals as behavioral criteria for take by Level B harassment.
With proposed sand sampling activities scheduled to begin in May 2016, the City of San Diego expects a range of harbor seals to be present daily during June with a maximum of up to 190 individuals and a seasonal decline through November to about 0 to 50 harbor seals present daily. As not all of the sampling activities have been planned, and there is uncertainty regarding the timing and number of all activities, we have assumed the maximum number of authorized sampling activities (16) occurring during the maximum haul out month (June) in order to estimate take numbers. If all of the estimated harbor seals present are taken by incidental harassment each day, there could be a maximum of 3,040 incidences of take (
Very few California sea lions or northern elephant seals are ever observed at the Children's Pool Beach. As noted above, Children's Pool is almost exclusively a harbor seal haul-out site and on rare occasions, one or two California sea lions or a single juvenile elephant seal have been observed on the sand or rocks at, or near, Children's Pool. However, as noted above, an UME has been in place since 2013 for California sea lions. According to the NMFS West Coast Region, California sea lion strandings in January-May of 2015 were over 10 times the average stranding level for the same five-month period during 2004-2012. The City of San Diego has requested take for these species due to their potential occurrence at this location and past monitoring experience at this location. As the previous IHA authorized take of two individual sea lions incidental to construction activities at Children's Pool, and numbers of sea lion sightings have been over 10 times the average, we estimate that up to 20 individuals may be incidentally taken by Level B harassment equating to 320 exposures (conservatively assuming 20 × 16 sampling events). As only one or two northern elephant seals are known to occur rarely at Children's Pool Beach, it was conservatively estimated that 16 individuals would be exposed to Level B harassment for a total of 16 takes (assuming one present for each of the 16 sampling events). Therefore, NMFS proposes authorizing the following numbers of incidental takes (
Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
In making a negligible impact determination, NMFS evaluated factors such as:
(1) The number of anticipated injuries, serious injuries, or mortalities;
(2) The number, nature, and intensity, and duration of Level B harassment; and
(3) The context in which the takes occur (
(4) The status of the stock or species of marine mammals (
(5) Impacts on habitat affecting rates of recruitment/survival; and
(6) The effectiveness of monitoring and mitigation measures.
Behavioral disturbance may potentially occur incidental to the visual presence of humans and sand sampling activities; however, pinnipeds at this site have likely adapted or become acclimated to human presence at this site. The City of San Diego has designated Children's Pool Beach as a shared use beach. Many activities currently take place at Children's Pool Beach and the surrounding shoreline areas including swimming, SCUBA diving, surfing, kayaking, tide pooling, and nature watching. These “urbanized” harbor seals do not exhibit sensitivity at a level similar to that noted in harbor seals in some other regions affected by human disturbance (Allen
No injuries (Level A harassment), serious injuries, or mortalities are anticipated to occur as a result of the City of San Diego's sand sampling activities, and none are proposed for authorization by NMFS. The proposed activities are not expected to result in the alteration of reproductive behaviors because of the moratorium on access to the beach during the pupping season, and the potentially affected species would be subjected to only temporary and minor behavioral impacts.
As discussed in detail above, the proposed project scheduling avoids sensitive life stages for Pacific harbor seals. Proposed project activities will commence June 1 and end by December 15. The commencement date occurs after the end of the pupping season, affords additional time to accommodate lactation and weaning of late-season pups, and takes into account periods of lowest haul-out occurrence. The end date falls approximately two weeks prior to January 1, the time after which most births occur, providing protection for pregnant and nursing harbor seals that may give birth before January 1.
Table 3 of this document outlines the number of Level B harassment takes that are anticipated as a result of these proposed activities. Due to the nature, degree, and context of Level B (behavioral) harassment anticipated and described (see “Potential Effects on Marine Mammals” section above) in this notice, this activity is not expected to impact rates of annual recruitment or survival for the affected species or stock (
The Children's Pool is one of the three known haul-out sites for Pacific harbor seal in San Diego County and the only rookery in San Diego County and the only mainland rookery on the U.S. west coast for this species between the border of Mexico and Point Mugu in Ventura County, CA. For the other marine mammal species that may occur within the action area (
None of the potentially affected marine mammal species under NMFS jurisdiction in the action area (Pacific harbor seals, California sea lions, and northern elephant seals) are listed as threatened or endangered under the ESA. To protect these animals (and other marine mammals in the action area), the City of San Diego shall schedule sand sampling activities during the daily period of lowest haul-out occurrence; limit activities to the hours of daylight; ensuring that technicians performing sand sampling remain at least three meters from any hauled out pinnipeds; use PSOs, prohibit sand sampling activities in the unlikely event that fur seals are present, and prohibit sand sampling activities during harbor seal pupping season.
Although behavioral modifications, including temporarily vacating the area during the proposed sand sampling activities, may be made by these species, the sand quality sampling activities would be fairly sporadic and would be of relatively short duration. NMFS believes that the time period of the proposed sand sampling activities, the requirement to implement mitigation measures (
Based on the analysis contained herein of the likely effects of the proposed specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the City of San Diego's activities would have a negligible impact on the affected marine mammal species or stocks.
As mentioned previously, NMFS estimates that three species of marine mammals under its jurisdiction could be potentially affected by Level B harassment over the course of the IHA. It is conservatively estimated that the instances of take by Level B harassment (amounting to 3,040 for Pacific harbor seals, 320 for California sea lions, and 16 for northern elephant seals) would be approximately 10%, 0.1%, and less than 0.01% of the respective California, U.S., and California breeding stocks. The population estimates for the marine mammal species that may be taken by Level B harassment were provided in Table 3 of this document.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed mitigation and monitoring measures, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks. See Table 3 for the proposed authorized take numbers of marine mammals.
Section 101(a)(5)(D) of the MMPA requires NMFS to determine that the authorization will not have an unmitigable adverse effect on the availability of marine mammal species or stocks for subsistence use. There are not relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for subsistence purposes.
NMFS (Permits and Conservation Division) has determined that an ESA section 7 consultation for the issuance of an IHA under section 101(a)(5)(D) of the MMPA for this activity is not necessary for the Guadalupe fur seal. This species is rare at Children's Pool Beach. Due to the fact that sightings have occurred in the area, and due to the declaration of a UME for this species in the area, ESA consultation was considered. However, it was determined that the sand sampling activities would have no potential to affect the Guadalupe fur seal because these activities would not occur if this species were present at Children's Pool Beach. No other ESA-listed species are expected to occur in the proposed project area.
To meet NMFS's National Environmental Policy Act (NEPA; 42 U.S.C. 4321
As a result of these preliminary determinations, NMFS proposes to issue an IHA to the City of San Diego for conducting sand quality study activities
The City of San Diego,, is hereby authorized under section 101(a)(5)(D) of the Marine Mammal Protection Act (16 U.S.C. 1371(a)(5)(D)), to harass small numbers of marine mammals incidental to the sand quality study activities at the Children's Pool Beach, June 1 through December 14, 2016, contingent upon the following conditions:
1.
This Authorization is valid from June 1, 2016 through June 30, 2017.
2.
This Authorization is valid only for the sand sampling activities at the Children's Pool Beach that shall occur in the following specified geographic area:
The La Jolla Children's Pool Beach at 850 Coast Boulevard, La Jolla California 92037 (32° 50′51.18″ North, 117° 16′41.94″ West), as specified in the City of San Diego's IHA application.
3.
(a) The incidental taking of marine mammals, by Level B harassment only, is limited to the following species in the La Jolla, California area:
(i)
(ii) If any marine mammal species are encountered during sand sampling activities that are not listed in Table 3 (above) and are likely to be taken by the sand quality study activities, then the City of San Diego must shut-down operations to avoid take.
(b) The taking by injury (Level A harassment), serious injury, or death of any of the species listed in Condition 3(a) above, or the taking of any kind of any other species of marine mammal, is prohibited and may result in the modification, suspension or revocation of this Authorization.
The methods authorized for taking by Level B harassment are limited to visual stimuli associated with sand sampling activities (walking beach transects, taking sand surface samples, and taking subsurface samples, including hammering core samples with a rubber mallet) without an amendment to this Authorization:
4.
The taking of any marine mammal in a manner prohibited under this Authorization must be reported immediately to the Office of Protected Resources, National Marine Fisheries Service (NMFS), at 301-427-8401.
5.
The City of San Diego is required to implement the following mitigation and monitoring requirements when conducting the specified activities:
(a) The sand sampling activities shall be prohibited until June 1, 2016 and shall be completed prior to December 15, 2016.
(b) To the maximum extent practicable, sand sampling activities shall be conducted from approximately 8:30 a.m. to 3:30 p.m.,; however, sand sampling activities may be extended from 7 a.m. to 7 p.m. (
(c) A trained Protected Species Observer (PSO) shall attend the project site 30 minutes prior until 30 minutes after sand sampling activities cease each day throughout the sand quality study window. The PSO shall be approved by NMFS prior to commencement of activities. The PSO shall search for marine mammals using binoculars and/or the naked eye within the study area. The PSO will observe from a station along the breakwater wall (weather permitting) as well as the base of the cliff.
(d) In the event that fur seals are observed either on the rocks, beach, or in the water at Children's Pool Beach prior to commencement of sand collection activities, these activities will be postponed until coordination with the stranding network is complete (including any potential 24-hour or 48-hour wait/observation period) and/or the animal either leaves, or is collected by the stranding network.
(e) The PSO shall use visual digital recordings and photographs to document individuals and behavioral responses to the sand sampling activities. The PSO shall make hourly counts of the number of pinnipeds present and record events that result in behavioral responses and changes, whether due to sand sampling activities or from public stimuli. During these events, pictures and videos will be taken when possible to document individuals and behavioral responses.
(f) A PSO shall record the following information when a marine mammal is sighted:
(i) Species, group size, age/size/sex categories (if determinable), behavior when first sighted and after initial sighting, heading (if consistent), distribution, bearing and distance relative to the sampling technicians (stimuli), group cohesiveness, duration of presence, apparent reaction to sand sampling activities (
(ii) Date, time, location, sand sampling activity (walking; surface sampling; subsurface sampling [hammering], etc), monitoring and mitigation measures implemented (or not implemented), tidal stage, weather conditions, Beaufort sea state, wind speed, visibility, and sun glare; and
(iii) The data listed under Condition 6(g)(ii) shall also be recorded at the start and end of each observation watch and during a watch whenever there is a change in one or more variables.
(g) A PSO shall also record the time of arrival and departure on site, commencement and cessation of sand sampling activities, and presence of humans on the beach. Whenever possible, the PSO should determine as to whether or not the harassment of pinnipeds is attributable to the sand sampling activities and/or the presence of the public on the beach and around the Children's Pool area. A PSO shall record the number of people on the beach and surrounding areas as well as their location relative to the animals.
(h) Buffer zones shall be established such that sand sampling technicians will remain at least three meters from any hauled out pinniped at all times.
6.
The City of San Diego is required to:
(a) Submit a draft report on all activities and monitoring results to the Office of Protected Resources, NMFS, within 90 days of the completion of the sand sampling activities at the Children's Pool Beach. This report must contain and summarize the following information:
(i) Dates, times, locations, weather, sea conditions (including Beaufort sea state and wind speed), and associated activities during all sand sampling activities and marine mammal sightings;
(ii) Species, number, location, distance from the PSO, and behavior of any marine mammals, as well as associated sand sampling activities, observed throughout all monitoring activities.
(iii) An estimate of the number (by species) of marine mammals that are known to have been exposed to the sand sampling activities (based on visual observation) with a discussion of any specific behaviors those individuals
(iv) A description of the implementation and effectiveness of the monitoring and mitigation measures of the IHA.
(b) Submit a final report to the Chief, Permits and Conservation Division, Office of Protected Resources, NMFS, within 30 days after receiving comments from NMFS on the draft report. If NMFS decides that the draft report needs no comments, the draft report shall be considered to be the final report.
7. In the unanticipated event that the City of San Diego discovers a live stranded marine mammal (sick and/or injured, or if any fur seals are observed) at Children's Pool, they shall immediately contact Sea World's stranded animal hotline at 1-800-541-7235. Sea World shall also be notified for dead stranded pinnipeds so that a necropsy can be performed. In all cases, the NMFS stranding coordinator shall be notified as well, but for immediate responses purposes, Sea World shall be contacted first.
8. In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this Authorization, such as an injury (Level A harassment), serious injury or mortality, the City of San Diego shall immediately cease the specified activities and immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS and the West Coast Regional Stranding Coordinator. The report must include the following information:
(a) Time, date, and location (latitude/longitude) of the incident; the type of activity involved; description of the circumstances during and leading up to the incident; water depth; environmental conditions (
Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with the City of San Diego to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The City of San Diego may not resume their activities until notified by NMFS via letter or email, or via telephone.
In the event that the City of San Diego discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (
In the event that the City of San Diego discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in Condition 2 to 4 of this Authorization (
In the event that the City of San Diego discovers any fur seals hauled out on the rocks or in sand at Children's Pool Beach prior to commencing sand sampling activities for the day, the City of San Diego shall contact the West Coast Regional Stranding Coordinator and sand sampling activities will not commence until the animal(s) either leave or are collected by the stranding network. The City will also report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS within 24 hours of the discovery. The City of San Diego shall provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Activities may continue after the animal(s) are no longer present while NMFS reviews the circumstances of the incident.
9. A copy of this Authorization must be in the possession of all contractors and PSOs operating under the authority of this IHA.
NMFS requests comment on our analysis, the draft authorization, and any other aspect of the preliminary determinations and notice of the proposed IHA for the City of San Diego's sand quality study activities at the La Jolla Children's Pool Beach. Please include with your comments any supporting data or literature citations to help inform our final decision on the City of San Diego's request for an MMPA authorization.
Office of the Assistant Secretary of Defense for Health Affairs, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by June 3, 2016.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Defense Health Agency, TRICARE Overseas Program Office, ATTN: Ms. Kimberly Stakes, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101, or call 703-681-8690.
The purpose of the WIC Overseas program is to provide supplemental foods and nutrition education to serve as an adjunct to good health care during critical times of growth and development, in order to prevent the occurrence of health problems, including drug and other substance abuse, and to improve the health status of program participants. The benefit is similar to the benefit provided under the domestic WIC program.
Respondents are individuals who are dependents of members of the armed forces stationed overseas, dependents of a civilian employee of a military department stationed overseas, and DoD contractors and their dependents stationed overseas who desire to receive supplemental food and nutrition education services. To be eligible for the program, a person must meet specific income guidelines. In determining income eligibility, the Department will use the Department of Health and Human Services income poverty table for the state of Alaska.
Federal Student Aid, Department of Education.
Notice.
The Secretary announces the annual updates to the I CR plan formula for 2016, as required by 34 CFR 685.209(b)(1)(ii)(A), to give notice to Direct Loan borrowers and the public regarding how monthly ICR payment amounts will be calculated for the 2016-2017 year.
The adjustments to the income percentage factors for the ICR plan formula contained in this notice are effective from July 1, 2016, to June 30, 2017, for any borrower who enters the ICR plan or has his or her monthly payment amount recalculated under the ICR plan during that period.
Ian Foss, U.S. Department of Education, 830 First Street NE., Room 113H2, Washington, DC 20202. Telephone: (202) 377-3681 or by email:
If you use a telecommunications device for the deaf or a text telephone, call the Federal Relay Service, toll free, at 1-800-877-8339.
Under the William D. Ford Federal Direct Loan (Direct Loan) Program, borrowers may choose to repay their non-defaulted loans (Direct Subsidized Loans, Direct Unsubsidized Loans, Direct PLUS Loans made to graduate or professional students, and Direct Consolidation Loans) under the ICR plan. The ICR plan bases the borrower's repayment amount on the borrower's income, family size, loan amount, and the interest rate applicable to each of the borrower's loans.
ICR is one of the income-driven repayment plans. Other income-driven repayment plans include the Income-Based Repayment (IBR) plan, the Pay As You Earn (PAYE) Repayment plan, and the Revised Pay As You Earn (REPAYE) Repayment plan. The IBR, PAYE, and REPAYE plans provide lower payment amounts than the ICR plan for most borrowers.
A Direct Loan borrower who repays his or her loans under the ICR plan pays the lesser of: (1) The amount that he or she would pay over 12 years with fixed payments multiplied by an income percentage factor; or (2) 20 percent of discretionary income.
Each year, to reflect changes in inflation, we adjust the income percentage factor used to calculate a borrower's ICR payment. We use the adjusted income percentage factors to calculate a borrower's monthly ICR payment amount when the borrower initially applies for the ICR plan or when the borrower submits his or her annual income documentation, as required under the ICR plan. This notice contains the adjusted income percentage factors for 2016, examples of how the monthly payment amount in ICR is calculated, and charts showing sample repayment amounts based on the adjusted ICR plan formula. This information is included in the following three attachments:
In Attachment 1, to reflect changes in inflation, we have updated the income percentage factors that were published in the
The income percentage factors reflected in Attachment 1 may cause a borrower's payments to be lower than they were in prior years, even if the borrower's income is the same as in the prior year. However, the revised repayment amount more accurately reflects the impact of inflation on the borrower's current ability to repay.
You may also access documents of the Department published in the
General notes about the examples in this attachment:
• We have a calculator that borrowers can use to estimate what their payment amount would be under the ICR plan. The calculator is called the “Repayment Estimator” and is available at
• The interest rates used in the examples are for illustration only. The actual interest rates on an individual borrower's Direct Loans depend on the loan type and when the postsecondary institution first disbursed the Direct Loan to the borrower.
• The Poverty Guideline amounts used in the examples are from the 2016 U.S. Department of Health and Human Services (HHS) Poverty Guidelines for the 48 contiguous States and the District of Columbia. Different Poverty Guidelines apply to residents of Alaska and Hawaii. The Poverty Guidelines for 2016 were published in the
• All of the examples use an income percentage factor corresponding to an adjusted gross income (AGI) in the table in Attachment 1. If your AGI is not listed in the income percentage factors table in Attachment 1, calculate the applicable income percentage by following the instructions under the “Interpolation” heading later in this attachment.
• Married borrowers may repay their Direct Loans jointly under the ICR plan. If a married couple elects this option, we add the outstanding balance on the Direct Loans of each borrower and we add together both borrowers' AGIs to determine a joint ICR payment amount. We then prorate the joint payment amount for each borrower based on the proportion of that borrower's debt to the total outstanding balance. We bill each borrower separately.
• For example, if a married couple, John and Sally, has a total outstanding Direct Loan debt of $60,000, of which $40,000 belongs to John and $20,000 to Sally, we would apportion 67 percent of the monthly ICR payment to John and the remaining 33 percent to Sally. To take advantage of a joint ICR payment, married couples need not file taxes jointly; they may file separately and subsequently provide the other spouse's tax information to the borrower's Federal loan servicer.
The formula to amortize a loan with a standard schedule (in which each payment is the same over the course of the repayment period) is as follows:
For example, assume that Billy has a $10,000 Direct Unsubsidized Loan with an interest rate of 6 percent.
The remainder of the examples in this attachment will only show the results of the formula.
Brenda is single with no dependents and has $15,000 in Direct Subsidized and Unsubsidized Loans. The interest rate on Brenda's loans is 6 percent, and she has an AGI of $29,131.
• 0.7189 × $146.38 = $105.23
• $29,131−$11,880 = $17,251
• $17,251 × 0.20 = $3,450.20
• $3,450.20 ÷ 12 = $287.52
Brenda would have a lower payment under other income-driven repayment plans. Specifically, Brenda's payment would be $89.31 under the PAYE and REPAYE repayment plans. However, Brenda's payment would be $133.96 under the IBR plan, which is higher than the payment she would have under the ICR plan.
Joseph is married to Susan and has no dependents. They file their Federal income tax return jointly. Joseph has a Direct Loan balance of $10,000, and Susan has a Direct Loan balance of $15,000. The interest rate on all of the loans is 6 percent.
Joseph and Susan have a combined AGI of $82,275 and are repaying their loans jointly under the ICR plan (for general information regarding joint ICR payments for married couples, see the fifth and sixth bullets under the heading “General notes about the examples in this attachment”).
• $10,000 + $15,000 = $25,000
• 1.094 × $243.96 = $266.90
• $82,275−$ 16,020 = $66,225
• $66,225 × 0.20 = $13,251
• $13,251 ÷ 12 = $1,104.25
For Joseph and Susan, the Income-Contingent Repayment plan provides the lowest monthly payment of all of the income-driven repayment plans. Joseph and Susan would not be eligible for the IBR or Pay As You Earn Repayment plans, and would have a combined monthly payment under the REPAYE Repayment plan of $485.38.
• $10,000 ÷ ($10,000 + $15,000) = 40 percent
• 0.40 × $266.90 = $106.76
For Susan, the monthly payment amount will be:
• $15,000 ÷ ($10,000 + $15,000) = 60 percent
• 0.60 × $266.90 = $160.14
David is single with no dependents and has $60,000 in Direct Subsidized and Unsubsidized Loans. The interest rate on all of the loans is 6 percent, and David's AGI is $34,661.
• 0.8033 × $585.51 = $470.34
• $34,661−$11,880 = $22,781
• $22,781 × 0.20 = $4,556.20
• $4,556.20 ÷ 12 = $379.68
David would have a lower payment under each of the other income-driven plans. Specifically, David's payment would be $140.34 under the PAYE and REPAYE repayment plans and $210.51 under the IBR plan.
The result is the income percentage factor that we will use to calculate Joan's monthly repayment amount under the ICR plan.
Below are two charts that provide first-year payment amount estimates for a variety of loan debt sizes and incomes under all of the income-driven repayment plans. The first chart is for single borrowers who have a family size of one. The second chart is for a borrower who is married or a head of household and who has a family size of three. The ICR plan calculations assume that the loan debt has an interest rate of 6 percent. For married borrowers, the calculations assume that the borrower files a joint Federal income tax return with his or her spouse. A field with a “-” character indicates that the borrower in the example would not be eligible to enter the applicable repayment based plan based on the borrower's income, loan debt, and family size.
20 U.S.C. 1087
Federal Student Aid, Department of Education.
Notice.
The Secretary announces deadline dates for the receipt of documents and other information from applicants and institutions participating in certain Federal student aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA), for the 2016-2017 award year. The Federal student aid programs covered by this deadline date notice are the Pell Grant, Direct Loan, TEACH Grant, and Iraq and Afghanistan Service Grant programs. The FSEOG, FWS, and Perkins Loan programs are only covered by this deadline date notice to the extent that a student receiving FSOEG, FWS, or Perkins Loan funds must submit a FAFSA, to the extent that the institution must receive the student's Institutional Student Information Record (ISIR) or Student Aid Report (SAR) for students requesting those funds, or to the extent that the institution must submit verification outcomes for students requesting those funds.
These programs, administered by the U.S. Department of Education (Department), provide financial assistance to students attending eligible postsecondary educational institutions to help them pay their educational costs.
Table A provides information and deadline dates for receipt of the FAFSA, corrections to and signatures for the FAFSA, ISIRs, and SARs, and verification documents.
The deadline date for the receipt of a FAFSA by the Department's Central Processing System is June 30, 2017, regardless of the method that the applicant uses to submit the FAFSA. The deadline date for the receipt of a signature page for the FAFSA (if required), correction, notice of change of address or school, or request for a duplicate SAR is September 9, 2017.
For all Federal student aid programs, an ISIR or SAR for the student must be received by the institution no later than the student's last date of enrollment for the 2016-2017 award year or September 23, 2017, whichever is earlier. As a reminder, a FAFSA must be submitted for the dependent student for whom a parent is applying for a Direct PLUS Loan.
Verification documents must be received by the institution no later than 120 days after the student's last date of enrollment for the 2016-2017 award year or September 23, 2017, whichever is earlier.
For all Federal student aid programs except for (1) Direct PLUS Loans that will be made to parent borrowers, and (2) Direct Unsubsidized Loans that will be made to dependent students who have been determined by the institution, pursuant to section 479A(a) of the HEA, to be eligible for such a loan without providing parental information on the FAFSA, the ISIR or SAR must have an official expected family contribution (EFC) and must be received by the institution no later than the earlier of the student's last date of enrollment for the 2016-2017 award year or September 23, 2017.
For a student who is requesting aid through the Pell Grant, FSEOG, FWS, and Federal Perkins Loan programs or for a student requesting Direct Subsidized Loans, who does not meet the conditions for a late disbursement under 34 CFR 668.164(g), a valid ISIR or valid SAR must be received by the student's last date of enrollment for the 2016-2017 award year or September 23, 2017, whichever is earlier.
In accordance with 34 CFR 668.164(g)(4)(i), an institution may not make a late disbursement of title IV student assistance funds later than 180 days after the date of the institution's determination that the student was no longer enrolled. Table A provides that, to make a late disbursement of title IV student assistance funds, an institution must receive a valid ISIR or valid SAR no later than 180 days after its determination that the student was no longer enrolled, but not later than September 23, 2017.
Table B provides the earliest and latest dates for institutions to submit Pell Grant, Iraq and Afghanistan Service Grant, Direct Loan, and TEACH Grant disbursement records to the Department's Common Origination and Disbursement (COD) System and deadline dates for such records if an institution requests and receives approval to submit such records after the established deadline.
An institution must submit Pell Grant, Iraq and Afghanistan Service Grant, Direct Loan, and TEACH Grant disbursement records to COD, as applicable, no later than 15 days after making the disbursement or becoming aware of the need to adjust a previously reported disbursement. In accordance with 34 CFR 668.164(a), title IV funds are disbursed on the date that the institution: (a) Credits those funds to a student's account in the institution's general ledger or any subledger of the general ledger; or (b) pays those funds to a student directly. Title IV funds are disbursed even if an institution uses its own funds in advance of receiving program funds from the Secretary.
An institution's failure to submit disbursement records within the required timeframe may result in the Secretary rejecting all or part of the reported disbursement. Such failure may also result in an audit or program review finding or the initiation of an adverse action, such as a fine or other penalty for such failure, in accordance with subpart G of the General Provisions regulations in 34 CFR part 668.
We publish a detailed discussion of the Federal student aid application process in the 2016-2017
Additional information on the institutional reporting requirements for the Pell Grant, Iraq and Afghanistan Service Grant, Direct Loan, and TEACH Grant programs is included in the 2016-2017
You may access these publications by selecting the “iLibrary” link at the Information for Financial Aid Professionals Web site at:
(1) Student Assistance General Provisions, 34 CFR part 668.
(2) Federal Pell Grant Program, 34 CFR part 690.
(3) William D. Ford Direct Loan Program, 34 CFR part 685.
(4) Teacher Education Assistance for College and Higher Education Grant Program, 34 CFR part 686.
Ian Foss, U.S. Department of Education, Federal Student Aid, 830 First Street NE., Union Center Plaza, Room 113H2, Washington, DC 20202-5345. Telephone: (202) 377-3681 or by email:
If you use a telecommunications device for the deaf (TDD) or text telephone (TTY), call the Federal Relay Service, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
20 U.S.C. 1070a, 1070a-1, 1070b-1070b-4, 1070g, 1070h, 1087a-1087j, and 1087aa-1087ii; 42 U.S.C. 2751-2756b.
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before June 3, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Kashka Kubzdela at
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Department of Energy.
Notice of Open Meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB) Chairs. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Wednesday, April 20, 2016 8:00 a.m.-5:00 p.m., Thursday, April 21, 2016 8:00 a.m.-12:30 p.m.
Doubletree Hotel, 215 South Illinois Avenue Oak Ridge, Tennessee 37830.
David Borak, Designated Federal Officer, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585; Phone: (202) 586-9928.
Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.
Tentative Agenda Topics:
Public Participation: The EM SSAB Chairs welcome the attendance of the public at their advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact David Borak at least seven days in advance of the
Office of Nonproliferation and Arms Control, Department of Energy.
Proposed subsequent arrangement.
This document is being issued under the authority of the Atomic Energy Act of 1954, as amended. The Department is providing notice of a proposed subsequent arrangement under the Agreement for Cooperation Concerning Civil Uses of Nuclear Energy Between the Government of the United States of America and the Government of Canada and the Agreement for Cooperation in the Peaceful Uses of Nuclear Energy Between the United States of America and the European Atomic Energy Community.
This subsequent arrangement will take effect no sooner than April 19, 2016.
Ms. Katie Strangis, Office of Nonproliferation and Arms Control, National Nuclear Security Administration, Department of Energy. Telephone: 202-586-8623 or email:
This subsequent arrangement concerns the retransfer of 591,716 kg of U.S.-origin natural uranium hexafluoride (UF6) (67.6% U), 400,000 kg of which is uranium, from Cameco Corporation (Cameco) in Saskatoon, Saskatchewan, to URENCO Deutschland GmbH in Gronau, Germany. The material, which is currently located at Cameco in Port Hope, Ontario, will be used for toll enrichment by URENCO Deutschland. The material was originally obtained by Cameco from Energy Fuels Resources, White Mesa Mill, pursuant to export license XSOU8798. In accordance with section 131a. of the Atomic Energy Act of 1954, as amended, it has been determined that this subsequent arrangement concerning the retransfer of nuclear material of United States origin will not be inimical to the common defense and security of the United States of America.
For the Department of Energy.
Office of Nonproliferation and Arms Control, Department of Energy.
Proposed subsequent arrangement.
This document is being issued under the authority of the Atomic Energy Act of 1954, as amended. The Department is providing notice of a proposed subsequent arrangement under the Agreement for Cooperation Concerning Civil Uses of Nuclear Energy Between the Government of the United States of America and the Government of Canada and the Agreement for Cooperation in the Peaceful Uses of Nuclear Energy Between the United States of America and the European Atomic Energy Community.
This subsequent arrangement will take effect no sooner than April 19, 2016.
Ms. Katie Strangis, Office of Nonproliferation and Arms Control, National Nuclear Security Administration, Department of Energy. Telephone: 202-586-8623 or email:
This subsequent arrangement concerns the retransfer of 210,059 kg of U.S.-origin natural uranium hexafluoride (UF6) (67.6% U), 142,000 kg of which is uranium, from Cameco Corporation (Cameco) in Saskatoon, Saskatchewan, to URENCO Ltd. (URENCO) in Almelo, The Netherlands. The material, which is currently located at Cameco in Port Hope, Ontario, will be used for toll enrichment by URENCO at its facility in Almelo, The Netherlands. The material was originally obtained by Cameco from Energy Fuels Resources, White Mesa Mill, pursuant to export license XSOU8798. In accordance with section 131a. of the Atomic Energy Act of 1954, as amended, it has been determined that this subsequent arrangement concerning the retransfer of nuclear material of United States origin will not be inimical to the common defense and security of the United States of America.
For the Department of Energy.
Wind and Water Power Technologies Office, Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of public workshop and webinar.
The Wind and Water Power Technologies Office within the U.S. Department of Energy (DOE) recently released a Request for Information to identify the challenges and opportunities faced by the pumped storage hydropower industry. DOE is now announcing two additional opportunities to obtain individual stakeholder insight into the technical and market challenges and potential pathways to facilitate the development of pumped storage in the U.S.: A public workshop and a subsequent webinar entitled, “Challenges and Opportunities for Pumped Storage Hydropower.”
The public workshop will be held on Wednesday, April 27, 2016, from 1:00
The public webinar will take place on Thursday, May 5, 2016, from 1:00 p.m. to 4:00 p.m. Eastern Time.
The public workshop will be held in the Congressional Room at the Capital Hilton located at 1001 16th St. NW., Washington, DC 20036.
The webinar will be broadcasted to the public online. Instructions for accessing the webinar will be shared prior to the event. Registration is required.
Questions may be directed to Daniel Rabon at (202) 586-1545 or by email at
Pumped storage hydropower (PSH) comprises the overwhelming majority (97%) of utility-scale storage in the U.S. The value proposition of PSH lies in its ability to provide operating flexibility to balance system loads and variable generation from other renewables. However, since 1995, only one PSH plant has been deployed in the U.S. Furthermore, while advanced PSH is being used worldwide, no single project in the U.S. is currently taking advantage of this technology.
DOE is looking to continue to assess and better understand the challenges faced by the PSH industry as they relate to technology advancements for small, modular and large systems, market structures and civil works, and their respective technical, financial, market and regulatory challenges. While DOE recently released a Request for Information on this topic, this public workshop and subsequent webinar provide an additional opportunity for the hydropower community to express thoughts, concerns, and ideas based on their own experience that will help inform program strategy. Topic areas of interest up for discussion will include technical and market challenges facing PSH development and potential pathways forward. An agenda will be distributed prior to the events.
The objective of the meeting is to ask for public input regarding the project described in this notice. To that end, it would be most helpful if members of the public provide information based on their personal experience, individual advice, and facts regarding this topic. It is not the objective of this meeting to obtain any group position or consensus. Rather, the DOE is seeking as many recommendations as possible from all individuals at this meeting.
Members of the public are welcome to attend the workshop. Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by Friday, April 22, 2016. Early registration is recommended because facilities are limited and, therefore, DOE may limit the number of participants from each organization. To register for the public workshop, please visit
Members of the public are welcome to attend the webinar. Persons interested in attending this public workshop must register online by Wednesday, May 4, 2016. To register for the public webinar, please visit
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Federal Energy Regulatory Commission (Commission) will convene a staff-led technical conference in the above-referenced proceedings on Friday, May 13, 2016 from 9:30 a.m. to 4:30 p.m. (EDT). The conference will be held in the Commission Meeting Room at Commission headquarters, 888 First Street NE., Washington, DC 20426. Commissioners may attend and participate.
The purpose of this conference is to discuss select issues related to a petition for rulemaking submitted by the American Wind Energy Association (Docket No. RM15-21-000). In addition, the conference will explore other generator interconnection issues, including interconnection of energy storage.
Discussions at the conference may involve issues raised in proceedings that are currently pending before the Commission. These proceedings include, but are not limited to:
Entergy Arkansas, Inc., Docket No. ER14-671-000;
Midcontinent Independent System Operator, Inc., Docket No. ER16-675-000;
California Independent System Operator Corporation, Docket No. ER16-693-000;
ISO New England, Inc., Docket No. ER16-946-000;
Midcontinent Independent System Operator, Inc., Docket No. ER16-1120-000; and
Midcontinent Independent System Operator, Inc., Docket No. ER16-1211-000.
Additional information regarding the conference program will be provided in subsequent supplemental notices of technical conference.
There is no fee for attendance. In-person attendees should allow time to pass through building security procedures before the 9:30 a.m. start time of the technical conference. Pre-registration is encouraged though not required. Attendees may register in advance at the following Web page:
The conference will be transcribed and webcast. Transcripts will be available immediately for a fee from Ace Reporting (202-347-3700). A link to the webcast of this event will be available in the Commission Calendar of Events at
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to
For more information about this technical conference, please contact Tony Dobbins at
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC's) regulations, 18 Code of Federal Regulations (CFR) Part 380 (Order No. 486, 52
Staff prepared a draft environmental assessment (DEA), which analyzes the potential environmental effects of constructing and operating a new diversion on the West Fork of Upper Battle Creek that would divert water to Bradley Lake and thereby increase generation at the project. The DEA concludes that authorizing the amendment, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the DEA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
Any comments should be filed within 30 days from the date of this notice. Comments may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
For further information, contact Steven Sachs by telephone at 202-502-8666 or by email at
On December 22, 2015, Energy Resources USA, Inc. (Energy Resources) filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Cedar Creek Hydroelectric Project (Cedar Creek Project or project) to be located at the U.S. Army Corps of Engineers' Cedar Creek Dam on the Cedar Creek River in Franklin County, Alabama. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) A control structure with three 9.5-foot-wide, 25-foot-long spill gates; (2) one 6-foot-diameter, 49-foot-long penstock with a butterfly valve; (3) a bifurcation structure; (4) two 4-foot-diameter, 32-foot-long penstocks; (5) a powerhouse containing two generating units with a total capacity of 1.5 megawatts; (6) a 1000-foot-long, 220-foot-wide tailrace; (7) a substation; and (8) a 4.5-mile-long, 69 kV transmission line. The proposed project would have an estimated average annual generation of 5,500 megawatt-hours, and operate as directed by the Corps.
The Commission strongly encourages electronic filing. Please file comments and motions to intervene using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's Web site at
On December 22, 2015, Energy Resources USA, Inc. (Energy Resources) filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Taylorsville Lake Dam Hydroelectric Project (Taylorsville Project or project) to be located at the U.S. Army Corps of Engineers' Taylorsville Lake Dam on the Salt River in Spencer County, Kentucky. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) A control structure with one spill gate; (2) one 8-foot-diameter, 120-foot-long penstock with a butterfly valve; (3) a bifurcation structure; (4) two 5.5-foot-diameter, 32-foot-long penstocks; (5) a powerhouse containing two generating units with a total capacity of 3 megawatts; (6) a 90-foot-long, 60-foot-wide tailrace; (7) a substation; and (8) a 2.5-mile-long, 69 kV transmission line. The proposed project would have an estimated average annual generation of 9,500 megawatt-hours, and operate as directed by the Corps.
The Commission strongly encourages electronic filing. Please file comments and motions to intervene using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's Web site at
Federal Energy Regulatory Commission, DOE.
Notice of information collection and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC Form 6-Q (Quarterly Financial Report of Oil Pipeline Companies).
Comments on the collection of information are due June 3, 2016.
You may submit comments (identified by Docket No. IC16-7-000) by either of the following methods:
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Ellen Brown may be reached by email at
The Commission uses the information collected by FERC Form 6-Q to carry out its responsibilities in implementing the statutory provisions of the ICA to include the authority to prescribe rules and regulations concerning accounts, records, and memoranda, as necessary or appropriate. Financial accounting and reporting provides necessary information concerning a company's past performance and its future prospects. Without reliable financial statements prepared in accordance with the Commission's Uniform System of Accounts and related regulations, the Commission would be unable to accurately determine the costs that relate to a particular time period, service, or line of business.
The Commission uses data from the FERC Form 6-Q to assist in:
1. Implementation of its financial audits and programs,
2. continuous review of the financial condition of regulated companies,
3. assessment of energy markets,
4. rate proceedings and economic analyses, and
5. research for use in litigation.
Financial information reported on the quarterly FERC Form 6-Q provides FERC, as well as customers, investors and others, an important tool to help identify emerging trends and issues affecting jurisdictional entities within the energy industry. It also provides timely disclosures of the impacts that new accounting standards, or changes in existing standards, have on jurisdictional entities, as well as the economic effects of significant transactions, events, and circumstances. The reporting of this information by jurisdictional entities assists the Commission in its analysis of profitability, efficiency, risk, and in its overall monitoring.
On September 24, 2015, PennEast Pipeline Company, LLC (PennEast) filed an application in Docket No. CP15-558-000 under section 7(c) of the Natural Gas Act seeking a Certificate of Public Convenience and Necessity to construct, operate, and maintain a new natural gas pipeline system in Pennsylvania and New Jersey. The proposed project is known as the PennEast Pipeline Project and will provide approximately 1.0 billion cubic feet per day of year-round transportation natural gas service to markets in eastern and southeastern Pennsylvania and New Jersey.
On October 8, 2015, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the project. Among other things, that notice alerted other agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on the request for a federal authorization within 90 days of the date of issuance of the Commission staff's final Environmental Impact Statement (EIS) for the PennEast Pipeline Project. This instant notice identifies the FERC staff's planned schedule for completion of the final EIS for the project.
Issuance of Notice of Availability of the final EIS—December 16, 2016.
90-day Federal Authorization Decision Deadline—March 16, 2017.
If a schedule change becomes necessary, additional notice will be provided so the relevant agencies are kept informed of the project's progress.
The project includes a total of 118.8 miles of pipeline and laterals composed of 115.0 miles of new, 36-inch-diameter pipeline extending from Luzerne County, Pennsylvania to Mercer County, New Jersey. The Project would also have three pipeline laterals: The 2.1-mile Hellertown Lateral consisting of 24-inch-diameter pipeline in Northampton County, Pennsylvania; the 0.1-mile Gilbert Lateral consisting of 12-inch-diameter pipeline in Hunterdon County, Pennsylvania; and the 1.5-mile Lambertville Lateral consisting of 36-inch-diameter pipeline in Hunterdon County, New Jersey.
The proposed aboveground facilities consist of a new, 47,700 horsepower compressor station in Kidder Township, Carbon County, Pennsylvania. The project would also include the construction of 8 meter and regulator stations, 11 mainline valves, and 11 pig launcher/receiver sites.
On October 10, 2014, the Commission staff granted PennEast's request to use the FERC's Pre-filing environmental review process and assigned the PennEast Pipeline Project Docket No. PF15-1-000. On January 13, 2015, the Commission issued, in that docket, a
The primary issues raised by the commenters during scoping included concerns about potential impacts on agricultural farms, ground water resources on Sourland Region, protected conservation lands, threatened and endangered species, archaeological sites, forest (
The U.S. Environmental Protection Agency, U.S. Army Corps of Engineers, U.S. Department of Agriculture, U.S. Fish and Wildlife Service, and U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration are cooperating agencies in the preparation of the EIS.
In order to receive notification of the issuance of the EIS and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (
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e. All local, state, and federal agencies, Indian tribes, and other interested parties are invited to participate by phone. Please call Andy Bernick at (202) 502-8660 by Thursday, April 21, 2016, to RSVP and to receive specific instructions on how to participate.
On December 22, 2015, Energy Resources USA, Inc. (Energy Resources) filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Nolin Lake Dam Hydroelectric Project (Nolin Project or project) to be located at the U.S. Army Corps of Engineers' Nolin Lake Dam on the Nolin River in Edmonson County, Kentucky. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) A control structure with three 9.5-foot-wide, 25-foot-long spill gates; (2) one 10-foot-diameter, 65-foot-long penstock with a butterfly valve; (3) a bifurcation structure; (4) two 6.5-foot-diameter, 32-foot-long penstocks; (5) a powerhouse containing two generating units with a total capacity of 7 megawatts; (6) a 1000-foot-long, 220-foot-wide tailrace; (7) a substation; and (8) a 3-mile-long, 69 kV transmission line. The proposed project would have an estimated average annual generation of 26,900 megawatt-hours, and operate as directed by the Corps.
The Commission strongly encourages electronic filing. Please file comments and motions to intervene using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's Web site at
On December 22, 2015, Energy Resources USA, Inc. (Energy Resources) filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Lake Tuscaloosa Dam Hydroelectric Project (Lake Tuscaloosa Project or project) to be located at the U.S. Army Corps of Engineers' Lake Tuscaloosa Dam on the North River in Tuscaloosa County, Alabama. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit
The proposed project would consist of the following: (1) A control structure with three 9.5-foot-wide, 25-foot-long spill gates; (2) one 6-foot-diameter, 98-foot-long penstock with a butterfly valve; (3) a bifurcation structure; (4) two 4-foot-diameter, 32-foot-long penstocks; (5) a powerhouse containing two generating units with a total capacity of 1.65 megawatts; (6) a 1000-foot-long, 220-foot-wide tailrace; (7) a substation; and (8) a 2.5-mile-long, 69 kV transmission line. The proposed project would have an estimated average annual generation of 5,200 megawatt-hours, and operate as directed by the Corps.
The Commission strongly encourages electronic filing. Please file comments and motions to intervene using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's Web site at
On December 22, 2015, Energy Resources USA, Inc. (Energy Resources) filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Rough River Lake Dam Hydroelectric Project (Rough River Project or project) to be located at the U.S. Army Corps of Engineers' Rough River Lake Dam on the Rough River in Breckinridge and Grayson Counties, Kentucky. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) A control structure with three 9.5-foot-wide, 25-foot-long spill gates; (2) one 9.5-foot-diameter, 130-foot-long penstock with a butterfly valve; (3) a bifurcation structure; (4) two 6.5-foot-diameter, 32-foot-long penstocks; (5) a powerhouse containing two generating units with a total capacity of 10 megawatts; (6) a 1000-foot-long, 220-foot-wide tailrace; (7) a substation; and (8) a 0.3-mile-long, 69 kV transmission line. The proposed project would have an estimated average annual generation of 8,700 megawatt-hours, and operate as directed by the Corps.
The Commission strongly encourages electronic filing. Please file comments and motions to intervene using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's Web site at
In a prior notice, the Commission scheduled a technical conference to review the submitted Other Federal Agency costs in the above-captioned docket. Due to the impact of the Nuclear Security Summit on March 31, 2016 the conference is postponed to April 7, 2016.
The technical conference will be held on April 7, 2016, in Conference Room 3M-1 at the Commission's headquarters, 888 First Street NE., Washington, DC. The technical conference will begin at 2:00 p.m. (EST).
Western Area Power Administration, DOE.
Notice of proposed base charge and rates.
Western Area Power Administration (Western) is proposing an adjustment to the Boulder Canyon Project (BCP) electric service base charge and rates. The current base charge and rates under Rate Schedule BCP-F9 expire September 30, 2016. The current base charge is not sufficient to cover all annual costs including operation and maintenance, replacements, and interest expense; and repay investment obligations within the required period. The proposed base charge will provide sufficient revenue to cover all annual costs and to repay investment obligations within the allowable period. Western will post a detailed rate package that identifies the reasons for the base charge and rates adjustment on its Web site during the consultation and comment period. The proposed base charge and rates are scheduled to become effective October 1, 2016, and will remain in effect through September 30, 2017. Publication of this
The consultation and comment period begins today and will end July 5, 2016. Western will present a detailed explanation of the proposed base charge and rates at a public information forum that will be held on April 27, 2016, at 10:30 a.m. Mountain Standard Time (MST), in Phoenix, Arizona. Western will accept oral and written comments at a public comment forum that will be held on May 25, 2016, at 10:30 a.m. MST. Western will accept written comments any time during the consultation and comment period.
The public information forum and public comment forum will be held at Western's Desert Southwest Customer Service Regional Office, located at 615 South 43rd Avenue, Phoenix, Arizona 85009. Send written comments to Mr. Ronald E. Moulton, Regional Manager, Desert Southwest Customer Service Region, Western Area Power Administration, P.O. Box 6457, Phoenix, AZ 85005-6457, email
As access to Western facilities is controlled, any United States (U.S.) citizen wishing to attend the forums must present an official form of picture identification (ID), such as a U.S. driver's license, U.S. passport, U.S. Government ID, or U.S. Military ID. Foreign nationals should contact Western via Mr. Scott Lund, Rates Manager, telephone (602) 605-2442 or email
Mr. Scott Lund, Rates Manager, Desert Southwest Customer Service Region, Western Area Power Administration, P.O. Box 6457, Phoenix, AZ 85005-6457, (602) 605-2442, or email
Rate Schedule BCP-F9 under Rate Order No. WAPA-171 was approved on an interim basis by the Deputy Secretary of Energy for a five-year period beginning on October 1, 2015, and ending September 30, 2020.
The proposed base charge and rates for BCP electric service are designed to recover an annual revenue requirement that includes investment repayment, interest, operation and maintenance, replacements, payments to states, visitor services, and uprating payments. The total costs are offset by the projected revenue from water sales, the visitor center, ancillary services, and late fees. The annual revenue requirement is the base charge for electric service divided equally between capacity and energy. The annual composite rate is the base charge divided by annual energy sales.
Rate Schedule BCP-F9 requires the annual calculation of the base charge and rates based on updated financial and hydrology data. The proposed base charge for fiscal year (FY) 2017 is $68,572,989 and the proposed composite rate is 19.60 mills/kilowatthour. The following table compares the existing and proposed base charge and composite rate.
The proposed FY 2017 base charge represents an increase of approximately 8 percent compared to the FY 2016 base charge. Increases in annual operation and maintenance and replacement costs, and decreases in projections of non-power revenue and carryover revenue account for the overall base charge increase.
The proposed FY 2017 composite rate represents an increase of approximately 7 percent compared to the FY 2016 composite rate. Increases in the proposed base charge and forecasted energy sales account for the composite rate increase. This proposal, effective October 1, 2016, is preliminary and is subject to change upon publication of the final base charge and rates.
Western will hold both a public information forum and a public comment forum. After review of public comments, Western will take further action on the proposed base charge and rates and follow procedures for public participation consistent with 10 CFR parts 903 and 904.
Western is establishing an electric service base charge and rates for BCP under the Department of Energy (DOE) Organization Act (42 U.S.C. 7152); the Reclamation Act of 1902 (ch. 1093, 32 Stat. 388), as amended and supplemented by subsequent
By Delegation Order No. 00-037.00A, effective December 25, 2013, the Secretary of Energy delegated: (1) The authority to develop power and transmission rates to Western's Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, to remand, or to disapprove such rates to the Federal Energy Regulatory Commission.
All brochures, studies, comments, letters, memorandums, or other documents Western initiates or uses to develop the proposed base charge and rates are available for inspection and copying at the Desert Southwest Customer Service Regional Office, Western Area Power Administration, located at 615 South 43rd Avenue, Phoenix, Arizona 85009. Many of these documents and supporting information are available on Western's Web site at:
In compliance with the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4321-4347; the Council on Environmental Quality Regulations for implementing NEPA (40 CFR parts 1500-1508); and DOE NEPA Implementing Procedures and Guidelines (10 CFR part 1021), Western is in the process of determining whether an environmental assessment or an environmental impact statement should be prepared or if this action can be categorically excluded from those requirements.
Western has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.
Environmental Protection Agency (EPA).
Notice.
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before May 4, 2016.
Submit your comments, identified by the docket identification (ID) number and the File Symbol of interest as shown in the body of this document, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Robert McNally, Biopesticides and Pollution Prevention Division (BPPD) (7511P), email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
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EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.
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5. EPA Registration Numbers: 59639-107 and 59639-202.
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7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: “Notice of Supplemental Distribution of a Registered Pesticide Product,” and identified by EPA ICR No. 0278.12 and OMB Control No. 2070-0044, represents the renewal of an existing ICR that is scheduled to expire on November 30, 2016. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that are summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.
Comments must be received on or before June 3, 2016.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0108, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Jeffrey Bryan, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-8782; email address:
Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.
2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
3. Enhance the quality, utility, and clarity of the information to be collected.
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
EPA will consider the comments received and amend the ICRs as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another
44 U.S.C. 3501
Environmental Protection Agency (EPA).
Notice.
The U.S. Environmental Protection Agency (EPA) is planning to submit a request to renew an existing information collection request (ICR), “Clean Water State Revolving Fund Program” (EPA ICR No. 1391.10, OMB Control No. 2040-0118), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through July 31, 2016. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Comments must be submitted on or before June 3, 2016.
Submit your comments, referencing Docket ID No. EPA-HQ-OW-2004-0015, online using
EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Mark Mylin, Municipal Support Division, Office of Wastewater Management, 4204M, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-0607; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR, docket number EPA-HQ-OW-2004-0015. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA (44 U.S.C. 3501
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• enhance the quality, utility and clarity of the information to be collected; and
• minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical or other technological collection techniques or other forms of information technology,
EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another
This ICR renews the Office of Management and Budget (OMB) Number 2040-0118 CWSRF ICR and provides updated estimates of the reporting burden associated with the information collection activities. The updated estimates are based on EPA's most recent public consultation and capture the estimated impact of the WRRDA amendments.
The individual information collections covered under this ICR are briefly described as follows:
The Capitalization Grant Agreement is the principal instrument by which a CWSRF commits to manage its revolving fund program in conformity with the requirements of the Clean Water Act. The grant agreement contains or incorporates by reference the intended use plan, application materials, required certifications, and other documentation required by EPA. The intended use plan describes how a CWSRF program intends to use its funds for the upcoming year to meet the objectives of the Clean Water Act (CWA).
The annual report indicates how the CWSRF has met its goals and objectives of the previous state fiscal year as stated in the grant agreement and, more specifically, in the intended use plan. The report provides information on loan recipients, loan amounts, loan terms, project categories of eligible costs, and similar data on other forms of assistance.
The CWA requires a CWSRF to undergo an annual audit. Though an audit conducted under the Single Audit Act meets this requirement, EPA still recommends that a CWSRF also undergo a separate independent audit as a best management practice. The audit must contain an opinion on the financial condition of the CWSRF program, a report on its internal controls, and a report on compliance with applicable laws and the CWA.
To meet the CWA objective of “promoting the efficient use of fund resources,” states must enter financial data, including project disbursements, into the CWNIMS database on an annual basis. This publicly available information is used by the EPA to assess compliance with the CWSRFs' mandate to use all funds in an “expeditious and timely” manner and achieve the objectives of the CWA. Project level data is collected on a quarterly basis using the CBR System to record projected environmental results from CWSRF projects.
Per EPA Grants Policy Issuance (GPI) 14-02: Enhancing Public Awareness of EPA Assistance Agreements, CWSRF borrowers must publicize the EPA's involvement in project funding only up to the funding amount in each year's capitalization grant. The CWSRFs have various options to meet this requirement.
With the exception of the public awareness policy, the respondents for the information collection activities are the state environmental departments, and/or finance agencies responsible for operating the CWSRFs. The public awareness policy directly impacts CWSRFs borrowers that are designated as recipients of federal funds. The burden associated with the public awareness policy may have an impact on small entities. However, this impact is mitigated by the fact that the CWSRFs have flexibility in determining which borrowers must comply with this requirement.
Though these information collection activities add additional burden, the total estimated reporting burden under this renewal is significantly lower compared to the previously approved ICR. The estimate of the annual burden has been decreased by 748,471 hours while the total annual cost burden has been decreased by $17,744,006. This significant revision is due to the removal of the burden associated with CWSRF applications and ongoing ARRA reporting.
Environmental Protection Agency (EPA).
Notice of proposed consent decree; request for public comment.
In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed consent decree to address a lawsuit filed by Center for Biological Diversity, Center for Environmental Health, and Neighbors for Clean Air (“Plaintiffs”) in the United States District Court for the Northern District of California:
Written comments on the proposed consent decree must be received by
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2016-0172, online at
Geoffrey L. Wilcox, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone: (202) 564-5601; fax number: (202) 564-5603; email address:
The proposed consent decree would resolve a lawsuit filed by the Plaintiffs seeking to compel EPA to take various actions required under CAA. The proposed consent decree would establish deadlines by which EPA must take certain actions specified in order to resolve the claims in the First Amended Complaint. Those actions are described generally below; see the proposed consent decree for the specific details.
First, Plaintiffs allege that EPA failed to meet a duty under section 110(k)(1)(B) to make a finding concerning whether the State of California has made a complete state implementation plan (“SIP”) submission to address nonattainment new source review (“NNSR”) requirements related to the 2006 fine particulate matter (“PM2.5”) National Ambient Air Quality Standard (“NAAQS”) for El Dorado and Yolo-Solano air districts in California. In the proposed consent decree, EPA agrees to take action to determine whether or not the state has made a complete SIP submission to address these requirements for each of these two areas by no later than May 30, 2016.
Second, Plaintiffs allege that EPA failed to meet a duty under section 110(k) to take final action to approve, disapprove, or conditionally approve, in whole or in part, certain complete SIP submissions from the States of Arizona, California, Idaho, Oregon, and Utah intended to address NNSR or other specific requirements related to the 2006 PM
Third, Plaintiffs allege that EPA has failed to meet a duty under section 110(c) to promulgate a federal implementation plan (“FIP”) for the State of Montana with respect to requirements of section 110(a)(2)(E)(ii) and section 128 pertaining to state boards that approve permits or enforcement orders, or to the head of an executive agency with similar powers. In the proposed consent decree, EPA agrees to take final action no later than September 30, 2016, with respect to this claim.
For all of the actions governed by the proposed consent decree, EPA would be required to deliver the notice to the Office of Federal Register for review and publication within 15 days of signature.
The proposed consent decree is in the docket for this action. For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this proposed consent decree should be withdrawn, the terms of the consent decree will be affirmed.
The official public docket for this action (identified by EPA-HQ-OGC-2016-0172) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Environmental Protection Agency (EPA).
Notice of availability.
The Environmental Protection Agency (EPA) is announcing the release of recommended aquatic life water quality criteria for cadmium. EPA has updated its national recommended ambient water quality criteria for cadmium in order to reflect the latest scientific information, and current EPA policies and methods. EPA's water quality criteria for cadmium provides recommendations to states and tribes authorized to establish water quality standards under the Clean Water Act. In adopting water quality standards, states set exposure protections for aquatic life; acute exposure to cadmium results in lethality, while chronic exposure to cadmium negatively impacts growth, development, behavior, reproduction, and immune and endocrine systems in aquatic life. Cadmium enters the environment by natural and human processes, however, human sources, such as mining and urban processes, are responsible for contributing approximately 90 percent of the cadmium found in surface waters.
Mike Elias, Health and Ecological Criteria Division, Office of Water (Mail Code 4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 566-0120; email address:
EPA's recommended water quality criteria are scientifically derived numeric values that protect aquatic life or human health from the deleterious effects of pollutants in ambient water. Section 304(a)(1) of the Clean Water Act (CWA) directs EPA to develop and publish and, from time to time, revise criteria for protection of aquatic life and human health that accurately reflect the latest scientific knowledge. Water quality criteria developed under section 304(a) are based solely on data and the latest scientific knowledge on the relationship between pollutant concentrations and environmental and human health effects. Section 304(a) criteria do not reflect consideration of economic impacts or the technological
EPA's recommended section 304(a) criteria provide technical information to states and authorized tribes in adopting water quality standards (WQS) that ultimately provide a basis for assessing water body health and controlling discharges or releases of pollutants. Under the CWA and its implementing regulations, states and authorized tribes are to adopt water quality criteria to protect designated uses (
Cadmium is a naturally occurring metal found in mineral deposits and distributed widely at low concentrations in the environment. Cadmium's primary industrial uses are for the manufacturing of batteries, pigments, plastic stabilizers, metal coatings, alloys and electronics. Recently, cadmium has been used in manufacturing nanoparticles (quantum dots) for use in solar cells and color displays. Cadmium is a non-essential metal with no biological function in aquatic life. Acute exposure causes mortality. Chronic exposure leads to adverse effects on growth, reproduction, immune and endocrine systems, development and behavior in aquatic organisms.
EPA prepared an update of the chronic aquatic life criteria document for cadmium based on the latest scientific information and current EPA policies and methods, including EPA's
The estuarine/marine acute criterion for dissolved cadmium is slightly more stringent than the 2001 recommended criterion, which is primarily due to the addition of new sensitive genera. Changes in suggested values between 2001 and 2016 can be found in Table 1 below.
As part of the WQS triennial review process defined in section 303(c)(1) of the CWA, the states and authorized tribes are responsible for maintaining and revising WQS. Standards consist of designated uses, water quality criteria to protect those uses, a policy for antidegradation, and may include general policies for application and implementation. Section 303(c)(1) requires states and authorized tribes to review and modify, if appropriate, their WQS at least once every three years.
States and authorized tribes must adopt water quality criteria that protect designated uses. Protective criteria are based on a sound scientific rationale and contain sufficient parameters or constituents to protect the designated uses. Criteria may be expressed in either narrative or numeric form. States and authorized tribes have four options when adopting water quality criteria for which EPA has published section 304(a) criteria. They may:
(1) Establish numerical values based on recommended section 304(a) criteria;
(2) Adopt section 304(a) criteria modified to reflect site-specific conditions;
(3) Adopt criteria derived using other scientifically defensible methods; or
(4) Establish narrative criteria where numeric criteria cannot be established or to supplement numerical criteria (40 CFR 131.11(b)).
EPA's regulation at 40 CFR 131.20(a) provides that if a state does not adopt new or revised criteria parameters for which EPA has published new or updated recommendations, then the state shall provide an explanation when it submits the results of its triennial review to the Regional Administrator consistent with CWA section 303(c)(1). The updated cadmium criteria supersede EPA's previous 304(a) criteria for cadmium. Consistent with 40 CFR 131.21, new or revised water quality criteria adopted into law or regulation by states and authorized tribes on or after May 30, 2000 are applicable water quality standards for CWA purposes only after EPA approval.
EPA conducted a contractor-led and independent external peer review of the draft Aquatic Life Ambient Water Quality Criteria for Cadmium document in October 2015. This document was released for 60 day public comment in 2016 and has been updated accordingly. The document may be found at:
10:00 a.m., Wednesday, April 20, 2016.
The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW., Washington, DC 20004 (enter from F Street entrance).
Open.
The Commission will hear oral argument in the matter
Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).
Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.
10:00 a.m., Thursday, April 21, 2016.
The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW., Washington, DC 20004 (enter from F Street entrance).
Open.
The Commission will consider and act upon the following in open session:
Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).
Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.
Board of Governors of the Federal Reserve System.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.
Comments must be submitted on or before June 3, 2016.
You may submit comments, identified by
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•
•
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All public comments are available from the Board's Web site at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public Web site at:
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
The following information collection, which is being handled under this delegated authority, has received initial Board approval and is hereby published for comment. At the end of the comment period, the proposed information
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or start up costs and costs of operation, maintenance, and purchase of services to provide information.
A financial institution engaged in CSFTs should maintain a set of formal, firm-wide policies and procedures that are designed to allow the institution to identify, evaluate, assess, document, and control the full range of credit, market, operational, legal, and reputational risks associated with these transactions. These policies may be developed specifically for CSFTs or included in the set of broader policies governing the institution generally. A financial institution operating in foreign jurisdictions may tailor its policies and procedures as appropriate to account for, and comply with, the applicable laws, regulations, and standards of those jurisdictions.
A financial institution's policies and procedures should establish a clear framework for the review and approval of individual CSFTs. These policies and procedures should set forth the responsibilities of the personnel involved in the origination, structuring, trading, review, approval, documentation, verification, and execution of CSFTs. A financial institution should define what constitutes a new complex structured finance product and establish a control process for the approval of such new product. An institution's policies also should provide for new complex structured finance products to receive the approval of all relevant control areas that are independent of the profit center before the products are offered to customers.
Board of Governors of the Federal Reserve System.
Notice.
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) invites comment on a proposal to revise the FR Y-7Q by collecting fourteen new data items to monitor compliance with enhanced prudential standards for foreign banking organizations (FBOs) adopted pursuant to Subparts N and O of Regulation YY (12 CFR part 252). The proposal would require an FBO with total consolidated assets of $50 billion or more to report the new data items in order to determine whether the FBO meets capital adequacy standards at the consolidated level that are consistent with the Basel capital framework.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
Comments must be submitted on or before June 3, 2016.
You may submit comments, identified by
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•
•
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All public comments are available from the Board's Web site at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-6974.
Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Board's public Web site at:
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions, including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
This information collection is mandatory pursuant to section 5(c) of the Bank Holding Company Act (12 U.S.C. 1844(c)) and sections 8(c) and 13 of the International Banking Act (12 U.S.C. 3106(c) and 3108)). Section 165 of the Dodd-Frank Act, (12 U.S.C. 5365), directs the Federal Reserve to establish enhanced prudential standards for certain companies, including certain FBOs. The data may not be confidential in all cases. However, individual respondents may request confidential treatment for any of these reports pursuant to sections (b)(4) and (b)(6) of the Freedom of Information Act (5 U.S.C. 522(b)(4) and (b)(6)). The applicability of these exemptions would be determined on a case-by-case basis. In addition, items 8.b and 8.c in Part 1B of the FR Y-7Q involve disclosure of capital buffers imposed by an FBO's home country supervisor. While some home country supervisors do not accord confidential status to that information or do so only on a case-by-case basis, others treat this information as confidential on a blanket basis under the belief that a more selective confidential treatment could signal an FBO's financial strength or weakness and could thereby cause substantial competitive harm. Because the information on items 8.b and 8.c may or may not be public depending on the FBO's home country, the Federal Reserve would grant confidential status, pursuant to FOIA exemption 4, only on a case-by-case basis.
The Federal Reserve proposes to revise the FR Y-7Q by collecting fourteen new data items to monitor compliance with enhanced prudential standards for FBOs adopted pursuant to Subparts N and O of Regulation YY. The new data items would be used to determine whether an FBO with total consolidated assets of $50 billion or more meets capital adequacy standards at the consolidated level that are consistent with the Basel capital framework. The proposed revision would be effective September 30, 2016, and, for some items, March 31, 2018.
Regulation YY requires an FBO with total consolidated assets of $50 billion or more to certify to the Federal Reserve that it meets capital adequacy standards on a consolidated basis, as established by its home-country supervisor, that are consistent with the regulatory capital framework published by the Basel Committee on Banking Supervision (BCBS), as amended from time to time (Basel capital framework). This requirement was intended to help ensure that the consolidated capital base supporting the activities of U.S. branches and agencies remains strong,
The proposal would require an FBO with total consolidated assets of $50 billion or more to complete a new section, Part 1B, effective September 30, 2016 (with three of the proposed items effective March 31, 2018). Proposed Part 1B would contain 14 items related to home country regulatory capital ratios that would be reported on a quarterly basis. The value of each of these items would be calculated on a consolidated basis according to the methodologies established by the FBO's home-country supervisor that are consistent with the Basel capital framework, as defined in Regulation YY.
The proposed line items that would be effective September 30, 2016, include: (1) Common equity tier 1 capital, (2) Additional tier 1 capital, (3) Tier 1 capital (sum of items 1 and 2), (4) Tier 2 capital, (5) Total risk-based capital (sum of items 3 and 4), (6) Capital conservation buffer, (7) Countercyclical capital buffer, (8) Other applicable capital buffer(s) (a) GSIB/DSIB buffer, (b) Pillar II buffer, (c) “Other” buffer, (9) Compliance with restrictions on capital distributions and discretionary bonus payments associated with a capital buffer.
The proposed line items that would be effective March 31, 2018, include: (10) Home country capital measure used in the numerator of the leverage ratio as set forth in the Basel capital framework, (11) Home country exposure measure used in the denominator of the leverage ratio as set forth in the Basel capital framework, (12) Minimum home country leverage ratio (if different from the leverage ratio in the Basel capital framework, as applicable).
Part 1A of the current FR Y-7Q form, which applies to all FBOs, collects tier 1 capital, total risk-based capital, risk-weighted assets, total consolidated assets and total combined assets of U.S. operations, net of intercompany balances and transactions between U.S. domiciled affiliates, branches, and agencies, and total U.S. non-branch assets. While the Federal Reserve does not propose to change existing items reported in Part 1A of the FR Y-7Q, the proposal would modify the instructions to clarify that an FBO would be required to report Tier 1 capital and Total risk-based capital only on Part 1B, if the FBO's home country methodologies are consistent with the Basel capital framework.
The proposal would not revise the reporting frequency for the FR Y-7Q. FBOs with total consolidated assets of less than $50 billion and that are not FHCs would only file Part 1A on an annual basis. FBOs who have elected to become FHCs and do not have $50 billion or more in total consolidated assets will file Part 1A on a quarterly basis. FBOs with total consolidated assets of $50 billion or more would complete both Part 1A
As noted above, the Federal Reserve would propose to determine confidentiality of the proposed items on a case-by-case basis. However, the Federal Reserve notes that some jurisdictions may treat this information as confidential on a blanket basis under the belief that a more selective confidential treatment could signal an FBO's financial strength or weakness and could thereby cause substantial competitive harm. The Federal Reserve seeks comment on whether these items should qualify for confidential treatment in all cases, such that treating this information as confidential on a blanket basis would be appropriate.
The FR Y-7N and FR Y-7NS are not being revised at this time. However, the estimated number of respondents is expected to decrease as a result of the designation of U.S. intermediate holding companies (IHCs) and recent proposed reporting requirements for the IHCs.
Board of Governors of the Federal Reserve System.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.
Comments must be submitted on or before June 3, 2016.
You may submit comments, identified by
•
•
•
•
•
All public comments are available from the Board's Web site at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
The following information collection, which is being handled under this delegated authority, has received initial Board approval and is hereby published for comment. At the end of the comment period, the proposed information collection, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions, including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or start up costs and costs of operation, maintenance, and purchase of services to provide information.
The FR 1379a is not considered confidential. The FR 1379b collects the respondent's name and the respondent may provide other personal information and information regarding his or her complaint. The FR 1379c collects the respondent's third-party representative if the respondent has such a representative. The FR 1379d collects the respondent's name and the respondent may provide other personal information and information regarding his or her complaint. Thus, some of the information collected on the FR 1379b, FR 1379c, and FR 1379d may be considered confidential under the Freedom of Information Act (5 U.S.C. 552(b)(4), (b)(6), (b)(7)).
Information obtained from small business and individuals may be kept confidential under the Freedom of Information Act (FOIA). Information obtained from small businesses can be considered confidential under exemption (b)(4) of the FOIA because the release of information obtained from small businesses would (1) impair the Board's ability to obtain this information from entities that could not be compelled to respond, and (2) cause substantial harm to the competitive position of the entity from whom the information was obtained (5 U.S.C. 552(b)(4)). In addition, information obtained from consumers may be kept confidential under exemption (b)(6) of the FOIA because the information the survey collects is the type of information that would constitute a clearly unwarranted invasion of personal privacy (
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than April 19, 2016
A. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166-2034. Comments can also be sent electronically to
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B. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
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C. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
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Agency for Healthcare Research and Quality (AHRQ), HHS.
Solicits nominations for new members of USPSTF.
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
All nominations submitted in writing or electronically will be considered for appointment to the USPSTF. Nominations must be received by May 15th of a given year to be
Nominations and applications are kept on file at the Center for Evidence and Practice Improvement, AHRQ, and are available for review during business hours. AHRQ does not reply to individual nominations, but considers all nominations in selecting members. Information regarded as private and personal, such as a nominee's social security number, home and email addresses, home telephone and fax numbers, or names of family members will not be disclosed to the public (in accord with the Freedom of Information Act, 5 U.S.C. 552(b)(6); 45 CFR 5.67).
Nominations may be submitted in writing or electronically, but should include:
1. The applicant's current curriculum vitae and contact information, including mailing address, email address, and telephone number, and
2. A letter explaining how this individual meets the qualification requirements and how he or she would contribute to the USPSTF. The letter should also attest to the nominee's willingness to serve as a member of the USPSTF.
AHRQ will later ask persons under serious consideration for USPSTF membership to provide detailed information that will permit evaluation of possible significant conflicts of interest. Such information will concern matters such as financial holdings, consultancies, non-financial scientific interests, and research grants or contracts.
To obtain a diversity of perspectives, AHRQ particularly encourages nominations of women, members of minority populations, and persons with disabilities. Interested individuals can self-nominate. Organizations and individuals may nominate one or more persons qualified for membership on the USPSTF at any time. Individuals nominated prior to May 15, 2015, who continue to have interest in serving on the USPSTF, should be re-nominated.
To qualify for the USPSTF and support its mission, an applicant or nominee should, at a minimum, demonstrate knowledge, expertise and national leadership in the following areas:
1. The critical evaluation of research published in peer-reviewed literature and in the methods of evidence review;
2. Clinical prevention, health promotion and primary health care; and
3. Implementation of evidence-based recommendations in clinical practice including at the clinician-patient level, practice level, and health-system level.
Additionally, the Task Force benefits from members with expertise in the following areas:
Public health
Health equity and the reduction of health disparities
Application of science to health policy
Behavioral medicine
Communication of scientific findings to multiple audiences including health care professionals, policy makers and the general public.
Candidates with experience and skills in any of these areas should highlight them in their nomination materials.
Applicants must have no substantial conflicts of interest, whether financial, professional, or intellectual, that would impair the scientific integrity of the work of the USPSTF and must be willing to complete regular conflict of interest disclosures.
Applicants must have the ability to work collaboratively with a team of diverse professionals who support the mission of the USPSTF. Applicants must have adequate time to contribute substantively to the work products of the USPSTF.
Submit your responses either in writing or electronically to: Lydia Hill, ATTN: USPSTF Nominations, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, 5600 Fishers Lane, Mailstop: 06E53A, Rockville, Maryland 20857,
Nominated individuals will be selected for the USPSTF on the basis of how well they meet the required qualifications and the current expertise needs of the USPSTF. It is anticipated that new members will be invited to serve on the USPSTF beginning in January 2017. All nominated individuals will be considered; however, strongest consideration will be given to individuals with demonstrated training and expertise in the areas of Pediatrics, Family Medicine, Internal Medicine, Obstetrics and Gynecology and Preventive Medicine. AHRQ will retain and may consider for future vacancies nominations received this year and not selected during this cycle.
Some USPSTF members without primary health care clinical experience may be selected based on their expertise in methodological issues such as meta-analysis, analytic modeling or clinical epidemiology. For individuals with clinical expertise in primary health care, additional qualifications in methodology would enhance their candidacy.
Lydia Hill at
Under Title IX of the Public Health Service Act, AHRQ is charged with enhancing the quality, appropriateness, and effectiveness of health care services and access to such services 42 U.S.C. 299(b). AHRQ accomplishes these goals through scientific research and promotion of improvements in clinical practice, including clinical prevention of diseases and other health conditions. See 42 U.S.C. 299(b).
The USPSTF, an independent body of experts in prevention and evidence- based medicine, works to improve the health of all Americans by making evidence-based recommendations about the effectiveness of clinical preventive services and health promotion. The recommendations made by the USPSTF address clinical preventive services for adults and children, and include screening tests, counseling services, and preventive medications.
The USPSTF was first established in 1984 under the auspices of the U.S. Public Health Service. Currently, the USPSTF is convened by the Director of AHRQ, and AHRQ provides ongoing scientific, administrative, and dissemination support for the USPSTF's operation. USPSTF members serve four year terms. New members are selected each year to replace those members who are completing their appointments.
The USPSTF is charged with rigorously evaluating the effectiveness, appropriateness and cost-effectiveness of clinical preventive services and formulating or updating recommendations regarding the appropriate provision of preventive services. See 42 U.S.C. 299b-4(a)(1). Current USPSTF recommendations and associated evidence reviews are available on the Internet (
USPSTF members currently meet three times a year for two days in the Washington, DC area. A significant portion of the USPSTF's work occurs between meetings during conference calls and via email discussions. Member duties include prioritizing topics, designing research plans, reviewing and
The meeting announced below concerns the CDC National Centers for Excellence in Youth Violence Prevention: Building the Evidence for Community- and Policy-Level Prevention, RFA-CE-15-002, initial review.
This publication corrects a notice that was published in the
M. Chris Langub, Ph.D., Scientific Review Officer, CDC, 4770 Buford Highway NE., Mailstop F-80, Atlanta, Georgia 30341, Telephone: (770) 488-3585,
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Special Interest Project (SIP) 16-006, Environmental Scan of Oral Health and Chronic Disease Integration.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA) PS16-003, Evaluating Locally-Developed or Adapted (Homegrown) Combination HIV Prevention Interventions for Transgender Persons who have Sex with Men; and FOA PS16-004, Increase Access to Care for Black Men Who Have Sex with Men.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned subcommittee:
The agenda is subject to change as priorities dictate.
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The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA), RFA-CE-16-003, Research on Prescription Opioid Use, Opioid Prescribing, and Associated Heroin Risk.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the aforementioned subcommittee:
In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2017.
The agenda is subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Administration for Community Living, HHS.
Notice.
As a result of the Workforce Opportunity Improvement Act (Pub. L. 113-128) signed by President Obama in July 2014, the Assistive Technology Act Data Reporting and Analysis cooperative agreement with the Center for Assistive Technology Act Data Assistance (CATADA) at the University of Massachusetts—Boston, Institute for Community Inclusion transferred from the U.S. Department of Education, Rehabilitation Services Administration to the U.S. Department of Health and Human Services, Administration for Community Living (ACL). The CATADA Project is a national technical assistance grant for assistive technology programs that provides a comprehensive and state-specific, regional and national data reporting system and resources to entities funded under Section 4 of the
The CATADA Project provides training and technical assistance on the use of an accessible national AT data reporting system that supports a day-to-day information collection tool and an aggregate report for the submission of federally required data and performance measures for all 56 State Grant for AT programs under the
The purpose of the National Activities cooperative agreement with the University of Massachusetts—Boston, Institute for Community Inclusion is to continue existing activities designed to support and improve the administration of the
For further information or comments regarding this action, contact Lori Gerhard, U.S. Department of Health and Human Services, Administration for Community Living, Center for Integrated Programs, Office of Consumer Access and Self-Determination, 330 C Street SW., Washington, DC 20201; telephone (202) 795-7348; fax (202) 205-0414; email
Administration for Community Living, HHS.
Notice.
The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the Committee's 2016 Report to the President (RTP). All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.
Dr. MJ Karimi, PCPID Team Lead, 330 C Street SW., 1108A, Washington, DC 20201. Email:
The general purpose of this meeting is to provide the members with an opportunity to further discuss the recommendation sections of the 2016 RTP.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for BRINTELLIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (in the
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product BRINTELLIX (vortioxetine hydrobromide). BRINTELLIX is indicated for treatment of major depressive disorder. Subsequent to this approval, the USPTO received a patent term restoration application for BRINTELLIX (U.S. Patent No. 7,144,884) from H. Lundbeck A/S, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BRINTELLIX represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for BRINTELLIX is 2,343 days. Of this time, 1,979 days occurred during the testing phase of the regulatory review period, while 364 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,353 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363,
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.
FDA has become aware that the drug products listed in the table in this document are no longer being marketed.
FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and public health stakeholders entitled “Emergency Use Authorization of Medical Products and Related Authorities.” The purpose of this draft guidance is to explain FDA's current thinking about policies on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats. This guidance, when finalized, will replace the current guidance “Emergency Use Authorization of Medical Products” (July 2007) and “Emergency Use Authorization Questions and Answers” (April 2009).
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 3, 2016. Submit either electronic or written comments on the collection of information by June 3, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Submit written requests for single copies of the draft guidance to Office of Counterterrorism and Emerging Threats, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4343, Silver Spring, MD 20993-0002, 301-796-8510. Send one self-addressed adhesive label to assist that office in processing your requests. See the
FDA is announcing the availability of a draft guidance for industry and public health stakeholders entitled “Emergency Use Authorization of Medical Products and Related Authorities.” This draft guidance explains FDA's policies
This document is intended to inform industry, government agencies, public health and emergency response stakeholders, and FDA staff of FDA's general recommendations and procedures for:
• Issuance of emergency use authorizations (EUAs) under section 564;
• Implementation of the emergency use authorities set forth in section 564A; and
• Reliance on the governmental pre-positioning authority set forth in section 564B.
Section 564, as amended by PAHPRA, permits the Commissioner to authorize the emergency use of an unapproved medical product or an unapproved use of an approved medical product for certain emergency circumstances after the Department of Health and Human Services Secretary has made a declaration of an emergency or threat justifying emergency use. The Commissioner may issue an EUA to allow an MCM to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a CBRN agent when available data meet specified criteria to support such uses and there are no adequate, approved, and available alternatives.
Section 564A, as added by PAHPRA, establishes streamlined mechanisms to facilitate preparedness and response activities involving certain FDA-approved MCMs without FDA issuing EUAs, which can be a resource-intensive process. These authorities, which apply only to eligible FDA-approved medical products intended for use during a CBRN emergency, include provisions that:
• Empower FDA to extend the expiration date of an eligible FDA-approved MCM stockpiled for use in a CBRN emergency and establish appropriate conditions relating to such extensions, such as appropriate storage, sampling, and labeling;
• Permit FDA to waive otherwise-applicable current good manufacturing practice requirements (
• Allow emergency dispensing of MCMs during an actual CBRN emergency event without requiring an individual prescription for each recipient of the MCM or all of the information otherwise required, or by responders who may not otherwise be licensed to dispense if permitted by State law in the State where such dispensing occurs, or if in accordance with an order issued by FDA; and
• Permit the Centers for Disease Control and Prevention to create and issue “emergency use instructions” concerning the FDA-approved conditions of use for eligible products.
These authorities, and the definition of eligible products to which they apply, are discussed in the draft guidance.
To enable stakeholders to prepare for potential rapid deployment of MCMs during an actual CBRN emergency, section 564B (also added by PAHPRA) permits Federal, State, and local governments to pre-position (
The provisions of this guidance, when finalized, will replace the current guidance “Emergency Use Authorization of Medical Products” (July 2007) and “Emergency Use Authorization Questions and Answers” (April 2009).
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on emergency use authorization of medical products and related authorities. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the PRA), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This guidance explains FDA's policies applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the FD&C Act as amended or added by PAHPRA. FDA has previously submitted, and OMB has approved under OMB control number 0910-0595, reporting and recordkeeping burden estimates for the EUA provisions of this guidance imposed by section 564 of the FD&C Act. This guidance incorporates provisions of the current guidance linked to OMB control number 0910-0595, “Emergency Use Authorization of Medical Products” (July 2007).
At this time FDA is not proposing or recommending any changes to the Federal SLEP or procedures for expiration date extensions for products tested by FDA through SLEP. Federal participants in SLEP will continue to submit requests to extend the expiration date of eligible MCMs using established processes.
For drug products not tested within the SLEP program, this guidance recommends that stakeholders consult with the relevant review Center regarding extending the useful shelf-life of a particular product. Stakeholders may need to submit a request for expiry date extensions for stockpiled medical products. Because any such request would be for an approved product, the burden on manufacturers making any such request would be covered by previously approved collections of information, including OMB control number 0910-0139 through May 31, 2018, and OMB control number 0910-0073 through February 28, 2017. FDA anticipates, however, that some requests for expiration date extensions may come from public health authorities maintaining non-Federal stockpiles of MCMs for emergency uses. Therefore, FDA is calculating reporting burden for State and local public health authorities who may need to submit such requests. FDA is not calculating any additional recordkeeping burden for these non-Federal public health authorities because currently these stakeholders maintain records for the MCMs they stockpile, which would include records of any expiration date requests or extensions.
This draft guidance refers to previously approved collections of information. These collections of information are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). These collections have been approved as follows: Adverse experience reporting for biological products is approved under OMB control number 0910-0308 through February 28, 2018; adverse drug experience reporting is approved under OMB control number 0910-0230 through December 31, 2018; adverse device experience reporting is approved under OMB control number 0910-0471 through May 31, 2017; investigational new drug application regulations are approved under OMB control number 0910-0014 through February 28, 2019; investigational device exemption reporting is approved under OMB control number 0910-0078 through March 31, 2016; current good manufacturing practices for finished pharmaceuticals are approved under OMB control number 0910-0139 through May 31, 2018; quality system regulations for finished devices are approved under OMB control number 0910-0073 through February 28, 2017; risk evaluation and mitigation strategy requirements are approved under OMB control number 0910-0001 for drug products through December 31, 2017, for biological products under OMB control number 0910-0338 through January 31, 2017, and for devices under OMB control numbers 0910-0078 through March 31, 2016 and 0910-0471 through May 31, 2017.
FDA estimates the burden of this collection of information as follows:
Persons with access to the Internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Labeling for Biosimilar Products.” This draft guidance is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert). This draft guidance provides an overview of FDA's recommendations for labeling for biosimilar products licensed under the Public Health Service Act (PHS Act).
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 3, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993, 301-796-1042, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Labeling for Biosimilar Products.” The Biologics Price Competition and Innovation Act of 2009 (BCPI Act), enacted as part of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) on March 23, 2010, created an abbreviated
In this draft guidance, FDA outlines its recommendations for biosimilar product labeling. A demonstration of biosimilarity means, among other things, that FDA has determined that there are no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity and potency. Accordingly, biosimilar applicants should incorporate relevant data and information from the reference product labeling, with appropriate product-specific modifications as described in the draft guidance.
We invite comment on the draft guidance, including whether patient labeling (
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on labeling for biosimilar products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). The collections of information under 21 CFR part 601 for the submission of a biologics license application under section 351(k) of the PHS Act have been approved under OMB control number 0910-0719; the collections of information under 21 CFR 201.57 for the submission of labeling have been approved under OMB control number 0910-0572; the collections of information under 21 CFR part 600 for the submission of adverse experience reporting for licensed biological products and general records have been approved under OMB control number 0910-0308; and the collections of information under 21 CFR part 600 for the submission of MedWatch reporting forms (FDA Form 3500 and FDA Form 3500A) have been approved under OMB control number 0910-0291.
Persons with access to the Internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (#156) entitled “Comparability Protocols—Chemistry, Manufacturing, and Controls Information for New Animal Drugs.” This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations to industry regarding comparability protocols that would be submitted in new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or supplements to these applications. This guidance also applies to comparability protocols submitted in investigational new animal drug (INAD), generic investigational new animal drug (JINAD), and veterinary master file (VMF) submissions that are referenced in applications. FDA is providing this guidance in response to requests from those interested in using comparability protocols.
Submit either electronic or written comments on Agency guidances at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0696,
In the
This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on Comparability Protocols—Chemistry, Manufacturing, and Controls Information for New Animal Drugs. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032; the collections of information in section 512(n)(1) of the FD&C Act (21 U.S.C. 360b) have been approved under OMB control number 0910-0669.
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 041” (Recognition List Number: 041), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective April 4, 2016
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
An electronic copy of Recognition List Number: 041 is available on the Internet at
Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-6287,
Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.
In a notice published in the
Modifications to the initial list of recognized standards, as published in the
These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA will use the term “Recognition List Number: 041” to identify these current modifications.
In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe
In section III, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.
In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 041.
FDA maintains the Agency's current list of FDA Recognized Consensus Standards in a searchable database that may be accessed directly at FDA's Internet site at
Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to
You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page,
Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of several Committee members are scheduled to end during the 2016 calendar year. Nominations of qualified candidates are being sought to fill the positions that are scheduled to be vacated.
Applications for individuals to be considered for appointment to the Committee must be received no later than 5 p.m. ET on April 25, 2016 at the address listed below.
All nominations should be mailed or delivered to Nancy C. Lee, Designated Federal Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's Health, Office of the Assistant Secretary for Health, Department of Health and Human Services, 200 Independence Avenue SW., Room 712E, Washington, DC 20201. Nomination materials, including attachments, may be submitted electronically to
Nancy C. Lee, Designated Federal Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's Health, Office of the Assistant Secretary for Health, Department of Health and Human Services, 200 Independence Ave. SW., Room 712E, Washington, DC 20201. Inquiries may also be made to
CFSAC was established on September 5, 2002. The purpose of the CFSAC is to provide advice and recommendations to the Secretary of HHS, through the ASH, on issues related to ME/CFS. CFSAC advises and makes recommendations on a broad range of topics including: (1) The current state of knowledge and research; the relevant gaps in knowledge and research about the epidemiology, etiologies, biomarkers, and risk factors relating to ME/CFS; and identifying potential opportunities in these areas; (2) impact and implications of current and proposed diagnostic and treatment methods for ME/CFS; (3) development and implementation of programs to inform the public, health care professionals, and the biomedical, academic, and research communities about ME/CFS advances; and (4) strategies to improve the quality of life of ME/CFS patients. The CFSAC charter is available at
Management and support services for Committee activities are provided by staff within the OASH. The ASH provides directions and guidance for services performed to support CFSAC activities and operation.
Individuals selected for appointment to the Committee will serve as voting members and may be invited to serve terms of up to four years.
To qualify for consideration of appointment to the Committee, an individual must possess demonstrated experience and knowledge in the designated fields or disciplines, as well as expert knowledge of the broad issues and topics pertinent to ME/CFS.
CFSAC members are authorized to receive a stipend for attending Committee meetings. Committee members also are authorized to receive per diem and reimbursement for travel expenses incurred for conducting Committee business.
Nomination materials should be typewritten. If mailed, please submit original documents. The nomination materials should be submitted (postmarked or received) no later than 5:00p.m. EDT on the date specified under
Telephone and facsimile submissions cannot be accepted.
Appointment to the Committee is made by the Secretary of HHS. The Department makes every effort to ensure that the membership of federal advisory committees is fairly balanced in terms of points of view represented. Every effort is made to ensure that a broad representation of geographic areas, females, ethnic and minority groups, and people with disabilities are given consideration for membership on federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Nominations must state that the nominee is willing to serve as a member of CFSAC and appears to have no conflict of interest that would preclude membership. Potential candidates are required to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts for an ethics analysis to be conducted to identify potential conflicts of interest.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10,796.
Notice is hereby given of a meeting of the Big Data to Knowledge Multi-Council Working Group.
The teleconference meeting will be open to the public as indicated below. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Name of Working Group: Big Data to Knowledge Multi-Council Working Group.
Open: 11:00 a.m. to 12:30 p.m.
Note: This portion of the meeting is open to the public but is being held by teleconference only. No physical meeting location is provided for any interested individuals to listen to committee discussions. Any individual interested in listening to the meeting discussions must call: 1-877-668-4493 and use Meeting number: 622 421 867 for access to the meeting. Participants can also join in on the viewing the presentation by clicking the following link Join WebEx meeting.
Any interested person may file written comments with the working group or submit questions by sending an email to the Contact Person listed on this notice. The email should include the name, addresses, telephone number and when applicable, the business or professional affiliation of the interested person.
Closed: 12:30 p.m.-3:30 p.m.
Additional information on data science is available at:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Frederick National Laboratory Advisory Committee to the National Cancer Institute.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will also be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NCI Shady Grove has instituted stringent procedures for entrance into the NCI Shady Grove building. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
National Institutes of Health, HHS.
Notice.
This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Ovensa, Inc. (“Ovensa”) located in Ontario, Canada.
U.S. Provisional Patent Application No. 62/034,995 filed August 8, 2014 entitled “Human Monoclonal Antibodies Specific for 5T4 and Methods of Their Use” [HHS Ref. No. E-158-2014/0-US-01];
PCT Application No. PCT/US2015/044253 filed August 8, 2015 entitled “Human Monoclonal Antibodies Specific for 5T4 and Methods of Their Use” [HHS Ref. No. E-158-2014/0-PCT-02].
The patent rights in these inventions have been assigned to the government of the United States of America.
The prospective exclusive license territory may be worldwide and the field of use may be limited to “the use of the Licensed Patent Rights in combination with the Licensee's proprietary or exclusively in-licensed platforms and technologies for the treatment, prevention or diagnosis of cancer.”
Only written comments and/or applications for a license which are received by the Technology Transfer Center at the National Cancer Institute on or before April 19, 2016 will be considered.
Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Rose Freel, Ph.D., Licensing and Patenting Manager, Technology Transfer Center, National Cancer Institute, 8490 Progress Drive, Riverside 5, Suite 400, Frederick, MD 21702; Telephone: (301) 624-1257; Email:
5T4 is an antigen expressed on many different types of cancers, especially solid tumors. Its expression is limited in normal tissue, but is prevalent in malignant tumors throughout their development making it an attractive target for cancer immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric tumors and as a result, has been used as a prognostic aid for these cancers. The role of 5T4 in antibody-directed immunotherapy has been studied using murine monoclonal antibodies (mAbs). In addition, the cancer vaccine TroVax (currently in clinical trials for multiple solid tumors) targets 5T4. The present invention describes the identification and characterization of two fully human mAbs (m1001 and m1002) that bind to 5T4. Since the mAbs are fully human, they could have less immunogenicity and better safety profiles than the existing mouse and humanized antibodies. These mAbs have the potential to be cancer therapeutics as naked mAbs, chimeric antigen receptors (CARs) or antibody-drug conjugates (ADCs).
The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7.
Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Notice is hereby given of a change in the meeting of the National Institute on Aging Special Emphasis Panel, May 09, 2016, 12:00 p.m. to May 09, 2016, 04:00 p.m., National Institute on Aging, Gateway Building, 7201 Wisconsin Ave., 2C212, Bethesda, MD 20892 which was published in the
The meeting notice is amended to change the time of the meeting on May 9, 2016 from 12:00 p.m. to 4:00 p.m. to the new time of 9:30 a.m. to 1:30 p.m. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Deafness and Other Communication Disorders Advisory Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, April 13, 2016, 01:00 p.m. to April 13, 2016, 04:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will be held on April 7, 2016 at 12:00 p.m.-4:00 p.m. The Panel Name of the meeting will be “Neurophysiology”. The location remains the same. The meeting is closed to the public.
National Institutes of Health, HHS.
Notice.
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to Great Lakes Neuroscience, Inc., which is located in Illinois, to practice the inventions embodied in the following patents: U.S. Patent 8,597,660, issued December 3, 2013 (HHS reference E-144-2010/0-US-02).
The patent rights in these inventions have been assigned to the United States of America. The prospective start-up exclusive license territory may be worldwide and the field of use may be limited to therapeutics for Multiple sclerosis, Acute Disseminated Encephalomyelitis (ADEM), Balo's disease, Clinically Isolated Syndrome, HTLV-1 Associated Myelopathy (HAM), Neuromyelitis optica and NMO spectrum disorder, Schilder's disease, Traverse myelitis, amyotrophic lateral sclerosis and other motor neuron diseases as follows: progressive bulbar palsy, primary lateral sclerosis, progressive muscular atrophy, spinal muscular atrophy, Kennedy's disease, and post polio syndrome.
Only written comments and/or applications for a license which are received by NINDS Technology Transfer on or before April 19, 2016 will be considered.
Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated start-up exclusive license should be directed to: Susan Ano, Ph.D., NINDS Technology Transfer, 31 Center Drive, Suite 8A52, MS2540, Bethesda, MD 20892; Telephone: (301) 435-5515; Email:
This invention discloses treating neurodegenerative diseases by administering cyclin dependent kinase 5 (Cdk5) inhibitory peptides derived from P35, the activator of Cdk5. Abnormally hyperactive Cdk5 has been shown to be associated with a variety of neurodegenerative disorders. This invention describes isolated peptide fragments, pharmaceutical compositions and methods for use of such for treating subjects with a neurodegenerative disease, such as Alzheimer's disease (AD), Amyotrophic Lateral Sclerosis (ALS) and Parkinson's disease (PD). An inhibitory fragment, TFP5, disclosed in this invention, has been shown to ameliorate symptoms of AD in disease animal models without any evidence of toxicity. In particular, TFP5 treatment of rat cortical neurons reduced hyperactivation of Cdk5 upon neuronal stress and insults. Following intraperitoneal (ip) injection, TFP5 was capable of crossing the blood-brain barrier and localizing within the brain where it was found to rescue memory deficits and pathology in a double transgenic mouse (APP/PS1) AD model.
The prospective start-up exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the
Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated start-up exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Notice is hereby given to clarify the meeting times of the Sleep Disorders Research Advisory Board, April 14-15, 2016, NHLBI/National Institutes of Health, Two Rockledge Center, 6701 Rockledge Drive, Conference Room 9100/9104, Bethesda, MD, which was published in the
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
Substance Abuse and Mental Health Services Administration, HHS.
Notice.
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the
A notice listing all currently HHS-certified laboratories and IITFs is published in the
If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter.
This notice is also available on the Internet at
Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N03A, Rockville, Maryland 20857; 240-276-2600 (voice).
The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Pub. L. 100-71. The “Mandatory Guidelines for Federal Workplace Drug Testing Programs,” as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies.
To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.
Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards.
In accordance with the Mandatory Guidelines dated November 25, 2008 (73 FR 71858), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens:
* The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS’ NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do.
Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (
Coast Guard, DHS.
Notice.
The purpose of this notice is to inform the public that the Coast Guard has recertified the Prince William Sound Regional Citizens' Advisory Council (PWSRCAC) as an alternative voluntary advisory group for Prince William Sound, Alaska. This certification allows the PWSRCAC to monitor the activities of terminal facilities and crude oil tankers under the Prince William Sound Program established by statute.
This recertification is effective for the period from February 29, 2016 through February 28, 2017.
LT Patrick Grizzle, Seventeenth Coast Guard District (dpi), by phone at (907)463-2809, email patrick.j.grizzle@Coast Guard.mil or by mail at P.O. Box 25517, Juneau, Alaska 99802.
As part of the Oil Pollution Act of 1990, Congress passed the Oil Terminal and Oil Tanker Environmental Oversight and Monitoring Act of 1990 (the Act), 33 U.S.C. 2732, to foster a long-term partnership among industry, government, and local communities in overseeing compliance with environmental concerns in the operation of crude oil terminals and oil tankers.
On October 18, 1991, the President delegated his authority under 33 U.S.C 2732(o) to the Secretary of Transportation in Executive Order 12777, section 8(g) (see 56 FR 54757; October 22, 1991) for purposes of certifying advisory councils, or groups, subject to the Act. On March 3, 1992, the Secretary redelegated that authority to the Commandant of the Coast Guard (see 57 FR 8582; March 11, 1992). The Commandant redelegated that authority to the Chief, Office of Marine Safety, Security and Environmental Protection (G-M) on March 19, 1992 (letter #5402).
On July 7, 1993, the Coast Guard published a policy statement, 58 FR 36504, to clarify the factors that shall be considered in making the determination as to whether advisory councils, or groups, should be certified in accordance with the Act.
The Assistant Commandant for Marine Safety and Environmental Protection (G-M), redelegated recertification authority for advisory councils, or groups, to the Commander, Seventeenth Coast Guard District on February 26, 1999 (letter #16450).
On September 16, 2002, the Coast Guard published a policy statement, 67 FR 58440, that changed the recertification procedures such that applicants are required to provide the Coast Guard with comprehensive information every three years (triennially). For each of the two years between the triennial application procedures, applicants submit a letter requesting recertification that includes a description of any substantive changes to the information provided at the previous triennial recertification. Further, public comment is not solicited prior to recertification during streamlined years, only during the triennial comprehensive review.
On March 1, 2003, the Coast Guard was transferred from the Department of Transportation (DoT) to the Department of Homeland Security (DHS) and retained the previous delegations that were provided while it was in the DoT.
The Alyeska Pipeline Service Company pays the PWSRCAC $2.9 million annually in the form of a longterm contract. In return for this funding, the PWSRCAC must annually show that it “fosters the goals and purposes” of OPA 90 and is “broadly representative of the communities and interests in the vicinity of the terminal facilities and Prince William Sound.” The PWSRCAC is an independent, nonprofit organization founded in 1989. Though it receives federal oversight like many independent, non-profit organizations, it is not a federal agency. The PWSRCAC is a local organization that predates the passage of OPA 90. The existence of the PWSRCAC was specifically recognized in OPA 90 where it is defined as an “alternate voluntary advisory group.”
Alyeska funds the PWSRCAC, and the Coast Guard makes sure the PWSRCRC operates in a fashion that is broadly consistent with OPA 90.
By letter dated Feb. 29, 2016, the Commander, Seventeenth Coast Guard certified that the PWSRCAC qualifies as an alternative voluntary advisory group under 33 U.S.C. 2732(o). This recertification terminates on February 28, 2017.
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; Extension of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Administrative Rulings. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with a change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before May 4, 2016 to be assured of consideration.
Interested persons are invited to submit written comments on
Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, at 202-325-0265.
This proposed information collection was previously published in the
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will become effective on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency for the State of Michigan (FEMA-3375-EM), dated January 16, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the emergency assistance being provided under this emergency declaration is extended to August 14, 2016.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Pennsylvania (FEMA-4267-DR), dated March 23, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated March 23, 2016, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the Commonwealth of Pennsylvania resulting from a severe winter storm and snowstorm during the period of January 22-23, 2016, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the Commonwealth. You are further authorized to provide snow assistance under the Public Assistance program for a limited period of time during or proximate to the incident period. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Donald L. Keldsen, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the Commonwealth of Pennsylvania have been designated as adversely affected by this major disaster:
Adams, Bedford, Berks, Blair, Bucks, Chester, Cumberland, Dauphin, Fayette, Franklin, Fulton, Juniata, Lancaster, Lebanon, Lehigh, Montgomery, Northampton, Perry, Philadelphia,
Adams, Bedford, Berks, Blair, Bucks, Chester, Cumberland, Dauphin, Fayette, Franklin, Fulton, Juniata, Lancaster, Lebanon, Lehigh, Montgomery, Northampton, Perry, Philadelphia, Schuylkill, Somerset, Westmoreland, and York Counties for snow assistance under the Public Assistance program for any continuous 48-hour period during or proximate the incident period.
All areas within the Commonwealth of Pennsylvania are eligible for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Final notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of July 20, 2016 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
(Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”)
I. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before July 5, 2016.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1601, to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
I. Watershed-based studies:
II. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will become effective on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Georgia (FEMA-4259-DR), dated February 26, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Georgia is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of February 26, 2016.
Union County for Public Assistance.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect
Comments are to be submitted on or before July 5, 2016.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1615, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Proposed Notice; withdrawal.
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed notice concerning proposed flood hazard determinations, which may include the addition or modification of any Base Flood Elevation, base flood depth, Special Flood Hazard Area boundary or zone designation, or regulatory floodway (herein after referred to as proposed flood hazard determinations) on the Flood Insurance Rate Maps and, where applicable, in the supporting
This withdrawal is effective April 4, 2016.
You may submit comments, identified by Docket No. FEMA-B-1553 to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
On January 19, 2016, FEMA published a proposed notice 81 FR 2898, proposing flood hazard determinations for Coconino County, Arizona, and Incorporated Areas. FEMA is withdrawing the proposed notice.
42 U.S.C. 4104; 44 CFR 67.4.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before July 5, 2016.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1604, to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
I. Watershed-based studies:
II. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Mississippi (FEMA-4268-DR), dated March 25, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated March 25, 2016, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Mississippi resulting from severe storms and flooding beginning on March 9, 2016, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Individual Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Lai Sun Yee, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Mississippi have been designated as adversely affected by this major disaster:
Bolivar, Coahoma, and Washington Counties for Individual Assistance.
All areas within the State of Mississippi are eligible for assistance under the Hazard Mitigation Grant Program.
Office of the Assistant Secretary for Public and Indian Housing, and Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice.
This notice is to solicit recommendations for specific policy proposals and methods of research and
Interested persons are invited to submit comments regarding specific policy and evaluation proposals to the Moving to Work Office, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 4130, Washington, DC 20410-0001 or email at
No Facsimile Comments. Facsimile (FAX) comments are not acceptable.
Public Inspection of Public Comments. A summary of all comments received by HUD will be made available on HUD's Web site at:
Questions concerning this notice should be directed to the Moving to Work Office, Office of Public and Indian Housing, Department of Housing and Urban Development at
The statutory purpose
(1) reduce cost and achieve greater cost effectiveness in federal expenditures;
(2) give incentives to families with children where the head of household is working; is seeking work; or is preparing for work by participating in job training, educational programs, or programs that assist people to obtain employment and become economically self-sufficient; and
(3) increase housing choices for eligible low-income families.
Agencies will be added to the MTW demonstration by cohort and per the Act: “the Secretary shall direct one specific policy change to be implemented by the agencies, and with the approval of the Secretary, such agencies may implement additional policy changes.”
As part of the process to expand the MTW demonstration, the Act states that “[t]he Secretary shall establish a research advisory committee which shall advise the Secretary with respect to specific policy proposals and methods of research and evaluation for the demonstration.” Through this Notice, HUD is requesting specific policy proposal recommendations, and methods for research and evaluation recommendations, that will inform the advisory committee in making its own recommendations to the Secretary.
With the expansion of the MTW demonstration, HUD aims to learn from MTW interventions in order to improve the delivery of federally assisted housing and promote self-sufficiency for low-income families across the country.
HUD seeks public comments on specific policy proposal recommendations, and research and evaluation proposal recommendations, as described in sections II.A and II.B below. Public housing agencies, HUD-assisted housing residents, researchers, and HUD stakeholders are encouraged to submit comments.
HUD seeks specific policy proposal recommendations related to the three MTW demonstration statutory objectives of cost effectiveness, self-sufficiency, and housing choice. For example, HUD is interested in specific policy areas such as:
• Increasing moves of low-income families to high-opportunity neighborhoods;
• Improving education outcomes through housing partnerships;
• Using administrative flexibilities to reduce costs and improve operations, governance, and financial management;
• Structuring alternative rent-setting methods;
• Streamlining admissions and/or occupancy policies (
• Developing strategies to better utilize project-based vouchers;
• Improving the health and well-being of elderly and disabled residents;
• Achieving the goal of ending homelessness for families, veterans, youth, and the chronically homeless; and
• Cultivating supportive or sponsor-based housing policies.
HUD also seeks recommendations for research and evaluation methods to be utilized in association with specific policy proposals that will be implemented by MTW agencies in the expanded MTW demonstration. The Act specifically requires that rigorous research methods be used to test the policy proposals. HUD seeks specific proposals of what the committee should consider as rigorous research in addition to randomized control trials. In addition, the law calls for the advisory committee to recommend what policies already are proven effective and could be implemented without further research. HUD seeks comment on what policies should be considered as having already been proven successful, with specific reference to the rigorous research that supports the claim.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Arlette Mussington, Office of Policy, Programs and Legislative Initiatives, PIH, Department of Housing and Urban Development, 451 7th Street SW., (L'Enfant Plaza, Room 2206), Washington, DC 20410; telephone 202-402-4109, (this is not a toll-free number). Persons with hearing or speech impairments may access this number via TTY by calling the Federal Information Relay Service at (800) 877-8339. Copies of available documents submitted to OMB may be obtained from Ms. Mussington.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35 as amended.
Bureau of Indian Affairs, Interior.
Notice.
The Pueblo of Sandia and State of New Mexico entered into a Tribal-State compact governing Class III gaming; this notice announces that the compact is taking effect.
Effective April 4, 2016.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the
Bureau of Indian Affairs, Interior.
Notice.
This notice announces the extension of the Class III gaming compact between the Flandreau Santee Sioux Tribe and the State of South Dakota.
This extension is effective on April 4, 2016.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
Pursuant to 25 CFR 293.5, an extension to an existing Tribal-State Class III gaming compact does not require approval by the Secretary if the extension does not modify any other terms of the compact. The Flandreau Santee Sioux Tribe and the State of South Dakota have reached an agreement to extend the expiration of their existing Tribal-State Class III gaming compact until September 7, 2016. This publishes notice of the new expiration date of the compact.
Bureau of Indian Affairs, Interior.
Notice.
The Pueblo of San Felipe and State of New Mexico entered into a Tribal-State compact governing Class III gaming; this notice announces that the compact is taking effect.
Effective April 4, 2016.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the
Bureau of Indian Affairs, Interior.
Notice.
This notice is intended to inform federally-recognized Indian Tribes of the application process and due date for the Indian Highway Safety Program for Fiscal Year 2017. In accordance with Federal law and as authorized by the Secretary of Transportation, the Bureau of Indian Affairs, through its Indian Highway Safety Program (IHSP), will make funds available to federally recognized Indian Tribes on an annual basis for implementing traffic safety programs and projects that are designed to reduce the number of traffic crashes, death, injuries and property damage within Indian country. All project applications received on or before the deadline will be reviewed and selected on a competitive basis.
IHSP mailed application packets to all Tribal leaders by February 15, 2016. Applications for program and/or project funds must be received on or before May 2, 2016. Applications not received by the IHSP by close of business on May 2, 2016, will not be considered and will be returned unopened.
Each Tribe must submit their application to the Bureau of Indian Affairs, Office of Justice Services, Attention: Indian Highway Safety Program Director, 1001 Indian School NE., Suite 251, Albuquerque, New Mexico 87104.
Tribes should direct questions or requests for copies of the application packet to: Kimberly Belone, Indian Highway Safety Program, 1001 Indian School NE., Suite 251, Albuquerque, New Mexico 87104; telephone (505) 563-3900.
The Federal-Aid Highway Act of 1973 (Pub. L. 93-87) provides for U.S. Department of Transportation (DOT) funding, through the National Highway Traffic Safety Administration (NHTSA) to assist Indian Tribes in implementing traffic safety projects. Any program or project request must be designed to reduce the number of motor vehicle traffic crashes and their resulting fatalities, injuries, and property damage on Indian reservations and within Indian communities. Motor vehicle crashes are the leading cause of death to American Indians/Alaska Natives for ages 1 to 44. Nationwide, 511 American Indians/Alaska Natives were killed in motor vehicle crashes in 2013. Of this total, 180 died on reservations. For additional American Indians/Alaska Natives fatality data, you can access the NHTSA fatality Web site at:
This notice solicits applications from federally recognized Indian Tribes eligible to receive this assistance. Grant funds awarded to Tribes as a result of this announcement are reimbursed for eligible costs incurred under the terms of 23 U.S.C. 402 and subsequent amendments.
For the purposes of application of this grant and the collection and distribution of the funds, Indian reservations are collectively considered a “State” and the Secretary of the Interior is considered the “Governor of a State.” The Secretary of the Interior delegated the authority to administer the programs for all the Indian Tribes in the United States to the Assistant Secretary—Indian Affairs. The Assistant Secretary—Indian Affairs further delegated the responsibility for administration of the Indian Highway Safety Program to the Bureau of Indian Affairs, Office of Justice Services, located in Albuquerque, New Mexico. The Program Director of the IHSP has staff members available to provide program and technical assistance to Indian Tribes. The IHSP maintains contact with NHTSA with respect to program approval, funding, and technical assistance. NHTSA is responsible for ensuring that the IHSP is carried out in accordance with 23 CFR part 1200 and other applicable Federal statutes and regulations.
The following highway safety program areas have been identified as priority program areas eligible for funding under 23 CFR 1200.11 on Tribal lands:
Other fundable program areas may be considered based upon well documented problem identification from the Tribes.
Proposals are being solicited for the following program areas:
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2.
3.
Each Tribe that would like to be considered for funding in FY 2017 must fill out and submit the project application that was mailed to the Tribal leaders. Applications will adhere to the following guidelines:
(1) Problem Identification. Highway traffic safety problems shall be based upon accurate Tribal data. Data should be complete and accurate and should show problems and/or trends. These data should be available in Tribal enforcement and traffic crash records.
(2) Goals, Performance Measures and Strategies. Tribes must provide the overall goals of the project as well as a list of performance measures and strategies to be used to evaluate performance. All goals, performance measures and strategies must have base line numbers and will be expressed in clearly defined, time-framed, and measurable terms. (Example: To decrease alcohol related motor vehicle crashes by _% from the 2015 number of __ to __ by the end of FY17). Performance measures should be aggressive but attainable and based on available data and trends.
(3) Training. Training identified in the application must relate directly to the project being proposed.
(4) Equipment. Any equipment identified in the application must relate directly to the project being proposed.
(5) Line Item Budget. The activities to be funded must be outlined in detail according to the following object groups: Personnel services; travel and training, operating costs and equipment. All Tribes applying for grants must attach a copy of the Tribe's indirect cost rate to the application.
(6) Funding Requirements. With the enactment of the Fixing America's Surface Transportation Act (FAST Act), the IHSP is required, in order to receive funds, to certify, on behalf of the Tribes, that the program will meet certain conditions and comply with all applicable rules and regulations for administering a highway safety program. In addition to program oversight and technical assistance, the BIA must certify that it will implement the following activities in support of national highway safety goals:
a. Participate in the national law enforcement mobilizations;
b. Encourage sustained enforcement of impaired driving, occupant protection and speeding;
c. Conduct an annual safety belt survey in accordance with criteria established by the Secretary to measure safety belt usage rates; and
d. Develop data systems to provide timely and effective data analysis to support allocation of highway traffic safety resources.
(7) In order to comply with the provisions of the FAST Act and the State Certifications and Assurances, the IHSP will allocate funds on behalf of the Tribes to implement the provisions listed in (6) above. Copies of the State Certifications and Assurances are available upon request or at:
(8) Funding Length. Traffic safety program funding is designed primarily as the source of invention and motivation. As a result, all projects are funded for a 12 month period of time. This program is not intended for long term financial support of continuing and on-going operations.
(9) Project monitoring length may exceed the grant period in the cases where distribution of purchase equipment is necessary.
A list of certifications is attached to the grant application and must be initialed to show acceptance by the Tribe. These certifications are required by the either the funding agency and/or the IHSP and include: Federal Funding Accountability and Transparency Act, Nondiscrimination, Drug Free Workplace Act of 1988, Equipment, Buy
Each Tribe must send its funding request on the appropriate application form to the BIA IHSP office in Albuquerque, New Mexico, by the close of business May 2, 2016. Request can be received by U.S. Mail or via email to:
A selection committee will review and evaluate each application requesting funding. Each member of the selection committee, by assigning points to the following four criteria, will rank each of the proposals based on the following criteria:
Criterion (1), the General Information section will include information on the type of grant, location, population and size of reservation, type of law enforcement and pertinent contact information. (10 points maximum).
Criterion (2), the strength of the Problem Identification based on verifiable, current and applicable data to indicate the extent of the traffic safety problem. (45 points maximum).
Criterion (3), the quality of the proposed solution plan based on aggressive but attainable Performance Measures and Strategies. (35 points maximum).
Criterion (4), details on necessity and reasonableness of the budget requested. (10 points maximum).
Once the selection committee concludes its evaluation, it will notify those Tribes it recommends for participation and funding by letter. Upon notification, each selected Tribe must provide a duly authorized Tribal resolution. The resolution must be on file before grants funds can be expended by or reimbursed to the Tribe.
The Program Director will notify each Tribe of non-selection.
Uniform grant administration procedures have been established on a national basis for all grant-in-aid programs by the Office of Management and Budget under 2 CFR part 200 “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards” and the DOT under 2 CFR part 1201. NHTSA has codified uniform procedures for State Highway Safety Programs in 23 CFR part 1200. 2 CFR part 200 and the “Highway Safety Grant Funding Guidance for NHTSA Field Administered Grants are the established cost principles applicable to grants and contracts through BIA and with Tribal governments. A copy of the Grant Funding Policy document can be obtained from the BIA IHSP office or at
Auditing of Highway Safety Projects will be included in the Tribal A-133 single audit requirement. Copies of Tribal audits must be available for inspection by the highway safety program staff. Tribes must provide monthly program status reports and a corresponding reimbursement claim to the BIA Indian Highway Safety Program, 1001 Indian School, Suite 251, Albuquerque, New Mexico 87104, in order to be reimbursed for program costs. These are to be submitted no later than 15 working days beyond the reporting month.
During the program year, it is the responsibility of the BIA IHSP office to review the implementation of Tribal traffic safety plans and programs, monitor the progress of their activities and expenditures and provide technical assistance as needed. This assistance may be on-site, by telephone, and/or a review of monthly progress claims.
Each project funded is required to submit an annual report that meets the minimum criteria as set forth in 23 CFR part 1200.35. This information will be contained in the annual report that is required to be submitted to NHTSA. The BIA IHSP will conduct an annual performance evaluation for each Highway Safety Project funded. Pursuant to 23 CFR part 1200.35, the evaluation will measure the actual accomplishments to the planned activity and how the project and activities funded contributed to the overall goal of the IHSP. Program staff will evaluate progress from baseline data as reported by the Tribe. BIA IHSP staff will evaluate the project on-site at the discretion of the IHSP Director.
National Park Service, Interior.
Request for nominations.
The National Park Service (NPS), U.S. Department of the Interior, proposes to appoint new members to the Preservation Technology and Training Board (Board). The NPS is requesting nominations for qualified persons to serve as members of the Board.
Written nominations must be received by May 4, 2016.
Kirk A. Cordell, Executive Director, National Center for Preservation Technology and Training, National Park Service, 645 University Parkway, Natchitoches, LA 71457, by telephone (318) 356-7444. In addition to U.S. mail or commercial delivery, written comments may be sent by fax to Mr. Cordell at (318) 356-9119, or submitted electronically on the center Web site:
Kirk A. Cordell, Executive Director, National Center for Preservation Technology and Training, National Park Service, 645 University Parkway, Natchitoches, LA 71457, by telephone (318) 356-7444.
The Board, established by Title IV, Section 404 of Public Law 102-575, October 30, 1992 (54 U.S.C. 305303), provides advice and professional oversight to the Secretary of the Interior and the National Center for Preservation Technology and Training regarding the activities of the Center.
Established within the Department of the Interior, the National Center for Preservation Technology and Training is located at Northwestern State University of Louisiana in Natchitoches, Louisiana. Title IV, Section 404 of Public Law 102-575, October 30, 1992, established the Board to provide advice and professional oversight to the Secretary of the Interior and the Center regarding the activities of the Center and to submit an annual report to the President and the Congress.
The Board is comprised of 13 members appointed for 4-year terms, as follows: (a) one member serving as the Secretary's designee; (b) six members who represent appropriate Federal, State, and local agencies, State and local historic preservation commissions, and other public and international organizations; and (c) six members on the basis of outstanding professional qualifications who represent major organizations in the fields of archeology, architecture, conservation, curation, engineering, history, historic preservation, landscape architecture, planning, or preservation education.
We are currently seeking one member serving as the Secretary's designee; and members appointed on the basis of outstanding professional qualifications who represent major organizations in the fields of archeology, architecture, conservation, curation, engineering, history, historic preservation, landscape architecture, planning, or preservation education.
Nominations should be typed and should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Board and permit the Department of the Interior to contact a potential member.
Members of the Board serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Board as approved by the Designated Federal Officer, members may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under Section 5703 of Title 5 of the United States Code.
Individuals who are Federally registered lobbyists are ineligible to serve on all Federal Advisory Committee Act (FACA) and non-FACA boards, committees, or councils in an individual capacity. The term “individual capacity” refers to individuals who are appointed to exercise their own individual best judgment on behalf of the government, such as when they are designated Special Government Employees, rather than being appointed to represent a particular interest.
Bureau of Ocean Energy Management (BOEM), Interior.
Rescheduling of public meetings.
BOEM is rescheduling meetings previously scheduled to be held in Washington, DC (April 4, 2016); Houston, TX (April 12, 2016); and New Orleans, LA (April 14, 2016) to elicit comments on the OCS Oil and Gas Leasing Program 2017-2022 Draft Programmatic Environmental Impact Statement (Draft Programmatic EIS), which has been prepared by BOEM to support the Proposed OCS Oil and Gas Leasing Program for 2017-2022 (2017-2022 Program). Rescheduled meetings will occur before the conclusion of the timeframe provided for public comments on the Draft Programmatic EIS (May 2, 2016). Rescheduled meetings will be announced through publication of a notice in the
Jill Lewandowski, Ph.D., Bureau of Ocean Energy Management, 45600 Woodland Road VAM-OEP, Sterling, VA 20166; Dr. Lewandowski may also be reached by telephone at (703) 787-1703.
All other public meetings will be held on the scheduled dates and at the locations previously announced:
Office of Justice Programs, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Assistance, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until May 4, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Chris Casto by mail at Bureau of Justice Assistance, Office of Justice Programs, U.S. Department of Justice, 810 7th Street NW., Washington, DC 20531; or by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
—Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
—Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
—Enhance the quality, utility, and clarity of the information to be collected; and/or
—Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Overview of this information collection:
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2.
3.
4.
Primary: Eligible survivors of fallen public safety officers.
Abstract: BJA's Public Safety Officers' Benefits (PSOB) Office will use the PSOB Claim Form information to confirm the eligibility of applicants to receive Public Safety Officers' Death Benefits. Eligibility is dependent on several factors, including public safety officer status, an injury sustained in the line of duty, and the claimant status in the beneficiary hierarchy according to the PSOB Act. In addition, information to help the PSOB Office identify an individual is collected, such as Social Security numbers, telephone numbers, and email addresses. Changes to the claim form have been made in an effort to streamline the application process and eliminate requests for information that are either irrelevant or already being collected by other means.
Others: None.
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6
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
Office of Justice Programs, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Assistance, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until May 4, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Chris Casto by mail at Bureau of Justice Assistance, Office of Justice Programs, U.S. Department of Justice, 810 7th Street NW., Washington, DC 20531; or by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
Office of Justice Programs, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Assistance, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until May 4, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Chris Casto by mail at Bureau of Justice Assistance, Office of Justice Programs, U.S. Department of Justice, 810 7th Street NW., Washington, DC 20531; or by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
Others: None.
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6.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
Office of Justice Programs, DOJ.
30-Day notice.
The Department of Justice (DOJ), Office of Justice Programs (OJP), National Institute of Justice (NIJ) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until May 4, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Michael O'Shea (202) 305-7954, National Institure of Justice (NIJ), Office of Justice Programs, U.S. Department of Justice, 810 Seventh Street NW., Washington, DC 20531 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
Notice.
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, “H-2A Temporary Employment Certification Program,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before May 4, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Contact Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
44 U.S.C. 3507(a)(1)(D).
This ICR seeks approval under the PRA for revisions to the H-2A Temporary Employment Certification Program. The Immigration and Nationality Act (INA) requires the Secretary of Labor to certify, among other things, that any foreign worker seeking to enter the United States (U.S.) to perform certain skilled or unskilled labor will not, by doing so, adversely affect wages and working conditions of U.S. workers similarly employed. The Secretary must also certify there are not sufficient U.S. workers able, willing, and qualified to perform such skilled or unskilled labor. Before any employer may petition for any temporary skilled or unskilled foreign workers, it must submit a request for certification to the Secretary containing the elements prescribed by the INA and regulations. This information collection has been classified as a revision, because the ETA has proposed changes to Appendix A to mirror the operational process implemented in the H-2B Temporary Employment Certification Program and to conform to the Department's H-2A Final Rule for employers seeking to hire temporary foreign workers for job opportunities in herding and production of livestock on the range. The Immigration and Nationality Act authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces its final decision to expand the scope of recognition for MET Laboratories, Inc. as a Nationally Recognized Testing Laboratory (NRTL).
The expansion of the scope of recognition becomes effective on April 4, 2016.
Information regarding this notice is available from the following sources:
OSHA hereby gives notice of the expansion of the scope of recognition of MET Laboratories, Inc. (MET), as an NRTL. MET's expansion covers the addition of five test standards to its scope of recognition. Additionally, OSHA announces a modification to the NRTL Program's List of Appropriate Test Standards to include three additional test standards.
OSHA recognition of an NRTL signifies that the organization meets the requirements specified by 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition and is not a delegation or grant of government authority. As a result of recognition, employers may use products properly approved by the NRTL to meet OSHA standards that require testing and certification of the products.
The Agency processes applications by an NRTL for initial recognition, or for expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the
MET submitted five applications, two dated April 6, 2015, (OSHA-2006-0028-0020) and three dated May 29, 2015 (OSHA-2006-0028-0021), to expand its recognition to include five additional test standards, including three test standards to be added to the NRTL Program's List of Appropriate Test Standards. OSHA staff performed a detailed analysis of the application packets and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.
OSHA published the preliminary notice announcing MET's expansion application and modification to the NRTL Program's List of Appropriate Test Standards in the
To obtain or review copies of all public documents pertaining to MET's application, go to
OSHA staff examined MET's expansion applications, its capability to meet the requirements of the test standards, and other pertinent information. Based on its review of this evidence, OSHA finds that MET meets the requirements of 29 CFR 1910.7 for expansion of its recognition, subject to the specified limitation and conditions listed below. OSHA, therefore, is proceeding with this final notice to grant MET's scope of recognition. OSHA limits the expansion of MET's recognition to testing and certification of products for demonstration of conformance to the test standards listed in Table 1 below.
Additionally, Table 2, below, lists the test standards new to the NRTL Program's List of Appropriate Test Standards. The Agency evaluated the standards to (1) verify they represent a product category for which OSHA requires certification by an NRTL, (2) verify the documents represent end products and not components, and (3) verify the documents define safety test specifications (not installation or operational performance specifications). Based on this evaluation, OSHA finds that they are appropriate test standards and has added these standards to the NRTL Program's List of Appropriate Test Standards.
OSHA's recognition of any NRTL for a particular test standard is limited to equipment or materials for which OSHA standards require third-party testing and certification before using them in the workplace. Consequently, if a test standard also covers any products for which OSHA does not require such testing and certification, an NRTL's scope of recognition does not include these products.
The American National Standards Institute (ANSI) may approve the test standards listed above as American National Standards. However, for convenience, we may use the designation of the standards-developing organization for the standard as opposed to the ANSI designation. Under the NRTL Program's policy (see OSHA Instruction CPL 1-0.3, Appendix C, paragraph XIV), any NRTL recognized for a particular test standard may use either the proprietary version of the test standard or the ANSI version of that standard. Contact ANSI to determine whether a test standard is currently ANSI-approved.
In addition to those conditions already required by 29 CFR 1910.7, MET must abide by the following conditions of the recognition:
1. MET must inform OSHA as soon as possible, in writing, of any change of ownership, facilities, or key personnel, and of any major change in its operations as an NRTL, and provide details of the change(s);
2. MET must meet all the terms of its recognition and comply with all OSHA policies pertaining to this recognition; and
3. MET must continue to meet the requirements for recognition, including all previously published conditions on MET's scope of recognition, in all areas for which it has recognition.
Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the scope of recognition of MET, subject to the limitation and conditions specified above, and adds three standards to the NRTL Program's List of Appropriate Test Standards..
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
Legal Services Corporation.
Notice.
The Legal Services Corporation (LSC) seeks public comment on alternative estimates of the LSC-eligible agricultural worker population in Michigan. LSC obtained current estimates of LSC-eligible agricultural worker populations from the United States Department of Labor's Employment Training Administration (ETA) for the states, territories, and DC in order to revise LSC's distribution of LSC Basic Field funding between legal services grants for serving (1) the eligible general population and (2) the eligible agricultural worker population. LSC published those estimates for comment and received suggestions for alternative estimates in Michigan. LSC is publishing the alternative Michigan estimates for public comment.
Comments must be submitted on or before May 19, 2016.
Written comments must be submitted to Mark Freedman, Senior Associate General Counsel, Legal Services Corporation, 3333 K St. NW., Washington, DC 20007-3522; 202-337-6519 (fax);
Mark Freedman, Senior Associate General Counsel, Legal Services Corporation, 3333 K St. NW., Washington, DC 20007-3522; 202-295-1623 (phone); 202-337-6519 (fax);
The Legal Services Corporation (LSC) seeks public comment on alternative estimates of the population of agricultural workers and dependents in Michigan who are LSC-eligible. The Michigan Advocacy Program (MAP) submitted these alternatives for LSC to use in lieu of the estimates provided by the U.S. Department of Labor's Employment Training Administration (ETA). LSC intends to select estimates to use for distribution of appropriated Basic Field Programs funds between legal services grants in Michigan serving the (1) eligible general population (Basic Field—General) and (2) the eligible agricultural worker population (Basic Field—Migrant).
On February 3, 2015, LSC published a notice for comment in the
MAP submitted proposals increasing the estimate of the number of eligible agricultural workers and dependents in Michigan, including by:
1. Increasing the estimate of total agricultural workers from 80,549 to 87,870; and
2. Increasing the percentage of dependents who are eligible from 31% to 60%. MAP provides analysis supporting these proposals in its comments.
LSC seeks comment solely on the specific MAP proposals enumerated above. Comments should specifically address the rationale provided by MAP in its comments.
U.S. Copyright Office, Library of Congress.
Extension of time to submit requests to participate in roundtable.
The United States Copyright Office is extending the deadline for the submission of requests to participate in the section 512 roundtables in New York and California, which were announced in its March 18, 2016 Notice of Inquiry.
Requests to participate in the section 512 roundtables are now due no later than 11:59 p.m. Eastern Time on April 11, 2016.
Those who seek to participate in the section 512 roundtables should complete and submit the form available through the Copyright Office's Web site at
Jacqueline C. Charlesworth, General Counsel and Associate Register of Copyrights,
The United States Copyright Office is undertaking a public study to evaluate the impact and effectiveness of the DMCA safe harbor provisions contained in section 512 of Title 17. On March 18, 2016, the Office issued a Notice of Inquiry announcing two two-day public roundtables in New York, New York on May 2 and 3, 2016, and Stanford, California on May 12 and 13, 2016.
The roundtables will offer an opportunity for interested parties to comment further on the issues raised in the Office's December 31, 2015 Notice of Inquiry regarding section 512.
10:00 a.m., Tuesday, April 12, 2016.
NeighborWorks America—Gramlich Boardroom, 999 North Capitol Street NE., Washington DC 20002.
Open (with the exception of Executive Session).
Jeffrey Bryson, EVP & General Counsel/Secretary, (202) 760-4101;
The General Counsel of the Corporation has certified that in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(2), (4) and (6) permit closure of the following portions of this meeting:
Nuclear Regulatory Commission.
License amendment application; withdrawal by applicant.
The U.S. Nuclear Regulatory Commission (NRC) has granted the request of Entergy Nuclear Operations, Inc. (Entergy, the licensee), to withdraw its application dated August 20, 2015, for a proposed amendment to Renewed Facility Operating License No. DPR-59, for the James A. FitzPatrick Nuclear Power Plant (JAF), located in Oswego County, New York. The proposed amendment would have revised the JAF Technical Specification (TS) to extend primary containment Type A and Type C leak rate test frequencies.
Please refer to Docket ID NRC-2016-0071 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
William Huffman, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2046; email:
The NRC has granted the request of Entergy to withdraw its August 20, 2015, application (ADAMS Accession No. ML15232A761) for proposed amendment to Renewed Facility Operating License No. DPR-59 for the JAF, located in Oswego County, New York.
The amendment would have revised TS 5.5.6, “Primary Containment Leak Rate Testing Program,” to allow permanent extension of the Type A Primary Containment Integrated Leak Rate Test interval to 15 years and to allow extension of Type C Local Leak Rate Test testing interval up to 75 months. Entergy withdrew the license amendment request because it intends to permanently cease power operations at JAF at the end of the current operating cycle and, therefore, no longer needs to change the primary containment leak rate test frequencies.
The Commission had previously issued a Notice of Consideration of Issuance of Amendment published in the
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an amendment to Priority Mail Contract 80 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On March 24, 2016, the Postal Service filed notice that it has agreed to an amendment to the existing Priority Mail Contract 80 negotiated service agreement approved in this docket.
The Postal Service also filed the unredacted Amendment under seal. The Postal Service seeks to incorporate by reference the Application for Non-Public Treatment originally filed in this docket for the protection of information that it has filed under seal. Notice at 1.
The Amendment revises section I.G. of the Existing Agreement to include an alternative provision for adjusting prices in the last contract year.
The Postal Service intends for the Amendment to become effective two business days after the date that the Commission completes its review of the Notice.
The Commission invites comments on whether the changes presented in the Postal Service's Notice are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR 3015.5, and 39 CFR part 3020, subpart B. Comments are due no later than April 5, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Natalie R. Ward to represent the interests of the general public (Public Representative) in this docket.
1. The Commission reopens Docket No. CP2014-38 for consideration of matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, the Commission appoints Natalie R. Ward to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
3. Comments are due no later than April 5, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail & First-Class Package Service Contract 17 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail & First-Class Package Service Contract 17 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-112 and CP2016-140 to consider the Request pertaining to the proposed Priority Mail & First-Class Package Service Contract 17 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 5, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Natalie R. Ward to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-112 and CP2016-140 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Natalie R. Ward is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 5, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 202 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail Contract 202 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-109 and CP2016-137 to consider the Request pertaining to the proposed Priority Mail Contract 202 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 5, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Gregory Stanton to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-109 and CP2016-137 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Gregory Stanton is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 5, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of First-Class Package Service Contract 48 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add First-Class Package Service Contract 48 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-111 and CP2016-139 to consider the Request pertaining to the proposed First-Class Package Service Contract 48 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 5, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Jennaca D. Upperman to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-111 and CP2016-139 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Jennaca D. Upperman is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 5, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 203 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
I. Introduction
II. Notice of Commission Action
III. Ordering Paragraphs
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail Contract 203 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-110 and CP2016-138 to consider the Request pertaining to the proposed Priority Mail Contract 203 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 5, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Cassie D'Souza to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-110 and CP2016-138 to
2. Pursuant to 39 U.S.C. 505, Cassie D'Souza is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 5, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 201 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail Contract 201 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-108 and CP2016-136 to consider the Request pertaining to the proposed Priority Mail Contract 201 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than April 5, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-108 and CP2016-136 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than April 5, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
On February 17, 2016, the Securities Investor Protection Corporation (“SIPC”) filed with the Securities and Exchange Commission (“Commission”), under sections 9(e)(1) and 3(e)(2)(A) of the Securities Investor Protection Act of 1970 (“SIPA”),
The Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”)
SIPC filed with the Commission on February 17, 2016 notification that the SIPC Board had determined not to raise the standard maximum cash advance amount above $250,000, and thereby maintain it at that level beginning January 1, 2017 and for the five-year period immediately thereafter.
SIPC described the factors the SIPC Board considered in making the determination to maintain the standard maximum cash advance amount at $250,000, including factors that it was required to consider under SIPA.
The SIPC Board also considered that, of the more than 625,000 allowed claims in completed or substantially completed liquidation proceedings as of December 31, 2014, the unsatisfied portion of cash claims amounted to $25 million. More than half of that amount related to only three claims that were submitted when the limit of protection for cash claims was less than the current $250,000. In the six SIPA proceedings initiated since 2010, the year the standard maximum cash advance amount was raised, SIPC has advanced funds for only one customer cash claim where the claim (but not the advance) exceeded $250,000.
The SIPC Board also considered that customer credit balances at brokerage firms had decreased at the end of 2013 and 2014, and that due to broker-dealers' offer of overnight “sweep” programs, customer free credit balances were being moved to bank accounts, with the protection of such accounts thereby transferred to the FDIC.
Further, the SIPC Board considered the relationship between the amount of the SIPC standard maximum cash advance amount and the maximum amount of protection afforded by the FDIC to customers of a failed bank. Increases to the limit of protection for cash claims under SIPA historically have moved in lockstep with increases in FDIC deposit insurance. The SIPC Board considered that FDIC deposit insurance is currently $250,000. The SIPC Board concluded that, on balance, in light of the unprecedented break with the FDIC limit that would result, with possibly harmful consequences, and the absence of evidence that an appreciable number of investors would be benefited, an adjustment to the limit of protection for cash claims in a SIPA liquidation proceeding would not be appropriate.
Section 3(e)(2)(A) of SIPA provides that the SIPC Board must file with the Commission any proposed amendment to a SIPC Rule.
The Commission finds, pursuant to section 3(e)(2)(D) of SIPA, that the determination of the SIPC Board not to adjust for inflation the standard maximum cash advance amount of $250,000 beginning January 1, 2017 and for the five-year period immediately thereafter is in the public interest and consistent with the purposes of SIPA. The Commission believes that maintaining the amount at $250,000 at this time to keep it aligned with the maximum amount of insurance provided by the FDIC is appropriate. For example, there could be unintended consequences resulting from raising the amount to a level that is higher than the maximum FDIC insurance amount, such as incentivizing investors to move additional funds to their brokerage accounts from bank accounts. Moreover, the Commission believes that maintaining the standard maximum cash advance amount at $250,000 is consistent with the public interest in light of the statistics considered by the SIPC Board that indicated that customer
SIPA requires that the Commission publish the standard maximum cash advance amount in the
By the Commission.
On February 9, 2016, BATS Exchange, Inc. (“BATS”), BATS Y-Exchange, Inc. (“BYX”), EDGX Exchange, Inc. (“EDGX”), and EDGA Exchange, Inc. (“EDGA”) (collectively, the “Exchanges” and each, an “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
On December 16, 2016, the Corporation filed a registration statement on Form S-1 with the Commission seeking to register shares of common stock and to conduct an initial public offering of those shares, which would be listed for trading on BATS. In connection with the IPO, the Exchanges filed a proposed rule change to amend and restate the Corporation's Current Certification of Incorporation and adopt those changes as the Corporation's Amended and Restated Certificate of Incorporation (the “New Certificate of Incorporation”) and amend and restate the Corporation's Current Bylaws and adopt those changes as its Amended and Restated Bylaws (the “New Bylaws”). The Exchanges anticipate that the Corporation's New Certificate of Incorporation and New Bylaws will become effective the moment before the closing of the IPO.
The Exchanges propose to revise the Current Certificate of Incorporation to reclassify all of the Corporation's existing stock as either “Voting Common Stock” or “Non-Voting Common Stock.”
Except for voting rights
The New Certificate of Incorporation would establish a “staggered” or classified board structure in which the Corporation's directors would be divided into three classes of equal size, to the extent possible.
According to the Exchanges, the New Certificate of Incorporation maintains and enhances the limitations on aggregate ownership and total voting power that exist under the Current Certificate of Incorporation.
The New Certificate of Incorporation would provide that any action required or permitted to be taken at an annual or special meeting of stockholders may be taken only upon the vote of stockholders at an annual or special meeting and may not be taken by written consent of stockholders without a meeting.
The New Certificate of Incorporation would require that certain provisions of the New Certificate of Incorporation may not be repealed or amended in any respect, and no other provision may be adopted, amended or repealed which would have the effect of modifying or permitting the circumvention of such provisions, unless such action is approved by the affirmative vote of at least 66
According to the Exchanges, the purpose of this supermajority requirement, which they believe is common among public companies, is to deter actions being taken that the Corporation believes may be detrimental to the Corporation, including any actions that could detrimentally affect its ability to comply with its unique responsibilities under the Act as the ultimate parent of four registered national securities exchanges.
According to the Exchanges, the proposal would also amend and restate various other provisions of the Current Certificate of Incorporation in a manner that the Exchanges believe are intended to reflect provisions that are more customary for publicly-owned companies organized under Delaware Law, such as those relating to the Corporation's preferred stock,
The Exchanges propose to revise the Current Bylaws to require stockholders to make certain disclosures and representations in notices to the Corporation concerning business proposals and director nominations at annual meetings, and to comply with longer advanced notice requirements.
The New Bylaws would only permit a special meeting of the stockholders to be called by the board of directors pursuant to a resolution adopted by the majority of the board.
The New Bylaws would also provide that only the chairman of the meeting or the board of directors would be permitted to adjourn a stockholder meeting.
The Exchanges propose that no action may be taken by written consent of the stockholders without a meeting, subject to the rights of any holders of Preferred Stock.
Under the New Bylaws, the board of directors would consist of one or more directors, with the exact number of directors to be determined by resolution adopted by the majority of the board of directors.
The Current Bylaws provide that the board of directors or any director may be removed, with or without cause, by the affirmative vote of at least 66
The Exchanges state that the purpose of this amendment is to align the Corporation's requirements for removal of directors with Delaware Law, which generally provides that, in the case of a corporation with a classified board, a simple majority of stockholders may remove any director, but only for cause, unless the certificate of incorporation provides otherwise.
The New Bylaws would provide that the bylaws may be altered, adopted, amended or repealed either by a majority of the board of directors, or by the stockholders with the affirmative vote of not less than 66
In addition to the board of directors and stockholder approval requirements, the New Bylaws would maintain the provisions requiring that, for so long as the Corporation will control a national securities exchange registered with the Commission under Section 6 of the Act, before any amendment to the New Bylaws may become effective, the amendment must be submitted to the board of directors of such exchange, and if required by Section 19 of the Act, filed with or filed with and approved by the Commission.
The New Bylaws make various non-substantive, stylistic or technical changes throughout. For example, the New Bylaws remove references to the Investor Rights Agreement, as the provisions of that agreement, other than certain registration rights, is expected to terminate upon the occurrence of the IPO.
After careful review of the proposal, the Commission finds that the proposed rule changes are consistent with the requirements of the Act and the rules and regulations thereunder applicable to
The Commission notes that the Exchanges have represented that the proposed rule changes relate solely to the certificate of the incorporation and bylaws of the Corporation and that each Exchange will continue to be governed by its respective existing certificate of incorporation and bylaws.
The Commission further notes that each Exchange has represented that the proposed rule change will maintain the existing ownership and voting limitations in the Current Certificate of Incorporation.
The Commission, therefore, believes that the proposed rule changes are consistent with Section 6(b)(1) of the Exchange Act, which requires each Exchange to have the ability to be so organized as to have the capacity to carry out the purposes of the Act and to comply, and to enforce compliance by its members and persons associated with its members, with provisions of the Act, the rules and regulations thereunder, and the rules of such Exchange.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On December 10, 2015, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade Shares of the Funds under NYSE Arca Equities Rule 8.600, which governs the listing and trading of Managed Fund Shares on the Exchange. The Shares will be offered by the Trust,
This Fund will seek to outperform the total return performance of the S&P 500 Dynamic Gold Hedged Index (“S&P Benchmark”)
The Fund will not directly hold gold futures contracts, commodity-related pooled vehicles, and options on commodity futures (as referenced below). Rather, the Fund expects to gain exposure to these instruments by investing up to 25% of its total assets, as measured at the end of every quarter of the Fund's taxable year, in a wholly-owned and controlled Cayman Islands subsidiary (“Subsidiary”). The Subsidiary will be advised by the Adviser, and the Fund's investment in the Subsidiary will primarily be intended to provide the Fund with exposure to the price of gold.
This Fund will seek to outperform the total return performance of the FTSE Emerging Gold Overlay Index (“FTSE Benchmark”)
The Fund will not directly hold gold futures contracts, commodity-related pooled vehicles, and options on commodity futures (as referenced below). Rather, the Fund expects to gain exposure to these instruments by investing up to 25% of its total assets, as measured at the end of every quarter of the Fund's taxable year, in a wholly-owned and controlled Cayman Islands subsidiary (“Subsidiary”). The Subsidiary will be advised by the Adviser, and the Fund's investment in the Subsidiary will primarily be intended to provide the Fund with exposure to the price of gold.
While each Fund will invest at least 80% of its net assets in the securities and financial instruments described above, each Fund may invest its remaining assets in the securities and financial instruments described below.
In addition to the exchange-traded equity securities described above for the Funds, the Funds may invest in the following exchange-traded equity securities: exchange-traded common stock (other than large-cap U.S. stocks or Emerging Markets Securities, respectively, for the respective Funds); exchange-traded preferred stock; exchange-traded warrants; exchange-traded MLPs; exchange-traded rights; and exchange-traded convertible securities.
In addition to the futures transactions described above, the Funds may engage in other index, commodity, and currency futures transactions, and may engage in exchange-traded options transactions on such futures. The Funds may use futures contracts and related options for bona fide hedging; to offset changes in the value of securities held or expected to be acquired or be disposed of; to gain exposure to a particular market, index, or instrument; or for other risk management purposes. The Funds also may purchase and write exchange-traded and over-the-counter put and call options on securities, securities indices, and currencies. A Fund may purchase put and call options on securities to protect against a decline in the market value of the securities in its portfolio or to anticipate an increase in the market value of securities that a Fund may seek to purchase in the future.
The Funds may invest in restricted (Rule 144A) securities.
Each Fund will also invest in cash and cash equivalents
The Funds will invest in the securities of other investment companies, including the Underlying Funds, to the extent that such an investment would be consistent with the requirements of Section 12(d)(1) of the 1940 Act, or any rule, regulation, or order of the Commission or interpretation thereof.
According to the Exchange, each Fund will achieve commodities exposure through investment in its respective Subsidiary. Such investment may not exceed 25% of a Fund's total assets, as measured at the end of every quarter of a Fund's taxable year. Each Subsidiary will invest in gold futures contracts, commodity-related pooled vehicles, options on commodity futures, and other investments (cash, cash equivalents, and Fixed Income Instruments with less than one year to maturity) intended to serve as margin or collateral or otherwise support the Subsidiary's derivatives positions. Unlike a Fund, the Subsidiary may invest without limitation in commodity futures and may use leveraged investment techniques. The Subsidiaries otherwise are subject to the same general investment policies and restrictions as the Funds.
Each Fund may invest up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including Rule 144A securities deemed illiquid by the Adviser,
Each Fund will concentrate its investments (
Each Fund will seek to qualify for treatment as a Regulated Investment Company under the Internal Revenue Code.
Each Fund's investments will be consistent with its investment objective and will not be used to enhance leverage.
After careful review, the Commission finds that the Exchange's proposal to list and trade the Shares is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission also finds that the proposal to list and trade the Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the Act,
Quotation and last-sale information for the Shares will be available via the Consolidated Tape Association (“CTA”) high-speed line. The Portfolio Indicative Value, as defined in NYSE Arca Equities Rule 8.600(c)(3), will be widely disseminated at least every 15 seconds during the Core Trading Session by one or more major market data vendors.
The Commission further believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Exchange will obtain a representation from the issuer of the Shares of each Fund that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time. Trading in Shares of each Fund will be halted if the circuit-breaker parameters in NYSE Arca Equities Rule 7.12 have been reached. Trading also may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable.
The Exchange represents that it deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. In support of this proposal, the Exchange has made the following representations:
(1) The Shares will conform to the initial and continued listing criteria under NYSE Arca Equities Rule 8.600.
(2) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(3) Trading in the Shares will be subject to the existing trading surveillances, which are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws.
(4) The regulatory staff of the Exchange or FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares, certain exchange-listed equity securities, certain futures, certain options on futures, and certain exchange-traded options with other markets and other entities that are members of the Intermarket Surveillance Group (“ISG”), and FINRA, on behalf of the Exchange, may obtain information regarding trading in such securities and financial instruments from such markets and other entities. In addition, the regulatory staff of the Exchange may obtain information regarding trading in such securities and financial instruments from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. FINRA, on behalf of the Exchange, also is able to access, as needed, trade information for certain fixed income securities held by a Fund reported to FINRA's Trade Reporting and Compliance Engine.
(5) Not more than 10% of the net assets of a Fund in the aggregate invested in futures contracts or options contracts shall consist of futures contracts or options contracts whose principal market is not a member of ISG or is a market with which the Exchange does not have a comprehensive surveillance sharing agreement.
(6) Prior to the commencement of trading of the Shares, the Exchange will inform its ETP Holders in a Bulletin of the special characteristics and risks associated with trading the Shares. The Bulletin will discuss the following: (a) The procedures for purchases and redemptions of Shares in Creation Unit aggregations (and that Shares are not individually redeemable); (b) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (c) the risks involved in trading the Shares during the Opening and Late Trading Sessions when an updated Portfolio Indicative Value will not be calculated or publicly disseminated; (d) how information regarding the Portfolio Indicative Value and the Disclosed Portfolio is disseminated; (e) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (f) trading information.
(7) For initial and continued listing, the Funds will be in compliance with Rule 10A-3 under the Act,
(8) The REX Gold Hedged S&P 500 ETF will not invest in non-U.S. stocks.
(9) The non-U.S. equity securities in the REX Gold Hedged FTSE Emerging Markets ETF portfolio will meet the following criteria on a continual basis: (i) Non-U.S. equity securities each shall have a minimum market value of at least $100 million; (ii) non-U.S. equity securities each shall have a minimum global monthly trading volume of 250,000 shares, or minimum global notional volume traded per month of $25,000,000, averaged over the last six months; (iii) the most heavily weighted non-U.S. equity security shall not exceed 25% of the weight of the Fund's entire portfolio, and, to the extent applicable, the five most heavily weighted non-U.S. equity securities shall not exceed 60% of the weight of the Fund's entire portfolio; and (iv) each non-U.S. equity security shall be listed and traded on an exchange that has last-sale reporting. In addition, non-exchange-listed ADRs will not exceed 10% of this Fund's net assets.
(10) While a Fund may invest in inverse ETFs and ETNs, a Fund will not invest in leveraged (
(11) Each Fund will achieve commodities exposure through investment in a Subsidiary, and such investment may not exceed 25% of a Fund's total assets, as measured at the end of every quarter of a Fund's taxable year.
(12) Each Fund may invest up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including Rule 144A securities deemed illiquid by the Adviser, consistent with Commission guidance.
(13) A minimum of 100,000 Shares for each Fund will be outstanding at the commencement of trading on the Exchange.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment Nos. 1, 2, 3, and 4 thereto, is consistent with Section 6(b)(5) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On December 16, 2015, Financial Industry Regulatory Authority, Inc. (“FINRA”) filed with the Securities and Exchange Commission (“SEC” or “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act,” “Exchange Act” or “SEA”)
The proposed rule change was published for comment in the
Institution of proceedings does not indicate that the Commission has
As described more
Furthermore, FINRA is proposing Rule 4580, which would impose recordkeeping requirements on FINRA member firms in connection with its pay-to-play rule that would allow examination of member firms' books and records for compliance with the pay-to-play rule.
The following is an overview of some of the key provisions in FINRA's proposed rules.
Proposed Rule 2030(a) would prohibit a covered member from engaging in distribution or solicitation activities for compensation with a government entity on behalf of an investment adviser that provides or is seeking to provide investment advisory services to such government entity within two years after a contribution to an official of the government entity is made by the covered member or a covered associate, including a person who becomes a covered associate within two years after the contribution is made.
FINRA explains that proposed Rule 2030(a) would not ban or limit the amount of political contributions a covered member or its covered associates could make.
FINRA states that, based on the definition of “regulated person” in the SEC Pay-to-Play Rule, it is required to adopt a rule that prohibits its member firms from engaging in distribution activities (as well as solicitation activities) with government entities if political contributions have been made.
However, FINRA also explains that, based on the definition of a “covered investment pool” in proposed Rule 2030(g)(3),
FINRA also states that, consistent with the SEC Pay-to-Play Rule, proposed Rule 2030(g)(11) defines the term “solicit” to mean: “(A) With respect to investment advisory services, to communicate, directly or indirectly, for the purpose of obtaining or retaining a client for, or referring a client to, an investment adviser; and (B) With respect to a contribution or payment, to communicate, directly or indirectly, for the purpose of obtaining or arranging a contribution or payment.”
Proposed Rule 2030(b) would also prohibit a covered member or covered associate from coordinating or soliciting any person or political action committee (PAC) to make any: (1) Contribution to an official of a government entity in respect of which the covered member is engaging in, or seeking to engage in, distribution or solicitation activities on behalf of an investment adviser; or (2) payment to a political party of a state or locality of a government entity with which the covered member is engaging in, or seeking to engage in, distribution or solicitation activities on behalf of an investment adviser.
FINRA's proposed pay-to-play rule contains three exceptions from the proposed rule's prohibitions: (1)
Proposed Rule 2030(c)(1) would except from the rule's restrictions contributions made by a covered associate who is a natural person to government entity officials for whom the covered associate was entitled to vote at the time of the contributions, provided the contributions do not exceed $350 in the aggregate to any one official per election.
The proposed rule would attribute to a covered member contributions made by a person within two years (or, in some cases, six months) of becoming a covered associate. However, proposed Rule 2030(c)(2) would provide an exception from the proposed rule's restrictions for covered members if a natural person made a contribution more than six months prior to becoming a covered associate of the covered member unless the covered associate engages in, or seeks to engage in, distribution or solicitation activities with a government entity on behalf of the covered member.
Proposed Rule 2030(c)(3) would provide an exception from the proposed rule's restrictions for covered members if the restriction is due to a contribution made by a covered associate and: (1) The covered member discovered the contribution within four months of it being made; (2) the contribution was less than $350; and (3) the contribution is returned within 60 days of the discovery of the contribution by the covered member.
Proposed Rule 2030(d)(1) provides that a covered member that engages in distribution or solicitation activities with a government entity on behalf of a covered investment pool
Proposed Rule 2030(e) provides that it shall be a violation of Rule 2030 for any covered member or any of its covered associates to do anything indirectly that, if done directly, would result in a violation of the rule.
Proposed Rule 2030(f) includes an exemptive provision for covered members, modeled on the exemptive provision in the SEC Pay-to-Play Rule, that would allow covered members to apply to FINRA for an exemption from the proposed rule's two-year time out.
The following is an overview of some of the key definitions in FINRA's proposed rules.
Proposed Rule 2030(g)(1) defines “contribution” to mean any gift, subscription, loan, advance, deposit of money, or anything of value made for the purpose of influencing the election for a federal, state or local office, and includes any payments for debts incurred in such an election or
Proposed Rule 2030(g)(2) defines the term “covered associates” to mean: “(A) Any general partner, managing member or executive officer of a covered member, or other individual with a similar status or function; (B) Any associated person of a covered member who engages in distribution or solicitation activities with a government entity for such covered member; (C) Any associated person of a covered member who supervises, directly or indirectly, the government entity distribution or solicitation activities of a person in subparagraph (B) above; and (D) Any political action committee controlled by a covered member or a covered associate.”
FINRA explains that an “official” (as defined in proposed Rule 2030(g)(8)) of a “government entity” (as defined in proposed Rule 2030(g)(7))—both of which FINRA states are consistent with the SEC Pay-to-Play Rule definitions—would include an incumbent, candidate or successful candidate for elective office of a government entity if the office is directly or indirectly responsible for, or can influence the outcome of, the hiring of an investment adviser or has authority to appoint any person who is directly or indirectly responsible for, or can influence the outcome of, the hiring of an investment adviser.
FINRA further states that the two-year time out would be triggered by contributions, not only to elected officials who have legal authority to hire the adviser, but also to elected officials (such as persons with appointment authority) who can influence the hiring of the adviser.
Proposed Rule 4580 would require covered members that engage in distribution or solicitation activities with a government entity on behalf of any investment adviser that provides or is seeking to provide investment advisory services to such government entity to maintain books and records that would allow FINRA to examine for compliance with its pay-to-play rule.
As noted above, the Commission received ten comment letters, from nine different commenters, on the proposed rule change.
As noted above, three commenters oppose the proposed rule as drafted based on First Amendment concerns.
Another commenter urged the Commission to reject FINRA's proposal because, according to that commenter, it impermissibly restricts core political speech in violation of the First Amendment.
Similarly, another commenter opposes FINRA's proposed rule, stating that the proposal is unlawful and unconstitutional.
Although not expressly opposing the proposed rules on First Amendment grounds, two other commenters also raise First Amendment comments.
Two commenters raised concerns regarding the application of the proposed rules to variable annuities.
One of these commenters also requests that proposed Rule 2030 be modified to, among other things, clarify that the distribution of a two-tiered product such as a variable annuity is not solicitation activity for an investment adviser and sub-advisers managing the funds available as investment options.
Two commenters also expressed concern that proposed rule 2030(d) would, in their view, re-characterize “ordinary” or “customary” distribution activities for covered investment pools as the solicitation of clients on behalf of the investment adviser to the covered investment pools.
Similarly, another commenter expressed concern with the apparent application of proposed Rule 2030(d) to traditional brokerage sales of mutual funds and variable annuities to participant-directed government-sponsored retirement plans.
One commenter generally expressed concern that Rule 2030 is unnecessarily ambiguous regarding the term distribution activities in Rule 2030(a).
This commenter also claims that, while the SEC Pay-to-Play Rule requires regulated persons to be subject to rules that prohibit them from engaging in certain distribution activities if certain political contributions have been made, Rule 206(4)-5 does not mandate the use of the term “distribution” in describing the conduct prohibited by the proposed rule, and suggested revised rule text reflecting that assertion.
The commenter believes that its suggested revisions would, among other things, eliminate the potential concern that a selling firm might violate Rule 2030 unknowingly due to being deemed to be acting on behalf of investment advisers or sub-advisers of underlying funds with which it has no relationship.
Two commenters requested clarification of certain defined terms used in the proposed rules.
Another commenter requests that FINRA clarify the definition of a “covered associate” and clarify and delineate the positions that would qualify someone as a covered “official.”
This commenter also claims that statements made by FINRA in the Notice regarding the proposed rule's anti-circumvention provision, proposed Rule 2030(e), combined with statements made in SEC staff guidance concerning whether contributions through PACs would violate the SEC Pay-to-Play Rule and section 208(d) of the Advisers Act, have the ability to chill contributions to PACs.
Several commenters raised concerns regarding the
One commenter requested that FINRA clarify the application of the proposed rule to existing government entity accounts or contracts.
One commenter claims that its members will face difficulties in attempting to comply with the proposed rules, and that these difficulties stem, primarily, from a requirement for independent firms to implement a rule that is premised on the notion that solicitation of clients is performed pursuant to a centralized process controlled by the management of a registered investment adviser.
One commenter claims that it continues to believe that not all payments to political parties or PACs should have to be maintained under the books and records requirements of proposed Rule 4580.
Two commenters suggested including more stringent requirements in FINRA's proposed rule.
Second, these same two commenters request that FINRA include a mandatory disgorgement provision for violations of its proposed rule.
Finally, one of these commenters believes that the current two-year cooling-off period in the proposal should be at least four years.
The Commission is instituting proceedings pursuant to Exchange Act Section 19(b)(2)(B) to determine whether the proposed rule change should be approved or disapproved.
Pursuant to Exchange Act Section 19(b)(2)(B),
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues raised by the proposed rule change. In particular, the Commission invites the written views of interested persons on whether the proposed rule change is inconsistent with Sections 15A(b)(6) and 15A(b)(9), or any other provision, of the Exchange Act, or the rules and regulations thereunder.
Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of views, data, and arguments, the Commission will consider, pursuant to Rule 19b-4, any request for an opportunity to make an oral presentation.
Interested persons are invited to submit written data, views, and arguments by April 25, 2016 concerning whether the proposed rule change should be approved or disapproved. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by May 19, 2016. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-FINRA-2015-056 and should be submitted on or before April 25, 2016. If comments are received, any rebuttal comments should be submitted by May 19, 2016.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to adopt requirements for the collection and transmission of data pursuant to Appendices B and C of the Regulation NMS Plan to Implement a Tick Size Pilot Program (“Plan”). The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
On August 25, 2014, NYSE Group, Inc., on behalf of the Exchange, NYSE MKT LLC, NYSE Arca, Inc., the Bats BZX Exchange, Inc. f/k/a BATS Exchange, Inc. (“BZX”), BATS BYX Exchange, Inc. f/k/a BATS Y-Exchange, Inc. (“BYX”), Bats EDGA Exchange, Inc., Bats EDGX Exchange, Inc., Chicago Stock Exchange, Inc., Financial Industry Regulatory Authority, Inc. (“FINRA”), NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, and the Nasdaq Stock Market LLC (collectively “Participants”), filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stocks of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan. As is described more fully below, the proposed rules would require member organizations to comply with the applicable data collection requirements of the Plan.
The Pilot will include stocks of companies with $3 billion or less in market capitalization, an average daily trading volume of one million shares or less, and a volume weighted average price of at least $2.00 for every trading day. The Pilot will consist of a control group of approximately 1400 Pilot Securities and three test groups with 400 Pilot Securities in each (selected by a stratified random sampling process).
In approving the Plan, the Commission noted that the Trading Center data reporting requirements would facilitate an analysis of the effects of the Pilot on liquidity (
The Plan contains requirements for collecting and transmitting data to the Commission and to the public.
Appendix B.II of the Plan (Market and Marketable Limit Order Data) requires Trading Centers to submit information relating to market orders and marketable limit orders, including the time of order receipt, order type, the order size, the National Best Bid and National Best Offer (“NBBO”) quoted price, the NBBO quoted depth, the average execution price-share-weighted average, and the average execution time-share-weighted average.
The Plan requires Appendix B.I and B.II data to be submitted by Participants that operate a Trading Center, and by members of the Participants that operate Trading Centers. The Plan provides that each Participant that is the Designated Examining Authority (“DEA”) for a member of the Participant that operates a Trading Center shall collect such data in a pipe delimited format, beginning six months prior to the Pilot Period and ending six months after the end of the Pilot Period. The Plan also requires the Participant, operating as DEA, to transmit this information to the SEC within 30 calendar days following month end.
The Exchange is proposing new Rule 67(b) to set forth the requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan. Proposed Rule 67(b) is substantially similar to the proposed rule changes by BZX that were recently approved by the Commission to adopt BZX Rule 11.27(b) which also sets forth requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan.
Proposed Rule 67(b)(1) requires that a member organization that operates a Trading Center shall establish, maintain and enforce written policies and procedures that are reasonably designed to comply with the data collection and transmission requirements of Items I and II to Appendix B of the Plan, and a member organization that is a Market Maker shall establish, maintain and enforce written policies and procedures that are reasonably designed to comply with the data collection and transmission requirements of Item IV of Appendix B of the Plan and Item I of Appendix C of the Plan.
Proposed Rule 67(b)(2) provides that the Exchange shall collect and transmit to the SEC the data described in Items I and II of Appendix B of the Plan relating to trading activity in Pre-Pilot Data Collection Securities
Appendix B.IV (Daily Market Maker Participation Statistics) requires a Participant to collect data related to
The Exchange understands that some member organizations may utilize a DEA that is not a Participant to the Plan and that their DEA would not be subject to the Plan's data collection requirements. In such case, a DEA that is not a Participant of the Plan would not be required to collect the required data and may not establish procedures for which member organizations it acts a DEA for to report the data required under subparagraphs (b)(3)(A) of Rule 67 and in accordance with Item IV of Appendix B of the Plan. Therefore, the Exchange proposes to adopt subparagraph (b)(3)(B) to Rule 67 to require a member organization that is a Market Maker whose DEA is not a Participant to the Plan to transmit the data collected pursuant to paragraph (3)(A) of Rule 67(b) to FINRA, which is a Participant to the Plan and is to collect data relating to Item IV of Appendix B of the Plan on behalf of the Participants. For Market Makers for which it is the DEA, FINRA issued a Market Maker Transaction Data Technical Specification to collect data on Pre-Pilot Data Collection Securities and Pilot Securities from Trading Centers to comply with the Plan's data collection requirements.
Proposed Rule 67(b)(3)(C) provides that the Exchange shall transmit the data collected by the DEA or FINRA pursuant to Rule 67(b)(3)(A) and (B) above relating to Market Maker activity on a Trading Center operated by the Exchange to the SEC in a pipe delimited format within 30 calendar days following month end. The Exchange shall also make such data publicly available on the Exchange Web site on a monthly basis at no charge and shall not identify the Trading Center that generated the data.
Appendix C.I (Market Maker Profitability) requires a Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA. Specifically, the Participant is required to collect the total number of shares of orders executed by the Market Maker; the raw Market Maker realized trading profits, and the raw Market Maker unrealized trading profits. Data shall be collected for dates starting six months prior to the Pilot Period through six months after the end of the Pilot Period. This data shall be collected on a monthly basis, to be provided in a pipe delimited format to the Participant, as DEA, within 30 calendar days following month end. Appendix C.II (Aggregated Market Maker Profitability) requires the Participant, as DEA, to aggregate the Appendix C.I data, and to categorize this data by security as well as by the control group and each Test Group. That aggregated data shall contain information relating to total raw Market Maker realized trading profits, volume-weighted average of raw Market Maker realized trading profits, the total raw Market Maker unrealized trading profits, and the volume-weighted average of Market Maker unrealized trading profits.
The Exchange is therefore proposing Rule 67(b)(4) to set forth the requirements for the collection and transmission of data pursuant to Appendix C.I of the Plan. Proposed Rule 67(b)(4)(A) requires that a member organization that is a Market Maker shall collect and transmit to their DEA the data described in Item I of Appendix C of the Plan with respect to executions in Pilot Securities that have settled or reached settlement date that were executed on any Trading Center. The proposed rule also requires member organizations to provide such data in a format required by their DEA by 12 p.m. EST on T+4 for executions during and outside of Regular Trading Hours in each: (i) Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period.
For the same reasons set forth above for subparagraph (b)(3)(B) to Rule 67, the Exchange proposes to adopt subparagraph (b)(4)(B) to Rule 67 to require a member organization that is a Market Maker whose DEA is not a Participant to the Plan to transmit the data collected pursuant to paragraph (4)(A) of Rule 67(b) to FINRA. As stated above, FINRA is a Participant to the Plan and is to collect data relating to Item I of Appendix C of the Plan on behalf of the Participants. For Market Makers for which it is the DEA, FINRA issued a Market Maker Transaction Data Technical Specification to collect data on Pre-Pilot Data Collection Securities and Pilot Securities from Trading Centers to comply with the Plan's data collection requirements.
The Exchange is also adopting a rule setting forth the manner in which Market Maker participation will be calculated. Item III of Appendix B of the Plan requires each Participant that is a national securities exchange to collect daily Market Maker registration statistics categorized by security, including the following information: (i) Ticker symbol; (ii) the Participant exchange; (iii) number of registered market makers; and (iv) the number of other registered liquidity providers. Therefore, the Exchange proposes to adopt Rule 67(b)(5) providing that the Exchange shall collect and transmit to the SEC the data described in Item III of Appendix B of the Plan relating to daily Market Maker registration statistics in a pipe delimited format within 30 calendar days following month end for: (i) Transactions in each Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) transactions in each Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period.
The Exchange is also proposing, through
The Exchange and the other Participants have determined that it is appropriate to create a new flag for reporting orders that are affected by the Limit-Up Limit-Down bands. Accordingly, a Trading Center shall report a value of “Y” to their DEA when the ability of an order to execute has been affected by the Limit-Up Limit-Down bands in effect at the time of order receipt. A Trading Center shall report a value of “N” to their DEA when the ability of an order to execute has not been affected by the Limit-Up Limit-Down bands in effect at the time of order receipt.
The Exchange is proposing
The Exchange is proposing
The Exchange is proposing
Finally, the Exchange is proposing
The proposed rule change will be effective on April 4, 2016.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant of the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. The Exchange believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan and applies specific obligations to member organizations in furtherance of compliance with the Plan.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant of the Plan. The Exchange also notes that the data collection requirements for member organizations that operate Trading Centers will apply equally to all such member organizations, as will the data collection requirements for Market Makers.
No written comments were solicited or received with respect to the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
CHX proposes to adopt Article 20, Rule 13 to implement the Regulation NMS Plan to Implement a Tick Size Pilot Program (“Plan”). Specifically, the Exchange proposes to adopt Article 20, Rule 13 to set forth the requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan. The proposed rule change is substantially similar to proposed rule changes recently approved or published by the Commission by the Bats BZX Exchange, Inc. f/k/a BATS Exchange, Inc. (“BZX”) to adopt BZX Rule 11.27(b)
The text of this proposed rule change is available on the Exchange's Web site at (
In its filing with the Commission, the CHX included statements concerning the purpose of and basis for the proposed rule changes and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The CHX has prepared summaries, set forth in sections A, B and C below, of the most significant aspects of such statements.
On August 25, 2014, NYSE Group, Inc., on behalf of the Exchange, Bats BYX Exchange, Inc., BZX, Bats EDGA Exchange, Inc., Bats EDGX Exchange, Inc., FINRA, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, the Nasdaq Stock Market LLC, New York Stock Exchange LLC (“NYSE”), NYSE MKT LLC, and NYSE Arca, Inc. (collectively “Plan Participants”), filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stocks of small-capitalization companies. Each Plan Participant is required to comply, and to enforce compliance by its members, as applicable, with the provisions of the Plan. As is described more fully below, the proposed rules would require CHX Participants
The Pilot will include stocks of companies with $3 billion or less in market capitalization, an average daily trading volume of one million shares or less, and a volume weighted average price of at least $2.00 for every trading day. The Pilot will consist of a control group of approximately 1400 Pilot Securities and three test groups with 400 Pilot Securities in each (selected by a stratified random sampling process).
In approving the Plan, the Commission noted that the Trading Center data reporting requirements would facilitate an analysis of the effects of the Pilot on liquidity (
The Plan contains requirements for collecting and transmitting data to the Commission and to the public.
Appendix B.II of the Plan (Market and Marketable Limit Order Data) requires Trading Centers to submit information relating to market orders and marketable limit orders, including the time of order receipt, order type, the order size, the National Best Bid and National Best Offer (“NBBO”) quoted price, the NBBO quoted depth, the average execution price-share-weighted average, and the average execution time-share-weighted average.
The Plan requires Appendix B.I and B.II data to be submitted by Plan Participants that operate a Trading Center, and by members of the Plan Participants that operate Trading Centers. The Plan provides that each Plan Participant that is the Designated Examining Authority (“DEA”) for a member of the Plan Participant that operates a Trading Center shall collect such data in a pipe delimited format, beginning six months prior to the Pilot Period and ending six months after the end of the Pilot Period. The Plan also requires the Plan Participant, operating as DEA, to transmit this information to the SEC within 30 calendar days following month end.
The Exchange is therefore proposing Article 20, Rule 13(b) to set forth the requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan. Proposed Article 20, Rule 13(b) is substantially similar to proposed rule changes by BZX that were recently approved or published by the Commission to adopt BZX Rule 11.27(b) which also sets forth requirements for the collection and transmission of data pursuant to Appendices B and C of the Plan;
• Proposed Article 20, Rule 13(b)(2)(A) is similar to proposed rule changes by FINRA that were recently approved or published by the Commission to adopt FINRA Rule 6191(b)(2).
• Proposed Article 20, Rule 13(b)(3)(B) is similar to approved BZX Rule 11.27(b)(3)(B), except that the Exchange is also proposing to require CHX Participant Market Makers for which the Exchange is the DEA to transmit Appendix B.IV data to FINRA directly, as discussed below.
• Proposed Article 20, Rule 13(b)(4)(B) is similar to approved BZX Rule 11.27(b)(4)(B), except that the Exchange is also proposing to require CHX Participant Market Makers for which the Exchange is the DEA to transmit Appendix C.I data to FINRA directly, as discussed below.
Proposed Article 20, Rule 13(b)(1) requires that a CHX Participant that operates a Trading Center shall establish, maintain and enforce written policies and procedures that are reasonably designed to comply with the data collection and transmission requirements of Items I and II to Appendix B of the Plan, and a CHX Participant that is a Market Maker shall establish, maintain and enforce written policies and procedures that are reasonably designed to comply with the data collection and transmission requirements of Item IV of Appendix B of the Plan and Item I of Appendix C of the Plan.
The Exchange notes that the data requirements of Items I and II to Appendix B of the Plan necessitates that the Exchange adopt two sets of rules: One for CHX Participants that operate Trading Centers subject to the Plan for which the Exchange is the DEA (
Similar to FINRA Rule 6191(b)(2)(A)(i), proposed Article 20, Rule 13(b)(2)(A)(i) requires that a CHX Participant that operates a Trading Center subject to the Plan, and for which CHX is the DEA, shall collect and transmit to the Exchange the data described in Items I and II of Appendix B of the Plan with respect to each Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and each Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period.
Section IV of the Plan (Policies and Procedures) provides that each Plan Participant that is the DEA of a member of a Plan Participant operating a Trading Center is required to develop appropriate policies and procedures for collecting and reporting the data described in Items I and II of Appendix B, as applicable, to the DEA Plan Participant. The Exchange has determined that all of the data required by Appendix B.I and B.II to the Plan currently is reported to the Exchange pursuant to CHX Article 11, Rule 3, which requires CHX Participants for which the Exchange is the DEA, among others, to record certain order and execution information into an electronic system designated by the Exchange. In the interest of increasing the efficiency of the data collection process and the consistency of that data to be collected under the Plan, the Exchange proposes to use Article 11, Rule 3 as the vehicle through which Trading Centers must comply with their reporting obligations pursuant to Appendix B.I and B.II of the Plan.
Accordingly, similar to FINRA Rule 6191(b)(2)(A)(ii), proposed Article 20, Rule 13(b)(2)(A)(ii) provides that each CHX Participant that operates a Trading Center subject to the Plan, and for which CHX is the DEA, shall meet the data collection and reporting requirements in Items I and II of Appendix B through their submission of data elements required pursuant to Article 11, Rule 3, as well as the following additional data elements, when an order in a Pilot Security or Pre-Pilot Data Collection Security is received or originated: (a) Whether the CHX Participant is a Trading Center in either the Pilot Security or the Pre-Pilot Data Collection Security; and (b) whether the order is routable.
Moreover, similar to FINRA Rule 6191(b)(2)(A)(iii), proposed CHX Article 20, Rule 13(b)(2)(A)(iii) provides that when an order in a Pilot Security or Pre-Pilot Data Collection Security is executed, each CHX Participant subject to this paragraph (b)(2)(A) shall comply with its collection and transmission obligations under Items I and II of Appendix B to the Plan and this Rule by identifying whether CHX Participant is relying upon the Retail Investor Order exception with respect to the execution of the order.
As an initial matter, only those CHX Participants that operate a Trading Center and for which the Exchange is the DEA are required to make any changes to their Article 11, Rule 3 data recording. CHX Participants that do not operate Trading Centers or that have another self-regulatory organization as DEA will be permitted to leave the new fields blank. CHX Participants that operate Trading Centers and which the Exchange is the DEA will be required to indicate their status as a Trading Center for new orders involving Pre-Pilot Data Collection Securities and Pilot Securities.
Moreover, the proposed rule change adds a new requirement to capture whether an order in a Pre-Pilot Data Collection Security or a Pilot Security received by a CHX Participant that operates a Trading Center and for which the Exchange is the DEA is routable
Similar to FINRA Rule 6191(b)(2)(A)(iv), proposed Article 20, Rule 13(b)(2)(A)(iv) provides that each CHX Participant that operates a Trading Center subject to the Tick Size Pilot Program, and for which the Exchange is the DEA, shall submit data required under this paragraph (b)(2)(A) by 8:00 a.m. CST the calendar day following the reportable event.
As set forth in Section VII of the Plan (Collection of Pilot Data) and similar to FINRA Rule 6191(b)(2)(B), proposed Article 20, Rule 13(b)(2)(A)(v) provides that the Exchange shall collect and transmit to the SEC the data described in Items I and II of Appendix B of the Plan and collected pursuant to this paragraph (b)(2)(A).
Proposed Article 20, Rule 13(b)(2)(B)(i) provides that the Exchange shall collect and transmit to the SEC the data described in Items I and II of Appendix B of the Plan relating to trading activity in Pre-Pilot Securities and Pilot Securities on a Trading Center operated by the Exchange. The Exchange shall transmit such data to the SEC in a pipe delimited format, on a disaggregated basis by Trading Center, within 30 calendar days following month end for: (i) Each Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) each Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period. The Exchange also shall make such data publicly available on the Exchange Web site on a monthly basis at no charge and will not identify the CHX Participant that generated the data.
Appendix B.IV (Daily Market Maker Participation Statistics) requires a Plan Participant to collect data related to Market Maker participation from each Market Maker
However, the Exchange understands that some CHX Participants may utilize a DEA that is not a Plan Participant to the Plan and that their DEA would not be subject to the Plan's data collection requirements. In such case, a DEA that is not a Plan Participant of the Plan would not be required to collect the required data and may not establish procedures for CHX Participants for which it acts as DEA to report the data required under subparagraphs (b)(3)(A) of proposed Article 20, Rule 13(b)(3)(A) and in accordance with Item IV of Appendix B of the Plan.
Moreover, to facilitate the linking of relevant transactions across various Trading Centers by a CHX Participant Market Maker, the Exchange proposes to require CHX Participants Market Makers for which the Exchange is the DEA to submit data relating to Item IV of Appendix B to FINRA directly.
Therefore, the Exchange proposes to adopt subparagraph (b)(3)(B) to proposed Article 20, Rule 13 to require a CHX Participant that is a Market Maker whose DEA (i) is not a Plan Participant to the Plan or (ii) is the Exchange to transmit the data collected pursuant to paragraph (3)(A) of proposed Article 20, Rule 13 to FINRA, which is a Plan Participant to the Plan and is to collect data relating to Item IV of Appendix B of the Plan on behalf of the Plan Participants. For Market Makers for which it is the DEA, FINRA issued a Market Maker Transaction Data Technical Specification to collect data on Pre-Pilot Data Collection Securities and Pilot Securities from Trading Centers to comply with the Plan's data collection requirements.
Proposed Article 20, Rule 13(b)(3)(C) provides that the Exchange shall transmit the data collected by the DEA or FINRA pursuant to proposed Article 20, Rule 13(b)(3)(A) and (B) above relating to Market Maker activity on a Trading Center operated by the Exchange to the SEC in a pipe delimited format within 30 calendar days following month end. The Exchange shall also make such data publicly available on the Exchange Web site on a monthly basis at no charge and shall not identify the Trading Center that generated the data.
Appendix C.I (Market Maker Profitability) requires a Plan Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA. Specifically, the Plan Participant is required to collect the total number of shares of orders executed by the Market Maker; the raw Market Maker realized trading profits, and the raw Market Maker unrealized trading profits. Data shall be collected for dates starting six months prior to the Pilot Period through six months after the end of the Pilot Period. This data shall be collected on a monthly basis, to be provided in a pipe delimited format to the Plan Participant, as DEA, within 30 calendar days following month end. Appendix C.II (Aggregated Market Maker Profitability) requires the Plan Participant, as DEA, to aggregate the Appendix C.I data, and to categorize this data by security as well as by the control group and each Test Group. That aggregated data shall contain information relating to total raw Market Maker realized trading profits, volume-weighted average of raw Market Maker realized trading profits, the total raw Market Maker unrealized trading profits, and the volume-weighted average of Market Maker unrealized trading profits.
The Exchange is therefore proposing Article 20, Rule 13(b)(4) to set forth the requirements for the collection and transmission of data pursuant to Appendix C.I of the Plan. Proposed Article 20, Rule 13(b)(4)(A) requires that a CHX Participant that is a Market Maker shall collect and transmit to their DEA the data described in Item I of Appendix C of the Plan with respect to executions in Pilot Securities that have settled or reached settlement date that were executed on any Trading Center. The proposed rule also requires CHX Participants to provide such data in a format required by their DEA by 12 p.m. EST on T+4 for executions during and outside of Regular Trading Hours in each: (i) Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period; and (ii) Pilot Security for the period beginning on the first day of the Pilot Period through six months after the end of the Pilot Period.
For the same reasons set forth above for subparagraph (b)(3)(B) to proposed Article 20, Rule 13, the Exchange proposes to adopt subparagraph (b)(4)(B) to proposed Article 20, Rule 13 to require a CHX Participant that is a Market Maker whose DEA (i) is not a Plan Participant to the Plan or (ii) the Exchange to transmit the data collected pursuant to paragraph (4)(A) of Article 20, Rule 13 to FINRA directly. As stated above, FINRA is a Plan Participant to the Plan and is to collect data relating to Item I of Appendix C of the Plan on behalf of the Plan Participants. For Market Makers for which it is the DEA, FINRA issued a Market Maker Transaction Data Technical Specification to collect data on Pre-Pilot Data Collection Securities and Pilot Securities from Trading Centers to comply with the Plan's data collection requirements.
The Exchange is also adopting a rule setting forth the manner in which Market Maker participation will be calculated. Item III of Appendix B of the Plan requires each Plan Participant that is a national securities exchange to collect daily Market Maker registration statistics categorized by security, including the following information: (i) Ticker symbol; (ii) the Plan Participant exchange; (iii) number of registered market makers; and (iv) the number of other registered liquidity providers. Therefore, the Exchange proposes to adopt proposed Article 20, Rule 13(b)(5) providing that the Exchange shall collect and transmit to the SEC the data described in Item III of Appendix B of the Plan relating to daily Market Maker registration statistics in a pipe delimited format within 30 calendar days following month end for: (i) Transactions in each Pre-Pilot Data Collection Security for the period beginning six months prior to the Pilot Period through the trading day immediately preceding the Pilot Period;
The Exchange is also proposing, through Interpretations and Policies, to clarify other aspects of the data collection requirements.
Interpretations and Policies .03 requires that CHX Participants populate a field to identify to their DEA whether an order is affected by the bands in place pursuant to the National Market System Plan to Address Extraordinary Market Volatility.
The Exchange and the other Plan Participants have determined that it is appropriate to create a new flag for reporting orders that are affected by the Limit-Up Limit-Down bands. Accordingly, a Trading Center shall report a value of “Y” to their DEA when the ability of an order to execute has been affected by the Limit-Up Limit-Down bands in effect at the time of order receipt. A Trading Center shall report a value of “N” to their DEA when the ability of an order to execute has not been affected by the Limit-Up Limit-Down bands in effect at the time of order receipt.
Interpretations and Policies .03 also requires, for securities that may trade in a foreign market, that the Plan Participant indicate whether the order was handled domestically, or routed to a foreign venue. Accordingly, the Plan Participant will indicate, for purposes of Appendix B.I, whether the order was: (1) Fully executed domestically, or (2) fully or partially executed on a foreign market. For purposes of Appendix B.II, the Plan Participant will classify all orders in securities that may trade in a foreign market Pilot and Pre-Pilot Securities as: (1) Directed to a domestic venue for execution; (2) may only be directed to a foreign venue for execution; or (3) was fully or partially directed to a foreign venue at the discretion of the CHX Participant. The Exchange believes that this proposed flag will better identify orders in securities that may trade in a foreign market, as such orders that were routed to foreign venues would not be subject to the Plan's quoting and trading requirements, and could otherwise compromise the integrity of the data.
Interpretations and Policies .04 relates to the time ranges specified in Appendix B.I.a(14), B.I.a(15), B.I.a(21) and B.I.a(22).
Interpretations and Policies .05 relates to the relevant measurement for purposes of Appendix B.I.a(31)-(33) reporting. Currently, the Plan states that this data shall be reported as of the time of order execution. The Exchange and the other Plan Participants believe that this information should more properly be captured at the time of order receipt as evaluating share-weighted average prices at the time of order receipt is more consistent with the goal of observing the effect of the Pilot on the liquidity of Pilot Securities. The Exchange is therefore proposing to make this change through Interpretations and Policies .05.
Interpretations and Policies .06 addresses the status of not-held and auction orders for purposes of Appendix
The Exchange is proposing Interpretations and Policies .07 to clarify the scope of the Plan as it relates to CHX Participants that only execute orders limited purposes. Specifically, the Exchange and the other Plan Participants believe that a CHX Participant that only executes orders otherwise than on a national securities exchange for the purpose of: (1) Correcting a bona fide error related to the execution of a customer order; (2) purchasing a security from a customer at a nominal price solely for purposes of liquidating the customer's position; or (3) completing the fractional share portion of an order
The Exchange is proposing Interpretations and Policies .08 to clarify that, for purposes of the Plan, Trading Centers must begin the data collection required pursuant to Appendix B.I.a(1) through B.II.(y) of the Plan and Item I of Appendix C of the Plan on April 4, 2016. While the Exchange or the CHX Participant's DEA will provide the information required by Appendix B and C of the Plan during the Pilot Period, the requirement that the Exchange or their DEA provide information to the SEC within 30 days following month end and make such data publicly available on its Web site pursuant to Appendix B and C shall commence six months prior to the beginning of the Pilot Period.
The Exchange is proposing Interpretations and Policies .09 to address the requirement in Appendix C.I(b) of the Plan that the calculation of raw Market Maker realized trading profits utilize a last in, first out (“LIFO”)-like method to determine which share prices shall be used in that calculation. The Exchange and the other Plan Participants believe that it is more appropriate to utilize a methodology that yields LIFO-like results, rather than utilizing a LIFO-like method, and the Exchange is therefore proposing Interpretations and Policies .09 to make this change.
Finally, the Exchange is proposing Interpretations and Policies .10 to address the securities that will be used for data collection purposes prior to the commencement of the Pilot. The Exchange and the other Plan Participants have determined that it is appropriate to collect data for a group of securities that is larger, and using different quantitative thresholds, than the group of securities that will be Pilot Securities. The Exchange is therefore proposing Interpretations and Policies .10 to define “Pre-Pilot Data Collection Securities” as the securities designated by the Plan Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C of the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. The Plan Participants shall compile the list of Pre-Pilot Data Collection Securities by selecting all NMS stocks with a market capitalization of $5 billion or less, a Consolidated Average Daily Volume (CADV) of 2 million shares or less and a closing price of $1 per share or more. The market capitalization and the closing price thresholds shall be applied to the last day of the Pre-Pilot measurement period, and the CADV threshold shall be applied to the
The proposed rule change will be operative on April 4, 2016.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant of the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. The Exchange believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan and applies specific obligations to CHX Participants in furtherance of compliance with the Plan.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant of the Plan. The Exchange also notes that the data collection requirements for CHX Participants that operate Trading Centers will apply equally to all such CHX Participants, as will the data collection requirements for Market Makers.
No written comments were either solicited or received.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4263-DR), dated 03/13/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Louisiana, dated 03/13/2016 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Pennsylvania (FEMA-4267-DR), dated 03/23/2016.
Submit completed loan applications to: U.S. Small Business Administration Processing, and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 03/23/2016, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14677B and for economic injury is 14678B.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Georgia (FEMA-4259-DR), dated 02/26/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Georgia, dated 02/26/2016, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4266-DR), dated 03/19/2016
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of TEXAS, dated 03/19/2016 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Mississippi (FEMA-4268-DR), dated 03/25/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 03/25/2016, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 146856 and for economic injury is 146860.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than June 3, 2016. Individuals can obtain copies of the collection instruments by writing to the above email address.
1. Application for Lump Sum Death Payment—20 CFR 404.390-404.392—0960-0013. SSA uses Form SSA-8-F4 to collect information needed to authorize payment of the lump sum death payment (LSDP) to a widow, widower, or children as defined in Section 202(i) of the Social Security Act (Act). Respondents complete the application for this one-time payment via paper form, telephone, or an in-person interview with SSA employees. Respondents are applicants for the LSDP.
Medical Report on Adult with Allegation of Human Immunodeficiency Virus Infection; Medical Report on Child with Allegation of Human Immunodeficiency Virus Infection—20 CFR 416.933-20 CFR 416.934—0960-0500. Section 1631(e)(i) of the Act authorizes the Commissioner of SSA to gather information to make a determination about an applicant's claim for Supplemental Security Income (SSI) payments; this procedure is the Presumptive Disability (PD). SSA uses Forms SSA-4814-F5 and SSA-4815-F6 to collect information necessary to determine if an individual with human immunodeficiency virus infection, who is applying for SSI disability benefits, meets the requirements for PD. The respondents are the medical sources of the applicants for SSI disability payments.
3. Complaint Form for Allegations of Discrimination in Programs or Activities Conducted by the Social Security Administration—0960-0585. SSA uses Form SSA-437 to investigate and formally resolve complaints of discrimination based on disability, race, color, national origin (including limited English language proficiency), sex (including sexual orientation and gender identity), age, religion, or retaliation for having participated in a proceeding under this administrative complaint process in connection with an SSA program or activity. Individuals who believe SSA discriminated against them on any of the above bases may file a written complaint of discrimination. SSA uses the information to (1) identify the complaint; (2) identify the alleged discriminatory act; (3) establish the date of such alleged action; (4) establish the identity of any individual(s) with information about the alleged discrimination; and (5) establish other relevant information that would assist in the investigation and resolution of the complaint. Respondents are individuals who believe an SSA program or activity, or SSA employees, contractors or agents discriminated against them.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects to which this notice pertains, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of a change in date and location of the Shipping Coordinating Committee (SHC) meeting announced in the
Due to security considerations, two valid, government issued photo identifications must be presented to gain entrance to the Headquarters building. It is recommended that attendees arrive to the Headquarters building no later than 30 minutes ahead of the scheduled SHC meeting for the security screening process. The Headquarters building is accessible by taxi and public transportation. Parking in the vicinity of the building is extremely limited and not guaranteed. Additional information is at
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to
You may submit comments by any of the following methods:
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You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to PPT Forms Officer, U.S. Department of State, CA/PPT/S/L 44132 Mercure Cir, P.O. Box 1227, Sterling, VA 20166-1227, or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The DS-11 solicits data necessary for Passport Services to issue a United States passport (book and/or card format) pursuant to authorities granted to the Secretary of State by 22 U.S.C. 211a
The issuance of U.S. passports requires the determination of identity, nationality, and entitlement with reference to the provisions of Title III of the Immigration and Nationality Act (INA) (8 U.S.C. 1401-1504), the 14th Amendment to the Constitution of the United States, other applicable treaties and laws, and implementing regulations at 22 CFR parts 50 and 51. The specific regulations pertaining to the Application for a U.S. Passport are at 22 CFR 51.20 through 51.28.
The information collected on the DS-11 is used to facilitate the issuance of passports to U.S. citizens and nationals. The primary purpose of soliciting the information is to establish citizenship, identity, and entitlement to the issuance of the U.S. passport or related service, and to properly administer and enforce the laws pertaining to the issuance thereof.
Passport Services collects information from U.S. citizens and non-citizen nationals when they complete and submit the Application for a U.S. Passport. Passport applicants can either download the DS-11 from the internet or obtain one from an Acceptance Facility/Passport Agency. The form must be completed and executed at an acceptance facility or passport agency, and submitted with evidence of citizenship and identity.
The proposed renewal of the DS-11 includes an advisory on the instructions that lawful permanent resident cards (green cards) that are submitted with Form DS-11 will be forwarded to U.S. Citizen and Immigration Services if the applicant is found to be a U.S. citizen. This advisory is consistent with an arrangement between the Department of State and the Department of Homeland Security, as green cards are property of the Department of Homeland Security.
The proposed renewal of Form DS-11 also includes a new instruction to applicants requiring submission of a photocopy of the applicant's evidence of U.S. citizenship, in addition to the official or certified copy that is currently required. The official or certified copy will continue to be used to determine whether the applicant has a valid claim to U.S. citizenship. The photocopy will be retained by the Department so that the Department has a complete and accurate record of what the applicant submitted with his or her U.S. passport application. Evidence of U.S. citizenship, however, is only annotated on the application, and a certified copy is generally not retained. The Department considered different alternatives to having the applicant submit a photocopy in addition to the official or certified copy; however, none of these alternatives were logistically feasible or cost effective. Based on a resource analysis study, the additional costs for labor, equipment, supplies, facility modifications and obtaining additional space makes it not feasible for the Department to make photocopies of primary citizenship evidence without significantly affecting agency operations and passport processing times. The Department determined that adding the requirement for a photocopy of the applicant's evidence of U.S. citizenship is the only feasible way to create a complete record of the documentation submitted with applications. The Department also believes that retaining copies of applicants' evidence of U.S. citizenship will help the Department develop and deliver online passport applicant services. Applicants currently submit a photocopy of their photo identification.
The Privacy Act statement has been amended to clarify that an applicant's failure to provide his or her Social Security number may result in the denial of an application, consistent with Section 32101 of the Fixing America's Surface Transportation Act (Pub. L. 114-94) which authorizes the Department to deny U.S. passport applications when the applicant failed to include his or her Social Security number. It also makes clear that failure to include one's Social Security number may also subject the applicant to a penalty enforced by the International Revenue Service. These requirements and the underlying legal authorities are further described on page 3 of the instructions titled “Federal Tax Law” which has also been amended to include a reference to Public Law 114-94.
CSX Transportation, Inc. (CSXT), filed a verified notice of exemption under 49 CFR part 1152 subpart F—
CSXT has certified that: (1) No local freight traffic has moved over the Line for at least two years; (2) because the Line is not a through line, no overhead traffic has operated or needs to be rerouted; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line is pending either with the Surface Transportation Board or any U.S. District Court or has been decided in favor of a complainant within the two-year period; and (4) the requirements at 49 CFR 1105.12 (newspaper publication) and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the discontinuance of service shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) to subsidize continued rail service has been received, this
A copy of any petition filed with the Board should be sent to CSXT's representative: Louis E. Gitomer, Law Offices of Louis E. Gitomer, LLC, 600 Baltimore Avenue, Suite 301, Towson, MD 21204.
If the verified notice contains false or misleading information, the exemption is void ab initio.
Board decisions and notices are available on our Web site at
By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the renewal of an information collection, as required by the Paperwork Reduction Act of 1995 (PRA).
An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning renewal of its information collection titled, “Examination Questionnaire.”
Comments must be submitted by June 3, 2016.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0199, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Shaquita Merritt, Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
The OCC is proposing to extend the approval for the following information collection:
Abstract: The OCC provides each national bank or Federal savings association with an Examination Survey at the end of its supervisory cycle (12- or 18-month period). This information collection permits banks to assess the OCC's bank supervisory activities, including the:
• Effectiveness of OCC communications with the bank;
• Reasonableness of OCC requests for data and information;
• Quality of OCC decisionmaking during the exam process;
• Professionalism of OCC examining staff; and
• Responsiveness of OCC examiners.
The OCC developed the survey at the suggestion of the banking industry. Banking industry members expressed a desire to provide examination-related feedback to the OCC. The Comptroller of the Currency and OCC supervisory staff considered that expressed need and concurred. Further, the Comptroller of the Currency and OCC supervisory staff find this information collection to be an important tool for measuring OCC examination performance, designing more efficient and effective examinations, and targeting examiner training.
This information collection continues to formalize and promote a long-standing OCC program. The OCC always has given the institutions it supervises the opportunity to provide input regarding the examination process.
The Post Exit Survey is no longer being used and has been deleted from this collection.
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the information collection burden;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the renewal of an information collection, as required by the Paperwork Reduction Act of 1995 (PRA).
An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning renewal of its information collection titled, “Lending Limits.”
Comments must be submitted by June 3, 2016.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0221, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Shaquita Merritt, Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
• Residential real estate loans or extensions of credit to one borrower in the lesser of the following two amounts: 10 percent of its capital and surplus; or the percent of its capital and surplus, in excess of 15 percent, that a State bank or savings association is permitted to lend under the State lending limit that is available for residential real estate loans or unsecured loans in the state where the main office of the national bank or savings association is located;
• Small business loans or extensions of credit to one borrower in the lesser of the following two amounts: 10 percent of its capital and surplus; or the percent of its capital and surplus, in excess of 15 percent, that a State bank is permitted to lend under the state lending limit that is available for small business loans or unsecured loans in the state where the main office of the national bank or home office of the savings association is located; and
• Small farm loans or extensions of credit to one borrower in the lesser of the following two amounts: 10 percent of its capital and surplus; or the percent of its capital and surplus, in excess of 15 percent, that a State bank or savings association is permitted to lend under the State lending limit that is available for small farm loans or unsecured loans in the State where the main office of the national bank or savings association is located.
An eligible national bank or savings association must submit an application to, and receive approval from, its supervisory office before using the supplemental lending limits in § 32.7(a). The supervisory office may approve a completed application if it finds that approval is consistent with safety and soundness. Section 32.7(b) provides that the application must include:
(1) Certification that the national bank or savings association is an eligible bank or eligible savings association;
(2) Citations to relevant State laws or regulations;
(3) A copy of a written resolution by a majority of the bank's or savings association's board of directors approving the use of the limits, and confirming the terms and conditions for use of this lending authority; and
(4) A description of how the board will exercise its continuing
12 CFR 32.9(b) provides national banks and savings associations with three alternative methods for calculating the credit exposure of derivative transactions other than credit derivatives (the Internal Model Method, the Conversion Factor Matrix Method, and the Remaining Maturity Method) and two alternative methods for calculating such exposure for securities financing transactions. The OCC provided these models to reduce the practical burden of such calculations, particularly for small and mid-size banks and savings associations.
Under 12 CFR 32.9(b)(1)(i)(C)(
All comments will be considered in formulating the subsequent submission and become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the information collection burden;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA).
An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning its information collection titled, “Community and Economic Development Entities, Community Development Projects, and Other Public Welfare Investments,” under 12 CFR 24 (“Part 24”).
Comments must be submitted on or before June 3, 2016.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0194, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not enclose any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
The OCC is proposing to extend the following information collection:
Section 24.5(a) provides that an eligible national bank may make an investment without prior notification to, or approval by, the OCC if the bank submits an after-the-fact notification of an investment within 10 days of making the investment.
Section 24.4(a) provides that a national bank may submit a written request or letter to the OCC to exceed the five percent limit for its aggregate, outstanding investments. The OCC may grant permission to the bank to make subsequent public welfare investments
Section 24.5(a)(5) provides that a national bank that is not an eligible bank, but that is at least adequately capitalized and has a composite rating of at least 3 with improving trends under the Uniform Financial Institutions Rating System, may submit a letter to the OCC requesting authority to submit after-the-fact notices of its investments.
Section 24.5(b) provides that if a national bank does not meet the requirements for after-the-fact notification, including if the bank's aggregate outstanding investments exceed the five percent limit, unless previously approved by the OCC for subsequent public welfare investments, the bank must submit an investment proposal to the OCC seeking permission to make the public welfare investment.
The OCC requests that OMB approve its revised estimates and extend its approval of the information collection.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
The Office of Resolution Management, Department of Veterans Affairs.
Notice.
The Office of Resolution Management (ORM), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 3, 2016.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Pamela Johnson at (501) 257-1585.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, ORM invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of ORM's functions, including whether the information will have practical utility; (2) the accuracy of ORM's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
The Veterans Health Administration (VHA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 3, 2016.
Submit written comments on the collection of information through the Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 461-6345.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
The Veterans Metrics Initiative: Linking Program Components to Post-Military Well-Being.
The concept and design of The Veterans Metrics Initiative (TVMI) were developed by a multi-disciplinary team of scientists from Department of Veterans Affairs, Department of Defense, academia, and private enterprise, under the auspices of the Henry Jackson Foundation for the Improvement of Military Medicine, to address the question: What works to help newly separated Veterans in their transition and reintegration into civilian life?
To answer this question, The Veterans Metrics Initiative will use a longitudinal study design to assess the well-being of a large sample of transitioning Veterans over time, while simultaneously examining the extent and range of program use by these Veterans over the same period. Because individual programs are numerous, widespread and often alike in design and service delivery, TVMI focuses specific and unique attention on program “components” as drivers of change. “Components” are defined as design and delivery elements that may be shared across multiple distinct programs separated geographically, administratively, or by their funding sources, but which exhibit undeniable similarities in their manner of approach to providing help. Simply, put, common components are techniques, strategies, or features used as part of a program. Components within programs include: (a) Knowledge (
a. Baseline Survey, VA Form 10-1500194(WS)—5,625 hours.
b. 6 mo. Survey, VA Form 10-1500189(WS)—3,938 hours.
c. 12 mo. Survey, VA Form 10-1500190(WS)—3,544 hours.
d. 18 mo. Survey, VA Form 10-1500191(WS)—3,190 hours.
e. 24 mo. Survey, VA Form 10-1500192(WS)—2,871 hours.
f. 30 mo. Survey, VA Form 10-1500193(WS)—2,584 hours.
a. Baseline Survey, VA Form 10-1500194(WS)—45 minutes.
b. 6 mo. Survey, VA Form 10-1500189(WS)—35 minutes.
c. 12 mo. Survey, VA Form 10-1500190(WS)—35 minutes.
d. 18 mo. Survey, VA Form 10-1500191(WS)—35 minutes.
e. 24 mo. Survey, VA Form 10-1500192(WS)—35 minutes.
f. 30 mo. Survey, VA Form 10-1500193(WS)—35 minutes.
a. Baseline Survey, VA Form 10-1500194(WS)—7,500.
b. 6 mo. Survey, VA Form 10-1500189(WS)—6,750.
c. 12 mo. Survey, VA Form 10-1500190(WS)—6,075.
d. 18 mo. Survey, VA Form 10-1500191(WS)—5,468.
e. 24 mo. Survey, VA Form 10-1500192(WS)—4,921.
f. 30 mo. Survey, VA Form 10-1500193(WS)—4,429.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 3, 2016.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506 (c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice; correction.
The Department of Veterans Affairs (VA) published a collection of information notice in the
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, at 202-632-7492.
In FR Doc. 2016-06271, published on March 21, 2016 at 81 FR 15152, make the following correction. On page 15152 in the third column, the notice should read as follows:
Estimated Annual Burden: 833.
Estimated Number of Respondents: 5,000.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 3, 2016.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before May 4, 2016.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
A. VA Form 22-1990 is completed by claimants who are submitting an initial (or original) claim for VA education benefits.
B. VA Form 22-1990E is completed by a claimant who wishes to transfer his or her Montgomery GI Bill entitlement to their dependent(s).
C. VA Form 22-1990N is used by a claimant who signed an enlistment contract with the Department of Defense for the NCS program and elected one of two education incentives.
D. VA Form 22-1990R is used by a claimant to request assistance in retraining to enter the workforce.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
• VA Form 22-1990 consists of 859,128 responses received via (Paper & VONAPP) for 2013, 2014 and 2015 rendering a total of 214,783 burden hours.
• VA Form 22-1990N consists of 37 responses received via (VONAPP) for 2013, 2014 and 2015 rendering a total of 9 burden hours.
• VA Form 1990E consists of 357 responses received via (VONAPP) for 2013, 2014 and 2015 rendering a total of 89 burden hours.
• VA Form 22-1990R consists of 0 responses received via (VONAPP for 2013, 2014 and 2015 rendering 0 burden hours.
By direction of the Secretary.
United States Patent and Trademark Office, Commerce.
Notice of Proposed Rulemaking.
The United States Patent and Trademark Office (“USPTO” or “Office”) proposes to amend the Trademark Rules of Practice (“Trademark Rules” or “Rules”), in particular the rules pertinent to practice before the Trademark Trial and Appeal Board (“Board”), to benefit the public by providing for more efficiency and clarity in inter partes and ex parte proceedings. Certain amendments are being proposed to reduce the burden on the parties, to conform the rules to current practice, to update references that have changed, to reflect technologic changes, and to ensure the usage of standard, current terminology. The proposed rules will also further strategic objectives of the Office to increase the end-to-end electronic processing.
Comments must be received by June 3, 2016 to ensure consideration.
The Office prefers that comments be submitted via electronic mail message to
Cheryl Butler, Trademark Trial and Appeal Board, by email at
To simplify proceedings, the Office proposes to resume service requirements for notices of opposition, petitions for cancellation, and concurrent use proceedings, and proposes to require parties to serve all other submissions and papers by email. The proposed amended rules promote other efficiencies in proceedings, such as imposing discovery limitations, and allowing parties to take testimony by affidavit or declaration, with the option for oral cross-examination. It is being proposed that the proportionality requirement implemented in the 2015 amendments to the Federal Rules of Civil Procedure be expressly incorporated into the Board's proposed amended rules, which in-part adapt to recent changes to the Federal Rules of Civil Procedure, while taking into account the administrative nature of Board proceedings.
Other proposed amended rules address the Board's standard protective order and codify recent case law, including the submission of internet materials. Recognition of remote attendance at oral hearings is proposed to be codified, and new requirements for notification to the Office and the Board when review by way of civil action is taken are proposed in order to avoid premature termination of a Board proceeding. The proposed amendments also make minor changes to correct or update certain rules so that they clearly reflect current Board practice and terminology.
References below to “the Act,” “the Trademark Act,” or “the statute” refer to the Trademark Act of 1946, 15 U.S.C. 1051
The last major set of rule changes at the Board took effect in 2007; the time is ripe for changes that will assist stakeholders in achieving more efficient practice before the Board. In the years since 2007, technology changes have allowed Board operations to move much closer toward the goal of realizing a fully integrated paperless filing and docketing system. In addition, many stakeholders have embraced use of the Board's Accelerated Case Resolution (“ACR”) procedures, which has provided the Board with insight as to the effectiveness of the various procedures to which users of ACR have agreed, and which can be leveraged to benefit all parties involved in Board proceedings. The Federal Rules of Civil Procedure have changed in ways that are appropriate for codification into Board rules at this time, and the Board rules must be updated to reflect precedential decisions of the Board and the courts.
The revised rules would apply to every pending case and every new case commenced on or after the effective date of the rulemaking. Any issues that may arise concerning the transition to the revised rules for cases pending as of the effective date of the rules would be addressed by the Board and the parties on a case-by-case basis, allowing for flexibility to respond to the unique needs in each case, particularly with respect to scheduling matters.
The Board's electronic filing system, ESTTA, came online in 2002. Since that time electronic filings with the Board have steadily increased. Today well over 95 percent of filings are submitted via ESTTA. In addition, during this time, the Board has effectively communicated with parties through email for notices, orders, and decisions when the party has provided an email address, and since 2006, the Board institution order has included a link to the case file in TTABVUE, the Board's database of electronic case files. In view of this trend, and to further streamline proceedings, the proposed rules require that all filings be made through ESTTA and provide that the Board will send its notices, orders, and decisions via email. Eastern Time continues to control the timeliness of filing dates.
ESTTA already requires plaintiffs commencing a trial proceeding to select relevant grounds for opposition and cancellation, enhancing the accuracy of notice pleading, and under the proposed rules defendants would be required to
The proposed rules codify that any notification of non-delivery of the Board's electronic notice of institution may also prompt additional notice of commencement of the case by publication in the USPTO Official Gazette. The Board would continue its practice of using other appropriate and available means to contact a party to ensure the real party in interest is notified of the proceeding. These changes recognize and embrace the shift by stakeholders from paper filing to electronic filing.
The Board would continue to accept paper filing of a notice of opposition or petition for cancellation in the rare circumstances when filing through ESTTA is not possible; however, parties attempting to commence a proceeding through a paper filing would have to concurrently file, to the attention of the Board, a petition to the Director with a showing that either ESTTA was unavailable due to technical problems or extraordinary circumstances are present. This procedure for paper filing would be required for all filings (
In the event of more serious circumstances that could affect the Office's filing systems, such as the disruption of Office systems in December 2015, the Board will be flexible in making accommodation for such an event.
In 2007, the USPTO amended the rules to require each plaintiff to serve the complaint on the defendant. This was a change from long-standing practice where the Board served the complaint on the defendant with the notice of institution. The proposed rules now shift the responsibility for serving the complaint back to the Board. However, in keeping with the progress toward complete use of electronic communication, the Board would not forward a paper copy of the complaint but rather would serve the complaint in the form of a link to TTABVUE in the notice of institution. In addition, recognizing that the correspondence address for a registered extension of protection under the Madrid Protocol, 15 U.S.C. 1141i, is the international registration holder's designated representative, the Board would forward the notice of institution to the registrant's designated representative.
Under the 2007 rules, parties are allowed (and encouraged) to stipulate to electronic service between the parties for all filings with the Board. Over the last few years, this has become the common practice, and the USPTO proposes to codify that practice by requiring service between parties by email for all filings with the Board and any other papers served on a party not required to be filed with the Board (
In view of service by email, the additional five days previously added to a prescribed period for response, to account for mail delays, would be removed. The response period for a motion would be initiated by its service date and would run for 20 days, except that the response period for summary judgment motions would remain 30 days. Similarly, no additional time would be available for the service of discovery responses.
The proposed rules adopt amendments to the Federal Rules of Civil Procedure by codifying the concept of “proportionality” in discovery. In addition, the proposed rules codify the ability of parties to stipulate to limit discovery by shortening the period, limiting requests, using reciprocal disclosures in lieu of discovery, or eliminating discovery altogether. To align further with the Federal Rules, the proposed rules explicitly include reference to electronically stored information (“ESI”) and tangible things as subject matter for discovery. The Board continues to view the universe of ESI within the context of its narrower scope of jurisdiction, as compared to that of the federal district courts. The burden and expense of e-discovery will weigh heavily in any consideration.
Under the proposed amendments, motions to compel initial disclosures must be filed within 30 days after the deadline for initial disclosures.
The proposed rules limit the number of requests for production of documents and requests for admissions to 75, the same as the current limitation on interrogatories, and remove the option to request additional interrogatories. In addition, the proposed rules allow for each party that has received produced documents to serve one comprehensive request for admission on the producing party, whereby the producing party would authenticate all produced documents or specify which documents cannot be authenticated. These proposed limitations on discovery simply recognize general practice and are meant to curtail abuse and restrain litigation expense for stakeholders. In view of the Board's narrow jurisdiction, the need to move for additional requests would be unlikely; however, the Office can revisit this issue based on comments from stakeholders.
Many commenced trial cases are quickly settled, withdrawn, or decided by default, and many others involve
Under the proposed rule changes, discovery must be served early enough in the discovery period that responses will be provided and all discovery will be complete by the close of discovery. This includes production of documents, which would have to be produced or inspected by the close of discovery.
Under the proposed rules, discovery disputes would have to be resolved promptly following the close of discovery. The current deadline for filing motions to compel is merely prior to the commencement of the first trial period. Under the proposed revisions, however, motions to compel discovery or to determine the sufficiency of responses to requests for admissions must be filed prior to the deadline for the plaintiff's pretrial disclosures for the first testimony period. These revisions are intended to avoid the expense and uncertainty that arise when discovery disputes erupt on the eve of trial. These changes would also ensure that pretrial disclosures would be made and trial preparation would be engaged in only after all discovery issues have been resolved. In addition, the Board would be able to reset the pretrial disclosure deadline and testimony periods after resolving any motions relating to discovery and allowing time for compliance with any orders requiring additional responses or production.
Parties would also be subject to a requirement to inform adverse parties when prospective witnesses located outside the United States are expected to be present in the United States. This obligation would continue through discovery (as well as during trial if the witness could be called to testify), subject to the Board's determination of whether the party has been reasonable in meeting this obligation.
In 2007, the rules were amended to make the Board's standard protective order applicable in all proceedings, during disclosure, discovery, and trial, though parties have been able to agree to alternative orders, subject to Board approval. This has worked well, and the proposed rules clarify that the protective order is imposed in all inter partes proceedings. Parties would continue to have the flexibility to move forward under an alternative order by stipulation or motion approved by the Board. The proposed rules also codify practice and precedent that the Board may treat as not confidential material which cannot reasonably be considered confidential, notwithstanding party designations.
Since 2007, several types of consented motions for extensions and suspensions have been granted automatically by the Board's electronic filing system and the proposed rules codify this practice, while retaining the ability of Board personnel to require that certain conditions be met prior to approval. Thus, the practice by which some consented motions to extend or suspend are not automatically approved and would be reviewed and processed by a Board paralegal or attorney would continue. In addition, non-dispositive matters could be acted on by paralegals, and the proposed rules clarify that orders on motions under the designation, “By the Trademark Trial and Appeal Board,” have the same legal effect as orders by a panel of three judges.
To clarify the obligations of the parties and render the status and timeline for a case more predictable, the proposed rules provide that a trial proceeding is suspended upon filing of a timely potentially-dispositive motion.
As with the timing of motions relating to discovery disputes that remain unresolved by the parties at the close of discovery, referenced above, motions for summary judgment also would have to be filed prior to the deadline for plaintiff's pretrial disclosures for the first testimony period. This would avoid disruption of trial planning and preparation through the filing, as late as on the eve of trial, of motions for summary judgment.
The existing rule for convening a pretrial conference because of the complexity of issues is proposed to be limited to exercise only by the Board, upon the Board's initiative.
For some time now parties have had the option to stipulate to ACR, which can be adopted in various forms. A common approach is for parties to stipulate that summary judgment cross motions will substitute for a trial record and traditional briefs at final hearing and the Board may resolve any issues of fact that otherwise might be considered subject to dispute. Other approaches adopted by parties utilizing the efficiencies of the ACR process have included agreements to limit discovery, agreements to shorten trial periods or the time between trial periods, stipulations to facts or to the admissibility of documents or other evidence, and stipulations to proffers of testimony by declaration or affidavit. These types of efficiencies would be codified by specifically providing for such stipulations and, most significantly, by allowing a unilateral option for trial testimony by affidavit or declaration subject to the right of oral cross examination by the adverse party or parties. Parties also would continue to be able to stipulate to rely on summary judgment materials as trial evidence.
The proposed rules would codify two changes in recent years, effected by case law and practice, expanding the option to submit certain documents by notice of reliance. First, the proposed rules codify existing law that pleaded registrations and registrations owned by any party may be made of record via notice of reliance by submitting therewith a current printout of information from the USPTO electronic database records showing current status and title. The rules currently allow for such printouts to be attached to the notice of opposition or petition for cancellation; the proposed change specifically also allows for such printouts to be submitted under notice of reliance. Second, the proposed rules codify that internet materials also may be submitted under a notice of reliance, as provided by
To alleviate any uncertainty, the proposed rules add a subsection to the requirements for a notice of reliance, specifically, to require that the notice indicate generally the relevance of the evidence and associate it with one or more issues in the proceeding. In an effort to curtail motion practice on this point, the proposed rule explicitly states any failure of a notice of reliance to meet this requirement would be considered a curable procedural defect. This codifies the holding of
Under the proposed rule changes, a party must file any motion to use a discovery deposition at trial along with its pretrial disclosures. Also, an adverse party would be able to move to quash a notice of testimony deposition if the witness was not included in the pretrial
Similar to the above-referenced proposal in regard to taking discovery from witnesses otherwise located outside the United States but who may be present in the United States during discovery, the proposed rules also provide that a party will have to inform adverse parties when it knows a prospective trial witness otherwise located outside the United States will be within the jurisdiction of the United States during trial.
In response to
The Board has seen an increase in testimony deposition transcripts that do not include a word index, and the proposed rules would require a word index for all testimony transcripts. For ease of review, deposition transcripts also would have to be submitted in full-sized format, not condensed with multiple pages per sheet. More broadly, the proposed rules would make clear that it is the parties' responsibility to ensure that all exhibits pertaining to an electronic submission must be clear and legible.
The proposed rules codify case law and Board practice under which the Board may sua sponte grant judgment for the defendant when the plaintiff has not submitted evidence, even where the plaintiff has responded to the Board's show cause order for failure to file a brief but has either not moved to reopen its trial period or not been successful in any such motion.
To alleviate confusion and codify case law, the proposed rules clarify that evidentiary objections may be set out in a separate appendix that does not count against the page limit for a brief and that briefs exceeding the page limit may not be considered by the Board.
Certain aspects of ex parte appeals procedure are clarified in the proposed amendments. Under the proposed rules, evidence shall not be submitted after the filing of the notice of appeal and may only be added to the record when attached to a timely request for reconsideration or via a request for remand. This is not a change to the substance of the existing rule, but is designed to address a recurring error by applicants during ex parte appeal.
Reply briefs in ex parte appeals would be limited to 10 pages. To facilitate consideration and discussion of record evidence, citation to evidence in all the briefs for the appeal, by the applicant and examining attorney, would be to the documents in the electronic application record by docket entry date and page number.
The proposed rules provide that, if during an inter partes proceeding the examining attorney believes certain facts render an applied-for mark unregistrable, the examining attorney should formally request remand of the application to the Trademark Examining Operation rather than simply notify the Board.
Correlative to electronic filing and communication, the Board also has made it possible for parties, examining attorneys, and members of the Board to attend hearings remotely through video conference. The proposed rules codify that option.
In 2.106(a) and 2.114(a) the proposed rules codify case law and practice to make it clear that when no answer has been filed, all other deadlines are tolled. If the parties have continued to litigate after an answer is late-filed, it would generally be viewed as a waiver of the technical default.
The proposed rules provide that a Notice of Opposition to an application under Trademark Act § 66(a) must identify the goods and services opposed and the grounds for opposition on the ESTTA cover sheet and may not be amended to expand the opposition to cover goods or services beyond those referenced on the ESTTA cover sheet. These amendments codify the holding of
Requirements for filing appeals of Board decisions are restructured to align with the rules governing review of Patent Trial and Appeal Board decisions. Further, all notices of appeal to the United States Court of Appeals for the Federal Circuit must be filed with the USPTO's Office of General Counsel and a copy filed with the Board via ESTTA. When a party seeks review of a Board inter partes decision by commencing a civil action, the proposed amendments clarify that a notice of such commencement must be filed with the Board via ESTTA to avoid premature termination of the Board proceeding during pendency of the civil action. The proposed amendments further require that both a notice and a copy of the complaint for review of an ex parte decision by way of civil action are to be filed with the USPTO's Office of General Counsel with a copy to be filed with the Board via ESTTA.
The Board began 2015 looking ahead to the implementation of changes in the Federal Rules of Civil Procedure then scheduled to take effect in December 2015. The Board also looked back on its multi-year campaign to promote the use of Accelerated Case Resolution, to determine lessons learned, and to identify ways to leverage the benefits of ACR into all Board trial cases. For these and other reasons, it became clear that the timing was right to consider updating the Board's rules. On January 29, 2015, the Board held an ESTTA Users Forum, directed to issues and matters involving electronic filing. On February 19, 2015, the Board held a Stakeholder Roundtable concerning matters of practice and received comments and suggestions from various organizations representing intellectual property user groups, including inside counsel, outside counsel, and mark owners and applicants. That February roundtable involved discussion of many of the provisions that are now included in the proposed rule package. The Board also engaged in significant stakeholder outreach throughout 2015, alerting users in locations across the country about the issues that they could expect to be addressed in prospective rulemaking. Finally, the Board engaged the Trademark Public Advisory Committee on process and procedure changes under consideration, on multiple occasions during the year. All of these events have enriched the process through which the Board has developed proposed rule changes and served as a precursor to the continuing discussion with stakeholders that the Office seeks through this Notice of Proposed Rulemaking.
The Office proposes to make the following amendments:
The Office proposes to amend § 2.92 to incorporate a nomenclature change from “Examiner of Trademarks” to “examining attorney.”
The Office proposes to amend § 2.98 to incorporate a nomenclature change from “examiner” to “examining attorney.”
The Office proposes to amend § 2.99(c) and (d) to change “notification” to “notice of institution” or “notice,” and to specify that the notice will be transmitted via email.
The Office proposes to revise § 2.99(d)(1) to remove the service requirement for applicants for concurrent use registration and to specify that the notice of institution will include a web link or web address for the concurrent use proceeding.
The Office proposes to amend § 2.99(d)(2) to clarify that an answer to the notice of institution is not required by an applicant or registrant whose application or registration is acknowledged in the concurrent use application.
The Office proposes to amend § 2.99(d)(3) to clarify that a user who does not file an answer when required is in default, but the burden of providing entitlement to registration(s) remains with the concurrent use applicant(s).
The Office proposes to amend § 2.99(f)(3) to incorporate a nomenclature change from “examiner” to “examining attorney.”
The Office proposes to amend § 2.101(a) and (b) to remove the opposer's requirement to serve a copy of the notice of opposition on applicant.
The Office proposes to amend § 2.101(b)(1) to require that oppositions be filed through ESTTA. The proposed amendment continues the existing unconditional requirement that an opposition to an application based on Section 66(a) of the Trademark Act must be filed through ESTTA, but provides that an opposition against an application based on Section 1 or 44 of the Act may be filed in paper form in the event that ESTTA is unavailable due to technical problems or when extraordinary circumstances are present. The proposed amendment codifies the use of electronic filing.
The Office proposes to amend § 2.101(b)(2) to require that a paper opposition to an application must be accompanied by a Petition to the Director under § 2.146(a)(5), with the required fees and showing, and to add that timeliness of the submission will be determined in accordance with §§ 2.195 through 2.198.
The Office proposes to amend § 2.101(c) by moving the content of paragraph (d)(1) to the end of paragraph (c).
The Office proposes to amend § 2.101(d) by removing paragraphs (1), (3), and (4), but retaining the content in paragraph (d)(2) in an undesignated paragraph, and providing that an ESTTA opposition cannot be filed absent sufficient fees and a paper opposition accompanied by insufficient fees may not be instituted, but a potential opposer may resubmit the opposition with the required fee if time remains. The proposed revisions are intended to simplify the rules pertaining to insufficient fees.
The Office proposes to amend § 2.101(d)(4) to rename it as § 2.101(e) and clarify that the filing date of an opposition is the date of electronic receipt in the Office of the notice of opposition and required fee and to add that the filing date for a paper filing, where permitted, will be determined in accordance with §§ 2.195 through 2.198.
The Office proposes to amend § 2.102 to omit references to “written” requests for extensions of time, as it is unnecessary in view of the requirement in § 2.191 that all business be conducted in writing.
The Office proposes to amend § 2.102(a)(1) to require that requests to extend the time for filing an opposition be filed through ESTTA. The proposed amendment continues the existing requirement that an opposition to an application based on Section 66(a) of the Act must be filed through ESTTA, but provides that an opposition against an application based on Section 1 or 44 of the Act may be filed in paper form in the event that ESTTA is unavailable due to technical problems or when extraordinary circumstances are present. The Office proposes to amend § 2.102(a)(2) to require that a paper request to extend the opposition period must be accompanied by a Petition to the Director under § 2.146(a)(5), with the required fees and showing, and to add that timeliness of the paper submission will be determined in accordance with §§ 2.195 through 2.198.
The Office proposes to amend § 2.102(b) to clarify that an opposition filed during an extension of time must be in the name of the person to whom the extension was granted except in cases of misidentification through mistake or where there is privity.
The Office proposes to amend § 2.102(c)(1) to clarify that a sixty-day extension is not available as a first extension of time to oppose. The Office proposes to amend § 2.102(c)(3) to clarify that only a sixty-day time period is allowed for a final extension of the opposition period.
The Office proposes to add new § 2.102(d), which clarifies that the filing date of a request to extend the time for filing an opposition is the date of electronic receipt in the Office of the notice of opposition and that the filing date for a paper filing, where permitted, will be determined in accordance with §§ 2.195 through 2.198.
The Office proposes to amend § 2.104(a) to specify that ESTTA requires the opposer to select relevant grounds for opposition, and the accompanying required statement supports and explains the grounds. The proposed amendment codifies current Office practice.
The Office proposes to add new § 2.104(c) to clarify that with respect to an opposition to an application filed under Section 66(a) of the Trademark Act, both the ESTTA cover sheet and accompanying statement must identify the goods and/or services opposed and the grounds for opposition and such an opposition may not be amended to include goods, services, or grounds beyond those set forth in the cover sheet. The proposed amendment conforms with Section 68(c)(3) of the Act, is consistent with the proposed amendment to § 2.107(b), and codifies current case law and practice.
The Office proposes to amend § 2.105(a) to remove the service requirement for opposers and to specify that the notice of institution constitutes service and will include a web link or web address to access the electronic proceeding record.
The Office proposes to amend §§ 2.105(b) and (c) to provide that it will effect service of the notice of opposition at the email or correspondence address
The Office proposes to amend § 2.106(a) to add that default may occur after the time to answer is reset and that failure to file a timely answer tolls all deadlines until the issue of default is resolved. The proposed amendment codifies current Office practice and is consistent with the Office's proposed amendment to § 2.114(a).
The Office proposes to amend § 2.106(b)(1) to specify that a reply to an affirmative defense shall not be filed.
The Office proposes to amend § 2.106(b)(2)(i) to add a requirement that an applicant subject to an opposition proceeding must promptly inform the Board of the filing of another proceeding between the same parties or anyone in privity therewith.
The Office proposes to amend § 2.106(b)(2)(iv) to clarify that the Board may sua sponte reset the times for pleading, discovery, testimony, briefs, or oral argument.
The Office proposes to amend § 2.107(a) to add that an opposition proceeding may not be amended to add a joint opposer.
The Office proposes to amend § 2.107(b) to clarify that, with respect to an opposition to an application filed under Section 66(a) of the Trademark Act, pleadings may not be amended to add grounds for opposition or goods or services beyond those set forth in the cover sheet, or to add a joint opposer. The proposed amendment conforms with Section 68(c)(3) of the Act, is consistent with the proposed amendment to § 2.104(c), and codifies current case law and practice.
The Office proposes to amend § 2.111(a) and (b) to remove the petitioner's requirement to serve a copy of the petition to cancel on registrant.
The Office proposes to amend § 2.111(c)(1) to require that a petition to cancel a registration be filed through ESTTA. The proposed amendment provides that a petition to cancel may be filed in paper form in the event that ESTTA is unavailable due to technical problems or when extraordinary circumstances are present. The Office proposes to amend § 2.111(c)(2) to require that a paper petition to cancel a registration must be accompanied by a Petition to the Director under § 2.146(a)(5), with the required fees and showing, and to add that timeliness of the submission, if relevant to a ground asserted in the petition to cancel, will be determined in accordance with §§ 2.195 through 2.198. The proposed amendments codify the use of electronic filing.
The Office proposes to delete § 2.111(c)(3) and add a new § 2.111(d), which provides that a petition for cancellation cannot be filed via ESTTA absent sufficient fees and a paper petition accompanied by insufficient fees may not be instituted. The proposed revisions are intended to simplify the rules pertaining to insufficient fees.
The Office proposes to amend § 2.111(c)(4) to renumber it as § 2.111(e), which clarifies that the filing date of a petition for cancellation is the date of electronic receipt in the Office of the petition and required fee and adds that the filing date for a paper petition for cancellation, where permitted, is the date identified in § 2.198.
The Office proposes to amend § 2.112(a) to add that the petition for cancellation must indicate, to the best of petitioner's knowledge, a current email address(es) of the current owner of the registration and of any attorney, as specified in §§ 11.14(a) and (c) of this Chapter, reasonably believed by the petitioner to be a possible representative of the owner in matters regarding the registration.
The Office proposes to further amend § 2.112(a) to specify that ESTTA requires the petitioner to select relevant grounds for cancellation, and the required accompanying statement supports and explains the grounds. The proposed amendment codifies current Office practice.
The Office proposes to amend § 2.113(a) to remove the service requirement for petitioners and to specify that the notice of institution constitutes service and will include a web link or web address to access the electronic proceeding record.
The Office proposes to amend §§ 2.113(b) and (c) to provide that it will effect service of the petition for cancellation at the email or correspondence address of record for the parties, their attorneys, or their domestic representatives. The Office further proposes to amend § 2.113(c) to insert subheadings (1), (2), and (3) for clarity and to provide in newly designated paragraph (3) that, in the case of a registration issued under 15 U.S.C. 1141(i), notice will be sent to the international registration holder's designated representative and constitutes service.
The Office proposes to amend § 2.113(d) to remove “petition for cancellation” and to provide that the courtesy copy of the notice of institution that shall be forwarded to the alleged current owner of the registration will include a web link or web address to access the electronic proceeding record.
The Office proposes to amend § 2.114(a) to add that default may occur after the time to answer is reset and that failure to file a timely answer tolls all deadlines until the issue of default is resolved. The proposed revision codifies current Office practice and is consistent with the Office's proposed amendment to § 2.106(a).
The Office proposes to amend § 2.114(b)(1) to add that a pleaded registration is a registration identified by number by the party in the position of plaintiff in an original or counterclaim petition for cancellation.
The Office proposes to amend § 2.114(b)(2)(i) to add a requirement that a party in the position of respondent and counterclaim plaintiff must promptly inform the Board of the filing of another proceeding between the same parties or anyone in privity therewith.
The Office proposes to amend § 2.114(b)(2)(iii) to clarify that the Board may sua sponte reset the period for filing an answer to a counterclaim. The Office proposes to amend § 2.114(b)(2)(iv) to clarify that the Board may sua sponte reset the times for pleading, discovery, testimony, briefs, or oral argument.
The Office proposes to amend § 2.114(c) to add that counterclaim petitions for cancellation may be withdrawn without prejudice before an answer is filed.
The Office proposes to amend § 2.116(e) to add that the submission of notices of reliance, declarations, and affidavits, as well as the taking of depositions, during the testimony period corresponds to the trial in court proceedings. The proposed revision codifies current Office practice and is consistent with proposed amendments relating to declarations and affidavits.
The Office proposes to amend § 2.116(g) to clarify that the Board's standard protective order, which is available on the Office's Web site, is automatically imposed throughout all
The Office proposes to amend § 2.117(c) to clarify that the Board may suspend proceedings sua sponte and retains discretion to condition approval of consented or stipulated motions to suspend on the provision by parties of necessary information about the status of settlement talks or discovery or trial activities.
The Office proposes to amend § 2.118 to add notification of non-delivery in paper or electronic form of Board notices and to delete the time period prescribed by the Director.
The Office proposes to incorporate the word “submissions” throughout § 2.119 to codify the use of electronic filing. The proposed amendment codifies the use of electronic filing.
The Office proposes to amend § 2.119(a) to remove the service requirements for notices of opposition and petitions to cancel, consistent with proposed amendments to §§ 2.101(a) and (b) and 2.111(a) and (b).
The Office proposes to amend § 2.119(b) to require that all submissions filed with the Board and any other papers served on a party be served by email, unless otherwise stipulated or service by email cannot be made due to technical problems or extraordinary circumstances.
The Office proposes to amend § 2.119(b)(3) to revise the manner of service on a person's residence by stating that a copy of a submission may be left with some person of suitable age and discretion who resides there. The proposed amendment is consistent with both the Patent Rules of Practice and the Federal Rules of Civil Procedure.
The Office proposes to amend § 2.119(b)(6) to remove the requirement for mutual agreement by the parties for service by other forms of electronic transmission and to remove service by notice published in the
The Office proposes to amend § 2.119(c) to remove the provision adding five days to the prescribed period for action after service by the postal service or overnight courier. All fifteen-day response dates initiated by a service date would be amended to twenty days.
The Office proposes to amend § 2.119(d) to add that no party may serve submissions by means of the postal service if a party to an inter partes proceeding is not domiciled in the United States and is not represented by an attorney or other authorized representative located in the United States.
The Office proposes to amend § 2.120(a)(1) to add the concept of proportionality in discovery, in conformance with the 2015 amendments to the Federal Rules of Civil Procedure, and to reorganize portions of the text for clarity.
The Office proposes to amend § 2.120(a)(2) to add headings for subparts (i) through (v) and to reorganize portions of the text for clarity.
The Office proposes to amend renumbered § 2.120(a)(2)(i) to specify that a Board Interlocutory Attorney or Administrative Trademark Judge will participate in a discovery conference when the Board deems it useful. The proposed revision codifies current Office practice.
The Office proposes to amend renumbered § 2.120(a)(2)(iii) to add that the Board may issue an order regarding expert discovery either on its own initiative or on notice from a party of the disclosure of expert testimony.
The Office proposes to amend renumbered § 2.120(a)(2)(iv) to add that parties may stipulate that there will be no discovery, that the number of discovery requests or depositions be limited, or that reciprocal disclosures be used in place of discovery. The proposed amendment codifies some of the stipulations successfully used by parties in ACR procedures and other proceedings incorporating ACR-type efficiencies. The Office proposes to further amend § 2.120(a)(2)(iv) to clarify that extensions of the discovery period granted by the Board will be limited. The Office proposes to further amend § 2.120(a)(2)(iv) to require that an expert disclosure deadline must always be scheduled prior to the close of discovery.
The Office proposes to amend § 2.120(a)(3) to require that discovery requests be served early enough in the discovery period that responses will be due no later than the close of discovery, and when the time to respond is extended, discovery responses may not be due later than the close of discovery. The proposed amendment is intended to alleviate motion practice prompted by responses to discovery requests served after discovery has closed.
The Office proposes to amend § 2.120(b) to require that any agreement by the parties as to the location of a discovery deposition shall be made in writing.
The Office proposes to amend the title of § 2.120(c) to clarify that it applies to foreign parties within the jurisdiction of the United States. The Office proposes to amend § 2.120(c)(2) to require that a party must inform every adverse party whenever a foreign party has or will have, during a time set for discovery, an officer, director, managing agent, or other person who consents to testify on its behalf present within the United States.
The Office proposes to amend § 2.120(d) to remove motions for leave to serve additional interrogatories. The Office proposes to revise § 2.120(d) such that it addresses only interrogatories, deleting subsections (1) and (2). Provisions relating to requests for production are moved to revised § 2.120(e), and §§ 2.120(f) through (k) are renumbered in conformance.
The Office proposes to amend § 2.120(e) to limit the total number of requests for production to seventy-five and to provide a mechanism for objecting to requests exceeding the limitation parallel to § 2.120(d). The Office proposes to further amend § 2.120(e) to clarify that the rule applies to electronically stored information as well as documents and tangible things; to provide that the time, place, and manner for production shall comport with the provisions of Rule 34 of the Federal Rules of Civil Procedure, or be made pursuant to agreement of the parties; and to delete that production will be made at the place where the documents and things are usually kept.
The Office proposes to amend renumbered § 2.120(f)(1) to clarify that the rule applies to electronically stored information as well as documents and tangible things. The Office proposes to further amend § 2.120(f)(1) to require that a motion to compel initial disclosures must be filed within thirty days after the deadline therefor and include a copy of the disclosures. The Office proposes to further amend § 2.120(f)(1) to require that a motion to compel discovery must be filed prior to the deadline for pretrial disclosures for the first testimony period, rather than the commencement of that period. The Office proposes to further amend § 2.120(f)(1) to clarify that the request for designation pertains to a witness. The Office proposes to further amend § 2.120(f)(1) to require a showing from the moving party that the party has
The Office proposes to amend renumbered § 2.120(f)(2) to clarify that when a motion to compel is filed after the close of discovery, the parties need not make pretrial disclosures until directed to do so by the Board.
The Office proposes to amend renumbered § 2.120(g) to conform to Federal Rule of Civil Procedure 26(c).
The Office proposes to amend renumbered § 2.120(i) to limit the total number of requests for admission to seventy-five and to provide a mechanism for objecting to requests exceeding the limitation parallel to §§ 2.120(d) and (e). The Office proposes to further amend § 2.120(i) to permit a party to make one comprehensive request for an admission authenticating documents produced by an adverse party.
The Office proposes to amend renumbered § 2.120(i)(1) to require that any motion to test the sufficiency of any objection, including a general objection on the ground of excessive number, must be filed prior to the deadline for pretrial disclosures for the first testimony period, rather than the commencement of that period. The Office proposes to further amend § 2.120(i)(1) to require a showing from the moving party that the party has made a good faith effort to resolve the issues presented in the motion.
The Office proposes to amend renumbered § 2.120(i)(2) to clarify that when a motion to determine the sufficiency of an answer or objection to a request for admission is filed after the close of discovery, the parties need not make pretrial disclosures until directed to do so by the Board.
The Office proposes to amend renumbered § 2.120(j)(1) to state more generally that the Board may schedule a telephone conference whenever it appears that a stipulation or motion is of such nature that a telephone conference would be beneficial. The Office proposes to amend § 2.120(j)(2) to remove provisions allowing parties to move for an in-person meeting with the Board during the interlocutory phase of an inter partes proceeding and the requirement that any such meeting directed by the Board be at its offices. The Board proposes to add new § 2.120(j)(3) to codify existing practice that parties may not make a recording of the conferences referenced in §§ 2.120(j)(1) and (2).
The Office proposes to amend renumbered § 2.120(k)(2) to change the time for a motion to use a discovery deposition to when the offering party makes its pretrial disclosures and to clarify that the exceptional circumstances standard applies when this deadline has passed.
The Office proposes to amend renumbered § 2.120(k)(3)(i) to clarify that the disclosures referenced are initial disclosures, to remove the exclusion of disclosed documents, and to incorporate a reference to new § 2.122(g).
The Office proposes to amend renumbered § 2.120(k)(3)(ii) to add that a party may make documents produced by another party of record by notice of reliance alone if the party has obtained an admission or stipulation from the producing party that authenticates the documents. This amendment is consistent with the proposed amendment in renumbered § 2.120(i) permitting a party to make one comprehensive request for an admission authenticating documents produced by an adverse party.
The Office proposes to amend renumbered § 2.120(k)(7) to add an authenticated produced document to the list of evidence that may be referred to by any party when it has been made of record.
The Office proposes to amend § 2.121(a) to clarify that evidence must be presented during a party's testimony period. The Office proposes to further amend § 2.121(a) to add that the resetting of a party's testimony period will result in the rescheduling of the remaining pretrial disclosure deadlines without action by any party. These amendments codify current Office practice.
The Office proposes to amend § 2.121(c) to add that testimony periods may be shortened by stipulation of the parties approved by the Board or may be extended on motion granted by the Board or order of the Board. The Office proposes to further amend § 2.121(c) to add that the pretrial disclosure deadlines associated with testimony periods may remain as set if a motion for an extension is denied. These amendments codify current Office practice.
The Office proposes to amend § 2.121(d) to add that stipulations to reschedule the deadlines for the closing date of discovery, pretrial disclosures, and testimony periods must be submitted through ESTTA with the relevant dates set forth and an express statement that all parties agree to the new dates. The proposed amendment codifies the use of electronic filing.
The Office proposes to amend § 2.121(e) to add that the testimony of a witness may be either taken on oral examination and transcribed or presented in the form of an affidavit or declaration, as provided in proposed amendments to § 2.123.
The Office proposes to further amend § 2.121(e) to add that a party may move to quash a noticed testimony deposition of a witness not identified or improperly identified in pretrial disclosures before the deposition. The proposed amendment codifies current Office practice.
The Office proposes to further amend § 2.121(e) to add that when testimony has been presented by affidavit or declaration, but was not covered by an earlier pretrial disclosure, the remedy for any adverse party is the prompt filing of a motion to strike, as provided in §§ 2.123 and 2.124. The proposed amendment aligns the remedy for undisclosed testimony by affidavit or declaration with the remedy for undisclosed deposition testimony.
The Office proposes to amend § 2.122(a) to clarify the title of the subsection and to specify that parties may stipulate to rules of evidence for proceedings before the Board. The Office proposes to further amend § 2.122(a), consistent with § 2.120(k)(7), to add that when evidence has been made of record by one party in accordance with these rules, it may be referred to by any party for any purpose permitted by the Federal Rules of Evidence. The proposed amendments codify current Office practice.
The Office proposes to amend § 2.122(b)(2) to clarify the title of the subsection and to clarify that statements made in an affidavit or declaration in the file of an application for registration or in the file of a registration are not evidence on behalf of the applicant or registrant and must be established by competent evidence.
The Office proposes to amend § 2.122(d)(2) to add a cross-reference to new § 2.122(g) and to specify that a registration owned by a party may be made of record via notice of reliance accompanied by a current printout of information from the electronic database records of the Office showing the current status and title of the registration. The proposed amendment codifies current case law and Office practice.
The Office proposes to amend § 2.122(e) to designate a new paragraph (e)(1), clarify that printed publications must be relevant to a particular proceeding, and add a cross-reference to new § 2.122(g).
The Office proposes to add new § 2.122(e)(2) permitting admission of internet materials into evidence by notice of reliance and providing requirements for their identification. The proposed amendment codifies current case law and Office practice.
The Office proposes to add new § 2.122(g) detailing the requirements for admission of evidence by notice of reliance. Section 2.122(g) provides that a notice must indicate generally the relevance of the evidence offered and associate it with one or more issues in the proceeding, but failure to do so with sufficient specificity is a procedural defect that can be cured by the offering party within the time set by Board order. The proposed amendment codifies current case law and Office practice.
The Office proposes to amend § 2.123(a)(1) to permit submission of witness testimony by affidavit or declaration, subject to the right of any adverse party to take and bear the expense of oral cross-examination of that witness, as provided in proposed amendments to § 2.121(e), and to add that the offering party must make that witness available. The proposed amendment is intended to promote efficient trial procedure.
The Office proposes to further amend § 2.123(a)(1) to move to § 2.123(a)(2) a provision permitting a motion for deposition on oral examination of a witness in the United States whose testimonial deposition on written questions has been noticed.
The Office proposes to further amend § 2.123(a)(2) to add that the party which has proffered a witness for testimonial deposition on written questions must inform every adverse party when it knows that such witness will be within the jurisdiction of the United States during such party's testimony period. The proposed amendment is consistent with the proposed amendment to § 2.120(c)(2) and is intended to promote efficient trial procedure by facilitating the use of deposition on oral examination instead of written questions when permissible.
The Office proposes to amend § 2.123(b) to remove the requirement for written agreement of the parties to submit testimony in the form of an affidavit, as provided in proposed amendments to § 2.123(a)(1), and to clarify that parties may stipulate to any relevant facts.
The Office proposes to amend § 2.123(c) to remove the option of identifying a witness by description in a notice of examination and to clarify that such notice shall be given to adverse parties before oral depositions.
The Office proposes to further amend § 2.123(c) to add that, when a party elects to take oral cross-examination of an affiant or declarant, the notice of such election must be served on the adverse party and a copy filed with the Board within 10 days from the date of service of the affidavit or declaration and completed within 20 days from the date of service of the notice of election.
The Office proposes to further amend § 2.123(c) to add that the Board may extend the periods for electing and taking oral cross-examination and, when necessary, shall suspend or reschedule proceedings in the matter to allow for the orderly completion of the oral cross-examination(s) that cannot be completed within a testimony period.
The Office proposes to amend § 2.123(e)(1) to specify that a witness must be sworn before providing oral testimony. The Office proposes to further amend § 2.123(e)(1) to move from § 2.123(e)(3) the provision that cross-examination is available on oral depositions. The Office proposes to further amend § 2.123(e)(1) to add that, where testimony is proffered by affidavit or declaration, cross-examination is available for any witness within the jurisdiction of the United States, as provided in proposed amendments to § 2.123(a)(1).
The Office proposes to amend § 2.123(e)(2) to remove provisions permitting depositions to be taken in longhand, by typewriting, or stenographically and to specify that testimony depositions shall be recorded.
The Office proposes to amend § 2.123(e)(3) to delete the provision that cross-examination is available on oral depositions, which the Office proposes to move to § 2.123(e)(1), and to insert subheadings (i) and (ii) for clarity.
The Office proposes to amend § 2.123(e)(4) to specify that the rule regarding objections pertains to oral examination.
The Office proposes to amend § 2.123(e)(5) to clarify that the rule regarding witness signature relates to the transcript of an oral deposition.
The Office proposes to amend § 2.123(f)(2) to require that deposition transcripts and exhibits shall be filed in electronic form using ESTTA. If the weight or bulk of an exhibit prevents its uploading to ESTTA, it shall be transmitted in a separate package, including an explanation as to why it could not be submitted electronically. The proposed amendment codifies the use of electronic filing.
The Office proposes to amend § 2.123(g)(1) to add that deposition transcripts must be submitted in full-sized format (one page per sheet), not condensed (multiple pages per sheet). The Office proposes to amend § 2.123(g)(3) to add that deposition transcripts must contain a word index, giving the pages where the words appear in the deposition.
The Office proposes to remove § 2.123(i), which permits inspection by parties and printing by the Office of depositions after they are filed in the Office. Subsections 2.123(j) through (l) are renumbered §§ 2.123(i) through (k) in conformance.
The Office proposes to amend renumbered § 2.123(j) to add that objection may be made to receiving in evidence any declaration or affidavit. The Office proposes to further amend renumbered § 2.123(j) to provide that objections may not be considered until final hearing.
The Office proposes to add new § 2.124(b)(3) to provide that a party desiring to take cross-examination by written questions of a witness who has provided testimony by affidavit or declaration shall serve notice on each adverse party and file a copy of the notice with the Board.
The Office proposes to amend § 2.124(d)(1) to clarify that the procedures for examination on written questions apply to both direct testimony and cross-examination. The Office proposes to further amend § 2.124(d)(1) to specify procedure for cross-examination by written questions of a witness who has provided testimony by affidavit or declaration.
The Office proposes to add new § 2.124(d)(3) to provide that service of written questions, responses, and cross-examination questions shall be in accordance with § 2.119(b).
The Office proposes to amend § 2.125 to renumber paragraphs (a) through (e) to (b) through (f) and to add new § 2.125(a) to require that one copy of a declaration or affidavit prepared in accordance with § 2.123, with exhibits, shall be served on each adverse party at the time the declaration or affidavit is submitted to the Board during the assigned testimony period.
The Office proposes to amend renumbered § 2.125(b) to add a cross-reference to § 2.124 and to clarify that the subsection applies to testimony depositions, including depositions on written questions.
The Office proposes to amend renumbered § 2.125(f) to permit sealing of a part of an affidavit or declaration.
The Office proposes to amend § 2.126 to renumber paragraph (a) to (b) and to add new paragraph (a) to require that submissions to the Board shall be made via ESTTA. The proposed amendment codifies the use of electronic filing.
The Office proposes to add new § 2.126(a)(1) to require that text in an electronic submission must be filed in at least 12-point type and double-spaced. The proposed amendment is consistent with the proposed amendment to § 2.126(b)(1).
The Office proposes to add new § 2.126(a)(2) to require that exhibits pertaining to an electronic submission must be made electronically as an attachment to the submission and must be clear and legible. The proposed amendment codifies the use of electronic filing.
The Office proposes to amend renumbered § 2.126(b) to permit submissions in paper form in the event that ESTTA is unavailable due to technical problems or when extraordinary circumstances are present. The Office proposes to further amend renumbered § 2.126(b) to require that submissions in paper form must be accompanied by a Petition to the Director under § 2.146(a)(5), with the required fees and showing.
The Office proposes to amend renumbered § 2.126(b)(1) to require that text in a paper submission must be filed in at least 12-point type. The proposed amendment is consistent with the proposed amendment to § 2.126(a)(1).
The Office proposes to remove the subsection previously designated § 2.126(b).
The Office proposes to amend § 2.126(c) to provide that submissions to the Board that are confidential in whole or part must be submitted using the “Confidential” selection available in ESTTA or, where appropriate, under a separate paper cover. The Office proposes to further amend § 2.126(c) to clarify that a redacted copy must be submitted concurrently for public viewing.
The Office proposes to amend § 2.127(a) to reflect that all response dates initiated by a service date are twenty days. The Office proposes to further amend § 2.127(a) to add that the time for filing a reply brief will not be reopened.
The Office proposes to amend § 2.127(b) to reflect that all response dates initiated by a service date are twenty days.
The Office proposes to amend § 2.127(c) to add that conceded matters and other matters not dispositive of a proceeding may be acted on by a Paralegal of the Board or by ESTTA and that motions disposed of by orders entitled “By the Trademark Trial and Appeal Board” have the same legal effect as orders by a panel of three Administrative Trademark Judges of the Board. The proposed amendments codify current Office practice.
The Office proposes to amend § 2.127(d) to clarify that a case is suspended when a party timely files any potentially dispositive motion.
The Office proposes to amend § 2.127(e)(1) to require that a motion for summary judgment must be filed prior to the deadline for pretrial disclosures for the first testimony period, rather than the commencement of that period. The Office proposes to further amend § 2.127(e)(1) to change references to Rule 56(f) to 56(d) in conformance with amendments to the Federal Rules of Civil Procedure. The Office proposes to further amend § 2.127(e)(1) to reflect that the reply in support of a motion for summary judgment is due twenty days after service of the response. The Office proposes to further amend § 2.127(e)(1) to add that the time for filing a motion under Rule 56(d) and a reply brief will not be reopened.
The Office proposes to amend § 2.127(e)(2) to add that if a motion for summary judgment is denied, the parties may stipulate that the materials submitted with briefs on the motion shall be considered at trial as trial evidence, which may be supplemented by additional evidence during trial. The proposed revision codifies an approach used by parties in proceedings incorporating ACR-type efficiencies at trial.
The Office proposes to amend § 2.128(a)(3) to add that, when the Board issues a show cause order for failure to file a brief and there is no evidence of record, if the party responds to the order showing good cause why judgment should not be entered based on loss of interest but does not move to reopen its testimony period based on demonstrable excusable neglect, judgment may be entered against the plaintiff for failure to take testimony or submit evidence. The proposed amendment codifies current case law and practice and is consistent with TBMP § 536 (2015).
The Office proposes to amend § 2.128(b) to add that evidentiary objections may be set out in a separate appendix that does not count against the briefing page limit. The proposed amendment codifies current case law and practice and is consistent with TBMP § 801.03. The Office proposes to further amend § 2.128(b) to add that briefs exceeding the page limits may not be considered by the Board, and this also codifies existing practice.
The Office proposes to amend § 2.129(a) to clarify that all statutory members of the Board may hear oral argument. The Office proposes to further amend § 2.129(a) to add that parties and members of the Board may attend oral argument in person or, at the discretion of the Board, remotely. The proposed amendment codifies current Office practices and is consistent with the Office's proposed amendments to § 2.142(e)(1).
The Office proposes to amend § 2.129(b) to add that the Board may deny a request to reset a hearing date for lack of good cause or if multiple requests for rescheduling have been filed.
The Office proposes to amend § 2.129(c) to reflect that all response dates initiated by a service date are twenty days.
The Office proposes to amend § 2.130 to add that if during an inter partes proceeding involving an application the examining attorney believes certain facts render the mark unregistrable the examining attorney should formally request remand of the application rather than simply notify the Board.
The Office proposes to amend § 2.132(a) to clarify that, if a plaintiff has not submitted evidence and its time for taking testimony has expired, the Board may grant judgment for the defendant sua sponte. The Office proposes to further amend § 2.132(a) to reflect that all response dates initiated by a service date are twenty days. The Office proposes to amend further § 2.132(a) to clarify the standard for the showing required not to render judgment dismissing the case is excusable neglect.
The Office proposes to amend § 2.132(b) to limit evidence to Office records showing the current status and title of a plaintiff's pleaded registrations. The Office proposes to further amend § 2.132(b) to reflect that all response dates initiated by a service date are twenty days. The Office proposes to further amend § 2.132(b) to clarify that the Board may decline to render
The Office proposes to amend § 2.134(b) to clarify that the subsection is applicable to extensions of protection in accordance with the Madrid Protocol.
The Office proposes to amend § 2.136 to specify when a proceeding will be terminated by the Board and the status of an application on termination of an opposition or concurrent use proceeding.
The Office proposes to amend § 2.142 to incorporate a nomenclature change from “examiner” to “examining attorney.”
The Office proposes to amend § 2.142(b)(2) to add that a reply brief from an appellant shall not exceed ten pages in length and that no further briefs are permitted unless authorized by the Board.
The Office proposes to add new § 2.142(b)(3) to specify that citation to evidence in briefs should be to the documents in the electronic application record by date, the name of the paper under which the evidence was submitted, and the page number in the electronic record. The proposed amendment is intended to facilitate review of record evidence by the applicant, the examining attorney, the Board, and the public.
The Office proposes to amend § 2.142(c) to add that the statement of issues in a brief should note that the applicant has complied with all requirements made by the examining attorney and not the subject of appeal.
The Office proposes to amend § 2.142(d) to clarify that evidence shall not be submitted after a notice of appeal is filed. The proposed amendment more directly states the existing rule. The Office proposes to further amend § 2.142(d) for clarity, including by specifying that an appellant or examining attorney who desires to introduce additional evidence after an appeal is filed must submit a request to the Board to suspend the appeal and remand the application for further examination.
The Office proposes to amend § 2.142(e)(1) to clarify that all statutory members of the Board may hear oral argument. The Office proposes to further amend § 2.142(e)(1) to add that appellants, examining attorneys, and members of the Board may attend oral argument in person or, at the discretion of the Board, remotely. The proposed amendment codifies current Office practice and is consistent with the Office's proposed amendments to § 2.129(a).
The Office proposes to amend § 2.142(e)(2) to add that a supervisory or managing attorney may designate an examining attorney to present oral argument and to delete the provision that the examining attorney designated must be from the same examining division.
The Office proposes to amend § 2.142(f)(1) to change the time for further examination of an application on remand from thirty days to the time set by the Board.
The Office proposes to amend § 2.145 by reorganizing the subjects covered and rewording some provisions to improve the clarity and structure of the rule and to align the provisions with the analogous rules governing judicial review of Patent Trial and Appeal Board decisions in 37 CFR part 90.
From a restructuring standpoint, certain proposed amendments result in existing provisions being moved to a different subsection of the rule. Specifically, provisions regarding appeals to the U.S. Court of Appeals for the Federal Circuit, which currently appear in subparts (a) and (b), are proposed to be grouped together under subpart (a). Provisions regarding the process provided for in Section 21(a)(1) of the Act, whereby an adverse party to a Federal Circuit appeal of an inter partes Board decision may file notice of its election to have proceedings conducted by way of a civil action, are proposed to be moved from subpart (c), which concerns civil actions, to revised subpart (b), with the subheading “For a notice of election under section 21(a)(1) to proceed under section 21(b) of the Act.”
Substantively, throughout § 2.145, the Office proposes to remove specific references to times for taking action or other requirements that are specified in the Act or another set of rules (
The Office also proposes to amend the provisions in § 2.145 that require copies of notices of appeal, notices of election, and notices of civil action to be filed with the Trademark Trial and Appeal Board to specify that such notices must be filed with the Board via ESTTA. These proposed amendments codify the use of electronic filing and enhance the Office's ability to handle properly applications, registrations, and proceedings while on review in federal court.
Regarding amendments to the requirements for appeals to the Federal Circuit, the Office proposes to amend § 2.145(a) to add subsections (1)-(3). The Office proposes to move the language currently in § 2.145 (a) to new (a)(1) and to amend it, in accordance with Section 21(a) of the Act, to include that a registrant who has filed an affidavit or declaration under Section 71 of the Trademark Act and is dissatisfied with the decision of the Director may appeal. The Office proposes to further amend § 2.145(a)(1) to add that it is unnecessary to request reconsideration before filing an appeal of a Board decision, but a party requesting reconsideration must do so before filing a notice of appeal. Proposed §§ 2.145(a)(2) and (3) specify the requirements contained in current §§ 2.145(a) and (b) for filing an appeal to the Federal Circuit.
Regarding amendments to the requirements for filing a civil action in district court in § 2.145(c), the Office proposes to add in § 2.145(c)(1) an amendment corresponding to the amendment to § 2.145(a)(1) that it is unnecessary for a party to request reconsideration before filing a civil action seeking judicial review of a Board decision, but a party requesting reconsideration must do so before filing the civil action. The Office proposes to replace current § 2.145(c)(2) with a provision that specifies the requirements for serving the Director with a complaint by an applicant or registrant in an ex parte case who seeks remedy by civil action under section 21(b) of the Act. The proposed amendment, which references Federal Rule of Civil Procedure 4(i) and § 104.2, is intended to facilitate proper service of complaints in such actions on the Director. The Office proposes to replace current § 2.145(c)(3) with a modified version of the provision currently in § 2.145(c)(4), to specify that the party who commences a civil action for review of a Board decision in an inter partes case must file notice thereof with the Trademark Trial and Appeal Board via ESTTA no later than five business days after filing the complaint in district
The Office proposes to amend § 2.145(d) regarding time for appeal or civil action by restructuring the subsections by the type of action (
The Office proposes to amend § 2.145(e) to specify that a request for extension of time to seek judicial review must be filed as provided in § 104.2 and addressed to the attention of the Office of the Solicitor, to which the Director has delegated his or her authority to decide such requests, with a copy filed with the Board via ESTTA. The proposed amendment is intended to facilitate proper filing of and timely action upon extension requests and to avoid premature termination of a Board proceeding.
The Office proposes to amend §§ 2.190(a) and (c) to reflect a nomenclature change from the Assignment Services Division to the Assignment Recordation Branch. The Office proposes to amend § 2.190(b) to direct that documents in proceedings before the Board be filed through ESTTA. The proposed amendment codifies the use of electronic filing.
The Office proposes to amend § 2.191 to direct that documents in proceedings before the Board be filed through ESTTA. The proposed amendment codifies the use of electronic filing.
Accordingly, prior notice and opportunity for public comment for the rule changes are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law.
For the reasons set forth herein, the Deputy General Counsel for General Law of the United States Patent and Trademark Office has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have a significant economic impact on a substantial number of small entities.
The proposed rules involve changes to rules of agency practice and procedure in matters before the Trademark Trial and Appeal Board. The primary changes are to codify certain existing practices, increase efficiency and streamline proceedings, and provide greater clarity as to certain requirements in Board proceedings. The proposed rules do not alter any substantive criteria used to decide cases.
The proposed rules will apply to all persons appearing before the Board. Applicants for a trademark are not industry specific and may consist of individuals, small businesses, non-profit organizations, and large corporations. The USPTO does not collect or maintain statistics in Board cases on small- versus large-entity applicants, and this information would be required in order to determine the number of small entities that would be affected by the proposed rules.
The burdens, if any, to all entities, including small entities, imposed by these rule changes will be minor and consist of additional responsibilities and procedural requirements on parties appearing before the Board. Two possible sources of burden may come from the proposed requirement that all submissions will be filed through the Board's online filing system, the Electronic System for Trademark Trials and Appeals (“ESTTA”), except in certain limited circumstances, and the requirement that service between parties be conducted by email for all filings with the Board and any other papers. For impacted entities that do not have the necessary equipment and internet service, this may result in additional costs to obtain this ability or to petition to file on paper. However, the USPTO does not anticipate this requirement to impact a significant number of entities impacted by this rule as well over 95 percent of filings are already submitted electronically, and it is common practice among parties to use electronic service for all filings with the Board.
In most instances the rule changes will lessen the burdens on parties, including small entities. For example, the Office proposes shifting away from the parties to itself the obligation to serve notices of opposition, petitions for cancellation, and concurrent use proceedings. Moreover, the proposed rules provide for the option of electronic service of other documents among the parties to a proceeding, thereby eliminating the existing need to arrange for the mailing or hand delivery of these documents. Also, the Office proposes making discovery less onerous for the parties by imposing limitations on the volume of discovery, incorporating a proportionality requirement, and allowing parties to present direct
Administrative practice and procedure, Trademarks.
For the reasons given in the preamble and under the authority contained in 15 U.S.C. 1113, 15 U.S.C. 1123, and 35 U.S.C. 2, as amended, the Office proposes to amend part 2 of title 37 as follows:
15 U.S.C. 1113, 15 U.S.C. 1123, 35 U.S.C. 2, Section 10(c) of Pub. L. 112-29, unless otherwise noted.
An interference which has been declared by the Director will not be instituted by the Trademark Trial and Appeal Board until the examining attorney has determined that the marks which are to form the subject matter of the controversy are registrable, and all of the marks have been published in the Official Gazette for opposition.
* * * If an application which is or might be the subject of a petition for addition to an interference is not added, the examining attorney may suspend action on the application pending termination of the interference proceeding.
(c) If no opposition is filed, or if all oppositions that are filed are dismissed or withdrawn, the Trademark Trial and Appeal Board will send a notice of institution to the applicant for concurrent use registration (plaintiff) and to each applicant, registrant or user specified as a concurrent user in the application (defendants). The notice for each defendant shall state the name and address of the plaintiff and of the plaintiff's attorney or other authorized representative, if any, together with the serial number and filing date of the application. If a party has provided the Office with an email address, the notice will be transmitted via email.
(d)(1) The Board's notice of institution will include a web link or web address for the concurrent use application proceeding contained in Office records.
(2) An answer to the notice is not required in the case of an applicant or registrant whose application or
(3) If an answer, when required, is not filed, judgment will be entered precluding the defaulting user from claiming any right more extensive than that acknowledged in the application(s) for concurrent use registration, but the burden of proving entitlement to registration(s) will remain with the concurrent use applicant(s).
(f) * * *
(3) A true copy of the court decree is submitted to the examining attorney; and
(a) An opposition proceeding is commenced by filing in the Office a timely notice of opposition with the required fee.
(b) Any person who believes that he, she or it would be damaged by the registration of a mark on the Principal Register may file an opposition addressed to the Trademark Trial and Appeal Board. The opposition need not be verified, but must be signed by the opposer or the opposer's attorney, as specified in § 11.1 of this chapter, or other authorized representative, as specified in § 11.14(b) of this chapter. Electronic signatures pursuant to § 2.193(c) are required for oppositions filed through ESTTA under paragraphs (b)(1) or (2) of this section.
(1) An opposition to an application must be filed through ESTTA. In the event that ESTTA is unavailable due to technical problems, or when extraordinary circumstances are present, an opposition against an application based on Section 1 or 44 of the Act may be filed in paper form. An opposition to an application based on Section 66(a) of the Act must be filed through ESTTA and may not under any circumstances be filed in paper form.
(2) A paper opposition to an application based on Section 1 or 44 of the Act must be filed by the due date set forth in paragraph (c) of this section and be accompanied by a Petition to the Director under § 2.146(a)(5), with the fees therefor and the showing required under paragraph (b)(1) of this section. Timeliness of the paper submission will be determined in accordance with §§ 2.195 through 2.198.
(c) The opposition must be filed within thirty days after publication (§ 2.80) of the application being opposed or within an extension of time (§ 2.102) for filing an opposition. The opposition must be accompanied by the required fee for each party joined as opposer for each class in the application for which registration is opposed (see § 2.6).
(d) An otherwise timely opposition cannot be filed via ESTTA unless the opposition is accompanied by a fee that is sufficient to pay in full for each named party opposer to oppose the registration of a mark in each class specified in the opposition. A paper opposition that is not accompanied by the required fee sufficient to pay in full for each named party opposer for each class in the application for which registration is opposed may not be instituted. If time remains in the opposition period as originally set or as extended by the Board, the potential opposer may resubmit the opposition with the required fee.
(e) The filing date of an opposition is the date of electronic receipt in the Office of the notice of opposition, and required fee. In the rare instances that filing by paper is permitted under these rules, the filing date will be determined in accordance with §§ 2.195 through 2.198.
(a) Any person who believes that he, she or it would be damaged by the registration of a mark on the Principal Register may file a request with the Trademark Trial and Appeal Board to extend the time for filing an opposition. The request need not be verified, but must be signed by the potential opposer or by the potential opposer's attorney, as specified in § 11.1 of this chapter, or authorized representative, as specified in § 11.14(b) of this chapter. Electronic signatures pursuant to § 2.193(c) are required for electronically filed extension requests.
(1) A request to extend the time for filing an opposition to an application must be filed through ESTTA. In the event that ESTTA is unavailable due to technical problems, or when extraordinary circumstances are present, a request to extend the opposition period for an application based on Section 1 or 44 of the Act may be filed in paper form by the opposition due date set forth in § 2.101(c). A request to extend the opposition period for an application based on Section 66(a) of the Act must be filed through ESTTA and may not under any circumstances be filed in paper form.
(2) A paper request to extend the opposition period for an application based on Section 1 or 44 of the Act must be filed by the due date set forth in § 2.101(c) and be accompanied by a Petition to the Director under § 2146(a)(5), with the fees therefor and the showing required under paragraph (a)(1) of this section. Timeliness of the paper submission will be determined in accordance with §§ 2.195 through 2.198.
(b) A request to extend the time for filing an opposition must identify the potential opposer with reasonable certainty. Any opposition filed during an extension of time must be in the name of the person to whom the extension was granted, except that an opposition may be accepted if the person in whose name the extension was requested was misidentified through mistake or if the opposition is filed in the name of a person in privity with the person who requested and was granted the extension of time.
(c) * * *
(1) A person may file a first request for (i) either a thirty-day extension of time, which will be granted upon request, or (ii) a ninety-day extension of time, which will be granted only for good cause shown. A sixty-day extension is not available as a first extension of time to oppose.
(2) If a person was granted an initial thirty-day extension of time, that person may file a request for an additional sixty-day extension of time, which will be granted only for good cause shown.
(3) * * * No other time period will be allowed for a final extension of the opposition period. * * *
(d) The filing date of a request to extend the time for filing an opposition is the date of electronic receipt in the Office of the request. In the rare instance that filing by paper is permitted under these rules, the filing date will be determined in accordance with §§ 2.195 through 2.198.
(e) Fees. [Reserved]
(a) The opposition must set forth a short and plain statement showing why
(c) An opposition to an application filed under Section 66(a) of the Act must identify the goods and/or services opposed and the grounds for opposition on the ESTTA cover sheet as well as in the accompanying statement. Opposition to a Section 66(a) application may not be amended to include goods, services or grounds beyond those set forth in the ESTTA cover sheet.
(a) When an opposition in proper form (see §§ 2.101 and 2.104) has been filed with the correct fee(s), and the opposition has been determined to be timely and complete, the Trademark Trial and Appeal Board shall prepare a notice of institution, which shall identify the proceeding as an opposition, number of the proceeding, and the application(s) involved; and the notice shall designate a time, not less than thirty days from the mailing date of the notice, within which an answer must be filed. If a party has provided the Office with an email address, the notice will be transmitted via email. The notice, which will include a web link or web address to access the electronic proceeding record, constitutes service of the notice of opposition to the applicant.
(b) The Board shall forward a copy of the notice to opposer, as follows:
(1) If the opposition is transmitted by an attorney, or a written power of attorney is filed, the Board will send the notice to the attorney transmitting the opposition or to the attorney designated in the power of attorney, provided that the person is an “attorney” as defined in § 11.1 of this chapter, at the email or correspondence address for the attorney.
(2) If opposer is not represented by an attorney in the opposition, but opposer has appointed a domestic representative, the Board will send the notice to the domestic representative, at the email or correspondence address of record for the domestic representative, unless opposer designates in writing another correspondence address.
(3) If opposer is not represented by an attorney in the opposition, and no domestic representative has been appointed, the Board will send the notice directly to opposer at the email or correspondence address of record for opposer, unless opposer designates in writing another correspondence address.
(c) The Board shall forward a copy of the notice to applicant, as follows:
(1) If the opposed application contains a clear indication that the application is being prosecuted by an attorney, as defined in § 11.1 of this chapter, the Board shall send the notice described in this section to applicant's attorney at the email or correspondence address of record for the attorney.
(2) If the opposed application is not being prosecuted by an attorney but a domestic representative has been appointed, the Board will send the notice described in this section to the domestic representative, at the email or correspondence address of record for the domestic representative, unless applicant designates in writing another correspondence address.
(3) If the opposed application is not being prosecuted by an attorney, and no domestic representative has been appointed, the Board will send the notice described in this section directly to applicant, at the email or correspondence address of record for the applicant, unless applicant designates in writing another correspondence address.
(a) If no answer is filed within the time initially set, or as may later be reset by the Board, the opposition may be decided as in case of default. The failure to file a timely answer tolls all deadlines, including the discovery conference, until the issue of default is resolved.
(b)(1) An answer shall state in short and plain terms the applicant's defenses to each claim asserted and shall admit or deny the averments upon which the opposer relies. If the applicant is without knowledge or information sufficient to form a belief as to the truth of an averment, applicant shall so state and this will have the effect of a denial. Denials may take any of the forms specified in Rule 8(b) of the Federal Rules of Civil Procedure. An answer may contain any defense, including the affirmative defenses of unclean hands, laches, estoppel, acquiescence, fraud, mistake, prior judgment, or any other matter constituting an avoidance or affirmative defense. When pleading special matters, the Federal Rules of Civil Procedure shall be followed. A reply to an affirmative defense shall not be filed. When a defense attacks the validity of a registration pleaded in the opposition, paragraph (b)(2) of this section shall govern. A pleaded registration is a registration identified by number by the party in the position of plaintiff in an original notice of opposition or in any amendment thereto made under Rule 15 of the Federal Rules of Civil Procedure.
(2)(i) A defense attacking the validity of any one or more of the registrations pleaded in the opposition shall be a compulsory counterclaim if grounds for such counterclaim exist at the time when the answer is filed. If grounds for a counterclaim are known to the applicant when the answer to the opposition is filed, the counterclaim shall be pleaded with or as part of the answer. If grounds for a counterclaim are learned during the course of the opposition proceeding, the counterclaim shall be pleaded promptly after the grounds therefor are learned. A counterclaim need not be filed if the claim is the subject of another proceeding between the same parties or anyone in privity therewith; but the applicant must promptly inform the Board, in the context of the opposition proceeding, of the filing of the other proceeding.
(ii) An attack on the validity of a registration pleaded by an opposer will not be heard unless a counterclaim or separate petition is filed to seek the cancellation of such registration.
(iii) The provisions of §§ 2.111 through 2.115, inclusive, shall be applicable to counterclaims. A time, not less than thirty days, will be designated by the Board within which an answer to the counterclaim must be filed.
(iv) The times for pleading, discovery, testimony, briefs or oral argument may be reset or extended when necessary, upon motion by a party, or as the Board may deem necessary, to enable a party fully to present or meet a counterclaim or separate petition for cancellation of a registration.
(a) Pleadings in an opposition proceeding against an application filed under section 1 or 44 of the Act may be amended in the same manner and to the same extent as in a civil action in a United States district court, except that, after the close of the time period for filing an opposition including any extension of time for filing an opposition, an opposition may not be amended to add to the goods or services opposed, or to add a joint opposer.
(b) Pleadings in an opposition proceeding against an application filed under section 66(a) of the Act may be amended in the same manner and to the same extent as in a civil action in a United States district court, except that, once filed, the opposition may not be amended to add grounds for opposition or goods or services beyond those identified in the notice of opposition, or to add a joint opposer. The grounds for opposition, the goods or services opposed, and the named opposers are limited to those identified in the ESTTA cover sheet regardless of what is contained in any attached statement.
(a) A cancellation proceeding is commenced by filing in the Office a timely petition for cancellation with the required fee.
(b) Any person who believes that he, she or it is or will be damaged by a registration may file a petition, addressed to the Trademark Trial and Appeal Board, for cancellation of the registration in whole or in part. The petition for cancellation need not be verified, but must be signed by the petitioner or the petitioner's attorney, as specified in § 11.1 of this chapter, or other authorized representative, as specified in § 11.14(b) of this chapter. Electronic signatures pursuant to § 2.193(c) are required for petitions submitted electronically via ESTTA. The petition for cancellation may be filed at any time in the case of registrations on the Supplemental Register or under the Act of 1920, or registrations under the Act of 1881 or the Act of 1905 which have not been published under section 12(c) of the Act, or on any ground specified in section 14(3) or (5) of the Act. In all other cases, the petition for cancellation and the required fee must be filed within five years from the date of registration of the mark under the Act or from the date of publication under section 12(c) of the Act.
(c)(1) A petition to cancel a registration must be filed through ESTTA. In the event that ESTTA is unavailable due to technical problems, or when extraordinary circumstances are present, a petition to cancel may be filed in paper form as provided in paragraph (c)(2) of this section.
(2) A paper petition to cancel a registration must be accompanied by a Petition to the Director under § 2.146(a)(5), with the fees therefor and the showing required under paragraph (c)(1) of this section. Timeliness of the paper submission, if relevant to a ground asserted in the petition to cancel, will be determined in accordance with §§ 2.195 through 2.198.
(d) The petition for cancellation must be accompanied by the required fee for each party joined as petitioner for each class in the registration(s) for which cancellation is sought (see § 2.6). A petition cannot be filed via ESTTA unless the petition is accompanied by a fee that is sufficient to pay in full for each named petitioner to seek cancellation of the registration(s) in each class specified in the petition. A petition filed in paper form that is not accompanied by a fee sufficient to pay in full for each named petitioner for each class in the registration(s) for which cancellation is sought may not be instituted.
(e) The filing date of a petition for cancellation is the date of electronic receipt in the Office of the petition and required fee. In the rare instances that filing by paper is permitted under these rules, the filing date of a petition for cancellation is the date identified in § 2.198.
(a) The petition for cancellation must set forth a short and plain statement showing why the petitioner believes he, she or it is or will be damaged by the registration, state the ground for cancellation, and indicate, to the best of petitioner's knowledge, the name and address, and a current email address(es), of the current owner of the registration, and of any attorney, as specified in §§ 11.14(a) and (c) of this Chapter, reasonably believed by the petitioner to be a possible representative of the owner in matters regarding the registration. ESTTA requires the petitioner to select relevant grounds for petition to cancel. The required accompanying statement supports and explains the grounds.
(b) When appropriate, petitions for cancellation of different registrations owned by the same party may be joined in a consolidated petition for cancellation. The required fee must be included for each party joined as a petitioner for each class sought to be cancelled in each registration against which the petition for cancellation has been filed.
(a) When a petition for cancellation in proper form (see §§ 2.111 and 2.112) has been filed and the correct fee has been submitted, the Trademark Trial and Appeal Board shall prepare a notice of institution which shall identify the proceeding as a cancellation, number of the proceeding and the registration(s) involved; and shall designate a time, not less than thirty days from the mailing date of the notice, within which an answer must be filed. If a party has provided the Office with an email address, the notice will be transmitted via email. The notice, which will include a web link or web address to access the electronic proceeding record, constitutes service to the registrant of the petition to cancel.
(b) The Board shall forward a copy of the notice to petitioner, as follows:
(1) If the petition for cancellation is transmitted by an attorney, or a written power of attorney is filed, the Board will send the notice to the attorney transmitting the petition for cancellation or to the attorney designated in the power of attorney, provided that person is an “attorney” as defined in § 11.1 of this chapter, to the attorney's email or correspondence address of record for the attorney.
(2) If petitioner is not represented by an attorney in the cancellation proceeding, but petitioner has appointed a domestic representative, the Board will send the notice to the domestic representative, at the email or correspondence address of record for the domestic representative, unless petitioner designates in writing another correspondence address.
(3) If petitioner is not represented by an attorney in the cancellation proceeding, and no domestic representative has been appointed, the Board will send the notice directly to petitioner, at the email or correspondence address of record for petitioner, unless petitioner designates in writing another correspondence address.
(c)(1) The Board shall forward a copy of the notice to the party shown by the records of the Office to be the current owner of the registration(s) sought to be cancelled, except that the Board, in its discretion, may join or substitute as respondent a party who makes a showing of a current ownership interest in such registration(s).
(2) If the respondent has appointed a domestic representative, and such appointment is reflected in the Office's records, the Board will send the notice only to the domestic representative at the email or correspondence address of record for the domestic representative.
(3) In the case of a registration issued under 15 U.S.C. 1141i, notice will be sent to the international registration holder's designated representative. The notice, which will include a web link or web address to access the electronic
(d) When the party alleged by the petitioner, pursuant to § 2.112(a), as the current owner of the registration(s) is not the record owner, a courtesy copy of the notice with a web link or web address to access the electronic proceeding record shall be forwarded to the alleged current owner. The alleged current owner may file a motion to be joined or substituted as respondent.
(a) If no answer is filed within the time initially set, or as may later be reset by the Board, the petition may be decided as in case of default. The failure to file a timely answer tolls all deadlines, including the discovery conference, until the issue of default is resolved.
(b)(1) An answer shall state in short and plain terms the respondent's defenses to each claim asserted and shall admit or deny the averments upon which the petitioner relies. If the respondent is without knowledge or information sufficient to form a belief as to the truth of an averment, respondent shall so state and this will have the effect of a denial. Denials may take any of the forms specified in Rule 8(b) of the Federal Rules of Civil Procedure. An answer may contain any defense, including the affirmative defenses of unclean hands, laches, estoppel, acquiescence, fraud, mistake, prior judgment, or any other matter constituting an avoidance or affirmative defense. When pleading special matters, the Federal Rules of Civil Procedure shall be followed. A reply to an affirmative defense need not be filed. When a defense attacks the validity of a registration pleaded in the petition, paragraph (b)(2) of this section shall govern. A pleaded registration is a registration identified by number by the party in position of plaintiff in an original petition for cancellation, or a counterclaim petition for cancellation, or in any amendment thereto made under Rule 15 of the Federal Rules of Civil Procedure.
(2)(i) A defense attacking the validity of any one or more of the registrations pleaded in the petition shall be a compulsory counterclaim if grounds for such counterclaim exist at the time when the answer is filed. If grounds for a counterclaim are known to respondent when the answer to the petition is filed, the counterclaim shall be pleaded with or as part of the answer. If grounds for a counterclaim are learned during the course of the cancellation proceeding, the counterclaim shall be pleaded promptly after the grounds therefor are learned. A counterclaim need not be filed if the claim is the subject of another proceeding between the same parties or anyone in privity therewith; but the party in position of respondent and counterclaim plaintiff must promptly inform the Board, in the context of the primary cancellation proceeding, of the filing of the other proceeding.
(ii) An attack on the validity of a registration pleaded by a petitioner for cancellation will not be heard unless a counterclaim or separate petition is filed to seek the cancellation of such registration.
(iii) The provisions of §§ 2.111 through 2.115, inclusive, shall be applicable to counterclaims. A time, not less than thirty days, will be designated by the Board within which an answer to the counterclaim must be filed. Such response period may be reset as necessary by the Board, for a time period to be determined by the Board.
(iv) The times for pleading, discovery, testimony, briefs, or oral argument may be reset or extended when necessary, upon motion by a party, or as the Board may deem necessary, to enable a party fully to present or meet a counterclaim or separate petition for cancellation of a registration.
(c) The petition for cancellation or counterclaim petition for cancellation may be withdrawn without prejudice before the answer is filed. After the answer is filed, such petition or counterclaim petition may not be withdrawn without prejudice except with the written consent of the registrant or the registrant's attorney or other authorized representative.
(c) The notice of opposition or the petition for cancellation and the answer correspond to the complaint and answer in a court proceeding.
(e) The submission of notices of reliance, declarations and affidavits, as well as the taking of depositions, during the assigned testimony periods correspond to the trial in court proceedings.
(f) Oral hearing, if requested, of arguments on the record and merits corresponds to oral summation in court proceedings.
(g) The Trademark Trial and Appeal Board's standard protective order is automatically imposed in all inter partes proceedings unless the parties, by stipulation approved by the Board, agree to an alternative order, or a motion by a party to use an alternative order is granted by the Board. The standard protective order is available at the Office's Web site. No material disclosed or produced by a party, presented at trial, or filed with the Board, including motions or briefs which discuss such material, shall be treated as confidential or shielded from public view unless designated as protected under the Board's standard protective order, or under an alternative order stipulated to by the parties and approved by the Board, or under an order submitted by motion of a party granted by the Board. The Board may treat as not confidential that material which cannot reasonably be considered confidential, notwithstanding a designation as such by a party.
(c) Proceedings may also be suspended sua sponte by the Board, or, for good cause, upon motion or a stipulation of the parties approved by the Board. Many consented or stipulated motions to suspend are suitable for automatic approval by ESTTA, but the Board retains discretion to condition approval on the party or parties providing necessary information about the status of settlement talks, discovery activities, or trial activities, as may be appropriate.
When a notice sent by the Office to any registrant or applicant is returned to the Office undelivered, including notification to the Office of non-delivery in paper or electronic form, additional notice may be given by publication in the Official Gazette.
(a) Except for the notice of opposition or the petition to cancel, every submission filed in the Office in inter partes cases, including notices of appeal to the courts, must be served upon the other party or parties. Proof of such service must be made before the submission will be considered by the Office. A statement signed by the attorney or other authorized representative, attached to or appearing on the original submission when filed, clearly stating the date and manner in which service was made will be accepted as prima facie proof of service.
(b) Service of submissions filed with the Board and any other papers served on a party not required to be filed with the Board, must be on the attorney or other authorized representative of the party if there be such or on the party if there is no attorney or other authorized representative, and must be made by email, unless otherwise stipulated, or if the serving party can show by written explanation accompanying the submission or paper, or in a subsequent amended certificate of service, that service by email was attempted but could not be made due to technical problems or extraordinary circumstances, then service may be made in any of the following ways:
(1) By delivering a copy of the submission or paper to the person served;
(2) By leaving a copy at the usual place of business of the person served, with someone in the person's employment;
(3) When the person served has no usual place of business, by leaving a copy at the person's residence, with some person of suitable age and discretion who resides there;
(4) Transmission by the Priority Mail Express® Post Office to Addressee service of the United States Postal Service or by first-class mail, which may also be certified or registered;
(5) Transmission by overnight courier;
(6) Other forms of electronic transmission.
(c) When service is made by first-class mail, Priority Mail Express®, or overnight courier, the date of mailing or of delivery to the overnight courier will be considered the date of service.
(d) If a party to an inter partes proceeding is not domiciled in the United States and is not represented by an attorney or other authorized representative located in the United States, none of the parties to the proceeding is eligible to use the service option under paragraph (b)(4) of this section. The party not domiciled in the United States may designate by submission filed in the Office the name and address of a person residing in the United States on whom may be served notices or process in the proceeding. If the party has appointed a domestic representative, official communications of the Office will be addressed to the domestic representative unless the proceeding is being prosecuted by an attorney at law or other qualified person duly authorized under § 11.14(c) of this subchapter. If the party has not appointed a domestic representative and the proceeding is not being prosecuted by an attorney at law or other qualified person, the Office will send correspondence directly to the party, unless the party designates in writing another address to which correspondence is to be sent. The mere designation of a domestic representative does not authorize the person designated to prosecute the proceeding unless qualified under § 11.14(a), or qualified under § 11.14(b) and authorized under § 2.17(f).
(e) Every submission filed in an inter partes proceeding, and every request for an extension of time to file an opposition, must be signed by the party filing it, or by the party's attorney or other authorized representative, but an unsigned submission will not be refused consideration if a signed copy is submitted to the Office within the time limit set in the notification of this defect by the Office.
(a)
(2)(i) The discovery conference shall occur no later than the opening of the discovery period, and the parties must discuss the subjects set forth in Rule 26(f) of the Federal Rules of Civil Procedure and any subjects set forth in the Board's institution order. A Board Interlocutory Attorney or Administrative Trademark Judge will participate in the conference upon request of any party made after answer but no later than ten days prior to the deadline for the conference, or when the Board deems it useful for the parties to have Board involvement. The participating attorney or judge may expand or reduce the number or nature of subjects to be discussed in the conference as may be deemed appropriate. The discovery period will be set for a period of 180 days.
(ii) Initial disclosures must be made no later than thirty days after the opening of the discovery period.
(iii) Disclosure of expert testimony must occur in the manner and sequence provided in Rule 26(a)(2) of the Federal Rules of Civil Procedure, unless alternate directions have been provided by the Board in an institution order or any subsequent order resetting disclosure, discovery or trial dates. If the expert is retained after the deadline for disclosure of expert testimony, the party must promptly file a motion for leave to use expert testimony. Upon disclosure by any party of plans to use expert testimony, whether before or after the deadline for disclosing expert testimony, the Board, either on its own initiative or on notice from either party of the disclosure of expert testimony, may issue an order regarding expert discovery and/or set a deadline for any other party to disclose plans to use a rebuttal expert.
(iv) The parties may stipulate to a shortening of the discovery period, that there will be no discovery, that the number of discovery requests or depositions be limited, or that reciprocal disclosures be used in place of discovery. Limited extensions of the discovery period may be granted upon stipulation of the parties approved by the Board, or upon motion granted by the Board, or by order of the Board. If a motion for an extension is denied, the discovery period may remain as originally set or as reset. Disclosure deadlines and obligations may be modified upon written stipulation of the parties approved by the Board, or upon motion granted by the Board, or by order of the Board, but the expert disclosure deadline must always be scheduled prior to the close of discovery. If a stipulation or motion for modification is denied, discovery disclosure deadlines may remain as originally set or reset and obligations may remain unaltered.
(v) The parties are not required to prepare or transmit to the Board a written report outlining their discovery conference discussions, unless the parties have agreed to alter disclosure or discovery obligations set forth by these rules or applicable Federal Rules of Civil Procedure, or unless directed to file such a report by a participating
(3) A party must make its initial disclosures prior to seeking discovery, absent modification of this requirement by a stipulation of the parties approved by the Board, or a motion granted by the Board, or by order of the Board. Discovery depositions must be properly noticed and taken during the discovery period. Interrogatories, requests for production of documents and things, and requests for admission must be served early enough in the discovery period, as originally set or as may have been reset by the Board, so that responses will be due no later than the close of discovery. Responses to interrogatories, requests for production of documents and things, and requests for admission must be served within thirty days from the date of service of such discovery requests. The time to respond may be extended upon stipulation of the parties, or upon motion granted by the Board, or by order of the Board, but the response may not be due later than the close of discovery. The resetting of a party's time to respond to an outstanding request for discovery will not result in the automatic rescheduling of the discovery and/or testimony periods; such dates will be rescheduled only upon stipulation of the parties approved by the Board, or upon motion granted by the Board, or by order of the Board.
(b)
(c)
(2) Whenever a foreign party is or will be, during a time set for discovery, present within the United States or any territory which is under the control and jurisdiction of the United States, such party may be deposed by oral examination upon notice by the party seeking discovery. Whenever a foreign party has or will have, during a time set for discovery, an officer, director, managing agent, or other person who consents to testify on its behalf, present within the United States or any territory which is under the control and jurisdiction of the United States, the party must inform every adverse party of such presence and such officer, director, managing agent, or other person who consents to testify in its behalf may be deposed by oral examination upon notice by the party seeking discovery. The party seeking discovery may have one or more officers, directors, managing agents, or other persons who consent to testify on behalf of the adverse party, designated under Rule 30(b)(6) of the Federal Rules of Civil Procedure. The deposition of a person under this paragraph shall be taken in the Federal judicial district where the witness resides or is regularly employed, or, if the witness neither resides nor is regularly employed in a Federal judicial district, where the witness is at the time of the deposition. This paragraph does not preclude the taking of a discovery deposition of a foreign party by any other procedure provided by paragraph (c)(1) of this section.
(d)
(e)
(f)
(2) When a party files a motion for an order to compel initial disclosures, expert testimony disclosure, or discovery, the case will be suspended by the Board with respect to all matters not germane to the motion. After the motion to compel is filed and served, no party should file any paper that is not germane to the motion, except as otherwise specified in the Board's suspension order. Nor may any party serve any additional discovery until the period of suspension is lifted or expires by or under order of the Board. The filing of a motion to compel any disclosure or discovery shall not toll the time for a party to comply with any disclosure requirement or to respond to any outstanding discovery requests or to appear for any noticed discovery deposition. If discovery has closed, however, the parties need not make pretrial disclosures until directed to do so by the Board.
(g)
(h)
(2) If a party fails to make required initial disclosures or expert testimony disclosure, and such party or the party's attorney or other authorized representative informs the party or parties entitled to receive disclosures that required disclosures will not be made, the Board may make any appropriate order, as specified in paragraph (h)(1) of this section. If a party, or an officer, director, or managing agent of a party, or a person designated under Rule 30(b)(6) or 31(a) of the Federal Rules of Civil Procedure to testify on behalf of a party, fails to attend the party's or person's discovery deposition, after being served with proper notice, or fails to provide any response to a set of interrogatories or to a set of requests for production of documents and things, and such party or the party's attorney or other authorized representative informs the party seeking discovery that no response will be made thereto, the Board may make any appropriate order, as specified in paragraph (h)(1) of this section.
(i)
(1) Any motion by a party to determine the sufficiency of an answer or objection, including testing the sufficiency of a general objection on the ground of excessive number, to a request made by that party for an admission must be filed prior to the deadline for pretrial disclosures for the first testimony period, as originally set or as reset. The motion shall include a copy of the request for admission and any exhibits thereto and of the answer or objection. The motion must be supported by a written statement from the moving party showing that such party or the attorney therefor has made a good faith effort, by conference or correspondence, to resolve with the other party or the attorney therefor the issues presented in the motion and has been unable to reach agreement. If issues raised in the motion are subsequently resolved by agreement of the parties, the moving party should inform the Board in writing of the issues in the motion which no longer require adjudication.
(2) When a party files a motion to determine the sufficiency of an answer or objection to a request for an admission, the case will be suspended by the Board with respect to all matters not germane to the motion. After the motion is filed and served, no party should file any paper that is not germane to the motion, except as otherwise specified in the Board's suspension order. Nor may any party serve any additional discovery until the period of suspension is lifted or expires by or under order of the Board. The filing of a motion to determine the sufficiency of an answer or objection to a request for admission shall not toll the time for a party to comply with any disclosure requirement or to respond to any outstanding discovery requests or to appear for any noticed discovery deposition. If discovery has closed, however, the parties need not make pretrial disclosures until directed to do so by the Board.
(j)
(2) Whenever it appears to the Trademark Trial and Appeal Board that
(3) Parties may not make a recording of the conferences referenced in paragraphs (j)(1) and (j)(2) of this section.
(k)
(2) Except as provided in paragraph (k)(1) of this section, the discovery deposition of a witness, whether or not a party, shall not be offered in evidence unless the person whose deposition was taken is, during the testimony period of the party offering the deposition, dead; or out of the United States (unless it appears that the absence of the witness was procured by the party offering the deposition); or unable to testify because of age, illness, infirmity, or imprisonment; or cannot be served with a subpoena to compel attendance at a testimonial deposition; or there is a stipulation by the parties; or upon a showing that such exceptional circumstances exist as to make it desirable, in the interest of justice, to allow the deposition to be used. The use of a discovery deposition by any party under this paragraph will be allowed only by stipulation of the parties approved by the Trademark Trial and Appeal Board, or by order of the Board on motion, which shall be filed when the party makes its pretrial disclosures, unless the motion is based upon a claim that such exceptional circumstances exist as to make it desirable, in the interest of justice, to allow the deposition to be used, even though such deadline has passed, in which case the motion shall be filed promptly after the circumstances claimed to justify use of the deposition became known.
(3)(i) A discovery deposition, an answer to an interrogatory, an admission to a request for admission, or a written initial disclosure, which may be offered in evidence under the provisions of paragraph (k) of this section, may be made of record in the case by filing the deposition or any part thereof with any exhibit to the part that is filed, or a copy of the interrogatory and answer thereto with any exhibit made part of the answer, or a copy of the request for admission and any exhibit thereto and the admission (or a statement that the party from which an admission was requested failed to respond thereto), or a copy of the written initial disclosure, together with a notice of reliance in accordance with § 2.122(g). The notice of reliance and the material submitted thereunder should be filed during the testimony period of the party that files the notice of reliance. An objection made at a discovery deposition by a party answering a question subject to the objection will be considered at final hearing.
(ii) A party that has obtained documents from another party through disclosure or under Rule 34 of the Federal Rules of Civil Procedure may not make the documents of record by notice of reliance alone, except to the extent that they are admissible by notice of reliance under the provisions of § 2.122(e), or the party has obtained an admission or stipulation from the producing party that authenticates the documents.
(4) If only part of a discovery deposition is submitted and made part of the record by a party, an adverse party may introduce under a notice of reliance any other part of the deposition which should in fairness be considered so as to make not misleading what was offered by the submitting party. A notice of reliance filed by an adverse party must be supported by a written statement explaining why the adverse party needs to rely upon each additional part listed in the adverse party's notice, failing which the Board, in its discretion, may refuse to consider the additional parts.
(5) Written disclosures, an answer to an interrogatory, or an admission to a request for admission, may be submitted and made part of the record only by the receiving or inquiring party except that, if fewer than all of the written disclosures, answers to interrogatories, or fewer than all of the admissions, are offered in evidence by the receiving or inquiring party, the disclosing or responding party may introduce under a notice of reliance any other written disclosures, answers to interrogatories, or any other admissions, which should in fairness be considered so as to make not misleading what was offered by the receiving or inquiring party. The notice of reliance filed by the disclosing or responding party must be supported by a written statement explaining why the disclosing or responding party needs to rely upon each of the additional written disclosures or discovery responses listed in the disclosing or responding party's notice, and absent such statement, the Board, in its discretion, may refuse to consider the additional written disclosures or responses.
(6) Paragraph (k) of this section will not be interpreted to preclude reading or use of written disclosures or documents, a discovery deposition, or answer to an interrogatory, or admission as part of the examination or cross-examination of any witness during the testimony period of any party.
(7) When a written disclosure, a discovery deposition, or a part thereof, or an answer to an interrogatory, or an admission, or an authenticated produced document has been made of record by one party in accordance with the provisions of paragraph (k)(3) of this section, it may be referred to by any party for any purpose permitted by the Federal Rules of Evidence.
(8) Written disclosures or disclosed documents, requests for discovery, responses thereto, and materials or depositions obtained through the disclosure or discovery process should not be filed with the Board, except when submitted with a motion relating to disclosure or discovery, or in support of or in response to a motion for summary judgment, or under a notice of reliance, when permitted, during a party's testimony period.
(a) The Trademark Trial and Appeal Board will issue a trial order setting a deadline for each party's required pretrial disclosures and assigning to each party its time for taking testimony and presenting evidence (“testimony period”). No testimony shall be taken or evidence presented except during the times assigned, unless by stipulation of the parties approved by the Board, or upon motion granted by the Board, or by order of the Board. The deadlines for pretrial disclosures and the testimony periods may be rescheduled by stipulation of the parties approved by the Board, or upon motion granted by the Board, or by order of the Board. If a motion to reschedule any pretrial disclosure deadline and/or testimony period is denied, the pretrial disclosure deadline or testimony period and any
(c) A testimony period which is solely for rebuttal will be set for fifteen days. All other testimony periods will be set for thirty days. The periods may be shortened or extended by stipulation of the parties approved by the Trademark Trial and Appeal Board, or may be extended upon motion granted by the Board, or by order of the Board. If a motion for an extension is denied, the testimony periods and their associated pretrial disclosure deadlines may remain as set.
(d) When parties stipulate to the rescheduling of a deadline for pretrial disclosures and subsequent testimony periods or to the rescheduling of the closing date for discovery and the rescheduling of subsequent deadlines for pretrial disclosures and testimony periods, a stipulation presented in the form used in a trial order, signed by the parties, or a motion in said form signed by one party and including a statement that every other party has agreed thereto, shall be submitted to the Board through ESTTA, with the relevant dates set forth and an express statement that all parties agree to the new dates.
(e) A party need not disclose, prior to its testimony period, any notices of reliance it intends to file during its testimony period. However, no later than fifteen days prior to the opening of each testimony period, or on such alternate schedule as may be provided by order of the Board, the party scheduled to present evidence must disclose the name and, if not previously provided, the telephone number and address of each witness from whom it intends to take testimony, or may take testimony if the need arises, general identifying information about the witness, such as relationship to any party, including job title if employed by a party, or, if neither a party nor related to a party, occupation and job title, a general summary or list of subjects on which the witness is expected to testify, and a general summary or list of the types of documents and things which may be introduced as exhibits during the testimony of the witness. The testimony of a witness may be taken upon oral examination and transcribed, or presented in the form of an affidavit or declaration, as provided in § 2.123. Pretrial disclosure of a witness under this subsection does not substitute for issuance of a proper notice of examination under § 2.123(c) or § 2.124(b). If a party does not plan to take testimony from any witnesses, it must so state in its pretrial disclosure. When a party fails to make required pretrial disclosures, any adverse party or parties may have remedy by way of a motion to the Board to delay or reset any subsequent pretrial disclosure deadlines and/or testimony periods. A party may move to quash a noticed testimony deposition of a witness not identified or improperly identified in pretrial disclosures before the deposition. When testimony has been presented by affidavit or declaration, but was not covered by an earlier pretrial disclosure, the remedy for any adverse party is the prompt filing of a motion to strike, as provided in §§ 2.123 and 2.124.
(a)
(b)
(2) The allegation in an application for registration, or in a registration, of a date of use is not evidence on behalf of the applicant or registrant; a date of use of a mark must be established by competent evidence. Specimens in the file of an application for registration, or in the file of a registration, are not evidence on behalf of the applicant or registrant unless identified and introduced in evidence as exhibits during the period for the taking of testimony. Statements made in an affidavit or declaration in the file of an application for registration, or in the file of a registration, are not evidence on behalf of the applicant or registrant and must be established by competent evidence.
(c)
(d)
(2) A registration owned by any party to a proceeding may be made of record in the proceeding by that party by appropriate identification and introduction during the taking of testimony or by filing a notice of reliance in accordance with paragraph (g) of this section, which shall be accompanied by a copy (original or photocopy) of the registration prepared and issued by the Office showing both the current status of and current title to the registration, or by a current printout of information from the electronic database records of the Office showing the current status and title of the registration. The notice of reliance shall be filed during the testimony period of the party that files the notice.
(e)
(2) Internet materials may be admitted into evidence under a notice of reliance in accordance with paragraph (g) of this section, in the same manner as a printed publication in general circulation, so long as the date the internet materials were accessed and their source (
(g)
(a)(1) The testimony of witnesses in inter partes cases may be submitted in the form of an affidavit or a declaration pursuant to § 2.20, filed during the proffering party's testimony period, subject to the right of any adverse party to elect to take and bear the expense of oral cross-examination of that witness as provided under paragraph (c) of this section if such witness is within the jurisdiction of the United States, or conduct cross-examination by written questions as provided in § 2.124 if such witness is outside the jurisdiction of the United States, and the offering party must make that witness available; or taken by deposition upon oral examination as provided by this section; or by deposition upon written questions as provided by § 2.124.
(2) A testimonial deposition taken in a foreign country shall be taken by deposition upon written questions as provided by § 2.124, unless the Board, upon motion for good cause, orders that the deposition be taken by oral examination or by affidavit or declaration, subject to the right of any adverse party to elect to take and bear the expense of cross-examination by written questions of that witness, or the parties so stipulate. If a party serves notice of the taking of a testimonial deposition upon written questions of a witness who is, or will be at the time of the deposition, present within the United States or any territory which is under the control and jurisdiction of the United States, any adverse party may, within twenty days from the date of service of the notice, file a motion with the Trademark Trial and Appeal Board, for good cause, for an order that the deposition be taken by oral examination. The proffering party must inform every adverse party when it knows that such witness will be within the jurisdiction of the United States during such party's testimony period.
(b)
(c)
(e)
(2) The deposition shall be taken in answer to questions, with the questions and answers recorded in their regular order by the officer, or by some other person (who shall be subject to the provisions of Rule 28 of the Federal Rules of Civil Procedure) in the presence of the officer except when the officer's presence is waived on the record by agreement of the parties. The testimony shall be recorded and transcribed, unless the parties present agree otherwise. Exhibits which are marked and identified at the deposition will be deemed to have been offered into evidence, without any formal offer thereof, unless the intention of the party marking the exhibits is clearly expressed to the contrary.
(3) If pretrial disclosures or the notice of examination of witnesses served pursuant to paragraph (c) of this section are improper or inadequate with respect to any witness, an adverse party may cross-examine that witness under protest while reserving the right to object to the receipt of the testimony in evidence. Promptly after the testimony is completed, the adverse party, to preserve the objection, shall move to strike the testimony from the record, which motion will be decided on the basis of all the relevant circumstances.
(i) A motion to strike the testimony of a witness for lack of proper or adequate pretrial disclosure may seek exclusion of the entire testimony, when there was no pretrial disclosure, or may seek exclusion of that portion of the testimony that was not adequately disclosed in accordance with § 2.121(e).
(ii) A motion to strike the testimony of a witness for lack of proper or
(4) All objections made at the time of an oral examination to the qualifications of the officer taking the deposition, or to the manner of taking it, or to the evidence presented, or to the conduct of any party, and any other objection to the proceedings, shall be noted by the officer upon the deposition. Evidence objected to shall be taken subject to the objections.
(5) When the oral deposition has been transcribed, the deposition transcript shall be carefully read over by the witness or by the officer to the witness, and shall then be signed by the witness in the presence of any officer authorized to administer oaths unless the reading and the signature be waived on the record by agreement of all parties.
(f)
(1) The officer shall annex to the deposition his or her certificate showing:
(i) Due administration of the oath by the officer to the witness before the commencement of his or her deposition;
(ii) The name of the person by whom the deposition was taken down, and whether, if not taken down by the officer, it was taken down in his or her presence;
(iii) The presence or absence of the adverse party;
(iv) The place, day, and hour of commencing and taking the deposition;
(v) The fact that the officer was not disqualified as specified in Rule 28 of the Federal Rules of Civil Procedure.
(2) If any of the foregoing requirements in paragraph (f)(1) of this section are waived, the certificate shall so state. The officer shall sign the certificate and affix thereto his or her seal of office, if he or she has such a seal. The party taking the deposition, or its attorney or other authorized representative, shall then promptly file the transcript and exhibits in electronic form using ESTTA. If the weight or bulk of an exhibit shall exclude it from such filing or prevent its uploading to ESTTA, it shall be transmitted by the party taking the deposition, or its attorney or other authorized representative, in a separate package marked and addressed as provided in this section, including an explanation as to why it could not be submitted electronically.
(g)
(2) Exhibits must be numbered or lettered consecutively and each must be marked with the number and title of the case and the name of the party offering the exhibit. Entry and consideration may be refused to improperly marked exhibits.
(3) Each deposition must contain a word index and an index of the names of the witnesses, giving the pages where the words appear in the deposition and where witness examination and cross-examination begin, and an index of the exhibits, briefly describing their nature and giving the pages at which they are introduced and offered in evidence.
(h)
(i)
(j)
(k)
(b)(1) * * *
(2) A party desiring to take a discovery deposition upon written questions shall serve notice thereof upon each adverse party and shall file a copy of the notice, but not copies of the questions, with the Board. The notice shall state the name and address, if known, of the person whose deposition is to be taken. If the name of the person is not known, a general description sufficient to identify the witness or the particular class or group to which he or she belongs shall be stated in the notice, and the party from whom the discovery deposition is to be taken shall designate one or more persons to be deposed in the same manner as is provided by Rule 30(b)(6) of the Federal Rules of Civil Procedure.
(3) A party desiring to take cross-examination, by written questions, of a witness who has provided testimony by affidavit or declaration shall serve notice thereof upon each adverse party and shall file a copy of the notice, but not copies of the questions, with the Board.
(d)(1) Every notice served on any adverse party under the provisions of paragraph (b) of this section, for the taking of direct testimony, shall be accompanied by the written questions to be propounded on behalf of the party who proposes to take the deposition. Every notice served on any adverse party under the provisions of paragraph (b)(3) of this section, for the taking of cross-examination, shall be accompanied by the written questions to be propounded on behalf of the party who proposes to take the cross-examination. Within twenty days from the date of service of the notice of taking direct testimony, any adverse party may serve cross questions upon the party who proposes to take the deposition. Any party who serves cross questions, whether in response to direct examination questions or under paragraph (b)(3) of this section, shall also serve every other adverse party. Within ten days from the date of service of the cross questions, the party who proposes to take the deposition, or who earlier offered testimony of the witness by affidavit or declaration, may serve redirect questions on every adverse party. Within ten days from the date of service of the redirect questions, any party who served cross questions may serve recross questions upon the party
(3) Service of written questions, responses, and cross-examination questions shall be in accordance with § 2.119(b).
(f) The party who took the deposition shall promptly serve a copy of the transcript, copies of documentary exhibits, and duplicates or photographs of physical exhibits on every adverse party. It is the responsibility of the party who takes the deposition to assure that the transcript is correct (see § 2.125(b)). If the deposition is a discovery deposition, it may be made of record as provided by § 2.120(k). If the deposition is a testimonial deposition, the original, together with copies of documentary exhibits and duplicates or photographs of physical exhibits, shall be filed promptly with the Trademark Trial and Appeal Board.
(a) One copy of the declaration or affidavit prepared in accordance with § 2.123, together with copies of documentary exhibits and duplicates or photographs of physical exhibits, shall be served on each adverse party at the time the declaration or affidavit is submitted to the Trademark Trial and Appeal Board during the assigned testimony period.
(b) One copy of the transcript of each testimony deposition taken in accordance with §§ 2.123 or 2.124, together with copies of documentary exhibits and duplicates or photographs of physical exhibits, shall be served on each adverse party within thirty days after completion of the taking of that testimony. If the transcript with exhibits is not served on each adverse party within thirty days or within an extension of time for the purpose, any adverse party which was not served may have remedy by way of a motion to the Trademark Trial and Appeal Board to reset such adverse party's testimony and/or briefing periods, as may be appropriate. If the deposing party fails to serve a copy of the transcript with exhibits on an adverse party after having been ordered to do so by the Board, the Board, in its discretion, may strike the deposition, or enter judgment as by default against the deposing party, or take any such other action as may be deemed appropriate.
(c) The party who takes testimony is responsible for having all typographical errors in the transcript and all errors of arrangement, indexing and form of the transcript corrected, on notice to each adverse party, prior to the filing of one certified transcript with the Trademark Trial and Appeal Board. The party who takes testimony is responsible for serving on each adverse party one copy of the corrected transcript or, if reasonably feasible, corrected pages to be inserted into the transcript previously served.
(d) One certified transcript and exhibits shall be filed with the Trademark Trial and Appeal Board. Notice of such filing shall be served on each adverse party and a copy of each notice shall be filed with the Board.
(e) Each transcript shall comply with § 2.123(g) with respect to arrangement, indexing and form.
(f) Upon motion by any party, for good cause, the Trademark Trial and Appeal Board may order that any part of an affidavit or declaration or a deposition transcript or any exhibits that directly disclose any trade secret or other confidential research, development, or commercial information may be filed under seal and kept confidential under the provisions of § 2.27(e). If any party or any attorney or agent of a party fails to comply with an order made under this paragraph, the Board may impose any of the sanctions authorized by § 2.120(h).
(a) Submissions shall be made to the Trademark Trial and Appeal Board via ESTTA.
(1) Text in an electronic submission must be filed in at least 12-point type and double-spaced.
(2) Exhibits pertaining to an electronic submission must be made electronically as an attachment to the submission and must be clear and legible.
(b) In the event that ESTTA is unavailable due to technical problems, or when extraordinary circumstances are present, submissions may be filed in paper form. Submissions in paper form must be accompanied by a Petition to the Director under § 2.146(a)(5), with the fees therefor and the showing required under this paragraph. A paper submission, including exhibits and depositions, must meet the following requirements:
(1) A paper submission must be printed in at least 12-point type and double-spaced, with text on one side only of each sheet;
(2) A paper submission must be 8 to 8.5 inches (20.3 to 21.6 cm.) wide and 11 to 11.69 inches (27.9 to 29.7 cm.) long, and contain no tabs or other such devices extending beyond the edges of the paper;
(3) If a paper submission contains dividers, the dividers must not have any extruding tabs or other devices, and must be on the same size and weight paper as the submission;
(4) A paper submission must not be stapled or bound;
(5) All pages of a paper submission must be numbered and exhibits shall be identified in the manner prescribed in § 2.123(g)(2);
(6) Exhibits pertaining to a paper submission must be filed on paper and comply with the requirements for a paper submission.
(c) To be handled as confidential, submissions to the Trademark Trial and Appeal Board that are confidential in whole or part pursuant to § 2.125(e) must be submitted using the “Confidential” selection available in ESTTA or, where appropriate, under a separate paper cover. Both the submission and its cover must be marked confidential and must identify the case number and the parties. A copy of the submission for public viewing with the confidential portions redacted must be submitted concurrently.
(a) Every motion must be submitted in written form and must meet the requirements prescribed in § 2.126. It shall contain a full statement of the grounds, and shall embody or be accompanied by a brief. Except as provided in paragraph (e)(1) of this section, a brief in response to a motion shall be filed within twenty days from the date of service of the motion unless another time is specified by the Trademark Trial and Appeal Board, or the time is extended by stipulation of the parties approved by the Board, or upon motion granted by the Board, or upon order of the Board. If a motion for an extension is denied, the time for responding to the motion remains as specified under this section, unless otherwise ordered. Except as provided in paragraph (e)(1) of this section, a reply brief, if filed, shall be filed within
(b) Any request for reconsideration or modification of an order or decision issued on a motion must be filed within one month from the date thereof. A brief in response must be filed within twenty days from the date of service of the request.
(c) Interlocutory motions, requests, conceded matters, and other matters not actually or potentially dispositive of a proceeding may be acted upon by a single Administrative Trademark Judge of the Trademark Trial and Appeal Board, or by an Interlocutory Attorney or Paralegal of the Board to whom authority to act has been delegated, or by ESTTA. Motions disposed of by orders entitled “By the Trademark Trial and Appeal Board” have the same legal effect as orders by a panel of three Administrative Trademark Judges of the Board.
(d) When any party timely files a potentially dispositive motion, including, but not limited to, a motion to dismiss, a motion for judgment on the pleadings, or a motion for summary judgment, the case is suspended by the Trademark Trial and Appeal Board with respect to all matters not germane to the motion and no party should file any paper which is not germane to the motion except as otherwise may be specified in a Board order. If the case is not disposed of as a result of the motion, proceedings will be resumed pursuant to an order of the Board when the motion is decided.
(e)(1) A party may not file a motion for summary judgment until the party has made its initial disclosures, except for a motion asserting claim or issue preclusion or lack of jurisdiction by the Trademark Trial and Appeal Board. A motion for summary judgment must be filed prior to the deadline for pretrial disclosures for the first testimony period, as originally set or as reset. A motion under Rule 56(d) of the Federal Rules of Civil Procedure, if filed in response to a motion for summary judgment, shall be filed within thirty days from the date of service of the summary judgment motion. The time for filing a motion under Rule 56(d) will not be extended or reopened. If no motion under Rule 56(d) is filed, a brief in response to the motion for summary judgment shall be filed within thirty days from the date of service of the motion unless the time is extended by stipulation of the parties approved by the Board, or upon motion granted by the Board, or upon order of the Board. If a motion for an extension is denied, the time for responding to the motion for summary judgment may remain as specified under this section. A reply brief, if filed, shall be filed within twenty days from the date of service of the brief in response to the motion. The time for filing a reply brief will not be extended or reopened. The Board will consider no further papers in support of or in opposition to a motion for summary judgment.
(2) For purposes of summary judgment only, the Board will consider any of the following, if a copy is provided with the party's brief on the summary judgment motion: Written disclosures or disclosed documents, a discovery deposition or any part thereof with any exhibit to the part that is filed, an interrogatory and answer thereto with any exhibit made part of the answer, a request for production and the documents or things produced in response thereto, or a request for admission and any exhibit thereto and the admission (or a statement that the party from which an admission was requested failed to respond thereto). If any motion for summary judgment is denied, the parties may stipulate that the materials submitted with briefs on the motion shall be considered at trial as trial evidence, which may be supplemented by additional evidence during trial.
(a)(1) * * *
(3) When a party in the position of plaintiff fails to file a main brief, an order may be issued allowing plaintiff until a set time, not less than fifteen days, in which to show cause why the Board should not treat such failure as a concession of the case. If plaintiff fails to file a response to the order, or files a response indicating that plaintiff has lost interest in the case, judgment may be entered against plaintiff. If a plaintiff files a response to the order showing good cause, but does not have any evidence of record and does not move to reopen its testimony period and make a showing of excusable neglect sufficient to support such reopening, judgment may be entered against plaintiff for failure to take testimony or submit any other evidence.
(b) Briefs must be submitted in written form and must meet the requirements prescribed in § 2.126. Each brief shall contain an alphabetical index of cited cases. Without prior leave of the Trademark Trial and Appeal Board, a main brief on the case shall not exceed fifty-five pages in length in its entirety, including the table of contents, index of cases, description of the record, statement of the issues, recitation of the facts, argument, and summary; and a reply brief shall not exceed twenty-five pages in its entirety. Evidentiary objections that may properly be raised in a party's brief on the case may instead be raised in an appendix or by way of a separate statement of objections. The appendix or separate statement is not included within the page limit. Any brief beyond the page limits and any brief with attachments outside the stated requirements may not be considered by the Board.
(a) If a party desires to have an oral argument at final hearing, the party shall request such argument by a separate notice filed not later than ten days after the due date for the filing of the last reply brief in the proceeding. Oral arguments will be heard by at least three Administrative Trademark Judges or other statutory members of the Trademark Trial and Appeal Board at the time specified in the notice of hearing. If any party appears at the specified time, that party will be heard. Parties and members of the Board may attend in person or, at the discretion of the Board, remotely. If the Board is prevented from hearing the case at the specified time, a new hearing date will be set. Unless otherwise permitted, oral arguments in an inter partes case will be limited to thirty minutes for each party. A party in the position of plaintiff may reserve part of the time allowed for oral argument to present a rebuttal argument.
(b) The date or time of a hearing may be reset, so far as is convenient and proper, to meet the wishes of the parties and their attorneys or other authorized
(c) Any request for rehearing or reconsideration or modification of a decision issued after final hearing must be filed within one month from the date of the decision. A brief in response must be filed within twenty days from the date of service of the request. The times specified may be extended by order of the Trademark Trial and Appeal Board on motion for good cause.
If, while an inter partes proceeding involving an application under section 1 or 44 of the Act is pending, facts appear which, in the opinion of the examining attorney, render the mark in the application unregistrable, the examining attorney should request that the Board remand the application. The Board may suspend the proceeding and remand the application to the trademark examining attorney for an ex parte determination of the question of registrability. A copy of the trademark examining attorney's final action will be furnished to the parties to the inter partes proceeding following the final determination of registrability by the trademark examining attorney or the Board on appeal. The Board will consider the application for such further inter partes action as may be appropriate.
If, during an inter partes proceeding involving an application under section 1 or 44 of the Act, facts are disclosed which appear to render the mark unregistrable, but such matter has not been tried under the pleadings as filed by the parties or as they might be deemed to be amended under Rule 15(b) of the Federal Rules of Civil Procedure to conform to the evidence, the Trademark Trial and Appeal Board, in lieu of determining the matter in the decision on the proceeding, may remand the application to the trademark examining attorney for reexamination in the event the applicant ultimately prevails in the inter partes proceeding. Upon remand, the trademark examining attorney shall reexamine the application in light of the matter referenced by the Board. If, upon reexamination, the trademark examining attorney finally refuses registration to the applicant, an appeal may be taken as provided by §§ 2.141 and 2.142.
(a) If the time for taking testimony by any party in the position of plaintiff has expired and it is clear to the Board from the proceeding record that such party has not taken testimony or offered any other evidence, the Board may grant judgment for the defendant. Also, any party in the position of defendant may, without waiving the right to offer evidence in the event the motion is denied, move for dismissal on the ground of the failure of the plaintiff to prosecute. The party in the position of plaintiff shall have twenty days from the date of service of the motion to show cause why judgment should not be rendered dismissing the case. In the absence of a showing of excusable neglect, judgment may be rendered against the party in the position of plaintiff. If the motion is denied, testimony periods will be reset for the party in the position of defendant and for rebuttal.
(b) If no evidence other than Office records showing the current status and title of plaintiff's pleaded registration(s) is offered by any party in the position of plaintiff, any party in the position of defendant may, without waiving the right to offer evidence in the event the motion is denied, move for dismissal on the ground that upon the law and the facts the party in the position of plaintiff has shown no right to relief. The party in the position of plaintiff shall have twenty days from the date of service of the motion to file a brief in response to the motion. The Trademark Trial and Appeal Board may render judgment against the party in the position of plaintiff, or the Board may decline to render judgment until all testimony periods have passed. If judgment is not rendered on the motion to dismiss, testimony periods will be reset for the party in the position of defendant and for rebuttal.
(b) After the commencement of a cancellation proceeding, if it comes to the attention of the Trademark Trial and Appeal Board that the respondent has permitted its involved registration to be cancelled under section 8 or section 71 of the Act of 1946, or has failed to renew its involved registration under section 9 of the Act of 1946, or has allowed its registered extension of protection to expire under section 70(b) of the Act of 1946, an order may be issued allowing respondent until a set time, not less than fifteen days, in which to show cause why such cancellation, failure to renew, or expiration should not be deemed to be the equivalent of a cancellation by request of respondent without the consent of the adverse party and should not result in entry of judgment against respondent as provided by paragraph (a) of this section. In the absence of a showing of good and sufficient cause, judgment may be entered against respondent as provided by paragraph (a) of this section.
After the Board has issued its decision in an opposition or concurrent use proceeding, and after the time for filing any appeal of the decision has expired, or any appeal that was filed has been decided and the Board's decision affirmed, the proceeding will be terminated by the Board. On termination of an opposition or concurrent use proceeding, if the judgment is not adverse to the applicant, the application returns to the status it had before the institution of the proceeding. If the judgment is adverse to the applicant, the application stands refused without further action and all proceedings thereon are considered terminated.
(b)(1) The brief of appellant shall be filed within sixty days from the date of appeal. If the brief is not filed within the time allowed, the appeal may be dismissed. The examining attorney shall, within sixty days after the brief of appellant is sent to the examining attorney, file with the Trademark Trial and Appeal Board a written brief answering the brief of appellant and shall mail a copy of the brief to the appellant. The appellant may file a reply brief within twenty days from the date of mailing of the brief of the examining attorney.
(2) Briefs must be submitted in written form and must meet the requirements prescribed in § 2.126. Each brief shall contain an alphabetical index
(3) Citation to evidence in briefs should be to the documents in the electronic application record by date, the name of the paper under which the evidence was submitted, and the page number in the electronic record.
(c) All requirements made by the examining attorney and not the subject of appeal shall be complied with prior to the filing of an appeal, and the statement of issues in the brief should note such compliance.
(d) Evidence shall not be submitted after the filing of a notice of appeal. If the appellant or the examining attorney desires to introduce additional evidence after an appeal is filed, the appellant or the examining attorney must submit a request to the Board to suspend the appeal and to remand the application for further examination.
(e)(1) If the appellant desires an oral hearing, a request should be made by a separate notice filed not later than ten days after the due date for a reply brief. Oral argument will be heard by at least three Administrative Trademark Judges or other statutory members of the Trademark Trial and Appeal Board at the time specified in the notice of hearing, which may be reset if the Board is prevented from hearing the argument at the specified time or, so far as is convenient and proper, to meet the wish of the appellant or the appellant's attorney or other authorized representative. Appellants, examining attorneys, and members of the Board may attend in person or, at the discretion of the Board, remotely.
(2) If the appellant requests an oral argument, the examining attorney who issued the refusal of registration or the requirement from which the appeal is taken, or in lieu thereof another examining attorney as designated by a supervisory or managing attorney, shall present an oral argument. If no request for an oral hearing is made by the appellant, the appeal will be decided on the record and briefs.
(3) Oral argument will be limited to twenty minutes by the appellant and ten minutes by the examining attorney. The appellant may reserve part of the time allowed for oral argument to present a rebuttal argument.
(f)(1) If, during an appeal from a refusal of registration, it appears to the Trademark Trial and Appeal Board that an issue not previously raised may render the mark of the appellant unregistrable, the Board may suspend the appeal and remand the application to the examining attorney for further examination to be completed within the time set by the Board.
(2) If the further examination does not result in an additional ground for refusal of registration, the examining attorney shall promptly return the application to the Board, for resumption of the appeal, with a written statement that further examination did not result in an additional ground for refusal of registration.
(3) If the further examination does result in an additional ground for refusal of registration, the examining attorney and appellant shall proceed as provided by §§ 2.61, 2.62, and 2.63. If the ground for refusal is made final, the examining attorney shall return the application to the Board, which shall thereupon issue an order allowing the appellant sixty days from the date of the order to file a supplemental brief limited to the additional ground for the refusal of registration. If the supplemental brief is not filed by the appellant within the time allowed, the appeal may be dismissed.
(4) If the supplemental brief of the appellant is filed, the examining attorney shall, within sixty days after the supplemental brief of the appellant is sent to the examining attorney, file with the Board a written brief answering the supplemental brief of appellant and shall mail a copy of the brief to the appellant. The appellant may file a reply brief within twenty days from the date of mailing of the brief of the examining attorney.
(6) If, during an appeal from a refusal of registration, it appears to the examining attorney that an issue not involved in the appeal may render the mark of the appellant unregistrable, the examining attorney may, by written request, ask the Board to suspend the appeal and to remand the application to the examining attorney for further examination. If the request is granted, the examining attorney and appellant shall proceed as provided by §§ 2.61, 2.62, and 2.63. After the additional ground for refusal of registration has been withdrawn or made final, the examining attorney shall return the application to the Board, which shall resume proceedings in the appeal and take further appropriate action with respect thereto.
(a)
(2) In all appeals under section 21(a), the appellant must take the following steps:
(i) File the notice of appeal with the Director, addressed to the Office of the General Counsel, as provided in § 104.2 of this chapter;
(ii) File a copy of the notice of appeal with the Trademark Trial and Appeal Board via ESTTA; and
(iii) Comply with the requirements of the Federal Rules of Appellate Procedure and Rules for the United States Court of Appeals for the Federal Circuit, including serving the requisite number of copies on the Court and paying the requisite fee for the appeal.
(3)
(ii) In inter partes proceedings, the notice of appeal must be served as provided in § 2.119.
(b)
(2) If an adverse party to an appeal taken to the United States Court of Appeals for the Federal Circuit by a
(i) File a notice of election with the Director, addressed to the Office of the General Counsel, as provided in § 104.2 of this chapter;
(ii) File a copy of the notice of election with the Trademark Trial and Appeal Board via ESTTA; and
(iii) Serve the notice of election as provided in § 2.119.
(c)
(2) Any applicant or registrant in an ex parte case who seeks remedy by civil action under section 21(b) of the Act must serve the summons and complaint pursuant to Rule 4(i) of the Federal Rules of Civil Procedure with the copy to the Director addressed to the Office of the General Counsel as provided in § 104.2 of this chapter. A copy of the complaint must also be filed with the Trademark Trial and Appeal Board via ESTTA.
(3) The party initiating an action for review of a Board decision in an inter partes case under section 21(b) of the Act must file notice thereof with the Trademark Trial and Appeal Board via ESTTA no later than five business days after filing the complaint in the district court. The notice must identify the civil action with particularity by providing the case name, case number, and court in which it was filed. A copy of the complaint may be filed with the notice. Failure to file the required notice can result in termination of the Board proceeding and further action within the United States Patent and Trademark Office consistent with the final Board decision.
(d)
(2)
(3)
(4)
(ii)
(e)
(i) Requested before the expiration of the period for filing an appeal or commencing a civil action, and upon a showing of good cause; or
(ii) Requested after the expiration of the period for filing an appeal or commencing a civil action, and upon a showing that the failure to act was the result of excusable neglect.
(2) The request must be filed as provided in § 104.2 of this chapter and addressed to the attention of the Office of the Solicitor. A copy of the request should also be filed with the Trademark Trial and Appeal Board via ESTTA.
(a)
(b)
(c)
All business with the Office should be transacted in writing. The personal appearance of applicants or their representatives at the Office is unnecessary. The action of the Office will be based exclusively on the written record. No attention will be paid to any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt. The Office encourages parties to file documents through TEAS wherever possible, or through ESTTA for documents in proceedings before the Trademark Trial and Appeal Board.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments.
NMFS has received a request from the U.S. Navy (Navy) for authorization to take marine mammals incidental to construction activities as part of a pier construction and support facilities project. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to the Navy to incidentally take marine mammals, by Level B Harassment only, during the specified activity.
Comments and information must be received no later than May 4, 2016.
Comments on the application should be addressed to Jolie Harrison, Supervisor, Incidental Take Program, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Laura McCue, Office of Protected Resources, NMFS, (301) 427-8401.
An electronic copy of the Navy's application and supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the Internet at:
The Navy has prepared a draft Environmental Assessment (
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
The incidental taking of small numbers of marine mammals may be allowed only if NMFS (through authority delegated by the Secretary) finds that the total taking by the specified activity during the specified time period will (i) have a negligible impact on the species or stock(s) and (ii) not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant). Further, the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such taking must be set forth, either in specific regulations or in an authorization.
The allowance of such incidental taking under section 101(a)(5)(A), by harassment, serious injury, death, or a combination thereof, requires that regulations be established. Subsequently, a Letter of Authorization may be issued pursuant to the prescriptions established in such regulations, providing that the level of taking will be consistent with the findings made for the total taking allowable under the specific regulations. Under section 101(a)(5)(D), NMFS may authorize such incidental taking by harassment only, for periods of not more than one year, pursuant to requirements and conditions contained within an IHA. The establishment of prescriptions through either specific regulations or an authorization requires notice and opportunity for public comment.
NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering.” The former is termed Level A harassment and the latter is termed Level B harassment.
On September 11, 2015, we received a request from the Navy for authorization to take marine mammals incidental to pile driving associated with the construction of a pier and support facilities at the U.S. Coast Guard (USCG) Air Station/Sector Field Office Port Angeles (AIRSTA/SFO Port Angeles), located in Port Angeles Harbor on the Ediz Hook peninsula, Port Angeles. The Navy submitted a revised version of the request on February 19, 2016, which we deemed adequate and complete on February 22, 2016.
The Navy proposes to initiate this multi-year project, involving impact and
The use of both vibratory and impact pile driving is expected to produce underwater sound at levels that have the potential to result in behavioral harassment of marine mammals. Take, by Level B Harassment only, has been requested for individuals of five species of marine mammals (harbor porpoise [
The Navy has increased security for in-transit Fleet Ballistic Missile Submarines (SSBNs) in inland marine waters of northern Washington by establishing a Transit Protection System (TPS) that relies on the use of multiple escort vessels. The purpose of the Pier and Support Facilities for TPS project is to provide a staging location for TPS vessels and crews that escort incoming and outgoing SSBNs between dive/surface points in the Strait of Juan de Fuca and Naval Base (NAVBASE) Kitsap Bangor.
Specific activities that can be expected to result in the incidental taking of marine mammals are limited to the driving of steel piles used for installation of the trestle/fixed pier/floating docks, and the removal of existing piles.
Vibratory pile driving is the preferred method for production piles and would be the initial starting point for each installation; however, impact pile driving methods may be necessary based on substrate conditions. Once a pile hits “refusal,” which is where hard solid or dense substrate (
All piles would be driven with a vibratory hammer for their initial embedment depths, while select piles may be finished with an impact hammer for proofing, as necessary. There would be no concurrent pile driving or multiple hammers operating simultaneously. Proofing involves striking a driven pile with an impact hammer to verify that it provides the required load-bearing capacity, as indicated by the number of hammer blows per foot of pile advancement. Sound attenuation measures (
Under the proposed action, in-water construction is anticipated to begin in 2016 and require two in-water work window seasons. The allowable season for in-water work, including pile driving, at AIRSTA/SFO Port Angeles is November 1, 2016 through February 15, 2017, and July 16, 2017 through October 31, 2017, a window established by the Washington Department of Fish and Wildlife in coordination with NMFS and the U.S. Fish and Wildlife Service (USFWS) to protect juvenile salmon (
AIRSTA/SFO Port Angeles is located in the Strait of Juan de Fuca, approximately 62 miles (100 km) east of Cape Flattery, and 63 miles (102 km) northwest of Seattle, Washington on the Olympic Peninsula (see Figure 1-1 in the Navy's application). The Strait of Juan de Fuca is a wide waterway stretching from the Pacific Ocean to the Salish Sea. The strait is 95 miles (153-km) long, 15.5 miles (25 km) wide, and has depths ranging from 180 m to 250 m on the pacific coast and 55 m at the sill. Please see Section 2 of the Navy's application for detailed information about the specific geographic region, including physical and oceanographic characteristics.
The purpose of the Pier and Support Facilities for TPS project (the project) is to provide a staging location for TPS vessels and crews that escort incoming and outgoing SSBNs between dive/surface points in the Strait of Juan de Fuca and Naval Base (NAVBASE) Kitsap Bangor. The Navy has increased security for in-transit Fleet Ballistic Missile Submarines (SSBNs) in inland marine waters of northern Washington by establishing a Transit Protection System (TPS) that relies on the use of multiple escort vessels. Construction of the pier and support facilities is grouped into three broad categories: (1) Site Work Activities (2) Construction of Upland Facilities (Alert Forces Facility [AFF] and Ready Service Armory [RSA]), and (3) Construction of Trestle/Fixed Pier/Floating Docks.
The trestle, fixed pier, and floating docks would result in a permanent increase in overwater coverage of 25,465 square-feet (ft
For the entire project, pile installation would include the installation and removal of 80 temporary indicator piles, installation of 60 permanent sheet piles, and installation of 144 permanent steel piles (Table 1). The indicator piles are required to determine if required bearing capacities will be achieved with the production piles, and to assess whether the correct vibratory and impact hammers are being used. The process will be to vibrate the piles to within 5 ft (1.5 m) of the target embedment depth required for the
A maximum of 75 days of pile driving may occur. Table 1 summarizes the number and nature of piles required for the entire project.
Pile installation will utilize vibratory pile drivers to the greatest extent possible, and the Navy anticipates that most piles will be able to be vibratory driven to within several feet of the required depth. Pile drivability is, to a large degree, a function of soil conditions and the type of pile hammer. Most piles should be able to be driven with a vibratory hammer to proper embedment depth. However, difficulties during pile driving may be encountered as a result of obstructions, such as rocks or boulders, which may exist throughout the project area. If difficult driving conditions occur, increased usage of an impact hammer will occur.
Pile production rates are dependent upon required embedment depths, the potential for encountering difficult driving conditions, and the ability to drive multiple piles without a need to relocate the driving rig. If difficult subsurface driving conditions (
There are eleven marine mammal species with recorded occurrence in the Strait of Juan de Fuca, including seven cetaceans and four pinnipeds. Of these eleven species, only five are expected to have a reasonable potential to be in the vicinity of the project site. These species are harbor porpoise (
We have reviewed the Navy's detailed species descriptions, including life history information, for accuracy and completeness and refer the reader to Sections 3 and 4 of the Navy's application instead of reprinting the information here. Please also refer to NMFS' Web site (
Table 2 lists the eleven marine mammal species with expected potential for occurrence in the vicinity of AIRSTA/SFO Port Angeles during the project timeframe, and summarizes key information regarding stock status and abundance. Taxonomically, we follow Committee on Taxonomy (2014). Please see NMFS' Stock Assessment Reports (SAR), available at
In the species accounts provided here, we offer a brief introduction to the species and relevant stock as well as available information regarding population trends and threats, and describe any information regarding local occurrence.
Although the humpback whale (
Harbor porpoises are found primarily in inshore and relatively shallow coastal waters (<100 m) from Point Barrow (Alaska) to Point Conception (California). Various genetic analyses and investigation of pollutant loads indicate a low mixing rate for harbor porpoises along the west coast of North America and likely fine-scale geographic structure along an almost continuous distribution from California to Alaska (
The Washington inland waters stock has a population estimate of 10,682 animals (Caretta
Within the Exclusive Economic Zone (EEZ) boundaries of the coastal waters of northern Oregon and Washington, harbor porpoise deaths are known to occur in the northern Washington marine set gillnet tribal fishery. Fishing effort in the coastal marine set gillnet tribal fishery has declined since 2004. A mean annual mortality of 3.0 harbor porpoise was calculated in 2007-2011 from stranding data. Since these deaths could not be attributed to a particular fishery, and were the only confirmed fishery-related deaths in this area in 2007-2011, they are noted in unknown West Coast fisheries (Caretta
In Washington inland waters, harbor porpoise are known to occur in the Strait of Juan de Fuca and the San Juan Island area year round (Calambokidis and Baird 1994; Osmek
Northern elephant seals that may occur in the activity area would belong to the California breeding stock. The current best abundance estimate for the California breeding stock of Northern elephant seal is 179,000 individuals (Caretta
The northern elephant seal occurs almost exclusively in the eastern and central North Pacific. Rookeries are located from central Baja California, Mexico, to northern California (Stewart and Huber 1993). Recent aerial surveys from April, 2015 reported no sighting of elephant seals in the Strait of Juan de Fuca (Smultsea
Small numbers of juvenile elephant seals haul out and go through their molting process in Washington State. Molting is a natural condition that takes 4 to 5 weeks to complete. In Washington inland waters, there are regular haul-out sites at Smith and Minor Islands, Dungeness Spit, and Protection Island in the Strait of Juan de Fuca that are thought to be used year round (Jeffries
Steller sea lions are distributed mainly around the coasts to the outer continental shelf along the North Pacific rim from northern Hokkaido, Japan through the Kuril Islands and Okhotsk Sea, Aleutian Islands and central Bering Sea, southern coast of Alaska and south to California (Loughlin
According to NMFS' recent status review (NMFS, 2013), the best available information indicates that the overall abundance of eastern DPS Steller sea lions has increased for a sustained period of at least three decades while pup production has also increased significantly, especially since the mid-1990s. Johnson and Gelatt (2012) provided an analysis of growth trends of the entire eastern DPS from 1979-2010, indicating that the stock increased during this period at an annual rate of 4.2 percent (90 percent CI 3.7-4.6). Most of the overall increase occurred in the northern portion of the range (southeast Alaska and British Columbia), but pup counts in Oregon and California also increased significantly (
Between 2008 and 2012, a minimum total of 64 animals from the eastern Steller sea lion stock were reported taken. The annual average take for subsistence harvest in Alaska was 11 individuals in 2004-08 (Muto and Angliss, 2015). Data on community subsistence harvests is no longer being collected, and this average is retained as an estimate for current and future subsistence harvest. Sea lion deaths are also known to occur because of illegal shooting, vessel strikes, or capture in research gear and other traps (Muto and Angliss, 2015). The mean average human-caused mortality and serious injury of eastern Steller sea lions for 2008-2012 from sources other than fisheries and Alaska Native harvest is 29.4.
The population is estimated to be within the range of 60,131 and 74,448 animals. This stock is not listed as “depleted” under the MMPA, and is not listed as “threatened” or “endangered” under the ESA (Alaska SAR). It is considered a strategic stock under the MMPA.
The eastern stock breeds in rookeries located in southeast Alaska, British Columbia, Oregon, and California. There are no known breeding rookeries in Washington (Allen and Angliss, 2014) but eastern stock Steller sea lions are present year-round along the outer coast of Washington, including immature animals or non-breeding adults of both sexes. In Washington, Steller sea lions primarily occur at haul-out sites along the outer coast from the Columbia River to Cape Flattery and in inland waters sites along the Vancouver Island coastline of the Strait of Juan de Fuca (Jeffries
There are no known Steller sea lions haul-outs in Port Angeles Harbor (WDFW, 2015). The nearest haul-out to the project site is approximately 12.5 miles (20 kilometers) across the Strait of Juan de Fuca at Race Rocks and identified to have an annual maximum number of greater than 100 animals (Wiles, 2015). Animal censuses at the Race Rocks Ecological Reserve between January 2014 and January 2016 indicated a peak abundance in September to December, with numbers that ranged from 200 to 500 individuals (Race Rocks Ecological Reserve Web site 2016). The Steller sea lions at Race Rocks are mainly bachelor bulls or juvenile yearlings. This is not a breeding colony, and mature females are not usually present (Race Rocks Ecological Reserve Web site 2016). In contrast, a haul-out about 30 miles (48 km) east of the project at Point Wilson was surveyed November 2013 with one Steller sea lion (WDFW, 2015). Steller sea lions could forage within Port Angeles Harbor, following local prey availability, but because haul-outs are far away, use of the area is likely limited.
Harbor seals inhabit coastal and estuarine waters and shoreline areas of the northern hemisphere from temperate to polar regions. The eastern North Pacific subspecies is found from Baja California north to the Aleutian Islands and into the Bering Sea. Multiple lines of evidence support the existence of geographic structure among harbor seal populations from California to Alaska (
Recent genetic evidence suggests that harbor seals of Washington inland waters may have sufficient population structure to warrant division into multiple distinct stocks (Huber
In 1999, the mean count of harbor seals occurring in Washington's inland waters was 7,213 (CV = 0.14) in Washington Northern Inland Waters (Caretta,
Harbor seals occur year round throughout the nearshore inland waters of Washington. Harbor seals are expected to occur year round in Port Angeles Harbor, with a nearby haul-out site on a log boom located approximately 1.7 miles (2.7 km) west of the project site that was last surveyed in March 2013 and had a total count of 73 harbor seals (WDFW 2015). Another haulout site is 1.3 miles (2.1 km) south of the project but is across the harbor that was last surveyed in July 2010 and had a total count of 87 harbor seals (WDFW 2015). The level of use of these haul-outs during the fall and winter is unknown, but is expected to be much less as air temperatures become colder than water temperatures, resulting in seals in general hauling out less (Pauli and Terhune 1987). Harbor seals may also use other undocumented haul-out sites near the project site. Recent aerial surveys from April, 2015 reported that harbor seals were the most commonly sighted pinniped in the Strait of Juan de Fuca, with nearly 1400 individuals sighted in 286 groups (Smultsea
California sea lions range from the Gulf of California north to the Gulf of Alaska, with breeding areas located in the Gulf of California, western Baja California, and southern California. Five genetically distinct geographic populations have been identified: (1) Pacific temperate, (2) Pacific subtropical, and (3-5) southern, central, and northern Gulf of California (Schramm
Trends in pup counts from 1975 through 2008 have been assessed for four rookeries in southern California and for haul-outs in central and northern California. During this time period counts of pups increased at an annual rate of 5.4 percent, excluding six El Nino years when pup production declined dramatically before quickly rebounding (Carretta
The average annual commercial fishery mortality is 331 animals per year. Total human-caused mortality of this stock is at least 389 animals per year. In addition, a summary of stranding database records for 2005-09 shows an annual average of 65 such events, which is likely a gross underestimate because most carcasses are not recovered. California sea lions may also be removed because of predation on endangered salmonids (seventeen per year, 2008-10) or incidentally captured during scientific research (three per year, 2005-09) (Carretta
An estimated 3,000 to 5,000 California sea lions migrate northward along the coast to central and northern California, Oregon, Washington, and Vancouver Island during the non-breeding season from September to May (Jeffries
During the summer, California sea lions breed on islands from the Gulf of California to the Channel Islands and seldom travel more than about 31 miles (50 km) from the islands. The primary rookeries are located on the California Channel Islands of San Miguel, San Nicolas, Santa Barbara, and San Clemente, probably in response to changes in prey availability. In the nonbreeding season, adult and subadult males migrate north along the coast to central and northern California, Oregon, Washington, and Vancouver Island, and return south in the spring. Their distribution shifts to the northwest in fall and to the southeast during winter and spring. Recent aerial surveys from April, 2015 reported 12 sightings of California sea lions in the Strait of Juan de Fuca representing 13 individuals (Smultsea
Dedicated, regular haul-outs used by adult and subadult California sea lions in Washington inland waters have been identified (Jeffries
This section includes a summary and discussion of the ways that components of the specified activity (
In the following discussion, we provide general background information on sound and marine mammal hearing before considering potential effects to marine mammals from sound produced by vibratory and impact pile driving.
Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in hertz (Hz) or cycles per second. Wavelength is the distance between two peaks of a sound wave; lower frequency sounds have longer wavelengths than higher frequency sounds and attenuate (decrease) more rapidly in shallower water. Amplitude is the height of the sound pressure wave or the `loudness' of a sound and is typically measured using the decibel (dB) scale. A dB is the ratio between a measured pressure (with sound) and a reference pressure (sound at a constant pressure, established by scientific standards). It is a logarithmic unit that accounts for large variations in amplitude; therefore, relatively small changes in dB ratings correspond to large changes in sound pressure. When referring to sound pressure levels (SPLs; the sound force per unit area), sound is referenced in the context of underwater sound pressure to 1 microPascal (μPa). One pascal is the pressure resulting from a force of one newton exerted over an area of one square meter. The source level (SL) represents the sound level at a distance of 1 m from the source (referenced to 1 μPa). The received level is the sound level at the listener's position. Note that all underwater sound levels in this document are referenced to a pressure of 1 μPa and all airborne sound levels in this document are referenced to a pressure of 20 μPa.
Root mean square (rms) is the quadratic mean sound pressure over the duration of an impulse. Rms is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1983). Rms accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.
When underwater objects vibrate or activity occurs, sound-pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in all directions away from the source (similar to ripples on the surface of a pond), except in cases where the source is directional. The compressions and decompressions associated with sound waves are detected as changes in pressure by aquatic life and man-made sound receptors such as hydrophones.
Even in the absence of sound from the specified activity, the underwater environment is typically loud due to ambient sound. Ambient sound is defined as environmental background sound levels lacking a single source or point (Richardson
• Wind and waves: The complex interactions between wind and water surface, including processes such as breaking waves and wave-induced bubble oscillations and cavitation, are a main source of naturally occurring ambient noise for frequencies between 200 Hz and 50 kHz (Mitson, 1995). In general, ambient sound levels tend to increase with increasing wind speed and wave height. Surf noise becomes important near shore, with measurements collected at a distance of 8.5 km from shore showing an increase of 10 dB in the 100 to 700 Hz band during heavy surf conditions.
• Precipitation: Sound from rain and hail impacting the water surface can become an important component of total noise at frequencies above 500 Hz, and possibly down to 100 Hz during quiet times.
• Biological: Marine mammals can contribute significantly to ambient noise levels, as can some fish and shrimp. The frequency band for biological contributions is from approximately 12 Hz to over 100 kHz.
• Anthropogenic: Sources of ambient noise related to human activity include transportation (surface vessels and aircraft), dredging and construction, oil and gas drilling and production, seismic surveys, sonar, explosions, and ocean acoustic studies. Shipping noise typically dominates the total ambient
The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardson
In-water construction activities associated with the project would include impact pile driving and vibratory pile driving. The sounds produced by these activities fall into one of two general sound types: Pulsed and non-pulsed (defined in the following). The distinction between these two sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing (
Pulsed sound sources (
Non-pulsed sounds can be tonal, narrowband, or broadband, brief or prolonged, and may be either continuous or non-continuous (ANSI, 1995; NIOSH, 1998). Some of these non-pulsed sounds can be transient signals of short duration but without the essential properties of pulses (
Impact hammers operate by repeatedly dropping a heavy piston onto a pile to drive the pile into the substrate. Sound generated by impact hammers is characterized by rapid rise times and high peak levels, a potentially injurious combination (Hastings and Popper, 2005). Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the sediment. Vibratory hammers produce significantly lower levels of sound than impact hammers. Peak SPLs may be 180 dB or greater, but are generally 10 to 20 dB lower than SPLs generated during impact pile driving of the same-sized pile (Oestman
Hearing is the most important sensory modality for marine mammals, and exposure to intense sound can have deleterious effects. To appropriately assess these potential effects, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (
• Low-frequency cetaceans (mysticetes): Functional hearing is estimated to occur between approximately 7 Hz and 25 kHz (up to 30 kHz in some species), with best hearing estimated to be from 100 Hz to 8 kHz (Watkins, 1986; Ketten, 1998; Houser
• Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Functional hearing is estimated to occur between approximately 150 Hz and 160 kHz, with best hearing from 10 to less than 100 kHz (Johnson, 1967; White, 1977; Richardson
• High-frequency cetaceans (porpoises, river dolphins, and members of the genera
• Pinnipeds in water; Phocidae (true seals): Functional hearing is estimated to occur between approximately 75 Hz to 100 kHz, with best hearing between 1-50 kHz (Møhl, 1968; Terhune and Ronald, 1971, 1972; Richardson
• Pinnipeds in water; Otariidae (eared seals): Functional hearing is estimated to occur between 100 Hz and 48 kHz for Otariidae, with best hearing between 2-48 kHz (Schusterman
The pinniped functional hearing group was modified from Southall
There are five marine mammal species (one cetacean and four pinniped [two otariid and two phocid] species) with expected potential to co-occur with Navy construction activities. Please refer to Table 2. The harbor porpoise is classified as a high-frequency cetacean.
Richardson
We describe the more severe effects (
When PTS occurs, there is physical damage to the sound receptors in the ear (
Relationships between TTS and PTS thresholds have not been studied in marine mammals—PTS data exists only for a single harbor seal (Kastak
Non-auditory physiological effects or injuries that theoretically might occur in marine mammals exposed to high level underwater sound or as a secondary effect of extreme behavioral reactions (
When a live or dead marine mammal swims or floats onto shore and is incapable of returning to sea, the event is termed a “stranding” (16 U.S.C. 1421h(3)). Marine mammals are known to strand for a variety of reasons, such as infectious agents, biotoxicosis, starvation, fishery interaction, ship strike, unusual oceanographic or weather events, sound exposure, or combinations of these stressors sustained concurrently or in series (
1.
Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
Currently, TTS data only exist for four species of cetaceans (bottlenose dolphin [
2.
Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok
Available studies show wide variation in response to underwater sound; therefore, it is difficult to predict specifically how any given sound in a particular instance might affect marine mammals perceiving the signal. If a marine mammal does react briefly to an underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant (
Changes in dive behavior can vary widely, and may consist of increased or decreased dive times and surface intervals as well as changes in the rates of ascent and descent during a dive (
Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure, so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators (
Variations in respiration naturally vary with different behaviors and alterations to breathing rate as a function of acoustic exposure can be expected to co-occur with other behavioral reactions, such as a flight response or an alteration in diving. However, respiration rates in and of themselves may be representative of annoyance or an acute stress response. Various studies have shown that
Marine mammals vocalize for different purposes and across multiple modes, such as whistling, echolocation click production, calling, and singing. Changes in vocalization behavior in response to anthropogenic noise can occur for any of these modes and may result from a need to compete with an increase in background noise or may reflect increased vigilance or a startle response. For example, in the presence of potentially masking signals, humpback whales and killer whales have been observed to increase the length of their songs (Miller
Avoidance is the displacement of an individual from an area or migration path as a result of the presence of a sound or other stressors, and is one of the most obvious manifestations of disturbance in marine mammals (Richardson
A flight response is a dramatic change in normal movement to a directed and rapid movement away from the perceived location of a sound source. The flight response differs from other avoidance responses in the intensity of the response (
Behavioral disturbance can also impact marine mammals in more subtle ways. Increased vigilance may result in costs related to diversion of focus and attention (
Many animals perform vital functions, such as feeding, resting, traveling, and socializing, on a diel cycle (24-hour cycle). Disruption of such functions resulting from reactions to stressors such as sound exposure are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall
3.
Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction, altered metabolism, reduced immune competence, and behavioral disturbance (
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and “distress” is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficient to restore normal function.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well-studied through controlled experiments and for both laboratory and free-ranging animals (
4.
Under certain circumstances, marine mammals experiencing significant masking could also be impaired from maximizing their performance fitness in survival and reproduction. Therefore, when the coincident (masking) sound is man-made, it may be considered harassment when disrupting or altering critical behaviors. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect.
The frequency range of the potentially masking sound is important in determining any potential behavioral impacts. For example, low-frequency signals may have less effect on high-frequency echolocation sounds produced by odontocetes but are more likely to affect detection of mysticete communication calls and other potentially important natural sounds such as those produced by surf and some prey species. The masking of communication signals by anthropogenic noise may be considered as a reduction in the communication space of animals (
Masking affects both senders and receivers of acoustic signals and can potentially have long-term chronic effects on marine mammals at the population level as well as at the individual level. Low-frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, with most of the increase from distant commercial shipping (Hildebrand, 2009). All anthropogenic sound sources, but especially chronic and lower-frequency signals (
In the absence of mitigation, impacts to marine species could be expected to include physiological and behavioral responses to the acoustic signature (Viada
Responses to continuous sound, such as vibratory pile installation, have not been documented as well as responses to pulsed sounds. With both types of pile driving, it is likely that the onset of pile driving could result in temporary, short term changes in an animal's typical behavior and/or avoidance of the affected area. These behavioral changes may include (Richardson
The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could be expected to be biologically significant if the change affects growth, survival, or reproduction. Significant behavioral modifications that could potentially lead to effects on growth, survival, or reproduction include:
• Drastic changes in diving/surfacing patterns (such as those thought to cause beaked whale stranding due to exposure to military mid-frequency tactical sonar);
• Longer-term habitat abandonment due to loss of desirable acoustic environment; and
• Longer-term cessation of feeding or social interaction.
The onset of behavioral disturbance from anthropogenic sound depends on both external factors (characteristics of sound sources and their paths) and the specific characteristics of the receiving animals (hearing, motivation, experience, demography) and is difficult to predict (Southall
The proposed activities at AIRSTA/SFO Port Angeles would not result in permanent impacts to habitats used directly by marine mammals, such as haul-out sites, but may have potential short-term impacts to food sources such as forage fish and salmonids. The only rookeries or major haul-out sites in close proximity to the project site are harbor seal haul-outs located approximately 1.7 miles (2.7 km) west, and another 1.3 miles (2.1 km) south of the project site. The next closest rookery or major haul-out site is 11.2 miles (18 km) away. The nearest Steller sea lion haul-out to the project site is approximately 12.5 miles (20 km) across the Strait of Juan de Fuca at Race Rocks. There are no ocean bottom structures of significant biological importance to marine mammals that may be present in the marine waters in the vicinity of the project area. Therefore, the main impact associated with the proposed activity would be temporarily elevated sound levels and the associated direct effects on marine mammals, as discussed previously in this document. The most likely impact to marine mammal habitat occurs from pile driving effects on likely marine mammal prey (
Construction activities would produce both pulsed (
The area likely impacted by the project is relatively small compared to the available habitat in the Port Angeles Harbor. Avoidance by potential prey (
In summary, given the short daily duration of sound associated with individual pile driving events and the relatively small areas being affected, pile driving activities associated with the proposed action are not likely to have a permanent, adverse effect on any fish habitat, or populations of fish species. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses.
Measurements from similar pile driving events were coupled with practical spreading loss to estimate zones of influence (ZOI; see Estimated Take by Incidental Harassment); these values were used to develop mitigation measures for pile driving activities at Port Angeles harbor. The ZOIs effectively represent the mitigation zone that would be established around each pile to prevent Level A harassment to marine mammals, while providing estimates of the areas within which Level B harassment might occur. In addition to the specific measures described later in this section, the Navy would conduct briefings between construction supervisors and crews, marine mammal monitoring team, and Navy staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.
The following measures would apply to the Navy's mitigation through shutdown and disturbance zones:
In order to document observed incidents of harassment, monitors record all marine mammal observations, regardless of location. The observer's location, as well as the location of the pile being driven, is known from a GPS. The location of the animal is estimated as a distance from the observer, which is then compared to the location from the pile. The received level may be estimated on the basis of past or
The following additional measures apply to visual monitoring:
(1) Monitoring will be conducted by qualified observers, who will be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Qualified observers are trained biologists, with the following minimum qualifications:
• Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;
• Advanced education in biological science or related field (undergraduate degree or higher required);
• Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience);
• Experience or training in the field identification of marine mammals, including the identification of behaviors;
• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and
• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
(2) Prior to the start of pile driving activity, the shutdown zone will be monitored for fifteen minutes to ensure that it is clear of marine mammals. Pile driving will only commence once observers have declared the shutdown zone clear of marine mammals; animals will be allowed to remain in the shutdown zone (
(3) If a marine mammal approaches or enters the shutdown zone during the course of pile driving operations, activity will be halted and delayed until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or fifteen minutes have passed without re-detection of the animal. Monitoring will be conducted throughout the time required to drive a pile.
Sound levels can be greatly reduced during impact pile driving using sound attenuation devices. There are several types of sound attenuation devices including bubble curtains, cofferdams, and isolation casings (also called temporary noise attenuation piles [TNAP]), and cushion blocks. The Navy proposes to use bubble curtains, which create a column of air bubbles rising around a pile from the substrate to the water surface. The air bubbles absorb and scatter sound waves emanating from the pile, thereby reducing the sound energy. Bubble curtains may be confined or unconfined. An unconfined bubble curtain may consist of a ring seated on the substrate and emitting air bubbles from the bottom. An unconfined bubble curtain may also consist of a stacked system, that is, a series of multiple rings placed at the bottom and at various elevations around the pile. Stacked systems may be more effective than non-stacked systems in areas with high current and deep water (Oestman
A confined bubble curtain contains the air bubbles within a flexible or rigid sleeve made from plastic, cloth, or pipe. Confined bubble curtains generally offer higher attenuation levels than unconfined curtains because they may physically block sound waves and they prevent air bubbles from migrating away from the pile. For this reason, the confined bubble curtain is commonly used in areas with high current velocity (Oestman
Both environmental conditions and the characteristics of the sound attenuation device may influence the effectiveness of the device. According to Oestman
• In general, confined bubble curtains attain better sound attenuation levels in areas of high current than unconfined bubble curtains. If an unconfined device is used, high current velocity may sweep bubbles away from the pile, resulting in reduced levels of sound attenuation.
• Softer substrates may allow for a better seal for the device, preventing leakage of air bubbles and escape of sound waves. This increases the effectiveness of the device. Softer substrates also provide additional attenuation of sound traveling through the substrate.
• Flat bottom topography provides a better seal, enhancing effectiveness of the sound attenuation device, whereas sloped or undulating terrain reduces or eliminates its effectiveness.
• Air bubbles must be close to the pile; otherwise, sound may propagate into the water, reducing the effectiveness of the device.
• Harder substrates may transmit ground-borne sound and propagate it into the water column.
The literature presents a wide array of observed attenuation results for bubble curtains (
To avoid loss of attenuation from design and implementation errors, the Navy has required specific bubble curtain design specifications, including testing requirements for air pressure and flow prior to initial impact hammer use, and a requirement for placement on the substrate. Bubble curtains shall be used during all impact pile driving. The device will distribute air bubbles around 100 percent of the piling perimeter for the full depth of the water column, and the lowest bubble ring shall be in contact with the mudline for the full circumference of the ring. We considered eight dB as potentially the best estimate of average SPL (rms) reduction, assuming appropriate deployment and no problems with the equipment. Therefore, an eight dB reduction was used in the Navy's analysis of pile driving noise in the environmental analyses.
In Port Angeles Harbor, designated timing restrictions exist for pile driving activities to avoid in-water work when salmonids and other spawning forage fish are likely to be present. The in-water work window is November 1, 2016-February 15, 2017, and July 16-October 31, 2017. All in-water construction activities will occur during daylight hours (sunrise to sunset) except from July 16 to February 15 when impact pile driving/removal will only occur starting 2 hours after sunrise and ending 2 hours before sunset, to protect foraging marbled murrelets during nesting season (April 1-September 23). Other construction (not in-water) may occur between 7 a.m. and 10 p.m., year-round.
The use of a soft-start procedure is believed to provide additional protection to marine mammals by warning or providing a chance to leave the area prior to the hammer operating at full capacity, and typically involves a requirement to initiate sound from vibratory hammers for fifteen seconds at reduced energy followed by a thirty-second waiting period. This procedure is repeated two additional times.
Implementation of soft start for vibratory pile driving during previous pile driving work for the Explosives Handling Wharf at Fort Hood Navy Base Kitsap Bangor led to equipment failure and serious human safety concerns, which resulted in discontinuation of the soft-start procedure for vibratory pile driving. The Marine Mammal Commission has stated that the soft-start is a viable, effective component of a mitigation plan designed to effect the least practicable impact on marine mammals. In response to this concern, NMFS formed a working group with the Navy in April 2014 to address the soft-start procedures. At this time, the EHW-2 project is the only project where the procedure has been waived.
For this proposed IHA, as a result of this potential low risk to human safety, we have determined vibratory soft start to be practicable, but if unsafe working conditions during soft-starts are reported by the contractor and verified by an independent safety inspection, the Navy may elect to discontinue vibratory soft-starts.
For impact driving, soft start will be required, and contractors will provide an initial set of strikes from the impact hammer at reduced energy, followed by a thirty-second waiting period, then two subsequent reduced energy strike sets. The reduced energy of an individual hammer cannot be quantified because of variation in individual drivers. The actual number of strikes at reduced energy will vary because operating the hammer at less than full power results in “bouncing” of the hammer as it strikes the pile, resulting in multiple “strikes.” Soft start for impact driving will be required at the beginning of each day's pile driving work and at any time following a cessation of impact pile driving of thirty minutes or longer.
We have carefully evaluated the Navy's proposed mitigation measures and considered their effectiveness in past implementation to preliminarily determine whether they are likely to effect the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals, (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation.
Any mitigation measure(s) we prescribe should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:
(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).
(2) A reduction in the number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).
(3) A reduction in the number (total number or number at biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).
(4) A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing the severity of behavioral harassment only).
(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time.
(6) For monitoring directly related to mitigation, an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on our evaluation of the Navy's proposed measures, we have preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking”. The MMPA implementing regulations at 50 CFR 216.104 (a)(13)
Any monitoring requirement we prescribe should accomplish one or more of the following general goals:
1. An increase in the probability of detecting marine mammals, both within defined zones of effect (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;
2. An increase in our understanding of how many marine mammals are likely to be exposed to stimuli that we associate with specific adverse effects, such as behavioral harassment or hearing threshold shifts;
3. An increase in our understanding of how marine mammals respond to stimuli expected to result in incidental take and how anticipated adverse effects on individuals may impact the population, stock, or species (specifically through effects on annual rates of recruitment or survival) through any of the following methods:
• Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict pertinent information,
• Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict pertinent information,
• Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;
4. An increased knowledge of the affected species; or
5. An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.
The Navy submitted a marine mammal monitoring plan as part of the IHA application for this project. It can be found on the Internet at
The Navy will collect sighting data and behavioral responses to construction for marine mammal species observed in the region of activity during the period of activity. All observers will be trained in marine mammal identification and behaviors and are required to have no other construction-related tasks while conducting monitoring. The Navy will monitor the shutdown zone and disturbance zone before, during, and after pile driving, with observers located at the best practicable vantage points. Based on our requirements, the Marine Mammal Monitoring Plan would implement the following procedures for pile driving:
• A minimum of three Marine Mammal Observers (protected species observers [PSOs]) would be present during both impact and vibratory pile driving/removal and would be located at the best vantage point(s) in order to properly see the entire shutdown zone and as much of the disturbance zone as possible.
• During all observation periods, observers will use binoculars and the naked eye to search continuously for marine mammals.
• If the shutdown zones are obscured by fog or poor lighting conditions, pile driving at that location will not be initiated until that zone is visible. Should such conditions arise while impact driving is underway, the activity would be halted.
• The shutdown and disturbance zones around the pile will be monitored for the presence of marine mammals before, during, and after any pile driving or removal activity.
Individuals implementing the monitoring protocol will assess its effectiveness using an adaptive approach. Monitoring biologists will use their best professional judgment throughout implementation and seek improvements to these methods when deemed appropriate. Any modifications to protocol will be coordinated between NMFS and the Navy.
We require that observers use approved data forms. Among other pieces of information, the Navy will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the Navy will attempt to distinguish between the number of individual animals taken and the number of incidents of take. We require that, at a minimum, the following information be collected on the sighting forms:
• Date and time that monitored activity begins or ends;
• Construction activities occurring during each observation period;
• Weather parameters (
• Water conditions (
• Species, numbers, and, if possible, sex and age class of marine mammals;
• Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
• Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
• Locations of all marine mammal observations; and
• Other human activity in the area.
A draft report would be submitted within ninety calendar days of the completion of the in-water work window. The report will include marine mammal observations pre-activity, during-activity, and post-activity during pile driving days, and will also provide descriptions of any problems encountered in deploying sound attenuating devices, any behavioral responses to construction activities by marine mammals and a complete description of all mitigation shutdowns and the results of those actions and an extrapolated total take estimate based on the number of marine mammals observed during the course of construction. A final report must be submitted within thirty days following resolution of comments on the draft report.
Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”
All anticipated takes would be by Level B harassment resulting from vibratory and impact pile driving and involving temporary changes in behavior. The proposed mitigation and monitoring measures are expected to minimize the possibility of injurious or
Low level responses to sound (
The project area is not believed to be particularly important habitat for marine mammals, nor is it considered an area frequented by marine mammals. Therefore, behavioral disturbances that could result from anthropogenic sound associated with these activities are expected to affect only a relatively small number of individual marine mammals, although those effects could be recurring over the life of the project if the same individuals remain in the project vicinity.
The Navy has requested authorization for the incidental taking of small numbers of Steller sea lions, California sea lions, harbor seals, Northern elephant seals, and harbor porpoises in Port Angeles Harbor that may result from pile driving during construction activities associated with the pier construction and support facilities project described previously in this document. In order to estimate the potential incidents of take that may occur incidental to the specified activity, we must first estimate the extent of the sound field that may be produced by the activity and then consider in combination with information about marine mammal density or abundance in the project area. We first provide information on applicable sound thresholds for determining effects to marine mammals before describing the information used in estimating the sound fields, the available marine mammal density or abundance information, and the method of estimating potential incidences of take.
We use generic sound exposure thresholds to determine when an activity that produces sound might result in impacts to a marine mammal such that a take by harassment might occur (Table 3). To date, no studies have been conducted that explicitly examine impacts to marine mammals from pile driving sounds or from which empirical sound thresholds have been established. These thresholds should be considered guidelines for estimating when harassment may occur (
This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20*log[range]). Cylindrical spreading occurs in an environment in which
The tables presented here detail representative pile driving SPLs that have been recorded from similar construction activities in recent years. Due to the similarity of these actions and the Navy's proposed action, these values represent reasonable SPLs which could be anticipated, and which were used in the acoustic modeling and analysis. Table 4 displays SPLs measured during pile installation using an impact hammer and Table 5 displays SPLs measured during pile installation using a vibratory hammer. For impact driving, average RMS values over 24-, 30-, and 36-in piles ranged from 181 dB to 198 dB. A source value of 193 dB rms at 10 m was the average value reported from the listed studies. For vibratory pile driving, source levels ranged depending on pile type and size. At 10 m, source values of 161 dB (16- to 24-in steel pipe pile), 167 dB (30- to 36-in steel pipe pile), were used.
All calculated distances to, and the total area encompassed by, the marine mammal sound thresholds are provided in Table 6. Although radial distance and area associated with the zone ensonified to 160 dB (the behavioral harassment threshold for pulsed sounds, such as those produced by impact driving) are presented in Table 6, this zone would be
Port Angeles Harbor does not represent open water, or free field, conditions. Therefore, sounds would attenuate as they encounter land masses or bends in the canal. As a result, the calculated distance and areas of impact for the 120-dB threshold cannot actually be attained at the project area. See Figure 6-1 of the Navy's application for a depiction of the size of areas in which each underwater sound threshold is predicted to occur at the project area due to pile driving.
As was discussed for underwater sound from pile driving, the intensity of pile driving sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. In order to determine reasonable airborne SPLs and their associated effects on marine mammals that are likely to result from pile driving at AIRSTA/SFO Port Angeles, studies with similar properties to the proposed action, as described previously, were evaluated. Table 7 details representative pile driving activities that have occurred in recent years. Due to the similarity of these actions and the Navy's proposed action, they represent reasonable SPLs which could be anticipated.
Based on these values and the assumption of spherical spreading loss, distances to relevant thresholds and associated areas of ensonification are presented in Table 8. See Figure 6-6 of the Navy's application for a depiction of the size of areas in which each airborne sound threshold is predicted to occur at the project area due to pile driving.
The Navy has developed, with input from regional marine mammal experts, estimates of marine mammal densities in Washington inland waters for the Navy Marine Species Density Database (NMSDD). A technical report (Hanser
For all species, the most appropriate information available was used to estimate the number of potential incidences of take. For harbor porpoise and Northern elephant seals, this involved reviewing historical occurrence and numbers, as well as group size to develop a realistic estimate of potential exposure. For Steller sea lion and California sea lions, this involved NMSDD data. For harbor seals, this involved site-specific data from published literature describing harbor seal research conducted in Washington and Oregon, including counts from haul-outs near Port Angeles Harbor (WDFW, 2015). Therefore, density was calculated as the maximum number of individuals expected to be present at a given time (Houghton
The take calculations presented here rely on the best data currently available for marine mammal populations in the Port Angeles Harbor. The formula was developed for calculating take due to pile driving activity and applied to each group-specific sound impact threshold. The formula is founded on the following assumptions:
• All marine mammal individuals potentially available are assumed to be present within the relevant area, and thus incidentally taken;
• An individual can only be taken once during a 24-h period;
• There were will be 75 total days of in-water activity and the largest ZOI equals 29.9 km
• Exposure modeling assumes that one impact pile driver and three vibratory pile drivers are operating concurrently; and,
• Exposures to sound levels above the relevant thresholds equate to take, as defined by the MMPA.
The calculation for marine mammal takes is estimated by:
The ZOI impact area is the estimated range of impact to the sound criteria. The relevant distances specified in Table 6 were used to calculate ZOIs around each pile. The ZOI impact area took into consideration the possible affected area of Port Angeles harbor from the pile driving site furthest from shore with attenuation due to land shadowing from bends in the shoreline. Because of the close proximity of some of the piles to the shore, the narrowness of the harbor at the project area, and the maximum fetch, the ZOIs for each threshold are not necessarily spherical and may be truncated.
While pile driving can occur any day throughout the in-water work window, and the analysis is conducted on a per day basis, only a fraction of that time (typically a matter of hours on any given day) is actually spent pile driving. Acoustic monitoring has demonstrated that Level B harassment zones for vibratory pile driving are likely to be smaller than the zones estimated through modeling based on measured source levels and practical spreading loss. Also of note is the fact that the effectiveness of mitigation measures in reducing takes is typically not quantified in the take estimation process. See Table 9 for total estimated incidents of take.
Pinnipeds that occur near the project site could be exposed to airborne sounds associated with pile driving that have the potential to cause behavioral harassment, depending on their distance from pile driving activities. Cetaceans are not expected to be exposed to airborne sounds that would result in harassment as defined under the MMPA.
Airborne noise will primarily be an issue for pinnipeds that are swimming or hauled out near the project site within the range of noise levels elevated above the acoustic criteria in Table 7. We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with heads above water. However, these animals would previously have been `taken' as a result of exposure to underwater sound above the behavioral harassment thresholds, which are in all cases larger than those associated with airborne sound. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Multiple incidents of exposure to sound above NMFS' thresholds for behavioral harassment are not believed to result in
We recognize that over the course of the day, while the proportion of animals in the water may not vary significantly, different individuals may enter and exit the water. Therefore, an instantaneous estimate of animals in the water at a given time may not produce an accurate assessment of the number of individuals that enter the water over the daily duration of the activity. However, no data exist regarding fine-scale harbor seal movements within the project area on time durations of less than a day, thus precluding an assessment of ingress or egress of different animals through the action area. As such, it is impossible, given available data, to determine exactly what number of individuals may potentially be exposed to underwater sound.
A typical pile driving day (in terms of the actual time spent driving) is somewhat shorter than may be assumed (
Harbor seals are not likely to have a uniform distribution as is assumed through use of a density estimate, but are likely to be relatively concentrated near areas of interest such as the haul-outs or foraging areas. The estimated 160 harbor seals is the maximum number of animals at haul-outs outside of the airborne Level B behavioral harassment zone; the number of exposures to individual harbor seals foraging in the underwater behavioral harassment zone would likely be much lower.
This tells us that (1) there are likely to be significantly fewer harbor seals in the majority of the action area than the take estimate suggests; and (2) pile driving actually occurs over a limited timeframe on any given day (
NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
Pile driving activities associated with the pier construction project, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in take, in the form of Level B harassment (behavioral disturbance) only, from underwater sounds generated from pile driving. Potential takes could occur if individuals of these species are present in the ensonified zone when pile driving is happening, which is likely to occur because (1) harbor seals are frequently observed in Port Angeles harbor in two known haul-out locations; or (2) cetaceans or pinnipeds transit the outer edges of the larger Level B harassment zone outside of the harbor.
No injury, serious injury, or mortality is anticipated given the methods of installation and measures designed to minimize the possibility of injury to marine mammals. The potential for these outcomes is minimized through the construction method and the implementation of the planned mitigation measures. Specifically, vibratory hammers will be the primary method of installation, and this activity does not have significant potential to cause injury to marine mammals due to the relatively low source levels produced (likely less than 180 dB rms) and the lack of potentially injurious source characteristics. Impact pile driving produces short, sharp pulses with higher peak levels and much sharper rise time to reach those peaks. When impact driving is necessary, required measures (use of a sound attenuation system, which reduces overall source levels as well as dampening the sharp, potentially injurious peaks, and implementation of shutdown zones) significantly reduce any possibility of injury. Given sufficient “notice” through use of soft start, marine mammals are expected to move away from a sound source that is annoying prior to it becoming potentially injurious. The likelihood that marine mammal detection ability by trained observers is high under the environmental conditions described for Port Angeles harbor further enables the implementation of shutdowns to avoid injury, serious injury, or mortality.
Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring). Most likely, individuals will simply move away from the sound source and be temporarily displaced from the areas of pile driving, although even this reaction has been observed primarily only in association with impact pile driving. Repeated exposures of individuals to levels of sound that may cause Level B harassment are unlikely to result in hearing impairment or to significantly disrupt foraging behavior. Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in fitness to those individuals, and thus would not result in any adverse impact to the stock as a whole. Level B harassment will be reduced to the level of least practicable impact through use of mitigation measures described herein and, if sound produced by project activities is sufficiently disturbing, animals are
For pinnipeds, no rookeries are present in the project area, but there are two haul-outs within 2.5 mi (4 km) of the project site. However, the project area is not known to provide foraging habitat of any special importance (other than is afforded by the known migration of salmonids). No cetaceans are expected within the harbor.
In summary, this negligible impact analysis is founded on the following factors: (1) The possibility of injury, serious injury, or mortality may reasonably be considered discountable; (2) the anticipated incidences of Level B harassment consist of, at worst, temporary modifications in behavior; (3) the absence of any major rookeries and only a few haul-out areas near or adjacent to the project site; (4) the absence of cetaceans within the harbor and generally sporadic occurrence outside of the ensonified area; (5) the absence of any other known areas or features of special significance for foraging or reproduction within the project area; and (6) the presumed efficacy of the planned mitigation measures in reducing the effects of the specified activity to the level of least practicable impact. In addition, none of these stocks are listed under the ESA or designated as depleted under the MMPA. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, including those conducted in nearby locations, demonstrate that the potential effects of the specified activity will have only short-term effects on individuals. The specified activity is not expected to impact rates of recruitment or survival and will therefore not result in population-level impacts. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, we preliminarily find that the total marine mammal take from Navy's pier construction activities will have a negligible impact on the affected marine mammal species or stocks.
The numbers of animals authorized to be taken for harbor porpoise, Northern elephant seal, and Steller and California sea lions would be considered small relative to the relevant stocks or populations (less than one percent for Northern elephant seal and California sea lion, less than four percent for Steller sea lion, and less than two percent for harbor porpoise) even if each estimated taking occurred to a new individual—an extremely unlikely scenario. For pinnipeds occurring in the nearshore areas, there will almost certainly be some overlap in individuals present day-to-day. Further, for the pinniped species, these takes could potentially occur only within some small portion of the overall regional stock. For example, of the estimated 296,750 California sea lions, only certain adult and subadult males—believed to number approximately 3,000-5,000 by Jeffries
For harbor seals, takes are likely to occur only within some portion of the population, rather than to animals from the Washington inland waters stock as a whole. It is estimated that, based on counts from the two nearby haul out sites, 160 harbor seals could potentially be in the vicinity to be exposed to the sound levels. This small number of individuals is expected to be the same animals exposed repeatedly, instead of new individuals being exposed each day. These animals, to which any incidental take would accrue, represent 1.5 percent of the most recent estimate of the stock abundance from the 2013 SAR.
As summarized here, the estimated numbers of potential incidents of harassment for these species are likely much higher than will realistically occur. This is because (1) we use the maximum possible number of days (75) in estimating take, despite the fact that multiple delays and work stoppages are likely to result in a lower number of actual pile driving days; and (2) sea lion estimates rely on the averaged maximum daily abundances per month, rather than simply an overall average which would provide a much lower abundance figure. In addition, potential efficacy of mitigation measures in terms of reduction in numbers and/or intensity of incidents of take has not been quantified. Therefore, these estimated take numbers are likely to be overestimates of individuals. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, we preliminarily find that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.
There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, we have determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
No marine mammal species listed under the ESA are expected to be affected by these activities. Therefore, we have determined that a section 7 consultation under the ESA is not required.
In compliance with the NEPA of 1969 (42 U.S.C. 4321
As a result of these preliminary determinations, we propose to issue an IHA to the Navy for conducting the described pier and support facilities for the transit protection system U.S. Coast Guard Air Station/Sector Field Office Port Angeles, Washington from November 1, 2016 through February 15, 2017, and July 16 through October 31, 2017 provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. The proposed IHA language is provided next.
This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).
1. This Incidental Harassment Authorization (IHA) is valid for one year from the date of issuance.
2. This IHA is valid only for pile driving and removal activities associated with construction of pier and support facilities for the transit protection system U.S. Coast Guard Air Station/Sector Field Office Port Angeles, Washington.
3. General Conditions
(a) A copy of this IHA must be in the possession of the Navy, its designees, and work crew personnel operating under the authority of this IHA.
(b) The species authorized for taking are the harbor seal (
(c) The taking, by Level B harassment only, is limited to the species listed in condition 3(b). See Table 1 below for numbers of take authorized.
(d) The taking by injury (Level A harassment), serious injury, or death of any of the species listed in condition 3(b) of the Authorization or any taking of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this IHA.
(e) The Navy shall conduct briefings between construction supervisors and crews, marine mammal monitoring team, and Navy staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.
(f) Prior to the start of pile driving or removal, the Navy will contact the Orca Network and/or Center for Whale Research to determine the location of the nearest marine mammal sightings. Daily sighting information reported on the Orca Network Twitter site (
4. Mitigation Measures
In order to ensure the least practicable impact on the species listed in condition 3(b), the holder of this Authorization is required to implement the following mitigation measures:
(a) During impact pile driving, the Navy shall implement a minimum shutdown zone of 10 m radius around the pile, to be effective for all species of pinniped, and a minimum shutdown zone of 30 m radius around the pile, to be effective for all species of cetacean. If a marine mammal comes within the relevant zone, operations shall cease.
(b) During vibratory pile driving and removal, the Navy shall implement a minimum shutdown zone of 10 m radius around the pile for marine mammals. If a marine mammal comes within this zone, such operations shall cease.
(c) The Navy shall similarly avoid direct interaction with marine mammals during in-water heavy machinery work other than pile driving that may occur in association with the wharf construction project. If a marine mammal comes within 10 m of such activity, operations shall cease and vessels shall reduce speed to the minimum level required to maintain steerage and safe working conditions, as appropriate.
(d) The Navy shall establish monitoring locations as described in the Marine Mammal Monitoring Plan. For all pile driving activities, a minimum of three PSOs will be present during all impact and vibratory pile driving/removal. PSOs would be positioned at the best practicable vantage points, taking into consideration security, safety, and space limitations at USCG AIRSTA/SFO Port Angeles. A minimum of three PSOs would be present during both impact and vibratory pile driving/removal. Both the injury and behavioral harassment zones would be monitored in order to remain in compliance with the MMPA. These observers shall record all observations of marine mammals, regardless of distance from the pile being driven, as well as behavior and potential behavioral reactions of the animals.
(e) Monitoring shall take place from 15 minutes prior to initiation of pile driving activity through 30 minutes post-completion of pile driving activity. Pre-activity monitoring shall be conducted for 15 minutes to ensure that the shutdown zone is clear of marine mammals, and pile driving may commence when observers have declared the shutdown zone clear of marine mammals. In the event of a delay or shutdown of activity resulting from marine mammals in the shutdown zone, animals shall be allowed to remain in the shutdown zone (
(f) If a marine mammal approaches or enters the shutdown zone, all pile driving activities at that location shall be halted. If pile driving is halted or delayed at a specific location due to the presence of a marine mammal, the activity may not commence or resume until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 15 minutes have passed without re-detection of the animal.
(g) Monitoring shall be conducted by qualified observers, as described in the Monitoring Plan. Trained observers shall be placed from the best vantage point(s) practicable to monitor for marine mammals and implement shutdown or delay procedures when applicable through communication with the equipment operator.
(h) Approved sound attenuation devices shall be used during impact pile driving operations. The Navy shall implement the necessary contractual
(i) The Navy shall use soft start techniques recommended by NMFS for pile driving.
i. For impact pile driving, the soft start requires contractors to provide an initial set of strikes from the impact hammer at reduced energy, followed by a 30-second waiting period, then two subsequent reduced energy strike sets. Soft start shall be implemented at the start of each day's impact pile driving and at any time following cessation of impact pile driving for a period of 30 minutes or longer.
ii. For vibratory pile driving, if a variable moment driver can be used, the contractor will initiate noise from vibratory drivers for 15 seconds at reduced energy, followed by a 30-second waiting period. The procedure shall be repeated two additional times. However, if a variable moment hammer proves infeasible for use with this project, or if unsafe working conditions during soft starts are reported by the contractor, the Navy may discontinue use of the vibratory soft start measure. The Navy will inform NMFS Office of Protected Resources if the soft-start procedure is discontinued.
(j) Pile driving shall only be conducted during daylight hours.
5. Monitoring
The holder of this Authorization is required to conduct marine mammal monitoring during pile driving activity. Marine mammal monitoring and reporting shall be conducted in accordance with the Monitoring Plan.
(a) The Navy shall collect sighting data and behavioral responses to pile driving for marine mammal species observed in the region of activity during the period of activity. All observers shall be trained in marine mammal identification and behaviors, and shall have no other construction related tasks while conducting monitoring.
(b) For all marine mammal monitoring, the information shall be recorded as described in the Monitoring Plan.
6. Reporting
The holder of this Authorization is required to:
(a) Submit a draft report on all marine mammal monitoring conducted under the IHA within 90 calendar days of the end of the in-water work period. A final report shall be prepared and submitted within 30 days following resolution of comments on the draft report from NMFS. This report must contain the informational elements described in the Monitoring Plan, at minimum (see
(b) Reporting injured or dead marine mammals:
i. In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as an injury (Level A harassment), serious injury, or mortality, Navy shall immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator, NMFS. The report must include the following information:
A. Time and date of the incident;
B. Description of the incident;
C. Environmental conditions (
D. Description of all marine mammal observations in the 24 hours preceding the incident;
E. Species identification or description of the animal(s) involved;
F. Fate of the animal(s); and
G. Photographs or video footage of the animal(s).
Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with Navy to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. Navy may not resume their activities until notified by NMFS.
i. In the event that Navy discovers an injured or dead marine mammal, and the lead observer determines that the cause of the injury or death is unknown and the death is relatively recent (
The report must include the same information identified in 6(b)(i) of this IHA. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with Navy to determine whether additional mitigation measures or modifications to the activities are appropriate.
ii. In the event that Navy discovers an injured or dead marine mammal, and the lead observer determines that the injury or death is not associated with or related to the activities authorized in the IHA (
7. This Authorization may be modified, suspended or withdrawn if the holder fails to abide by the conditions prescribed herein, or if the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals.
We request comment on our analysis, the draft authorization, and any other aspect of this Notice of Proposed IHA for Navy's wharf construction activities. Please include with your comments any supporting data or literature citations to help inform our final decision on Navy's request for an MMPA authorization.
Department of Education, Department of Homeland Security, Department of Agriculture, Agency for International Development, Department of Housing and Urban Development, Department of Justice, Department of Labor, Department of Veterans Affairs, Department of Health and Human Services.
Final rule.
The Agencies publishing this final rule amend or establish their regulations to implement Executive Order 13279, as amended by Executive Order 13559. Executive Order 13279 established fundamental principles to guide the policies of Federal agencies regarding the participation of faith-based and other community organizations in programs that the Federal agencies administer. Executive Order 13559 amended Executive Order 13279 to clarify those principles and add certain protections for beneficiaries of Federal social service programs.
For general information, please contact Melissa Rogers, White House Office of Faith-Based and Neighborhood Partnerships, 202-456-3394 or via email at
For information regarding each agency's implementation of these final regulations, the contact information for that agency follows.
• DEPARTMENT OF EDUCATION: Rev. Brenda Girton-Mitchell, Director, Center for Faith-Based and Neighborhood Partnerships, Office of the Secretary, U.S. Department of Education, 400 Maryland Avenue SW., Room 1E110-A, Washington, DC 20202-6132, Telephone: 202-401-1876. If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
• DEPARTMENT OF HOMELAND SECURITY: Scott Shuchart, Office for Civil Rights and Civil Liberties, Department of Homeland Security, 202-401-1474 (telephone), 202-357-1196 (facsimile),
• DEPARTMENT OF AGRICULTURE: Norah Deluhery, Director, Center for Faith-Based and Neighborhood Partnerships, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250; telephone number 202-720-2032 (this is not a toll-free number). Persons with disabilities or who require alternative means of communication (Braille, large print, audio tape, etc.) should contact the USDA Target Center at 202-720-2600 (voice and TDD).
• AGENCY FOR INTERNATIONAL DEVELOPMENT: J. Mark Brinkmoeller, Director, Center for Faith-Based and Community Initiatives, USAID, Room 6.07-023, 1300 Pennsylvania Avenue NW., Washington, DC 20523; telephone: 202-712-4080 (this is not a toll-free number). If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
• DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT: Paula Lincoln, Director, Center for Faith-Based and Neighborhood Partnerships, Department of Housing and Urban Development, 451 7th Street SW., Room 10184, Washington, DC 20410-7000; telephone number 202-708-2404 (this is not a toll-free number). If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
• DEPARTMENT OF HEALTH AND HUMAN SERVICES: Acacia Bamberg Salatti, Director, U.S. Department of Health and Human Services Center for Faith-Based and Neighborhood Partnerships, 200 Independence Avenue SW., Room 747D, Washington, DC 20201 or via email at
• DEPARTMENT OF JUSTICE: Theron Pride, Chief of Staff/Senior Counsel, Office of the Assistant Attorney General, Office of Justice Programs, U.S. Department of Justice, Washington, DC 20531; telephone: 202-307-5933. If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
• DEPARTMENT OF LABOR: Naomi Barry-Pérez, Director, Civil Rights Center, U.S. Department of Labor, Frances Perkins Building, 200 Constitution Ave. NW., Room N-4123, Washington, DC 20210; telephone: 202-693-6500. Please note this is not a toll-free number. If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
• DEPARTMENT OF VETERANS AFFAIRS: Stephen B. Dillard, Deputy Director, Faith-based and Neighborhood Partnership (00FB), Office of the Secretary, Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 20420, 202-461-7689. (This is not a toll-free telephone number.) If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
On Thursday, August 6, 2015, the nine agencies participating in this joint final rulemaking each published a separate notice of proposed rulemaking (NPRM) in volume 80 of the
1. Agency for International Development (USAID), 80 FR 47237;
2. Department of Agriculture (USDA), 80 FR 47243;
3. Department of Education (ED), 80 FR 47253;
4. Department of Health and Human Services (HHS), 80 FR 47271;
5. Department of Homeland Security (DHS), 80 FR 47283;
6. Department of Housing and Urban Development (HUD), 80 FR 47301;
7. Department of Justice (DOJ), 80 FR 47315;
8. Department of Labor (DOL), 80 FR 47327;
9. Department of Veterans Affairs (VA), 80 FR 47339.
This preamble refers to these agencies as “the Agencies.” This final rulemaking notice publishes the final regulations of all the Agencies in a single document. The Agencies decided to publish a joint final rule because most of the comments received by the Agencies addressed issues that were relevant to all of the Agencies' proposed rules. This final rule addresses cross-cutting issues first, followed by separate agency-specific discussions of issues particular to each Agency. Following the preamble, each Agency makes final amendments to its regulations or establishes new final regulations, in CFR title and part order, to implement the requirements in Executive Order 13279, as amended by Executive Order 13559.
On December 12, 2002, President George W. Bush signed Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations (67 FR 77141), available at
To comply with this Executive order, most of the Agencies participating in this joint final rule amended their regulations to clarify that faith-based or religious organizations (faith-based organizations) are eligible to participate in programs administered by each Agency on the same basis as any other private organization. Some of the participating Agencies also had regulations predating the regulations implementing Executive Order 13279 that generally prohibited organizations from using Federal funds to support religious activities. See,
Shortly after taking office, on February 5, 2009, President Barack Obama signed Executive Order 13498, Amendments to Executive Order 13199 and Establishment of the President's Advisory Council for Faith-Based and Neighborhood Partnerships (74 FR 6533), available at https://www.thefederalregister.org/fdsys/pkg/FR-2009-02-09/pdf/E9-2893.pdf. Executive Order 13498 changed the name of the White House Office of Faith-Based and Community Initiatives to the White House Office of Faith-Based and Neighborhood Partnerships and established the President's Advisory Council on Faith-Based and Neighborhood Partnerships (Advisory Council). The President created the Advisory Council to bring together experts to, among other things, make recommendations to the President for changes in policies, programs, and practices that affect the delivery of services by faith-based and other neighborhood organizations.
The Advisory Council issued its recommendations in a report to the President in March 2010 entitled
President Obama signed Executive Order 13559, Fundamental Principles and Policymaking Criteria for Partnerships With Faith-Based and Other Neighborhood Organizations, on November 17, 2010, 75 FR 71319, available at
• Require agencies that administer or award Federal financial assistance for social service programs to implement protections for the beneficiaries or prospective beneficiaries of those programs. These protections include: (1) Ensuring that written notice of the Executive order's provisions
• Affirm that decisions about awards of Federal financial assistance must be free from political interference or even the appearance of such interference, and must be made on the basis of merit, not on the basis of the religious affiliation, or lack thereof, of the recipient organization;
• Affirm that the Federal Government has an obligation to monitor and enforce standards regarding the relationship between religion and government in ways that avoid excessive entanglement between religious bodies and governmental entities;
• Clarify (1) the principle that organizations engaging in explicitly religious activities must separate these activities in time or location from programs supported with direct Federal financial assistance (Executive Order 13279 stated this requirement as applying to “inherently religious” activities); (2) that such activities cannot be subsidized with direct Federal financial assistance; and (3) that participation in those activities must be voluntary for the beneficiaries of the social service program supported with direct Federal financial assistance;
• Emphasize that faith-based providers are eligible to compete for assistance under Federal Government social service programs and to participate in those programs while maintaining their religious identity as described in the Executive order;
• Require agencies that provide Federal financial assistance for social service programs to post online the regulations, guidance documents, and policies that have implications for faith-based and other neighborhood organizations, as well as a list of entities receiving that assistance; and
• Clarify that the Executive order principles apply to sub-awards as well as to prime awards.
In addition, Executive Order 13559 created the Interagency Working Group on Faith-Based and Other Neighborhood Partnerships (Working Group) to review and evaluate existing agency regulations, guidance documents, and policies for consistency with the Executive order, and to submit a report to the President recommending the amendments, changes, or additions necessary to ensure that regulations and guidance documents associated with the distribution of Federal financial assistance for social service programs are consistent with the fundamental principles set forth in the Executive order. The Executive order mandated that this report include a model set of regulations and guidance documents for the Agencies to adopt in a number of areas, including, among other things, prohibited uses of direct Federal financial assistance and separation requirements, protections for religious identity, the distinction between “direct” and “indirect” Federal financial assistance, and protections for beneficiaries of social service programs.
The Executive order required that, following receipt of the Working Group's report, the Office of Management and Budget (OMB), in coordination with the U.S. Department of Justice, issue guidance to agencies on the implementation of the Executive order. In August 2013, OMB issued that guidance consistent with the model regulations and guidance issued by the Working Group. Memorandum for the Heads of Executive Departments and Agencies, from Sylvia M. Burwell, Director, Office of Management and Budget,
In addition to these final regulations, each Agency will provide policy guidance or reference materials to assist recipients
These final regulations are effective on May 4, 2016. Recipients must comply with these final regulations by July 5, 2016. Note: If a recipient receives a new or continuation (renewal) award before the effective date, in most cases that award will not be subject to these final regulations and, therefore, the recipient will not have to comply with the regulations on or after the compliance date. However, some awards made before the effective date of these regulations may contain conditions that would make these regulations apply. Recipients that have awards subject to these conditions would have to comply with the final regulations on the compliance date
Unless otherwise specified in an agency-specific part of this preamble,
• Require the Agencies to ensure that all decisions about Federal financial assistance to recipient organizations are free from political interference, or even the appearance of such interference, and are based on merit, not based on the organization's religious affiliation or lack thereof.
• Make clear that faith-based organizations are eligible to participate in the Agencies' social service programs on the same basis as any other private organization.
• Replace the term “inherently religious activities” with the term “explicitly religious activities” in existing regulations, or establish “explicitly religious” in new regulations as the basis for determining which activities cannot be supported with direct Federal financial assistance.
• Make clear that all organizations that receive Federal financial assistance are prohibited from discriminating against beneficiaries in the provision of program services based on religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice, while also noting that organizations that participate in programs funded by indirect financial assistance need not modify their program activities to accommodate beneficiaries who choose to expend the indirect aid on those organizations' programs.
• Distinguish between “direct” and “indirect” Federal financial assistance.
• Require faith-based organizations that receive direct Federal financial assistance under a domestic social service program to provide written notice of certain protections to beneficiaries of the program. Specifically, an organization that receives direct Federal financial assistance, as defined in these final regulations, is required to give notice to beneficiaries that—
(1) The organization may not discriminate against a beneficiary based on religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(2) The organization may not require a beneficiary to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by the beneficiaries in those activities must be purely voluntary;
(3) The organization must separate in time or location any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
(4) If a beneficiary or prospective beneficiary objects to the religious character of the organization, the organization will undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary does not object; and
(5) A beneficiary or prospective beneficiary may report violations of these protections, including any denials of services or benefits, to the Federal agency or intermediary administering the program.
• To account for unique circumstances that could arise under some programs, provide that, when the nature of the service provided or exigent circumstances make it impracticable to provide the written notice in advance of the actual service, domestic service providers must advise beneficiaries of their protections at the earliest available opportunity.
• Require faith-based recipients of domestic direct social service program assistance to undertake reasonable efforts to identify an alternative provider, if a beneficiary or prospective beneficiary objects to the religious character of the faith-based organization, and to refer the beneficiary to an identified alternative provider.
• Make clear that a faith-based organization that provides services to a beneficiary supported only by “indirect Federal financial assistance” is not required to (1) provide written notice to beneficiaries, (2) make reasonable efforts to refer a beneficiary to an alternative provider if the beneficiary objects to the religious character of the faith-based provider, or (3) separate explicitly religious activities in time or location from programs supported with indirect Federal financial assistance.
The major cross-cutting issues that were raised in the comments are discussed in this part III of the preamble. Many commenters filed similar or identical comments with all the Agencies. Thus, unless otherwise noted in response to a particular comment, the responses in this part are adopted by the Agencies, regardless of whether a particular Agency received a particular comment. This preamble does not discuss editorial suggestions made by the commenters.
The Agencies note that, after each discussion of a comment, there are two headings: “Change” and “Affected regulations.” Under the “Change” heading, the Agencies have tried to describe what types of changes have been made to the agency's proposed regulations in these final regulations as a result of the comment. Under the “Affected regulations” heading, the Agencies have sought to list only those sections of the final regulations that have been changed from the language in the NPRM as a result of the comment.
Some changes have been made to the proposed regulations in order to assure greater uniformity across Agencies in the final regulations, consistent with the fundamental principles described in section 2 of the Executive order. These uniformity changes are described in the agency-specific sections of part IV of this preamble. Also, comments that raised agency-specific issues or require explanation of how a cross-cutting issue affects certain agency-specific programs are addressed in part IV of this preamble.
Also, several commenters suggested that more of the Agencies should include language in their regulations that is similar to language in DOJ's current regulations, which state that faith-based organizations should not be disqualified from receiving Federal financial assistance due to their religious motivation, influence, character, or affiliation. See existing regulations at 28 CFR 38.1(e).
The Agencies recognize that the meaning of “explicitly religious” is central to many provisions of the regulations, but they believe that the term's meaning is best conveyed by reference to program-specific examples. Accordingly, the Agencies anticipate providing additional policy guidance or reference materials to recipients and to the public. For example, to the extent that particular direct aid programs involve counseling, the Agency will note in policy guidance or reference materials that counselors may not encourage beneficiaries to accept religious teachings or discourage them from doing so.
The Agencies also find it unnecessary to include additional language stating that faith-based organizations should not be disqualified from receiving Federal financial assistance due to their religious motivation, influence, character, or affiliation. In its proposed regulations, DOJ included language on this issue in the context of restating all of its current regulations on partnerships with faith-based and other neighborhood organizations in addition to the regulations it proposed to add or alter as part of this rulemaking. 80 FR at 47324 (proposed 28 CFR 38.5(d)). DOJ's current regulations state that faith-based organizations should not be disqualified from receiving Federal financial assistance due to their religious motivation, influence, character, or affiliation. 28 CFR 38.1(e). In addition, HHS's proposed regulations combined its existing regulations on faith-based and other neighborhood organizations that had been in separate sections (one addressing discretionary grants and another discussing formula and block grants) into one entirely new part that addresses all grants. Thus, HHS's current and proposed regulations state that organizations may not be disqualified from participating in the HHS awarding agency's programs because the organizations “are motivated or influenced by religious faith to provide social services, or because of their religious character or affiliation.” 28 CFR 87.1(f) (current); 80 FR at 47280 (proposed 45 CFR 87.3(e)). DHS does not have current regulations regarding these partnerships, so DHS included this concept in its proposed regulations. 80 FR at 47297 (proposed 19 CFR 19.3(e)). ED, USDA, USAID, HUD, DOL, and VA have similar current regulations, but did not restate those regulations as a part of this rulemaking. In sum, Agencies other than DHS already have such language in their current regulations, and DHS is making minor changes to better align with the other Agencies to ensure that religious organizations may seek assistance without discrimination based on the organization's religious character, affiliation, influence, or motivation. See final regulations at 6 CFR 19.3(e) (DHS); 7 CFR 16.3(a) (USDA); 22 CFR 205.1(f) (USAID); 24 CFR 5.109(c) (HUD); 28 CFR 38.5(d) (DOJ); 29 CFR 2.32(c) (DOL); 34 CFR 75.52(a)(2), 76.52(a)(2) (ED); 38 CFR 62.62(a) (VA); 45 CFR 87.3(a), (e) (HHS).
Other commenters objected to regulatory language providing more generally that “[r]eligious activities that can be publicly funded under the Establishment Clause” are also excluded from the definition of “explicitly religious activities.” See,
Some of the Agencies participating in this final rulemaking must address these comments differently because they do not have any chaplaincy programs or language about chaplaincy in their current rules (ED, HUD, USDA) or because they are not changing their current language on the subject (DOL). Those Agencies will explain the basis for their different approaches in the agency-specific preambles following this joint preamble.
Commenters with a variety of perspectives on these issues noted opportunities for revising various provisions of the regulations to reflect their positions, whether by inserting language more sharply differentiating the regulations applicable to direct and indirect Federal financial assistance, or by removing language in some current and proposed regulations that did differentiate them. Some commenters also urged that the definition of “indirect Federal financial assistance” be revised to better reflect requirements for “true private choice” as set forth in
As commenters noted, however, there was considerable variation in the way the Agencies addressed this issue in their proposed regulations. Some Agencies (DHS and DOJ) would have limited nondiscrimination obligations to recipients of direct aid. See proposed regulations at 80 FR at 47298 (6 CFR 19.5) (DHS); 80 FR at 47324 (28 CFR 38.5(c)) (DOJ). Other Agencies (HUD and HHS) would have expressly made these nondiscrimination obligations apply to all programs funded by Federal financial assistance, which would include both direct and any indirect aid programs. See proposed regulations at 80 FR at 47311 (24 CFR 5.109(h)) (HUD); 80 FR at 47280 (45 CFR 87.3(d)) (HHS). ED's proposed regulations did not address this issue because ED has existing regulations that prohibit religious discrimination by recipients of grants and subgrants awarded under ED programs (see existing regulations at 34 CFR 75.52(e), 76.52(e)), and the only indirect aid program it manages is subject to specific statutory provisions that prohibit religious discrimination against beneficiaries.
In responding to the comments and formulating final regulations, the Agencies focused on the value of achieving uniformity on this issue. Executive Order 13559 established the Interagency Working Group with the specific purpose of creating as much uniformity as possible in these regulations. Executive Order 13279, § 3, as amended by Executive Order 13559, § 1(c). Achieving greater uniformity on this issue will better serve providers and beneficiaries, especially those who are involved in programs administered by more than one agency, by avoiding subjecting them to inconsistent obligations.
The Agencies also focused on the fact that the text of section 2(d) of the Executive order does not limit these nondiscrimination obligations to direct aid programs. It states that all organizations that receive Federal financial assistance under social service programs should be prohibited from discriminating against beneficiaries or prospective beneficiaries of the social service programs on the basis of religion or religious belief. It also states that, in providing services supported in whole or in part with Federal financial assistance and in their outreach activities related to such services, no organizations should be allowed to discriminate against current or prospective program beneficiaries on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice.
Moreover, by ensuring that beneficiaries and potential beneficiaries cannot be required to even attend or in any way participate in a religious practice, Executive Order 13559 strengthened the nondiscrimination requirements previously in place in several respects. Compare Executive Order 13279, § 2(d), 67 FR at 77142 (organizations should not be allowed to discriminate against current or prospective beneficiaries on the basis of “a refusal to actively participate in a religious practice”), with Executive Order 13279, § 2(d), as amended by Executive Order 13559, 75 FR at 71320 (organizations should not be allowed to discriminate against current or prospective beneficiaries based on “a refusal to attend or participate in a religious practice”).
Additionally, the Agencies focused on the potential implications of the various approaches urged in the comments. In particular, the Agencies focused on the potential implications of maintaining the current regulations of some of the Agencies, which would seemingly allow providers to turn away indirect aid beneficiaries on the basis of religion or religious beliefs or lack thereof. Such an outcome seems inconsistent with a key policy goal articulated by Executive Order 13559—strengthening religious liberty protections for beneficiaries. It also seems inconsistent with the views of many of the commenters.
In light of these considerations, the final regulations closely track the Executive order and are uniform across the Agencies. Specifically, the final regulations of each Agency state that any organization that participates in a program funded by Federal financial assistance shall not, in providing services or in outreach activities related to such services, discriminate against a program beneficiary or prospective program beneficiary on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice. See final regulations at 6 CFR 19.5 (DHS); 7 CFR 16.4(a) (USDA); 24 CFR 5.109(h) (HUD); 28 CFR 38.5(c) (DOJ); 29 CFR 2.33(a) (DOL); 2 CFR 3474.15(f), 34 CFR 75.52(e), 76.52(e) (ED); 38 CFR 50.1(f), 61.64(a), 62.62(a) (VA); 45 CFR 87.3(d) (HHS). At the same time, the final regulations provide that an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program. See final regulations at 2 CFR 3474.15(f), 34 CFR 75.52(e), 76.52(e) (ED); 6 CFR 19.5 (DHS); 7 CFR 16.4(a) (USDA); 24 CFR 5.109(h) (HUD); 28 CFR 38.5(c) (DOJ); 29 CFR 2.33(a) (DOL); 38 CFR 50.1(f) (VA); 45 CFR 87.3(d) (HHS).
For example, a faith-based organization receiving indirect aid that offers a Bible study as part of its programming need not remove that study from its program activities or create alternative programming for an indirect aid beneficiary who does not wish to participate in the Bible study. Faith-based organizations offering for sale food that is compliant with a particular religious diet could take a form of indirect assistance as payment for that food without also offering food that is compliant with some other religious diet. And a substance abuse recovery program, like a 12-step program, that includes religious content that is integral to the program would not be required to alter its program to accommodate an objector who pays for the program with indirect aid.
Finally, the Agencies note that the definition of “indirect financial assistance” aligns with the constitutional principles addressed in
Also, the nature of certain indirect aid programs would make it extremely difficult to ensure that all beneficiaries receive a written notice. For example, there are more than a quarter million stores, farmers' markets, direct marketing farmers, homeless meal providers, treatment centers, group homes, and other participants across the nation that are authorized Supplemental Nutrition Assistance Program (SNAP) retailers. If providers receiving indirect aid were required to give written notice to beneficiaries, all of these retailers would have to have the notices ready at all times to provide to any person using SNAP benefits. While the Agencies decline to impose this requirement, they note that, in appropriate cases, they may encourage indirect aid recipients to inform beneficiaries of the protections provided under these regulations.
The Agencies also note that, while these regulations do not require written notice for indirect recipients of Federal financial assistance, there may be other applicable statutory or regulatory obligations that require recipients to notify beneficiaries that discrimination on the basis of religion is prohibited.
The Agencies agree with the commenter that the quoted language should be included in Agencies' written notices. Further, the Agencies' regulations should similarly include this language. Regarding the request to provide a more specific explanation of what constitutes explicitly religious activities, the Agencies believe that the notice needs to remain more general because it must be provided across a broad array of programs. Adding more specificity could lead to confusion in the context of some programs. Therefore, the Agencies decline to include in the beneficiary notice a more expansive explanation or specific list of activities that are considered “explicitly religious.”
The Agencies also decline to require providers to specifically mention any services or information that the provider refuses to provide due to religious or moral objections. The Agencies believe that such issues are beyond the scope of the Executive order.
Federal laws prohibiting discrimination on the basis of disability require, in pertinent part, provision of program access, necessary auxiliary aids and services, physical access, and reasonable modification and accommodations to policies, practices, and procedures for persons with disabilities. See,
The Agencies that have included a “for staff use only” section in their model forms (USDA and HUD) do not believe that including this section on the same page as the notice will impact beneficiaries' actions or will deter beneficiaries from requesting an alternative provider. Moreover, because those Agencies included the written forms only as a model, moving the “for staff use only” section is unnecessary because providers can include other formats as the commenters requested.
The Agencies have sought to minimize the burden of the referral requirement to the greatest degree possible—while still fully implementing the Executive order—by limiting the referral requirement to “reasonable efforts” and providing assistance in cases where the faith-based organization is unable, on its own, to make a referral. As discussed in the Agencies' NPRM preambles or below, the Agencies believe that the number of requests for referrals will be minimal and that, on average, referrals will take no more than two hours. The Agencies' estimate of the number of referral requests faith-based organizations are likely to receive is based on SAMHSA's experience that its referral requirement has resulted in no requests for referrals that the Agencies know of to date. The Agencies now clarify that a provider need not spend more than approximately two hours of staff time in order to fulfill the “reasonable efforts” requirement. To be clear, the Agencies expect that much less staff time will be required to make a successful referral in most cases. Finally, the Agencies acknowledge that, in programs governed by the Charitable Choice provisions listed above, the statutes take precedence over these regulations, and the Government will continue to bear the full burden of making referrals as specified in those statutes.
As for the commenters' concern about the organizations' potential liability for the alternative providers' actions, these regulations are in no way intended to open the door to liability for faith-based organizations. Executive Order 13559 specifically notes that it “is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, Agencies, or entities, its officers, employees, or agents, or any other person.” Executive Order 13559, § 2(d), 75 FR at 71323; see also Executive Order 13279, § 7, 67 FR at 77144.
Regarding the question of why a beneficiary would need to object, a beneficiary may, for example, be uncomfortable with receiving services in a location with religious symbols or from a faith-based organization even when the service being provided is secular in nature. Therefore, consistent with the Executive order, the notice of beneficiary rights will provide an opportunity for the beneficiary to object to receiving services from the faith-based organization on the basis of its religious character, even in circumstances where the organization is conducting its services in accordance with these final regulations.
The Agencies encourage faith-based organizations to provide information to beneficiaries about potential alternative providers. However, the Agencies decline to require organizations to provide beneficiaries with written information regarding alternative providers, because Executive Order 13559 does not require such notice and because this could impose an unwarranted burden on faith-based organizations.
The Agencies agree with the commenters that they must vigorously monitor and enforce applicable regulations in this regard. However, certain Agencies are constrained by statutes, resources, or both from establishing a central office to monitor and enforce compliance with the requirements in these final regulations. Therefore, the Agencies have concluded that each Agency needs to maximize its resources to ensure that recipients comply with these final regulations in a manner consistent with the Agency's statutes, other regulations, and structure. Because each Agency has a unique structure and statutory enforcement requirements, each Agency describes in its agency-specific preamble, or will describe in its policy guidance or reference materials, how its offices will ensure compliance with these final regulations.
As stated in its regulations, DOJ will require specific assurances from all organizations that they will comply with the final regulations. See proposed regulations at 80 FR at 47325 (28 CFR 38.7(a)) and final regulations at 28 CFR 38.7(a). Several commenters recommended that the other Agencies adopt similar regulations. However, many Agencies already collect the information needed to assure that their grantees and subgrantees comply with all Federal requirements applicable to their grant programs, including the new requirements established in these final regulations. For example, many Agencies require applicants to provide certain standard assurances in the Standard Form 424 (SF-424), see,
The Agencies do agree that organizations that receive direct Federal financial assistance need to be aware of these new requirements and have meaningful guidance from the Agencies to assist them in complying with the requirements. As already noted, the Agencies will provide training and policy guidance or other reference materials to grantees to effectively implement these final regulations. To ensure that the Agencies meet this objective, each Agency is devoting substantial resources to ensure that its program staff understand their responsibilities to ensure that grantees, subgrantees, and contractors that provide social services to beneficiaries under programs of direct Federal financial assistance comply with these final regulations. Given the substantial work needed to make sure that all grantees, intermediaries, and subgrantees understand what they must do under these final regulations, the Agencies have decided to delay the date by which recipients of Federal financial assistance must comply with these final regulations beyond the standard 30 days. These final regulations will become effective in 30 days. However, the Agencies have decided to delay the compliance date for 90 days, as discussed in other parts of this preamble.
Finally, under the current regulations established under Executive Order 13279 (
Based on these considerations, the Agencies decline to make any changes to the proposed regulations regarding the eligibility of faith-based organizations to receive grants under Federal social service assistance programs.
ED received comments on its proposed regulations from 93 parties. As reflected below, unless otherwise specified, all comments received by ED are addressed fully in the discussion of cross-cutting issues in part III of this preamble, and those responses are adopted by ED. Some of the cross-cutting comments addressed in part III of the preamble were not received by ED and ED concurs in the part III resolution of those comments unless specifically noted either in part III or this agency-specific part IV.A of the preamble.
ED addresses in this part of the preamble the ED-specific comments not addressed in part III of the preamble and provide ED-specific findings and certifications. ED does not discuss in this part of the preamble minor or technical changes that were made to provide greater consistency or simplify the language in the regulations.
This agency-specific discussion has the same organization as part III of the preamble, outlined as follows:
If ED does not need to address a comment outlined above, ED notes “Covered in part III of this preamble.”
With the exception of the response to the comments regarding chaplaincy and similar services, ED adopts the responses in the cross-cutting section of the preamble related to prohibited uses of direct Federal financial assistance. Regarding chaplaincy and similar services, ED agrees that those services should not be subject to direct Federal financial assistance restrictions and, therefore, are not subject to the requirements in the final regulations regarding separation of time or place and the notice and referral requirements. ED, however, declines to include language in its final regulations regarding chaplaincy and similar services because it has no programs that fund such services.
Consistent with the discussion in part III, the provision in ED's final regulations prohibiting discrimination against beneficiaries on the basis of religion, religious belief, a refusal to hold a religious belief, or refusal to attend or participate in a religious practice applies to all private organizations receiving ED funds under program of direct Federal financial assistance, regardless of whether they received direct or indirect financial assistance. See 2 CFR 3474.15(f), 34 CFR 75.52(e), 76.52(e).
ED adopts the response in part III to comments regarding the distinction between direct and indirect Federal financial assistance. ED notes, however, that since ED published the NPRM there has been one significant change related to this topic. Specifically, in the NPRM ED stated that ED had two programs that provided “indirect Federal financial assistance,” as defined in the proposed regulations. One of those exceptions involved supplemental educational services (SES). ED indicated that in most cases an SES provider that contracts with a local educational agency (LEA) pursuant to section 1116 of title I, part A of the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the No Child Left Behind Act of 2001, would be providing services under a program supported only by “indirect Federal financial assistance” because, by statute, the government program is neutral toward religion and it is the parents who choose from among approved providers of SES. However, on December 10, 2015, the President signed into law the Every Student Succeeds Act (ESSA), Pub. L. 114-95, which reauthorizes the ESEA. Among the changes to the ESEA under the ESSA, ED notes that LEAs will no longer be required to provide SES, starting in Federal fiscal year 2017. The other exception discussed in the NPRM, the District of Columbia School Choice Incentive Program (DC Choice Program), is unaffected by the ESSA and will continue to provide indirect Federal financial assistance. As noted in the NPRM, the DC Choice program is subject to statutory nondiscrimination requirements not included in these final regulations.
Except as required in these final regulations, ED does not use the term “intermediaries” in its regulations, but it does administer programs that provide assistance through pass-through entities that act as intermediaries. ED's pass-through entities are States that administer programs under the regulations that apply only to State-administered programs. See 34 CFR part 76. A few of ED's discretionary grant programs also authorize grantees to award subgrants and those programs are subject to ED's grant administration regulations in 34 CFR part 75. The regulations in parts 75 and 76 describe the different responsibilities that States and other grantees that are authorized to award subgrants have regarding the subgrants they award. ED also notes that in cases where a subgrantee awards a contract to a faith-based organization to provide program services under a program of direct Federal financial assistance, the subgrantee acts as an intermediary of the faith-based contractor. See 2 CFR 3474.15; 34 CFR 76.52, 76.712-76.714.
This issue was addressed in part III of the preamble. In addition, ED made edits to the regulations requiring faith-based organizations to provide the notice specified in appendix A to 24 CFR part 75. These changes clarify that a faith-based organization that provides program services to beneficiaries under an ED program of direct Federal financial assistance may do so under a contract, as well as under a grant or subgrant. Regardless of whether the program services are provided under a contract, grant, or subgrant, faith-based organizations have the same responsibilities to give notice to beneficiaries of their rights.
ED's final regulations include changes to the proposed regulations regarding the notice that faith-based organizations must provide beneficiaries. As described in part III of this preamble, ED
Consistent with the discussion in part III of this preamble, ED has made changes to the language regarding the rights of beneficiaries and in the notice that must be provided to beneficiaries under a direct Federal financial assistance program. The notice now specifically informs beneficiaries that they have a right to file a complaint regarding any denials of services or benefits. See 34 CFR 75.712(a)(5), appendix A to part 75, paragraph (5), and 76.712(a)(5).
Covered in part III of this preamble.
Covered in part III of this preamble.
Covered in part III of this preamble.
Covered in part III of this preamble.
Covered in part III of this preamble.
Covered in part III of this preamble.
Covered in part III of this preamble.
Covered in part III of this preamble.
As discussed in part III of this preamble, one commenter was concerned that at least one agency did not clearly indicate when a faith-based organization had a duty to make reasonable efforts to refer a beneficiary to an alternative provider. ED notes that its final regulations include a notice, specified in appendix A, that faith-based organizations are required to use and that notice includes a check box for a beneficiary to object to the religious character of the organization. When that notice is returned with the objection box checked, a faith-based organization's duty to make reasonable efforts to refer a beneficiary to an alternative provider will be clear.
Covered in part III of this preamble.
Covered in part III of this preamble.
Covered in part III of this preamble.
The form included as appendix A to part 75 specifically gives beneficiaries three options. The beneficiary can ask the faith-based organization to do one of the following: (1) Follow up with the beneficiary, providing a name and contact information; (2) follow up with the alternative service provider; or (3) not follow up. The policy guidance ED is developing to assist faith-based organizations in complying with the final regulations will emphasize the organizations' responsibility to comply with the wishes stated on the form.
ED noted in the preamble to its proposed regulations that ED had regulations outside its proposed regulations that required its grantees and subgrantees to maintain records regarding all activities related to the projects and programs they administer. See 2 CFR 200.333, 3474.1; 34 CFR 75.731, 76.731. Therefore, ED did not include any recordkeeping requirements in its proposed regulations. As noted in part III.D.2.f of this preamble, the Agencies made changes to clarify the responsibilities of faith-based service providers to distinguish between their obligations if they made a successful referral or could not make a referral. ED decided to add language to its revised §§ 75.713(d) and 76.713(d) to clarify the types of records that a faith-based organization would have to maintain, at a minimum, if it made a successful referral. See revised §§ 75.713(d)(1), 76.713(d)(1). These changes were not needed to require recordkeeping regarding referrals but to clarify what types of records had to be maintained, at a minimum.
Consistent with the discussion in part III, ED has made changes to the proposed regulations to distinguish between the responsibilities of faith based organizations when they make a successful referral and when they are unable to refer a beneficiary to an alternative provider. If a faith-based organization makes a successful referral, the final regulations specify the content of the record that the organization must maintain, requiring a record of the name of the alternative provider and its address and contact information. However, when an organization cannot make a referral, the organization must promptly notify the entity that made the award under which the referral could not be made. For example, a grantee that could not make a referral would have to promptly notify ED and a subgrantee that could not make a referral would notify the State or other pass-through entity. See final regulations at 34 CFR 75.713(d), 76.713(d). If the entity that made the award cannot identify an alternative provider to which a referral can be made on behalf of the faith-based organization, it must promptly notify the entity that awarded it financial assistance. For example, if a faith-based subgrantee can't make a referral and promptly reports that fact to its pass-through entity and the pass-through entity also cannot identify and make a referral, the pass-through entity must promptly notify ED, which would then be responsible for determining whether a referral can be made. All grantees and subgrantees of ED must maintain financial records and records regarding compliance with grant requirements, including those in these final regulations. See final regulations at 2 CFR 200.333; 34 CFR 75.730-75.732, 76.730, 76.731. Those records must include documentation of the efforts made by the faith-based organization to make a referral and its prompt reporting to its awarding agency if it can't make a referral to an alternative provider.
ED has made changes to the proposed regulations so that, in these final regulations, grantees, including States, and subgrantees must make the initial effort to determine whether a referral can be made when a faith-based organization cannot make a referral to an alternative provider. Under the proposed regulations, the order in which intermediaries and ED must
ED notes that in the case of subgrants awarded by States, the States are much more aware of the resources in their States and are better equipped to identify potential alternative providers than ED. Therefore, ED has changed the language in 34 CFR 75.713(d) and 76.713(d) to make clear that the subgrantee or grantee, including a State, that made the award under which the referral could not be made must determine whether a referral to an alternative can be made. Ultimately, if neither the subgrantee nor grantee, including a State, can identify an alternative service provider, the grantee must notify ED, which would then have to determine whether a referral can be made. ED is developing policy guidance to assist subgrantees and grantees, including States, in developing procedures to determine whether an alternative placement can be made.
Covered in part III of this preamble.
Consistent with the discussion of this comment in part III, ED has made changes to the proposed regulations to more closely track the language in Executive Order 13559, which provides that decisions “about awards of Federal financial assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of the religious affiliation of a recipient organization or lack thereof.” The proposed regulations did not include the phrase “or lack thereof.” These final regulations now include that phrase. See final regulations at 2 CFR 3474.15(b)(2); 34 CFR 75.52(a)(2), 76.52(b)(2).
ED is developing policy guidance to ensure that its grantees, subgrantees, and contractors of those recipients are fully informed of their responsibilities regarding the treatment of private organizations and that these organizations understand their responsibilities toward the beneficiaries they serve under programs funded by ED. Within 90 days after this final rule is published, ED intends to provide training to its employees regarding their responsibility to ensure that faith-based organizations are treated fairly in competitions administered by ED. ED will also train its employees so they can provide policy guidance to applicants and grantees, ensuring that they are aware of their responsibilities under these final regulations.
Covered in part III of this preamble.
Covered in part III of this preamble.
Covered in part III of this preamble.
As noted in part III of this preamble, ED proposed regulations that would apply to all of its discretionary grant programs because most of its programs are social service programs. There was no need to delineate which ED programs are social service programs because these final regulations do not apply to the student financial assistance programs of ED. Those programs are not subject to the grant regulations in 34 CFR parts 75 and 76, which apply only to discretionary and State-administered programs of ED. These regulations also do not apply to ED's research programs because, even though those programs are subject to these final regulations in 34 CFR parts 75 and 76, they do not serve beneficiaries. Given that these regulations do not apply to student financial assistance or research programs, they also do not address whether a particular program was considered a “social service” program.
Covered in part III of this preamble.
Covered in part III of this preamble.
As noted in the discussion of the monitoring issues in this ED-specific part of the final rule notice, ED is developing training for its employees and policy guidance and resource materials to ensure compliance with these final regulations.
The following reflect ED findings and certifications that are not otherwise addressed in Part V.
The Paperwork Reduction Act of 1995 (PRA) does not require you to respond to a collection of information unless it displays a valid OMB control number. ED displays the valid OMB control number assigned to the collection of information and notice requirements in these final regulations at the end of each affected section of the regulations. The preamble to ED's NPRM assessed the burden imposed under the following proposed regulations: 2 CFR 3474.15; 34 CFR 75.712, 75.713, appendix A to part 75, 76.712, and 76.713. See 80 FR 47253 at 47261-47265. These final regulations make minor changes to these proposed regulations to clarify the information that faith-based organizations must
In accordance with section 411 of the General Education Provisions Act, 20 U.S.C. 1221e-4, ED requested comments in the NPRM on whether the proposed regulations would require transmission of information that any other agency or authority of the United States gathers or makes available.
Unlike most of the other Agencies, DHS has not previously issued final regulations related to the participation of faith-based organizations in DHS programs. In 2008, DHS issued a notice of proposed rulemaking on this subject. Nondiscrimination in Matters Pertaining to Faith-Based Organizations, 73 FR 2187 (Jan. 14, 2008). In 2015, DHS issued a supplemental notice of proposed rulemaking (“SNPRM”) in concert with the other Agencies. The SNPRM addressed comments received in response to the 2008 notice of proposed rulemaking and proposed additional changes to address Executive Order 13559. Except as directly relevant to additional comments received on the supplemental notice, DHS does not further address those earlier comments here. DHS incorporates by reference the preambles to the 2008 and 2015 proposals, except where the 2008 proposed regulations were superseded by the discussion in the SNPRM, or either proposal is superseded by the discussion here.
DHS received a total of 86 comments on its SNPRM by October 7, 2015, and did not consider one comment received substantially after that date. Many of the comments were identical or nearly identical to comments provided to the other Agencies and addressed above in part III, although some of these cross-cutting comments did not directly apply, or did not apply in the same way, to DHS. Some of those cross-cutting comments included additional remarks related to DHS's SNPRM; in addition, DHS received several other comments specific to its SNPRM. Approximately half of the comments DHS received were identical, or nearly identical, to one another. Many comments expressed general support for the regulations, while other comments flatly opposed any Federal financial assistance being provided to faith-based organizations. Those general issues were addressed in part III above.
In the following discussion, we address DHS-specific issues related to each of the comment areas addressed in part III. Except where specifically noted, to the extent that a comment addressed in part III pertained to the DHS SNPRM, DHS adopts the analysis provided therein. In addition to the changes noted here, DHS has made small editorial changes to improve the readability of the final regulations.
The following responds to additional comments received in response to the SNPRM.
DHS concurs with the discussion of this subject in part III. DHS's SNPRM included language that faith-based organizations may not be disqualified from receiving grant funds due to their religious motivation, character or affiliation. This revised language appears in final 6 CFR 19.3(b).
As explained in part III, DHS has made changes to 6 CFR 19.3(e) to harmonize language with the Agencies and further clarify that the regulations do not affect DHS's ability to fund services that can permissibly be funded under the Establishment Clause, notably chaplaincy services. All of the comments DHS received on this subject are addressed in part III.
As explained in part III, DHS's SNPRM had differentiated more sharply than some other Agencies with respect to the application of nondiscrimination requirements to beneficiaries of indirect assistance. For the reasons explained above, the final DHS regulations are now consistent with those of other Agencies; the beneficiary protection against nondiscrimination now also applies to programs in which faith-based organizations receive indirect assistance. Although recipients of indirect assistance must comply with the nondiscrimination requirement, such recipients need not modify their program activities to accommodate beneficiaries. These changes appear in final 6 CFR 19.5.
DHS concurs in the discussion of this subject in part III. DHS's SNPRM made clear that the individual beneficiary notice is only required for recipients of direct assistance. Accordingly, no change is made in response to that issue. However, DHS has revised the requirements related to the content of beneficiary notices to specify that providers cannot discriminate based on a refusal to hold a religious belief or to attend or participate in a religious practice. See 6 CFR 19.6(a)(1) and appendix A. DHS is also adding, in final 6 CFR 19.7(d), the requirement that, when a provider has been unable to make a referral, it report that failure promptly, as explained in part III.
With respect to determining which entity is responsible for making a referral in programs with both an intermediary and a sub-recipient provider, DHS has added clarifying language to 6 CFR 19.7(d). Under the final regulations, an organization unable to make a referral after reasonable efforts may notify either DHS or the intermediary, and then either DHS or the intermediary will determine
While a central notice board, used in addition to individual beneficiary notices, would be consistent with the regulations if an organization chose to erect one, DHS declines to require such a board. Some covered social service programs may not offer their services in a location where a large board would be feasible or meaningful. As explained in the supplemental notice, DHS anticipates that in cases where individual notices are impracticable, such as during a brief, potentially one-time interaction (
Conversely, DHS believes that basing referrals on a beneficiary's objection to the “religious character” of the organization is sufficiently clear to beneficiaries and recipients. While additional policy guidance or reference materials may be provided at a later time, DHS expects the term will be understood broadly without further interpretation. DHS does not intend, and does not expect of its recipients, to scrutinize the religious nature of a beneficiary's objection. Rather, recipients should take reasonable steps to identify a suitable referral, as required in the regulations, whenever a beneficiary asserts such an objection. The beneficiary notice form, for this same reason, does not seek any detail on the specific nature of a beneficiary's objection.
DHS concurs in the discussion in part III. Accordingly, DHS has added language in 6 CFR 19.3(c) clarifying that award decisions must be free of the appearance of political interference, and may not be on the basis of religion or religious belief or lack thereof, or on the basis of religious or political affiliation.
In addition to the discussion in part III, with which DHS concurs, DHS received the following comment:
With respect to conditioning funds on compliance, 6 CFR 19.4(c) requires all DHS programs to apply the same standards to faith-based and other organizations, and requires recipient organizations to comply with all program requirements. This is tantamount to expressly conditioning the funding on compliance with program requirements, as the commenter suggests. 6 CFR 19.5 notes that recipients may be subject to sanctions and penalties for failure to abide by the nondiscrimination requirements. DHS already has in place monitoring protocols to review recipients of DHS assistance, including intermediaries, for compliance with the terms and conditions of awards of Federal financial assistance. These terms and conditions include applicable statutory and regulatory requirements. DHS will revise those protocols as necessary to ensure that compliance with these regulations is monitored along with the other terms and conditions that apply to covered financial assistance.
DHS concurs in the discussion in part III. While DHS received comments addressing discrimination on the basis of religion in employment, that issue was addressed in the response to comments on the initial proposed rulemaking, and no new issues were raised. DHS received comments on two additional issues that were within the scope of the supplemental notice:
Under the Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, DHS has considered whether these regulations would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
Given the lack of specific small entity data, DHS included an initial regulatory flexibility analysis in the SNPRM even though DHS does not believe these regulations will impose a significant economic impact on a substantial number of small entities. See 80 FR 47294-95. Commenters on the SNPRM did not provide significant additional specific small entity data. Accordingly, DHS incorporates by reference the SNRPM's initial regulatory flexibility analysis into this rule's final regulatory flexibility analysis. Except as specifically stated below, DHS continues to use the total estimate of approximately 2,600 faith-based recipient organizations for purposes of this regulatory analysis, as well as the other components of the cost estimates that DHS used in its SNPRM.
As described above, DHS has made every effort to ensure that the disclosure and referral requirements of the regulations impose minimum burden and allow maximum flexibility in implementation by providing a model notice to beneficiaries and model beneficiary referral request form in appendix A, and by not requiring the social service providers to follow a specific procedure for the referrals. In addition, individual advance notice forms are not required where it is impracticable to provide them. Where individual, advance written notice is impracticable because the recipient and beneficiary have only a brief, potentially one-time interaction, such as at a soup kitchen, DHS believes a conspicuous posted notice would suffice.
DHS estimates it will take no more than two hours for providers to familiarize themselves with the notice requirements and print and duplicate an adequate number of disclosure notices and referral request forms for potential beneficiaries, and a cost in paper and toner of no more than approximately $100.
DHS further estimates a total cost of making referrals of approximately $13,000, spread out over the approximately 2,600 faith-based recipient organizations.
This estimate yields a total estimate of approximately $13,000—one half of what the SNPRM estimated based on a four-hour period of reasonable effort.
Hence DHS estimates a total burden of less than $200 per year for each of approximately 2,600 faith-based recipient organizations. This is an impact to a substantial number of small entities. However, DHS does not believe that a compliance cost of less than $200 per provider per year is significant percentage of a provider's total revenue. In addition, after the first year, DHS expects the labor cost associated with compliance will likely decrease significantly because small service providers will be familiar with the requirements.
DHS expects that this estimate likely overestimates the actual cost burden associated with this rulemaking. Consequently, DHS believes these final regulations would not impose a significant economic impact on a substantial number of small entities.
Under the Paperwork Reduction Act (PRA) of 1995, Public Law 104-13, all agencies are required to submit to the OMB, for review and approval, any reporting requirements inherent in a rule. See 44 U.S.C. 3506. Specifically, a Federal agency may not conduct or sponsor a collection of information unless OMB approves the collection of information under the PRA, and the collection of information must display a currently valid OMB control number. Notwithstanding any other provisions of law, no person will be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number. 44 U.S.C. 3512; 5 CFR part 1320.
The regulations include new requirements. Section 19.6 requires faith-based or religious organizations that provide social services to beneficiaries under a DHS program supported by direct Federal financial assistance to give beneficiaries (or prospective beneficiaries) a notice instructing them of their rights and protections under this regulation and to make reasonable efforts to identify and refer beneficiaries requesting referrals to alternative service providers. The content of the notice and the actions the faith-based or religious organizations must take if a beneficiary objects to the religious character of the organization are described in the preamble and in the regulatory text; an optional model form is provided as appendix A. The burden of providing the notice to beneficiaries and identifying and referring a
Pursuant to program guidance and grant agreements, faith-based organizations that would be subject to these requirements would have to retain records to show that they have made referrals or sought assistance from an intermediary or DHS. Faith-based organizations could meet such a retention requirement by maintaining, in the case of paper notices, the bottom portion of a notice that takes the form of the model provided in the appendix. DHS does not include an estimate of the burden of records retention.
DHS has retention requirements included in information collection instruments for DHS programs. Those collection instruments cover burdens imposed under program and administrative requirements under current information collection instruments that are approved by OMB and each of those collections has an OMB-assigned information collection control number.
The retention burden that will be added to those information collection instruments under these regulations is so small as to not be measurable in the context of all the program and administrative requirements in the existing program collection instruments. For example, a grantee or subgrantee that has to provide notice under these regulations could meet the record-keeping requirement by collecting the tear-off portion of the notice for those beneficiaries that request alternative provider and keeping it in a designated folder. Therefore, DHS has determined that no burden would be added that would require estimates of time and cost burden as a result of maintaining records of compliance with the regulations.
DHS must impose the third-party notice requirements to implement the requirements of Executive Order 13559.
DHS has submitted an information collection request (ICR) to OMB to obtain PRA approval for the information collection formatting requirements contained in this rule. Control number 1601-NEW has been assigned to the instrument. The burden for the information collection provisions of this rule can be summarized as follows:
Agency: U.S. Department of Homeland Security, Office for Civil Rights and Civil Liberties.
Title of Collection: Written Notice of Beneficiary Protections.
OMB ICR Reference Number Control Number: 201505-1601-001.
Affected Public: State and local governments, not-for-profit organizations.
• Total Estimated Number of Organizations: R, where R represents the total number of entities that must give notice. To estimate this number, DHS relied upon information from two of its grant-making components: FEMA and USCIS. FEMA estimates that there are approximately 2,600 grantees and subgrantees that would have to provide some form of notice to beneficiaries.
• Total Estimated Number of Notices: N, where N equals the total number of beneficiaries under DHS social service programs to whom provision of an individual written notice would be practicable. Faith-based organizations covered by these regulations are required to provide, where practicable, a notice to each beneficiary of DHS-supported social service programs.
Where using this methodology was not feasible due to data limitations, DHS relied on subject matter experts in the relevant grant program to make an appropriate best estimate.
• Total Estimated Annual Burden to Provide Each Notice: 60,000 minutes, or 1,000 hours (equivalent to 60,000 × T, where T is less than or equal to one minute).
• Total Estimated Annual Number of Requests for Referrals: N × Z, where Z is the percentage of beneficiaries or potential beneficiaries who request referrals. DHS assumes that Z is equal to .0025.
• Total time required to complete a referral T, where T is less than or equal to 2 hours.
• Total Estimated Annual Referral Burden Hours: B, where B is equal to the following:
The recipient provider will be required to complete the referral form, notify the awarding entity, and maintain information only if a beneficiary requests a referral to an alternate provider.
U.S. Department of Homeland Security Management Directive (MD) 023-01 establishes procedures that the Department and its components use to comply with the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321-4375, and the Council on Environmental Quality (CEQ) regulations for implementing NEPA, 40 CFR parts 1500-1508. CEQ regulations allow Federal agencies to establish categories of actions which do not individually or cumulatively have a significant effect on the human environment and, therefore, do not require an Environmental Assessment or Environmental Impact Statement. 40
DHS has analyzed these regulations under MD 023-01 and has determined that this action is one of a category of actions which does not individually or cumulatively have a significant effect on the human environment. These regulations clearly fit within the two Categorical Exclusions found in MD 023-01: A3(a): “Promulgation of rules . . . of a strictly administrative and procedural nature”; and A5: “Awarding of contracts for technical support services, ongoing management and operation of government facilities, and professional services that do not involve unresolved conflicts concerning alternative uses of available resources.” These regulations are not part of a larger action. They present no extraordinary circumstances creating the potential for significant environmental effects. Therefore, these regulations are categorically excluded from further NEPA review.
On August 6, 2015, the Department of Agriculture (USDA) published a proposed rule at to amend its “Equal Treatment” regulations at 7 CFR part 16 consistent with Executive Order 13559. USDA received comments from 97 parties. The overwhelming majority of comments received by USDA are addressed in the cross-cutting section at part III of this preamble. USDA adopts all of those responses that apply to all of the Agencies that are publishing final regulations, unless otherwise noted in the following discussion. Those responses also indicate that Agencies will issue policy guidance or reference materials that will further clarify various issues, such as the prohibition against “explicitly religious” activities. USDA will issue non-regulatory guidance that will address all of those issues. USDA believes such guidance will be the most effective way to address a variety of more detailed matters in the contexts in which they typically apply to USDA programs. USDA will also continue to provide training for USDA employees and grantees involved in those programs to which these rules are most typically involved.
We concur in the resolution of the issues in part III of the preamble. Specifically;
• USDA adopts the Executive order's exact language that decisions about awards of Federal financial assistance must be made on the basis of merit and not an organization's religious character or affiliation, or lack thereof; and language prohibiting discrimination against beneficiaries based on religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice.
• USDA has revised 7 CFR 16.4(g)(3) consistent with the cross-cutting section of this preamble in part III.D.2, entitled “Referrals.” As indicated therein, the obligation that religious organizations will have to notify their awarding entities of any alternative provider referrals is more limited in this final regulation. This final regulation only requires religious organizations to notify their awarding Agencies when they are unable to identify an alternative provider, rather than also requiring them to provide such notice any time they make a referral. It also now requires that such reports be made “promptly.” USDA agrees with the commenters that recommended these changes.
USDA addresses below the USDA-specific comments that are not addressed in part III of the joint preamble, using the same subheadings to which these comments would apply in that section. After those comments USDA-specific regulatory findings and certifications are indicated.
USDA agrees that record-keeping of referrals is important. USDA will continue to conduct oversight according to its program activities, and will provide program specific guidance on record-keeping because smaller program record-keeping requirements may be ill-suited for larger programs. For instance, USDA has estimated that The Emergency Food Assistance Program (TEFAP) would likely serve nearly 3.5 million people affected by this rule, and may issue nearly 3,500 referrals. Applying the same record-keeping requirements for smaller programs to TEFAP, which is largely made-up of volunteer-based organizations, may prove to be too burdensome. Thus, FNS will provide program specific guidance on record-keeping requirements consistent with redesignated 7 CFR 16.1.
Additionally, as stated in the preamble to the proposed rule, “[i]t must be noted that in some instances, the awarding entity may also be unable to identify a suitable alternate provider within a reasonable geographic proximity.” Thus, the regulation requires only that the service provider “refer the beneficiary to an alternate provider, within reasonable geographic proximity to the provider,
The Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to the notice and comment rulemaking requirements under the Administrative Procedure Act (5 U.S.C. 553) or any other statute, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. USDA has determined that this rule will not have a significant impact on a substantial number of small entities. Consequently, USDA has not prepared a regulatory flexibility analysis.
This final rule has been reviewed in accordance with Executive Order 12988, “Civil Justice Reform.” The provisions of this final rule will not have preemptive effect with respect to any State or local laws, regulations, or policies that conflict with such provision or which otherwise impede their full implementation. The rule will not have retroactive effect.
This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
USDA's Center for Faith-Based and Neighborhood Partnerships has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under Executive Order 13175. If a Tribe requests consultation, the Center for Faith-Based and Neighborhood Partnerships will work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.
In accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. chapter 35, as amended), an agency may not conduct or sponsor a collection of information, and a person is not required to respond to a collection of information, unless the collection displays a currently valid OMB control number. The preamble to the USDA's proposed regulations assessed the burden imposed under this final regulation. This final regulation makes no changes to the proposed regulations and, therefore, do not affect USDA's burden analysis.
USAID received a total of 237 comments on its August 6, 2015 NPRM, and did not consider any comments received after that comment end date of October 7, 2015. Many of the comments were identical to comments provided to the other Agencies and addressed above in part III, although many of these cross-cutting comments did not directly apply, or did not apply in the same way, to USAID. Some of those cross-cutting comments included additional remarks specific to USAID's proposed regulations; in addition, USAID received several other comments only directed to its proposed regulations. Approximately 90% of the comments USAID received were identical or nearly identical to one another.
As reflected below, unless otherwise specified, for those comments received by USAID that are addressed fully in the cross-cutting section in part III, USAID adopts those responses. We address in this part IV.D of the preamble the USAID-specific comments not addressed in part III of the preamble and provide the USAID-specific findings and certifications.
Some of the cross-cutting comments addressed in part III of the preamble were not received by USAID, but are nevertheless applicable to the USAID regulations. Unless noted either in part III or this agency-specific part IV.D of the preamble, we concur in the resolution of the issues in that part of the preamble.
As noted in the August 6, 2015 NPRM, on March 25, 2011, USAID issued an NPRM proposing amendments to 22 CFR 205.1(d) of the final rule on participation by religious organizations in USAID programs originally published on October 20, 2004 (69 FR 61716, codified at 22 CFR parts 202, 205, 211, and 226 (22 CFR part 226 is now codified at 2 CFR part 700)). That process is ongoing. USAID is not making any amendments to 22 CFR 205.1(d) under this rulemaking.
In addition to the applicable cross-cutting comments on the issue of prohibited use of direct Federal financial assistance that are summarized in part III of this preamble, USAID provides the following additional discussion.
USAID does not fund indirect Federal financial assistance programs as that term is used within Executive Order 13559. Thus, USAID did not include a discussion of indirect Federal financial assistance in its NPRM and does not adopt the discussion of the issue in part III B of this preamble.
USAID does not adopt the discussion of the cross-cutting comments related to protections for beneficiaries discussed in part III of this preamble. Instead, USAID addresses the comments it received on that topic in the following discussion.
Other commenters agreed with USAID's decision not to require written notice of beneficiary rights. These commenters highlighted the administrative concerns inherent in providing a written notice. Commenters forecasted that additional regulatory burdens would “diminish the ability of the faith-based community and other neighborhood organization[s] to carry out their intended purposes of providing services to those in need in a timely and efficient manner.” Other commenters opposed the notice requirement as a matter of fairness, arguing that “the secular agency should have a similar burden to refer to a religious organization” so that “the government is neither favoring nor discriminating against a religious or a secular” organization.
This report also, however, emphasized that it focused mostly on domestic programs. The report states: “When applying [the guidance contained in this report] to the special circumstances of programs operating in foreign countries, additional considerations may be implicated. Guidance for these programs should be provided, as appropriate, by departments and agencies operating them in consultation with the Department of Justice, rather than by this report, which focuses largely on domestic considerations.” These final regulations reflect these consultations.
USAID operates in more than 100 countries, many of which are home to multiple, varied national languages. In many of these countries, all of the beneficiaries of USAID programs speak languages other than English. Also, many of the countries in which USAID operates support an official state religion or incorporate religion into government apparatuses. Accordingly, in a large number of cases, there simply would be no alternative provider that would meet the criteria contemplated by the Executive order and the Working Group report. In the international context, therefore, the notice and referral requirements are unworkable and could place an excessive burden on faith-based organizations. Thus, USAID declines to place such a requirement on these providers. Of course, USAID will continue to update and enhance its training, including its training on beneficiary protections, in accordance with the non-regulatory changes required by Executive Order 13559. USAID also notes that it communicates and promotes important religious freedom messages through separate, targeted programs, such as its democracy, human rights, and vulnerable populations initiatives.
Other commenters supported USAID's decision not to require referrals to alternative providers. These commenters highlighted the practical difficulties inherent in the referral process. Specifically, these commenters argued that many faith-based organizations lack the personnel and finances necessary to comply with a complex referral regime. These commenters further highlighted the “extreme and difficult circumstances” unique to international service work, as well as the reality that “there are no
As also noted above, USAID specifically considered the fact that many of the countries in which it operates support an official state religion or incorporate religion into government apparatuses. Accordingly, in a large number of cases, there simply would be no alternative provider that would meet the criteria contemplated by the Executive order and the Working Group report. In the international context, therefore, the notice and referral requirements are unworkable and could place an excessive burden on faith-based organizations. Thus, USAID declines to place such a requirement on these providers.
USAID's existing regulations on this topic are already subject to the above processes. While USAID is making changes to its regulations pursuant to this rulemaking, those changes do not increase the burden of ensuring compliance with the regulations. Because USAID is not adopting the requirements for written notice to beneficiaries or referrals to alternative providers, both of which could require the addition of new monitoring processes, USAID believes its existing processes are sufficient to monitor and ensure compliance with USAID's regulations, including these final regulations. USAID will nevertheless continue to enhance its training on compliance with the requirements of the Establishment Clause.
USAID adopts the discussion of Other Issues found in part III.G of this preamble, and provides the additional information on definitions below.
USAID does not provide a definition of “social service program” or “Federal financial assistance” because such definitions are not necessary for its regulations. USAID has already included the definitions appropriate for its programs in its existing regulations, found at 22 CFR 205.1(a).
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
These regulations do not impose any new recordkeeping requirements nor do they change or modify an existing information collection activity. Thus, the Paperwork Reduction Act does not apply to these final regulations.
This joint final regulation updates all existing HUD regulations governing the equal participation of faith-based organizations in HUD programs to reflect the new fundamental principles and policymaking criteria in Executive Order 13559. HUD's proposed regulations included amendments to 24 CFR 5.109 to reflect the Executive Order 13559 changes, and amendments to 24 CFR parts 92, 570, 574, 576, 578, 582, 583, and 1003 to replace duplicate faith-based regulations with cross-references to 24 CFR 5.109. The proposed rule also included a sample written notice for beneficiaries. Consistent with the discussion of the final regulation in part II, the cross-cutting responses to public comments in part III, and HUD's agency-specific section in part IV.E, HUD makes the following minor changes:
• HUD adopts the Executive order's approach that decisions about awards of Federal financial assistance must be made on the basis of merit and not an organization's religious character or affiliation, or lack thereof; and language prohibiting discrimination against beneficiaries based on religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice.
• HUD clarifies (1) that beneficiaries may report any suspected violation of these protections, to include any denial of services or benefits by an organization, by contacting or filing a written complaint to HUD or an intermediary, if applicable; (2) which party is responsible for seeking an alternative provider after the faith-based organization has undertaken a reasonable effort to locate an alternative provider; and (3) the recordkeeping requirements for referring organizations.
HUD at the final rule includes a sample written notice which follows this regulation in the
Unless otherwise specified, all comments received by HUD are addressed fully in the cross-cutting comment summary section in part III of this preamble and the responses to those comments are adopted by HUD. HUD addresses here the HUD-specific comments not addressed in part III of the preamble, provides agency-specific responses called for in part III, and provides the HUD-specific findings and certifications. This agency-specific discussion is organized in the same manner as part III of the preamble.
In response to HUD's proposed regulation, HUD received 84 public comments. HUD received an additional comment after the deadline and while the comment will not be part of the rule's official docket, HUD has reviewed the comment to determine if issues were raised that were not addressed in comments submitted by the deadline. HUD received comments from providers, religious associations, nonprofit organizations and interested individuals. HUD received many comments in support of the proposed regulation's inclusion of new definitions, the beneficiary protections, and clarification of explicitly religious activities. Commenters also wrote in support of the changes provided to strengthen religious protection for both faith-based providers and beneficiaries. HUD appreciates those comments in support of its rule.
The following scenario provides an example: The local public housing authority (PHA) accepts an eligible family to the Housing Choice Voucher program in accordance with 24 CFR part 982. Under program regulations, the family may select a private-market housing unit of its choosing and benefit from rental subsidy payments paid to the owner of the unit on the family's behalf. When the family selects a unit and the PHA determines that the unit meets the housing quality standards and other program requirements, the owner of the unit enters into a housing assistance payments (HAP) contract with the PHA to receive the rental subsidy payments. The owner of the unit in this example only becomes subject to the nondiscrimination requirements of 24 CFR 5.109(h) upon execution of the HAP contract. Under this scenario, the owner of the unit, if not otherwise receiving direct Federal financial assistance for the housing, is not subject to other provisions of this regulation. HUD will provide additional guidance on how this regulation applies to indirect Federal financial assistance programs.
If HUD or an intermediary is notified of a suspected violation of the requirements, the information will be handled in the same manner that complaints of possible violations of other program requirements are handled, which may include HUD undertaking some form of investigation and seeking a response from a recipient before making a determination on a complaint that HUD receives. Whenever a recipient of HUD Federal financial assistance fails or refuses to comply with the requirements of this regulation, such failure or refusal constitutes a violation of the requirements under the program in which the recipient is operating, and the recipient will be subject to the remedies available to correct the violation, as provided for under the applicable program, which may include the withholding of HUD assistance.
Furthermore, if a suspected violation of the requirements under this rule concerns possible housing discrimination, then an individual may file a complaint under the Fair Housing Act. A complaint of discrimination based on religion or any other protected characteristic may be investigated and enforced under the Fair Housing Act. Such complaints can be filed through HUD's Office of Fair Housing and Equal Opportunity at:
Disposition or change in use of real property by an entity that is not a faith-based organization is subject to the requirements that apply to the HUD program that funded acquisition or improvement of the real property. In some HUD programs, the 2 CFR part 200, subpart D, requirements apply to disposition and change in use of such real property. In other programs, however, program-specific requirements replace the real property requirements at 2 CFR part 200, subpart D. When program-specific requirements replace the Government-wide regulations at 2 CFR part 200, subpart D, for real property disposition, 24 CFR 5.109(j) does not change that with respect to entities that are not faith-based organizations. For example, disposition of CDBG-funded real property owned by an entity that is not a faith-based organization is subject to the real property requirements in 24 CFR part 570, but not 2 CFR 200.311.
In accordance with Executive Order 13175 entitled “Consultation and Coordination With Indian Tribal Governments”, issued on November 6, 2000, HUD has consulted with representatives of tribal governments concerning the subject of this rule. HUD, through a letter dated November 19, 2014, provided Indian tribes and Alaska Native Villages the opportunity to comment on the substance of the regulatory changes during the development of the August 6, 2015, proposed rule. HUD received no comments in response to those letters. Additionally, the August 6, 2015, proposed rule provided Indian tribes with an additional opportunity to comment on the proposed regulatory changes.
The Regulatory Flexibility Act (5 U.S.C. 601
This final regulation provides more access for entities to participate in HUD programs by clarifying requirements for participation in HUD programs. In addition, the final regulation requires that faith-based organizations that carry out activities under a HUD program with direct Federal financial assistance must give beneficiaries and prospective beneficiaries written notice of the protections listed at 24 CFR 5.109(g). This includes notification that the organization must undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection, if the beneficiary objects to the religious character of the organization. The organization must inform the beneficiary or prospective beneficiary in writing and the organization would be required to maintain records of the referral.
In HUD's implementation of Executive Order 13559, HUD has made every effort to ensure that the beneficiary protections requirements of the final regulation, including providing written notice and a referral, impose minimum burden and allow maximum flexibility in implementation by providing a sample notice that organizations may provide to beneficiaries informing them of the protections and by not prescribing a specific format for making referrals. HUD estimates it will take no more than 2 hours for providers to familiarize themselves with the notice requirements of this final regulation and print and duplicate an adequate number of written notices for prospective beneficiaries. In addition, HUD estimates an upper limit of $100 for the annual cost of materials (paper, ink, toner) to print multiple copies of the notices. HUD notes that, after the first year, the labor costs associated with compliance will likely decrease significantly because providers will be familiar with the requirements. Because these costs will be borne by every faith-based organization that carries out an activity under a HUD program with direct Federal financial assistance, HUD believes that a substantial number of small entities will be affected by this provision. However, HUD does not believe that the compliance cost estimated per provider per year is significant.
The final regulation will also require faith-based organizations, upon a beneficiary's objection, to make reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection. HUD estimates that each referral will require no more than 2 hours of a provider's time. Although HUD does not have any way to determine the number of referrals that will occur in any 1 year, HUD does not believe that referral costs will be significant for small providers.
This final regulation includes a new information collection section, at 24 CFR 5.109(g), which would impose requirements on faith-based organizations that carry out activities under a HUD program with direct Federal financial assistance to give beneficiaries (or prospective beneficiaries) written notice of certain protections described in this final regulation; beneficiaries can provide a written response that may impose a burden under the Paperwork Reduction Act (PRA); and faith-based organizations, or intermediary, must provide a referral if a beneficiary or prospective beneficiary objects to the religious character of the organization. This regulation also requires the retention of records to show that the referral requirements in this rulemaking have been met.
The information collection requirements in the proposed regulations were submitted to OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In accordance with the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the
This final regulation sets forth nondiscrimination standards. Accordingly, under 24 CFR 50.19(c)(3), this final regulation is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
The regulatory amendments contained in this final regulation apply to all HUD assistance programs for which faith-based organizations are eligible to participate. The Catalog of Federal Domestic Assistance (CFDA) number for a particular HUD program may be found on the CFDA Web site at
Unless otherwise specified, all comments received by DOJ are addressed fully in part III of the preamble. Here, DOJ addresses the DOJ-specific comments not addressed in part III, and provides DOJ-specific findings and certifications. This agency-specific discussion is organized in the same manner as part III. Sections for which DOJ received no agency-specific comments have been omitted.
DOJ used “may” in its proposed 28 CFR 38.8 to indicate that the office within DOJ designated to enforce the regulations would have discretion in opening investigations and conducting compliance reviews. The drafters' intention in using “may” was not to absolve DOJ from its responsibility to enforce the regulations but to indicate that the enforcement office was not bound to investigate all complaints, as some complaints on their face may not have merit or the enforcement office may not have the capacity to investigate all complaints based on its staffing and budget. DOJ has resolved this concern in these final regulations by clarifying which office has that responsibility.
OCR prefers the complaint to be in writing so as to collect as much information as possible about an allegation of noncompliance and provides accommodations to any individual requiring special assistance for completing a complaint form. These accommodations will be available to assist any beneficiary who wishes to make a report under this regulation. However, OCR agrees that beneficiaries should not always be required to report a violation in writing and will accept other forms of complaint, including oral complaints.
The following reflect DOJ findings and certifications that are not addressed in part V.
The Regulatory Flexibility Act (RFA) at 5 U.S.C. 603(a) requires agencies to prepare and make available for public comment an initial regulatory flexibility analysis that describes the impact of the proposed rule on small entities. The RFA at 5 U.S.C. 605(b) allows an agency not to prepare an analysis if it certifies that the rulemaking will not have a significant economic impact on a substantial number of small entities. Furthermore, under the Small Business
Except when the nature of the service provided or exigent circumstances make it impracticable, the regulation requires a faith-based or religious organization administering a program that is supported by direct Federal financial assistance to give written notice to beneficiaries and prospective beneficiaries of their rights under these regulations. These include the right of the beneficiary to object to the religious character of the organization and the obligation of the organization in those circumstances to undertake reasonable efforts to refer the beneficiary to an alternative provider. The organization must inform the beneficiary or prospective beneficiary of those rights in writing and maintain a record of where the beneficiary is referred if a referral is made. If the organization is unable to identify an alternative provider, it must notify the awarding entity of that fact and also maintain a record for review.
DOJ has made every effort to ensure that the notice and referral requirements of the regulations impose minimum burden and allow maximum flexibility in implementation. These regulations include a model Written Notice of Beneficiary Protections in appendix A with the required language that organizations must give to beneficiaries to inform them of their rights and protections, along with a model Beneficiary Referral Request form in appendix B. DOJ estimates it will take no more than two hours for organizations to familiarize themselves with the notice and referral requirements and print and duplicate an adequate number of notice and referral forms for potential beneficiaries. DOJ estimates an upper limit of $50/hour for the labor cost to prepare the forms (or $100 per service provider per year)
The “load factor” is the wage multiplier used to estimate the total cost to the employer of compensating the employee for both wages
The regulations require faith-based or religious organizations that provide social services, at the beneficiary's request, to make reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection based on the provider's religious character. DOJ has provided a model Beneficiary Referral Request form for organizations to use in appendix B. Although DOJ does not have any way to determine the number of referrals that will occur in any one year, DOJ does not believe that referral costs will be appreciable for small faith-based organizations.
Executive Order 12988 provides that agencies shall draft regulations to avoid drafting errors and ambiguity, minimize litigation, provide clear legal standards for affected conduct, and promote simplification and burden reduction. These regulations meet the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
These final regulations include a new information collection section, at 28 CFR 38.6(c)(1), which would impose requirements on faith-based organizations that carry out activities under a program supported with direct Federal financial assistance from DOJ to give beneficiaries (or prospective beneficiaries) written notice of certain protections described in these final regulations. A beneficiary who objects to the religious character of the organization may make a written request for a referral to an alternative provider, and faith-based organizations (or, under certain circumstances, an intermediary) must undertake reasonable efforts to provide the referral if the beneficiary makes the request. The regulations also require that the organization retain records to show that it has met the referral requirements. The regulations thus may impose a burden under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
The information collection requirements in the proposed regulations were submitted to OMB under the PRA. In accordance with the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number. 44 U.S.C. 3507(a), 3512. The information collection requirements of these regulations were assigned OMB Control Number 1121-0353.
No comments were received that specifically addressed the paperwork burden analysis of the information collections at the proposed rule stage. As a result, DOJ has not revised the paperwork burden analysis and has not changed these final regulations in connection with the administrative burden.
On August 6, 2015, DOL published proposed regulations (80 FR 47327) as part of its effort to fulfill its responsibilities under Executive Order 13559. The proposal sought to revise DOL's existing regulations on the subject, codified at 29 CFR part 2 subpart D, that were promulgated following the issuance of Executive Order 13279 in 2002.
DOL has amended the final regulations in response to comments relevant to all of the Agencies' proposed regulations for the reasons discussed in part III of the joint preamble, as well as
The significant changes from DOL's proposed regulations are as follows, and are discussed in more detail as necessary in the issue-by-issue discussion and are designed to achieve the following:
• Clarify that the nondiscrimination obligations set forth in 29 CFR 2.33(a) apply to programs funded directly or indirectly by Federal financial assistance consistent with the approach discussed in part III, and deleting the existing 29 CFR 2.33(c) consistent with this clarification.
• Include among the beneficiary protections the requirement that a religious organization may not discriminate against a beneficiary for refusing to hold a religious belief or refusing to attend or participate in religious practices. However, further clarification is added to state that programs funded by indirect financial assistance need not modify those programs to accommodate a beneficiary. These changes are made to maintain greater uniformity with the other Agencies administering Executive Order 13559.
• Consistent with part III, DOL's final regulations limit religious organizations' mandatory reporting to occasions where the organization is unable to identify an alternative provider, instead of mandating reporting any time a referral is made as was proposed in the NPRM, and requires that such reports be made promptly.
• Move the text of the required notice and referral request from within the regulations at 29 CFR 2.35(a) to separate appendices to the regulation.
DOL departs slightly with the regulatory approach of at least some of the other Agencies on some issues due to organizational and programmatic differences, as well as DOL's existing regulations on religious liberty protections and the equal treatment of faith-based organizations. A summary of these, expanded upon in the issue-by-issue discussion below, are as follows:
• Maintaining the language in DOL's existing regulations on chaplaincy.
• Maintaining a proposed regulation detailing the obligations of intermediaries to ensure compliance of non-governmental organizations it selects to provide services with Federal financial assistance.
• Maintaining the proposed “Notice of Beneficiary Religious Liberty Protections” and “Beneficiary Referral Request” form in the regulation, but moving the contents to a new appendix A and B, respectively.
• Consistent with other Agencies who administer Federal financial assistance outside of the United States, the final regulations limit applicability of the notice and referral obligations to social service programs within the United States.
Finally, consistent with the Executive order, part III, and as further detailed below, DOL will also promulgate guidance for DOL-supported social service programs and intermediaries to effectively implement these final regulations, including, but not limited to, monitoring of recipients by intermediaries, reporting on the alternative provider referral system, and posting of the “Notice of Beneficiary Religious Liberty Protections.”
DOL does make additional technical changes, replacing the term “intermediary” as used in the proposed regulatory text with “DOL social service intermediary provider,” which is the term that is defined in the regulation at 29 CFR 2.31(f).
DOL agrees with the issues raised by the commenter. In the 2012 report issued by the interagency working group tasked with promulgating this regulation, the group stated that “When applying [the guidance contained in this report] to the special circumstances of programs operating in foreign countries, additional considerations may be implicated. Guidance for these programs should be provided, as appropriate, by departments and agencies operating them in consultation with the Department of Justice, rather than by this report, which focuses largely on domestic considerations.”
The Agencies' joint submission relevant to Executive Orders 12866 and 13563 is set forth in part V, General Certifications. DOL joins that portion of the preamble in full. What follows below is a discussion of issues relevant
The only provisions of these final regulations likely to impose costs on the regulated community are the requirements that DOL social service providers with a religious affiliation: (1) Give beneficiaries a written notice informing them of their religious liberty rights when seeking or obtaining services supported by direct DOL financial assistance, (2) at the beneficiary's request, make reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection, and (3) document such action. To minimize compliance costs on DOL social service providers, DOL provides the exact text of the notice to providers in appendices to its regulations at 29 CFR part 2, subpart D, and will also make the text available through its agency Web site.
An estimate of the cost of providing this notice and referring beneficiaries is discussed in the Paperwork Reduction Act agency-specific section of these final regulations. To minimize compliance costs and allow maximum flexibility in implementation, DOL has elected not to establish a specific format for the referrals required when beneficiaries request an alternative provider. To estimate the cost of the referral provision, DOL would need to know the number of religious direct social service providers funded by DOL annually, the number of beneficiaries who would ask for a referral, and the costs of making the referral and notifying relevant parties of the referral.
Because the notice and referral obligations are new requirements for DOL-funded social service programs, there is no known source of information to quantify precisely the numbers or proportions of program beneficiaries who will request referral to alternative providers. We are not aware of any instances in which a beneficiary of a program of DOL has objected to receiving services from a faith-based organization. There is a possibility that because of these regulations, when beneficiaries start receiving notices of their right to request referral to an alternative service provider, more of them may raise objections. However, our estimate of the number of referrals is also informed by the experience of SAMHSA, which administers beneficiary substance abuse service programs under titles V and XIX of the Public Health Service Act, 42 U.S.C. 290aa
Notwithstanding the absence of concrete data, DOL believes that these regulations are not significant within the meaning of the Executive order because the annual costs associated with complying with the written notice and referral requirements will not approach $100 million.
The Regulatory Flexibility Act (5 U.S.C. 601
As described in regulatory impact analysis section of the proposed regulation, DOL has made every effort to ensure that the disclosure and referral requirements of the proposed regulations impose minimum burden and allow maximum flexibility in implementation by providing the notice for providers to give beneficiaries informing them of their rights and by not proscribing a specific format for making referrals. DOL estimates it will take no more than two minutes for providers to print, duplicate, and distribute an adequate number of disclosure notices for potential beneficiaries. Using the May 2013 Bureau of Labor Statistics hourly mean wage for a Training and Development Specialist of $29.22 results in an estimate of the labor cost per service provider of preparing the notice of approximately $0.97. In addition, DOL estimates an upper limit of $100 for the annual cost of materials (paper, ink, toner) to print multiple copies of the notices. Because these costs will be borne by every small service provider with a religious affiliation, DOL believes that a substantial number of these small entities may be affected by this provision. However, DOL does not believe that a compliance cost of less than $200 per provider per year is a significant percentage of a provider's total revenue. In addition, we note that after the first year, the labor cost associated with compliance will likely decrease significantly because small service providers will be familiar with the requirements.
The final regulations will also require religious social service providers, at the beneficiary's request, to make reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection. If an organization is unable to identify an alternative provider, the organization is required to notify the awarding entity and that entity is to determine whether there is any other suitable alternative provider to which the beneficiary may be referred. A DOL social service intermediary may request assistance from DOL in identifying an alternative service provider. DOL estimates that each referral request will require no more than two hours of a Training and Development Specialist's time to process at a labor cost of $29.22 per hour. Although DOL does not have any way to determine the number of referrals that will occur in any one year, based on available data on the SAMHSA program, DOL has no evidence to suggest either this number will be significant or that referral costs will be appreciable for small service providers.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)), DOL submitted a new information collection request (ICR) to OMB in accordance with 44 U.S.C. 3507(d), contemporaneously with the publication of the notice of proposed rulemaking for OMB's review. OMB
In addition to requesting comments on the ICR during the proposed regulations stage (pre-clearance), the OMB and DOL specifically requested comments on the ICR that:
• Evaluate whether the collections of information are necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected, and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of IT (
As instructed by OMB, prior to publication of the final regulations, DOL submitted to OMB a summary of the comments received on the proposed information collections and any changes made in the final regulations in response to the comments. No public comments were received that specifically addressed the paperwork burden analysis of the information collections at the proposed regulations stage. Three comments were submitted, as described elsewhere in this preamble, generally disagreeing with the administrative burden developed by DOL without any attendant data or alternative analysis. As a result, DOL has not revised the paperwork burden analysis and no changes have been made in the final regulations in connection with the administrative burden. One comment was received concerning the appropriate follow-up procedure when a referral is made to an alternative provider. DOL has made a minor revision to the model notice and referral form in response to this comment that does not change the burden estimate.
A copy of this ICR with applicable supporting documentation including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
DOL's new information collections are contained in 29 CFR 2.34 and 2.35 of these final regulations. DOL's final regulation at 29 CFR 2.34 imposes requirements on religious social service providers to give beneficiaries and potential beneficiaries a standardized notice instructing them of their rights and requiring a written response only in those few cases where a beneficiary requests a referral. DOL determined this notice is not a collection of information subject to OMB clearance under the PRA because the Federal Government has provided the exact text that a provider must use. See 5 CFR 1320.3(c)(2). The beneficiary's response, however, is subject to OMB clearance under the PRA. Care has been taken to obtaining minimal identifying information and providing check boxes for material responses.
DOL's final regulation at 29 CFR 2.35 requires that when a beneficiary or prospective beneficiary of a social service program supported by direct DOL financial assistance objects to the religious character of an organization that provides services under the program, that organization must promptly undertake reasonable efforts to identify and refer the beneficiary to an alternative provider. The referral process entails a collection of information subject to PRA clearance, specifically, informing the beneficiary of a referral to an alternative provider. Under 29 CFR 2.35(d), the organization is required to maintain a record of referrals to alternative providers as well as to notify the awarding entity and maintain a record for review if the organization is unable to identify an alternative provider. That awarding entity is to determine whether there is any other suitable alternative provider to which the beneficiary may be referred. The final regulation at 29 CFR 2.35(e) specifically notes that a DOL social service intermediary provider may request assistance from DOL in identifying an alternative service provider. Further, the Executive order and the final regulations require the relevant government agency to ensure that appropriate and timely referrals are made to an appropriate provider, and that referrals are made in a manner consistent with applicable privacy laws and regulations.
Religious social service providers subject to these requirements must keep records to show they have met the referral requirements. In the case of paper notices, religious social service providers may meet the record-keeping requirements by keeping the bottom portion of the notice. For those religious social service providers that provide notice electronically, the notices must include a means for beneficiaries to request an alternative placement—and follow-up, if desired—that is recorded so that the religious social service providers may retain evidence of compliance with this final regulation. DOL does not estimate the burden of maintaining the records needed to demonstrate compliance with the requirements imposed on the religious social service providers. The record-keeping burden that this regulation adds is so small that, under most programs, it does not measurably increase the burden that already exists under current program and administrative requirements. If, due to the unique nature of a particular program, the record-keeping burden associated with this regulation is large enough to be measurable, that burden will be calculated under the record-keeping and reporting requirements of the affected program and identified in information collection requests that are submitted to OMB for PRA approval. Therefore, DOL does not include any estimate of record-keeping burden in this PRA analysis.
The burden for the information collection provisions of these final regulations can be summarized as follows:
DOL certifies that these regulations have been assessed according to section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-227, 112 Stat. 2681), for its effect on family well-being. It will not adversely affect the well-being of the nation's families. Therefore, DOL certifies that these proposed regulations do not adversely impact family well-being.
On August 6, 2015, VA published a proposed regulation (80 FR 47340). VA received 87 comments in response to its proposed regulation. Unless otherwise specified, all comments received by VA are addressed fully in the cross-cutting section in part III and those responses are adopted by VA. VA addresses in this part the VA-specific comments not addressed in part III of the preamble, provides agency-specific response called for in part III, and provides the VA-specific findings and certifications. This agency-specific discussion is organized in the same manner as part III of the preamble. VA does not discuss minor or technical changes that were made to provide greater consistency or simplify the language in the regulations.
Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number. See also 5 CFR 1320.8(b)(3)(vi).
This final rule will impose the following new information collection requirements. 38 CFR 50.2 will require faith-based or religious organizations that receive direct VA financial assistance in providing social services to beneficiaries to provide to beneficiaries (or prospective beneficiaries) written notice informing them of certain protections. As required by the 44 U.S.C. 3507(d), VA submitted these information collections to OMB for its review, and the information collection is pending OMB approval. Consistent with the applicable cross-cutting comments in part III of this preamble related to the written notice, VA revises its written notice to indicate that an organization receiving direct financial assistance from VA may not discriminate against a beneficiary on the basis of religion, religious belief, refusal to hold a religious belief, or a refusal to attend or participate in a religious practice. In addition, VA revises its written notice to state that “we cannot guarantee that in every instance an alternate provider will be available.”
Notice of OMB approval for this information collection will be published in a future
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Although small entities participating in VA's Grant and Per Diem and and Supportive Services for Veteran Families programs will be affected by this final rule, any economic impact will be minimal. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.024, VA Homeless Providers Grant and Per Diem Program; 64.033, VA Supportive Services for Veteran Families Program.
On August 6, 2015, HHS published a proposed rule at 80 FR 47272 to amend its “Equal Treatment” regulations at 45 CFR part 87 consistent with Executive Order 13559. The proposed rule also changed the format of the initial rule, which was published in 2004, so that it no longer separates applicable clauses based on grant type (
While some of the cross-cutting comments addressed in part III of the preamble were not received by HHS, we concur in the resolution of the issues in that part of the preamble. Further, the cross-cutting section of the preamble indicates that the Agencies have agreed to make certain changes to their regulations that were already reflected in HHS's NPRM, and it is therefore not necessary for HHS to make such changes. For example, while some agencies are making changes to the sections of their regulations that address anti-discrimination against beneficiaries, HHS does not need to make those changes because HHS's proposed regulations already included the desired language. An overview of each section of the final regulation text, and the rationale for most of the amendments to the 2004 “Equal Treatment” rules, can be found in the preamble to the proposed rule. Given the preamble to the HHS proposed regulation, and the limited changes to that regulation, this final regulation is limited to discussing the following eight substantive changes to the proposed regulation that was in the NPRM:
First, HHS has revised 45 CFR 87.2, entitled “Applicability,” to exempt Child Care and Development Fund (CCDF) grants from the provisions that the NPRM had proposed to make applicable to that program, because beneficiaries in that program already have the option to obtain certificates or vouchers that enable them to choose among available providers. Consequently, it is not necessary to apply the new rules to CCDF grants in order to make alternative providers available to persons with religious objections to faith-based providers. Thus, this final regulation will not apply to CCDF, which is consistent with our past practice.
CCDF programs are governed by an authorizing statute (42 U.S.C. 9858-9858q) and regulation (45 CFR part 98) each of which includes six clauses addressing religious issues, such as participation of religious organizations, nondiscrimination against beneficiaries on the basis of religion and a bar against directly funding religious activity. Since the time that the Equal Treatment rules were initially published in 2004, they have not been applicable to CCDF. Rather, the Administration of Children and Families, Office of Child Care, issued a policy that grantees should follow the rules as a matter of good practice, to the extent that doing so does not conflict with the Child Care and Development Block Grant Act and implementing regulations. See
Second, HHS has broadened the religious nondiscrimination clause in 45 CFR 87.3(d) to prohibit not only religious discrimination in the delivery of services, but also the outreach for such services. The new rule states that an organization that participates in any programs funded by financial assistance from an HHS awarding agency shall not discriminate against a program beneficiary or prospective program beneficiary on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice, not only when providing services but also when conducting outreach activities related to those services. HHS agrees with the Agencies' rationale for this change, as described in part III.B of the preamble, subtitled “Direct and Indirect Federal Financial Assistance.” The change is also consistent with HHS's practice since the inception of the Equal Treatment rules in 2004.
Third, HHS has also revised 45 CFR 87.3(d) to state that an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on that organization's program. This change is described in part III.B of the preamble, subtitled “Direct and Indirect Federal Financial Assistance,” and we agree with the Agencies' rationale for the change.
Fourth, HHS has revised the notice, nondiscrimination and alternative provider requirements at 45 CFR 87.3(i)(1), 87.3(i)(1)(i), 87.3(i)(1)(iv)-(v), and 87.3(j) to encompass not only beneficiaries but also prospective beneficiaries. This is consistent with the approach taken by the other agencies. This way, faith-based or religious organizations must provide the notice of beneficiary protections to both beneficiaries and prospective beneficiaries. Further, an HHS-funded social service provider may not discriminate against either a beneficiary or prospective beneficiary on the basis of religion, religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice. Finally, either a beneficiary or prospective beneficiary may object to the religious character of an HHS-funded social service provider and request an alternative one.
Fifth, HHS has revised the notice requirement in 45 CFR 87.3(i)(1)(iv) to explicitly state that when a beneficiary or prospective beneficiary objects to the religious character of a faith-based or religious organization that provides
Sixth, HHS has revised both the regulations at 45 CFR 87.3(i)(1)(v) and the sample “Written Notice of Beneficiary Protections” in appendix I consistent with the discussion in part III.D.1, entitled “Beneficiary Notice.” We and the other agencies agree with the commenter's concern that the final regulations should make clear that each beneficiary's right to report a violation of these protections includes the right to file a complaint of any denials of services or benefits that violates these final regulations. As indicated in the text of the final regulations, such reports and complaints may be made to the HHS office that awarded the grant at issue. In addition, complaints of religious discrimination in some particular programs may also be reported in writing to the HHS Office for Civil Rights (OCR). Those programs and the bases of such complaints are more specifically identified on the OCR Web site at
Seventh, HHS has revised 45 CFR 87.3(k) consistent with the cross-cutting section of this preamble in part III.D.2 entitled “Referrals.” As indicated therein, the obligation that faith-based and religious organizations have under these final regulations to notify their awarding entities of any alternative provider referrals is now more limited than it was in the proposed rule. The final regulations only require faith-based or religious organizations to notify their awarding agencies when they are unable to identify an alternative provider, rather than also requiring them to provide such notice any time they make a referral. The final regulations also now require that these reports be made “promptly.” HHS agrees with the commenters who recommended these changes.
Eighth, 45 CFR 87.3(k) is also amended to require any organization that is successful in making a referral to an alternative provider, under 45 CFR 87.3(j), to then maintain a record of that referral. As indicated in part III.D.2 of the preamble, subtitled “Notification of Government and timeframe of referral,” this requirement is consistent with that which all of the Agencies have adopted. The requirement will enable HHS and intermediary organizations to monitor grantees and subgrantees, respectively, to ensure that they comply with the alterative provider requirement, and is also consistent with HHS cost and accounting regulations at 45 CFR 75.302(a).
The remainder of this final regulation is identical to HHS's proposed rule text, with the exception of some additional clarifying changes. HHS addresses below the HHS-specific comments that are not addressed in part III of the joint preamble, using the same subheadings to which these comments would apply in that section. After those comments, HHS-specific regulatory findings and certifications are indicated.
As to prayer, HHS will note in guidance that attending a federally-supported program does not affect an individual's right to pray. Program beneficiaries may engage in prayer, generally, subject to the same rules designed to prevent material disruption of the program that are applied to any other privately-initiated speech. This is because the bar against use of Federal financial assistance for explicitly religious activities applies to activities, speech, and materials that are generated or controlled by the administrators, instructors, or officials of the federally-financed program. The requirement generally does not apply to the activities of beneficiaries whose speech is not controlled, encouraged, or approved after the fact by program administrators, instructors, or officials.
CCDF quality improvement grants are awarded directly to grant recipients, rather than through certificates or vouchers, and therefore religious activities may not be part of the quality improvement services funded by the grants. When the recipient of a quality improvement grant provides secular technical assistance to a faith-based child care provider that provider may still continue to accept certificates or vouchers to administer a program that includes explicitly religious content.
HHS will ordinarily inform prospective applicants as to whether available grants are governed by these rules in our HHS notices announcing the availability of grant awards. Given the large volume and wide array of grant programs administered by HHS, we believe this is a more practical approach to identifying applicable programs rather than listing all of them in this rule. Consequently, HHS declines the recommendation to do so.
When making the decisions as to whether other provisions in these regulations should apply to these three Charitable Choice programs, HHS was mindful of the need to avoid conflicts between this regulation and the statutory Charitable Choice provisions that apply to SAMHSA, TANF and CSBG. HHS was also mindful of the need to balance the goals of promoting uniformity and clarity while enhancing beneficiary protections, with the goal of minimizing the number of new regulations in programs that already comply with the fundamental elements of these Executive Order 13559 amendments. We believe that the approach to those three programs in the HHS proposed rule was a reasonable balance between these goals; and as explained earlier in this preamble, Child Care and Development Fund (CCDF) grants should be exempt in the final rule for these reasons. Thus, while we understand and appreciate the commenter's recommendation, we decline the recommendation to apply these regulatory provisions to TANF, SAMHSA and CCDF or apply more of the new provisions to CSBG.
The TANF and SAMHSA programs all remain governed by the Charitable Choice statutes and rules cited above, and CCDF grants remain governed by the Child Care and Development Block Grant Act and its implementing regulations cited at the beginning of the HHS overview of its proposed changes. We intend to state in upcoming sub-regulatory guidance, which will aid grantees in identifying “explicitly religious” activities, that the terms “inherently religious” or “sectarian activities” are used in the three Charitable Choice rules and the CCDF regulations each has the same meaning as the term “explicitly religious” activities as used in these regulations. We also intend to state in our guidance that the distinctions between “direct” and “indirect” forms of funding as used in the TANF and SAMHSA Charitable Choice statutes, and CCDF program regulations, should be defined consistent with the definitions in these regulations.
The Agencies' joint submission relevant to Executive Orders 12866 and 13563 is set forth in part V. HHS joins that portion of the preamble in full, and what follows below is a discussion of issues relevant to HHS's final regulation. As HHS indicated in the NPRM, Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule that: (1) Has an annual effect on the economy of $100 million or more or adversely and materially affects a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or Tribal governments or communities (also referred to as “economically significant”); (2) creates serious inconsistency or otherwise interferes with an action taken or planned by another agency; (3) materially alters the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866.
HHS believes that the only provisions of this rule likely to impose costs on the regulated community are the requirements that HHS faith-based or religious social service providers: (1) Give beneficiaries a written notice informing them of their religious liberty protections when seeking or obtaining services supported by direct HHS financial assistance, (2) at the beneficiary's request, make reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection, and (3) document such action. To minimize compliance costs and allow maximum flexibility in implementation, the final regulations provide the language to be included in the notice directly within the regulations. Additionally, the preamble includes an example of the notice in appendix I to the preamble. An estimate of the burden, in term of the number of hours involved in referring beneficiaries, is discussed in the Paperwork Reduction Act section of this preamble, which cross-references the NPRM preamble.
At this time, there is no known source of information to quantify precisely the numbers or proportions of program beneficiaries who will request referral to alternative providers. HHS is not aware of any instances in which a beneficiary of a program of HHS has objected to receiving services from a faith-based organization. There is however a possibility that HHS will begin to see objections when, as a result of the implementation of these final regulations, beneficiaries begin to receive notices of their option to request referral to an alternative service provider. HHS must therefore estimate that the number of requests for referrals will be one per year for each faith-based or religious organization that receives HHS funding through prime or sub-awards. While a precise estimate is not available, HHS believes that this estimate is reasonable, though it likely errs on the higher end in view of HHS's experience. The Substance Abuse and Mental Health Services Administration (SAMHSA), which administers beneficiary substance abuse service programs under titles V and XIX of the Public Health Service Act, 42 U.S.C. 290aa
Notwithstanding the absence of concrete data, HHS believes that this rule is not significant within the meaning of the Executive order because the annual costs associated with complying with the written notice and referral requirements will not approach $100 million.
The Regulatory Flexibility Act (RFA) at 5 U.S.C. 603(a) requires agencies to prepare and make available for public comment an initial regulatory flexibility analysis which will describe the impact of the proposed rule on small entities. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. Furthermore,
As HHS indicated in the preamble to the proposed rule, under the Initial Regulatory Flexibility Analysis, HHS has made every effort to ensure that the disclosure and referral requirements of the rule impose minimum burden and allow maximum flexibility in implementation by providing in the rule the notice for providers to give beneficiaries informing them of their protections and by not proscribing a specific format for making referrals. HHS believes the conclusions that we provided in the preamble remain accurate, and refer persons to our analysis in that preamble.
The purposes of the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
A Federal agency may not conduct or sponsor a collection of information unless it is approved by OMB under the PRA, and displays a currently valid OMB control number, and the public is not required to respond to a collection of information unless it displays a currently valid OMB control number. Also, notwithstanding any other provisions of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number (44 U.S.C. 3512). As we indicated in the NPRM, this rule may require the collection of additional information from beneficiaries should a request for referral to an alternative service provider be received. Consequently, HHS submitted a new information collection request (ICR) to OMB contemporaneously with the publication of the NPRM. OMB assigned Control Number 201507-0990-011 on November 27, 2015.
In the NPRM preamble, HHS provided an assessment of the collection burden that we continue to believe to be accurate. HHS refers to that NPRM preamble for our PRA analysis because it also remains applicable to these final regulations. HHS did not receive any comments concerning the PRA analysis in our preamble to the proposed rule, with the exception of one comment that was sent to the Agencies. That comment maintained that the Agencies' estimate that the referral option will take no more than two hours was without basis, and is among those addressed in the preamble at part III.D.2, under “Referrals,” beneath the subheading “Burdens, duties and liability of the referring organization.” HHS agrees with the Agencies' conclusion that the two hour referral time estimate, which was indicated in our NPRM preamble, was reasonable and HHS has not changed it.
HHS certifies that these regulations have been assessed according to section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681), for its effect on family well-being. The regulations will not adversely affect the well-being of the nation's families. Therefore, HHS certifies that this rule does not adversely impact family well-being.
Under Executive Order 12866, the head of each agency must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by OMB. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a regulation that may
(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as an “economically significant” regulation);
(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in Executive Order 12866.
58 FR 51735, 51738 (Oct. 4, 1993).
The heads of the Agencies have determined that this final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
The Agencies have also reviewed these regulations under Executive Order 13563, which supplements and reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, section 1(b) of Executive Order 13563 requires that an agency:
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives, and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance that regulated entities must adopt; and
(5) Identify and assess available alternatives to direct regulation, including providing economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or providing information that enables the public to make choices.
76 FR 3821, 3821 (Jan. 21, 2011). Section 1(c) of Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” Id. The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.” Memorandum for the Heads of Executive Departments and Agencies, and of Independent Regulatory Agencies, from Cass R. Sunstein, Administrator, Office of Information and Regulatory Affairs,
The Agencies are issuing these final regulations upon a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, the Agencies selected those approaches that maximize net benefits. Based on the analysis that follows, the Agencies believe that these final regulations are consistent with the principles in Executive Order 13563.
The Agencies also have determined that this regulatory action does not unduly interfere with State, local, or tribal governments in the exercise of their governmental functions.
In accordance with Executive Orders 12866 and 13563, the Agencies have assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs associated with this regulatory action are those resulting from the requirements of Executive Order 13279, as amended by Executive Order 13559, and those determined to be necessary for administering the Agencies' programs and activities.
These regulations are not a “major rule” as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804(2). These regulations will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1532(a), requires that a Federal agency determine whether a regulation proposes a Federal mandate that would result in increased expenditures by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any single year. If a regulation would result in increased expenditures in excess of $100 million, UMRA requires the agency to prepare a written statement containing, among other things, a qualitative and quantitative assessment of the anticipated costs and benefits of the Federal mandate. The Agencies have reviewed these regulations in accordance with UMRA and determined that the total cost to implement the regulations in any one year will not meet or exceed $100 million. The regulations do not include any Federal mandate that may result in increased expenditure by State, local, and tribal governments in the aggregate of more than $100 million, or increased expenditures by the private sector of more than $100 million. Accordingly, the Agencies certify that UMRA does not require any further action.
Section 6 of Executive Order 13132 requires Federal agencies to consult with State entities when a regulation or policy will have substantial direct effects on the States, the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government within the meaning of Executive Order 13132. 64 FR 43255, 43257 (Aug. 10, 1999). Section 3(b) of Executive Order 13132 further provides that Federal agencies may implement a regulation limiting the policymaking discretion of the States only where there is constitutional and statutory authority for the regulation and the regulation is appropriate in light of the presence of a problem of national significance. 64 FR at 43256.
These final regulations do not have a substantial direct effect on the States or the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government, within the meaning of Executive Order 13132. Furthermore, constitutional and statutory authority supports the regulations, and they are appropriate in light of the presence of a problem of national significance.
These regulations affect programs that are subject to the requirements of Executive Order 12372, 47 FR 30959 (July 16, 1982), and the Agency regulations implementing that order. One of the objectives of Executive Order 12372 is to foster an intergovernmental partnership and a strengthened federalism. Id. at 30959. Executive Order 12372 relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance. Id.
This document provides early notification of the Agencies' specific plans and actions for the programs affected by these final regulations.
Accounting, Administrative practice and procedure, Adult education, Aged, Agriculture, American Samoa, Bilingual education, Blind, Business and industry, Civil rights, Colleges and universities, Communications, Community development, Community facilities, Copyright, Credit, Cultural exchange programs, Educational facilities, Educational research, Education, Education of disadvantaged, Education of individuals with disabilities, Educational study programs, Electric power, Electric power rates, Electric utilities, Elementary and secondary education, Energy conservation, Equal educational opportunity, Federally affected areas, Government contracts, Grant programs, Grant programs—agriculture, Grant programs—business and industry, Grant programs—communications, Grant programs—education, Grant programs—energy, Grant programs—health, Grant programs—housing and community development, Grant programs—social programs, Grant administration, Guam, Home improvement, Homeless, Hospitals, Housing, Human research subjects, Indians, Indians—education, Infants and children, Insurance, Intergovernmental relations, International organizations, Inventions and patents, Loan programs, Loan programs social programs, Loan programs—agriculture, Loan programs—business and industry, Loan programs—communications, Loan programs—energy, Loan programs—health, Loan programs—housing and community development, Manpower training programs, Migrant labor, Mortgage insurance, Nonprofit organizations, Northern Mariana Islands, Pacific Islands Trust Territories, Privacy, Renewable Energy, Reporting and recordkeeping requirements, Rural areas, Scholarships and fellowships, School construction, Schools, Science and technology, Securities, Small businesses, State and local governments, Student aid, Teachers, Telecommunications, Telephone, Urban areas, Veterans, Virgin Islands, Vocational education, Vocational rehabilitation, Waste treatment and disposal, Water pollution control, Water resources, Water supply, Watersheds, Women.
Civil rights, Government contracts, Grant programs, Nonprofit organizations, Reporting and recordkeeping requirements.
Administrative practice and procedure, Grant programs.
Foreign aid, Grant programs, Nonprofit organizations.
Administrative practice and procedure, Aged, Claims, Crime, Government contracts, Grant programs—housing and community development, Individuals with disabilities, Intergovernmental relations, Loan programs—housing and community development, Low and moderate income housing, Mortgage insurance, Penalties, Pets, Public housing, Rent subsidies, Reporting and recordkeeping requirements, Social security, Unemployment compensation, Wages.
Administrative practice and procedure, Aged, Claims, Crime, Government contracts, Grant programs—housing and community development, Individuals with disabilities, Intergovernmental relations, Loan programs—housing and community development, Low and moderate income housing, Mortgage insurance, Penalties, Pets, Public housing, Rent subsidies, Reporting and recordkeeping requirements, Social security, Unemployment compensation, Wages.
Administrative practice and procedure, American Samoa, Community development block grants, Grant programs—education, Grant programs—housing and community development, Guam, Indians, Loan programs—housing and community development, Low and moderate income housing, Northern Mariana Islands, Pacific Island Trust Territory, Puerto Rico, Reporting and recordkeeping requirements, Student aid, Virgin Islands.
Administrative practice and procedure, American Samoa, Community development block grants, Grant programs—education, Grant programs—housing and community development, Guam, Indians, Loan programs—housing and community development, Low and moderate income housing, Northern Mariana Islands, Pacific Island Trust Territory, Puerto Rico, Reporting and recordkeeping requirements, Student aid, Virgin Islands.
Community facilities, Grant programs—housing and community development, Grant programs—social programs, Homeless, Reporting and recordkeeping requirements.
Community facilities, Continuum of Care, Emergency solutions grants, Grant programs—housing and community development, Grant programs—social programs, Homeless, Rural housing, Reporting and recordkeeping requirements, Supportive housing programs—housing and community development, Supportive services.
Alaska, Community development block grants, Grant programs—housing and community development, Grant programs— Indians, Indians, Reporting and recordkeeping requirements.
Administrative practice and procedure, Grant programs, Reporting and recordkeeping requirements, Nonprofit organizations.
Administrative practice and procedure, Claims, Courts, Government employees, Religious Discrimination.
Accounting, Copyright, Education, Grant programs—education, Inventions and patents, Private schools, Reporting and recordkeeping requirements.
Accounting, Administrative practice and procedure, American Samoa, Education, Grant programs—education, Guam, Northern Mariana Islands, Pacific Islands Trust Territory, Prisons, Private schools, Reporting and recordkeeping requirements, Virgin Islands.
Administrative practice and procedure, Alcohol abuse, Alcoholism, Day care, Dental health, Drug abuse, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Mental health programs, Per-diem program, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.
Administrative practice and procedure, Alcohol abuse, Alcoholism, Day care, Dental health, Drug abuse, Government contracts, Grant programs—health, Grant programs—veterans, Health, are, Health facilities, Health professions, Health records, Homeless, Mental health programs, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.
Administrative practice and procedure, Day care, Disability benefits, Government contracts, Grant programs—health, Grant programs—housing and community development, Grant programs—Veterans, Health care, Homeless, Housing, Indians—lands, Individuals with disabilities, Low and moderate income housing, Manpower training programs, Medicaid, Medicare, Public assistance programs, Public housing, Relocation assistance, Rent subsidies, Reporting and recordkeeping requirements, Rural areas, Social security, Supplemental Security Income (SSI), Travel and transportation expenses, Unemployment compensation.
Administrative practice and procedure, Grant programs—social programs, Nonprofit organizations, Public assistance programs.
Grant programs—social programs.
For the reasons discussed in the preamble, the Department of Education amends part 3474 of title 2 of the Code of Federal Regulations (CFR) and parts 75 and 76 of title 34 of the CFR as follows:
20 U.S.C. 1221e-3, 3474, and 2 CFR part 200, unless otherwise noted.
(a) This section establishes responsibilities that grantees and subgrantees have in selecting contractors to provide direct Federal services under a program of the Department. Paragraphs (c)(1), (d)(1), and (f) of this section establish requirements that supplement the procurement requirements in 2 CFR 200.313 through 200.326. Every contract between a grantee or subgrantee and a faith-based organization under a program of direct Federal financial assistance must include conditions to implement the requirements in paragraphs (c)(1), (d)(1), and (f) of this section.
(b)(1) A faith-based organization is eligible to contract with grantees and subgrantees, including States, on the same basis as any other private organization, with respect to contracts for which such other organizations are eligible.
(2) In selecting providers of goods and services, grantees and subgrantees, including States, must not discriminate for or against a private organization on the basis of the organization's religious character or affiliation and must ensure that the award of contracts is free from political interference, or even the appearance of such interference, and is done on the basis of merit, not on the basis of religion or religious belief, or lack thereof.
(c)(1) The provisions of 34 CFR 75.532 and 76.532 (Use of funds for religion prohibited), 75.712 and 76.712 (Beneficiary protections: Written notice), and 75.713 and 76.713 (Beneficiary protections: Referral requirements) that apply to a faith-based organization that is a grantee or subgrantee also apply to a faith-based organization that contracts with a grantee or subgrantee, including a State.
(2) The requirements referenced under paragraph (c)(1) of this section do not apply to a faith-based organization that provides goods or services to a beneficiary under a program supported only by indirect Federal financial assistance, as defined in 34 CFR 75.52(c)(3) and 76.52(c)(3).
(d)(1) A private organization that engages in explicitly religious activities, such as religious worship, instruction, or proselytization, must offer those activities separately in time or location from any programs or services supported by a contract with a grantee or subgrantee, including a State, and attendance or participation in any such explicitly religious activities by beneficiaries of the programs and services supported by the contract must be voluntary.
(2) The limitations on explicitly religious activities under paragraph (d)(1) of this section do not apply to a faith-based organization that provides services to a beneficiary under a program supported only by indirect Federal financial assistance, as defined in 34 CFR 75.52(c)(3) and 76.52(c)(3).
(e)(1) A faith-based organization that contracts with a grantee or subgrantee, including a State, may retain its independence, autonomy, right of expression, religious character, and authority over its governance.
(2) A faith-based organization may, among other things—
(i) Retain religious terms in its name;
(ii) Continue to carry out its mission, including the definition, development, practice, and expression of its religious beliefs;
(iii) Use its facilities to provide services without removing or altering religious art, icons, scriptures, or other symbols from these facilities;
(iv) Select its board members and otherwise govern itself on a religious basis; and
(v) Include religious references in its mission statement and other chartering or governing documents.
(f) A private organization that contracts with a grantee or subgrantee, including a State, may not discriminate against a beneficiary or prospective beneficiary in the provision of program goods or services on the basis of religion or religious belief, a refusal to hold a religious belief, or refusal to attend or participate in a religious practice. However, an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program.
(g) A religious organization's exemption from the Federal prohibition on employment discrimination on the basis of religion, in section 702(a) of the Civil Rights Act of 1964, 42 U.S.C. 2000e-1(a), is not forfeited when the organization contracts with a grantee or subgrantee.
20 U.S.C. 1221e-3 and 3474, unless otherwise noted.
(a) * * *
(2) In the selection of grantees, the Department may not discriminate for or against a private organization on the basis of the organization's religious character or affiliation and must ensure that all decisions about grant awards are free from political interference, or even the appearance of such interference, and are made on the basis of merit, not on the basis of religion or religious belief, or the lack thereof.
(c)(1) A private organization that engages in explicitly religious activities, such as religious worship, instruction, or proselytization, must offer those activities separately in time or location from any programs or services supported by a grant from the Department, and attendance or participation in any such explicitly religious activities by beneficiaries of the programs and services supported by the grant must be voluntary.
(2) The limitations on explicitly religious activities under paragraph (c)(1) of this section do not apply to a faith-based organization that provides services to a beneficiary under a program supported only by “indirect Federal financial assistance.”
(3) For purposes of 2 CFR 3474.15, 34 CFR 75.52, 75.712, 75.713, 75.714, and appendix A to this part, the following definitions apply:
(i) Direct Federal financial assistance means that the Department, a grantee, or a subgrantee selects a provider and either purchases goods or services from that provider (such as through a contract) or awards funds to that provider (such as through a grant, subgrant, or cooperative agreement) to carry out services under a program of the Department. Federal financial assistance shall be treated as direct unless it meets the definition of “indirect Federal financial assistance.”
(ii) Indirect Federal financial assistance means that the choice of a service provider under a program of the Department is placed in the hands of the beneficiary, and the cost of that service is paid through a voucher, certificate, or other similar means of government-funded payment. Federal financial assistance provided to an organization is “indirect” under this definition if—
(A) The government program through which the beneficiary receives the voucher, certificate, or other similar means of government-funded payment is neutral toward religion;
(B) The organization receives the assistance as the result of the decision of the beneficiary, not a decision of the government; and
(C) The beneficiary has at least one adequate secular option for use of the voucher, certificate, or other similar means of government-funded payment.
(e) A private organization that receives any Federal financial assistance under a program of the Department shall not discriminate against a beneficiary or prospective beneficiary in the provision of program services or in outreach activities on the basis of religion or religious belief, a refusal to hold a religious belief, or refusal to attend or participate in a religious practice. However, an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program.
(a) A faith-based organization that receives a grant, subgrant, or contract under a program of the Department supported in whole or in part by direct Federal financial assistance must give written notice to a beneficiary or prospective beneficiary of certain protections. This notice must state that:
(1) The organization may not discriminate against a beneficiary or prospective beneficiary on the basis of religion or religious belief, a refusal to hold a religious belief, or refusal to attend or participate in a religious practice;
(2) The organization may not require a beneficiary to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by the beneficiaries in such activities must be purely voluntary;
(3) The organization must separate in time or location any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
(4) If a beneficiary or prospective beneficiary objects to the religious character of the organization, the organization will undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection; and
(5) A beneficiary or prospective beneficiary may report a violation of these protections to, or file a written complaint regarding a denial of services or benefits with, the subgrantee, grantee, or Department that made the award under which the violation or denial occurred.
(b)(1) A faith-based organization that receives a grant, subgrant, or contract under a program of the Department must provide beneficiaries or prospective beneficiaries with the written notice required under paragraph (a) of this section prior to the time they enroll in or receive services from the organization.
(2) When the nature of the services provided or exigent circumstances make it impracticable to provide the written notice in advance of the actual services, the organization must advise beneficiaries of their protections at the earliest available opportunity.
(c) The notice that a faith-based organization must use to notify beneficiaries or prospective beneficiaries of their rights under paragraph (a) of this section is specified in appendix A to this part.
(a) If a beneficiary or prospective beneficiary of a program of the Department supported in whole or in part by direct Federal financial assistance objects to the religious character of a faith-based organization that provides services under the program, that organization must promptly undertake reasonable efforts to identify and refer the beneficiary or prospective beneficiary to an alternative provider to which the beneficiary or prospective beneficiary has no objection.
(b)(1) A faith-based organization may satisfy the requirement in paragraph (a) of this section by referring a beneficiary or prospective beneficiary to another faith-based organization if the beneficiary or prospective beneficiary does not object to that provider.
(2) If the beneficiary or prospective beneficiary requests a secular provider, and one is available, the faith-based organization must make a referral to that provider.
(c) The faith-based organization must make a referral to an alternative provider that—
(1) Is in reasonable geographic proximity to the location where the beneficiary or prospective beneficiary is receiving or would receive services (except for services provided by telephone, internet, or similar means);
(2) Offers services that are similar in substance and quality to those offered by the organization; and
(3) Has the capacity to accept additional beneficiaries.
(d)(1) When a faith-based organization makes a referral to an alternative provider, the organization must maintain a record of the referral in its grant records, including the date of the referral, the name of the alternative provider, its address, and contact information for the alternative provider;
(2) When a faith-based organization determines that it is unable to identify an alternative provider, the organization must promptly notify the subgrantee, grantee, or Department that made the award under which the referral could not be made. If the organization is unable to identify an alternative provider, the subgrantee, grantee, or Department that made the award under which the referral could not be made must determine whether there is any other suitable alternative provider to which the beneficiary or prospective beneficiary may be referred. If the entity that made the award under which the referral could not be made cannot make a referral, that entity must promptly notify the grantee or the Department, as appropriate, and the grantee or the Department must determine whether a suitable referral can be made.
If a grantee under a discretionary grant program of the Department has the
A faith-based organization that serves beneficiaries under a program funded in whole or in part by direct Federal financial assistance from the U.S. Department of Education must provide the following notice, or an accurate translation of this notice, to a beneficiary or prospective beneficiary of the program.
Because this program is supported in whole or in part by direct Federal financial assistance from the U.S. Department of Education, we are required to let you know that—
(1) We may not discriminate against you on the basis of religion or religious belief, a refusal to hold a religious belief, or refusal to attend or participate in a religious practice;
(2) We may not require you to attend or participate in any explicitly religious activities that are offered by us, and any participation by you in such activities must be purely voluntary;
(3) We must separate in time or location any privately funded explicitly religious activities from activities supported under this [insert the grant, subgrant, or contract name and identifying number of this award to the faith-based organization] by direct Federal financial assistance under this program;
(4) If you object to the religious character of our organization, we will undertake reasonable efforts to identify and refer you to an alternative provider to which you have no objection; however, we cannot guarantee that, in every instance, an alternative provider will be available; and
(5) You may report violations of these protections to, or file a written complaint regarding a denial of services or benefits under this award with, [Insert the name of the entity that awarded the grant, subgrant, or contract under which the violation occurred].
We must give you this written notice before you enroll in our program or receive services from the program.
If you object to receiving services from us based on the religious character of our organization, please complete this form and return it to the program contact identified above. If you object, we will make reasonable efforts to refer you to another service provider. With your consent, we will follow up with you or the organization to which you were referred to determine whether you contacted that organization.
20 U.S.C. 1221e-3 and 3474, unless otherwise noted.
(a) * * *
(2) In the selection of subgrantees and contractors, States may not discriminate for or against a private organization on the basis of the organization's religious character or affiliation and must ensure that all decisions about subgrants are free from political interference, or even the appearance of such interference, and are made on the basis of merit, not on the basis of religion or religious belief or a lack thereof.
(c)(1) A private organization that engages in explicitly religious activities, such as religious worship, instruction, or proselytization, must offer those activities separately in time or location from any programs or services supported by a subgrant from a State under a State-administered program of the Department, and attendance or participation in any such explicitly religious activities by beneficiaries of the programs and services supported by the subgrant must be voluntary.
(2) The limitations on explicitly religious activities under paragraph (c)(1) of this section do not apply to a faith-based organization that provides services to a beneficiary under a program supported only by “indirect Federal financial assistance.”
(3) For purposes of 2 CFR 3474.15, 34 CFR 76.52, 76.712, 76.713, and 76.714, the following definitions apply:
(i) Direct Federal financial assistance means that the Department, grantee, or subgrantee selects a provider and either purchases services from that provider (such as through a contract) or awards funds to that provider (such as through a grant, subgrant, or cooperative agreement) to carry out services under a program of the Department. Federal financial assistance shall be treated as direct unless it meets the definition of “indirect Federal financial assistance.”
(ii) Indirect Federal financial assistance means that the choice of a service provider under a program of the Department is placed in the hands of the beneficiary, and the cost of that service is paid through a voucher, certificate, or other similar means of government-funded payment. Federal financial assistance provided to an organization is “indirect” under this definition if—
(A) The government program through which the beneficiary receives the voucher, certificate, or other similar means of government-funded payment is neutral toward religion;
(B) The organization receives the assistance as the result of the decision of the beneficiary, not a decision of the government; and
(C) The beneficiary has at least one adequate secular option for use of the voucher, certificate, or other similar means of government-funded payment.
(e) A private organization that receives any Federal financial assistance under a program of the Department shall not discriminate against a beneficiary or prospective beneficiary in the provision of program services or in outreach activities on the basis of religion or religious belief, a refusal to hold a religious belief, or refusal to attend or participate in a religious practice. However, an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program.
(a) A faith-based organization that receives a grant, subgrant, or contract under a State-administered program of the Department supported in whole or in part by direct Federal financial assistance must give written notice to a beneficiary or prospective beneficiary of certain protections. This notice must state that:
(1) The organization may not discriminate against a beneficiary or prospective beneficiary on the basis of religion, or religious belief, a refusal to hold a religious belief, or refusal to attend or participate in a religious practice;
(2) The organization may not require a beneficiary to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by the beneficiaries in such activities must be purely voluntary;
(3) The organization must separate in time or location any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
(4) If a beneficiary or prospective beneficiary objects to the religious character of the organization, the organization will undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection; and
(5) A beneficiary or prospective beneficiary may report violations of these protections to, or may file a written complaint regarding a denial of services or benefits, with the State agency administering the program or subgrantee that made the award under which the violation occurred.
(b)(1) A faith-based organization that receives a subgrant or contract under a State-administered program of the Department must provide beneficiaries with the written notice required under paragraph (a) of this section prior to the time they enroll in or receive services from the organization.
(2) When the nature of the services provided or exigent circumstances make it impracticable to provide the written notice in advance of the actual services, the organization must advise beneficiaries of their protections at the earliest available opportunity.
(c) The notice that a faith-based organization must use to notify beneficiaries or prospective beneficiaries of their rights under paragraph (a) of this section is specified in appendix A to part 75.
(a) If a beneficiary or prospective beneficiary of a State-administered program of the Department supported in whole or in part by direct Federal financial assistance objects to the religious character of a faith-based organization that provides services under the program, that organization must promptly undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary or prospective beneficiary has no objection.
(b)(1) A faith-based organization may satisfy the requirement in paragraph (a) of this section by referring a beneficiary or prospective beneficiary to another faith-based organization if the beneficiary or prospective beneficiary does not object to that provider.
(2) If the beneficiary or prospective beneficiary requests a secular provider, and one is available, the faith-based organization must make a referral to that provider.
(c) The faith-based organization must make a referral to an alternative provider that—
(1) Is in reasonable geographic proximity to the location where the beneficiary or prospective beneficiary is receiving or would receive services (except for services provided by telephone, internet, or similar means);
(2) Offers services that are similar in substance and quality to those offered by the organization; and
(3) Has the capacity to accept additional beneficiaries.
(d)(1) When a faith-based organization makes a referral to an alternative provider, the organization must maintain a record of the referral in its grant records, including the date of the referral, the name of the alternative provider, its address, and contact information for the alternative provider.
(2) When the organization determines that it is unable to identify an alternative provider, the organization must promptly notify the State or subgrantee that made the award under which the referral could not be made. If the organization is unable to identify an alternative provider, the State agency or subgrantee that made the award under which the referral could not be made must determine whether there is any other suitable alternative provider to which the beneficiary or prospective beneficiary may be referred. If the entity that made the award under which the referral could not be made cannot make a referral, that entity must promptly notify the grantee or the Department, as appropriate, and the grantee or the Department must determine whether a suitable referral can be made.
If a grantee under a State-administered program of the Department has the authority under the grant or subgrant to select a private organization to provide services supported by direct Federal financial assistance under the program by subgrant, contract, or other agreement, the grantee must ensure compliance with applicable Federal requirements governing contracts, grants, and other agreements with faith-based organizations, including, as applicable, §§ 76.52, 76.532, and 76.712-76.713 and 2 CFR 3474.15. If the intermediary (pass-through) is a nongovernmental organization, it retains all other rights of a nongovernmental organization under the program's statutory and regulatory provisions.
5 U.S.C. 301; Pub. L. 107-296; E.O. 13279, 67 FR 77141; E.O. 13403, 71 FR 28543; E.O. 13498, 74 FR 6533; and E.O. 13559, 75 FR 71319.
It is the policy of the Department of Homeland Security (DHS) to ensure the equal treatment of faith-based organizations in social service programs administered or supported by DHS or its component agencies, enabling those organizations to participate in providing important social services to beneficiaries. The equal treatment policies and requirements contained in this part are generally applicable to faith-based organizations participating or seeking to participate in any such programs. More specific policies and requirements regarding the participation of faith-based organizations in individual programs may be provided in the statutes, regulations, or guidance governing those programs, such as regulations in title 44 of the Code of Federal Regulations. DHS or its components may issue policy guidance and reference materials at a future time with respect to the applicability of this policy and this part to particular programs.
For purposes of this part:
(1) The government program through which the beneficiary receives the voucher, certificate, or other similar means of government-funded payment is neutral toward religion;
(2) The organization receives the assistance as a result of a decision of the beneficiary, not a decision of the government; and
(3) The beneficiary has at least one adequate secular option for the use of the voucher, certificate, or other similar means of government-funded payment.
(1) Child care services, protective services for children and adults, services for children and adults in foster care, adoption services, services related to the management and maintenance of the home, day care services for adults, and services to meet the special needs of children, older individuals, and individuals with disabilities (including physical, mental, or emotional disabilities);
(2) Transportation services;
(3) Job training and related services, and employment services;
(4) Information, referral, and counseling services;
(5) The preparation and delivery of meals and services related to soup kitchens or food banks;
(6) Health support services;
(7) Literacy and mentoring programs;
(8) Services for the prevention and treatment of juvenile delinquency and substance abuse, services for the prevention of crime and the provision of assistance to the victims and the families of criminal offenders, and services related to intervention in, and prevention of, domestic violence; and
(9) Services related to the provision of assistance for housing under Federal law.
(a) Faith-based organizations are eligible, on the same basis as any other organization, to seek and receive direct financial assistance from DHS for social service programs or to participate in social service programs administered or financed by DHS.
(b) Neither DHS, nor a State or local government, nor any other entity that administers any social service program supported by direct financial assistance from DHS, shall discriminate for or against an organization on the basis of the organization's religious motivation, character, or affiliation.
(c) Decisions about awards of Federal financial assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of religion or religious belief or lack thereof, or on the basis of religious or political affiliation.
(d) Nothing in this part shall be construed to preclude DHS or any of its components from accommodating religious organizations and persons to the fullest extent consistent with the Constitution and laws of the United States.
(e) All organizations that participate in DHS social service programs, including religious organizations, must carry out eligible activities in accordance with all program requirements and other applicable requirements governing the conduct of DHS-supported activities, including those prohibiting the use of direct financial assistance from DHS to engage in explicitly religious activities. No grant document, agreement, covenant, memorandum of understanding, or policy issued by DHS or an intermediary in administering financial assistance from DHS shall disqualify a religious organization from participating in DHS's social service programs because such organization is motivated or influenced by religious faith to provide social services or because of its religious character or affiliation.
(a) Organizations that receive direct financial assistance from DHS to participate in or administer any social service program may not use direct Federal financial assistance that it receives (including through a prime or sub-award) to support or engage in any explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization) or in any other manner prohibited by law.
(b) Organizations receiving direct financial assistance from DHS for social service programs are free to engage in explicitly religious activities, but such activities must be
(1) Clearly distinct from programs specifically supported by direct federal assistance;
(2) Offered separately, in time or location, from the programs, activities, or services specifically supported by direct DHS financial assistance pursuant to DHS social service programs; and
(3) Voluntary for the beneficiaries of the programs, activities, or services specifically supported by direct DHS financial assistance pursuant to DHS social service programs.
(c) All organizations that participate in DHS social service programs, including religious organizations, must carry out eligible activities in accordance with all program requirements and other applicable requirements governing the conduct of DHS-supported activities, including those prohibiting the use of direct financial assistance from DHS to engage in explicitly religious activities. No grant document, agreement, covenant, memorandum of understanding, or policy issued by DHS or a State or local government in administering financial assistance from DHS shall disqualify a religious organization from participating in DHS's social service programs because such organization is motivated or influenced by religious faith to provide social services or because of its religious character or affiliation.
(d) The use of indirect Federal financial assistance is not subject to the restriction in paragraphs (a), (b), and (c) of this section.
(e) Nothing in this part restricts DHS's authority under applicable federal law to fund activities, such as the provision of chaplaincy services, that can be directly funded by the Government consistent with the Establishment Clause.
An organization that receives financial assistance from DHS for a social service program shall not, in providing services or in outreach activities related to such services, favor or discriminate against a beneficiary of said program or activity on the basis of religion or religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice. Organizations that favor or discriminate against a beneficiary will be subject to applicable sanctions and penalties, as established by the requirements of the particular DHS social service program or activity. However, an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program.
(a) Faith-based or religious organizations providing social services to beneficiaries under a DHS program supported by direct Federal financial assistance must give written notice to beneficiaries of certain protections. Such notice may be given in the form set forth in appendix A of this part. This notice must state that:
(1) The organization may not discriminate against beneficiaries on the basis of religion or religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(2) The organization may not require beneficiaries to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by beneficiaries in such activities must be purely voluntary;
(3) The organization must separate in time or location any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
(4) If a beneficiary objects to the religious character of the organization, the organization will undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection; and
(5) Beneficiaries may report an organization's violations of these protections, including any denials of services or benefits by an organization, by contacting or filing a complaint with the DHS Office for Civil Rights and Civil Liberties, or to any intermediary awarding entity.
(b) This written notice must be given to beneficiaries prior to the time they enroll in the program or receive services from such programs. When the nature of the service provided or exigent circumstances make it impracticable to provide such written notice in advance of the actual service, service providers must advise beneficiaries of their protections at the earliest available opportunity.
(a) If a beneficiary of a social service program covered under § 19.6 objects to the religious character of an organization that provides services under the program, that organization must promptly undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection.
(b) A referral may be made to another religiously affiliated provider, if the beneficiary has no objection to that provider. But if the beneficiary requests a secular provider, and a secular provider is available, then a referral must be made to that provider.
(c) Except for services provided by telephone, internet, or similar means, the referral must be to an alternative provider that is in reasonable geographic proximity to the organization making the referral and that offers services that are similar in substance and quality to those offered by the organization. The alternative provider also must have the capacity to accept additional clients.
(d) When the organization makes a referral to an alternative provider, it shall keep a record of that referral. If the organization determines that it is unable to identify an alternative provider, the organization shall both keep a record and promptly notify either DHS or an intermediary awarding entity. If the organization is unable to identify an alternative provider, DHS or the intermediary shall determine whether there is any other suitable alternative provider to which the beneficiary may be referred. An intermediary that receives a request for assistance in identifying an alternative provider shall notify, and may request assistance from, DHS.
(a) A faith-based organization that applies for, or participates in, a social service program supported with Federal financial assistance may retain its independence and may continue to carry out its mission, including the definition, development, practice, and expression of its religious beliefs, provided that it does not use direct Federal financial assistance contrary to § 19.4.
(b) Faith-based organizations may use space in their facilities to provide social services using financial assistance from DHS without removing or concealing religious articles, texts, art, or symbols.
(c) A faith-based organization using financial assistance from DHS for social service programs retains its authority over internal governance, and may also retain religious terms in its organization's name, select its board members on a religious basis, and include religious references in its organization's mission statements and other governing documents.
(a) A faith-based organization's exemption, set forth in section 702(a) of the Civil Rights Act of 1964 (42 U.S.C. 2000e-1), from the Federal prohibition on employment discrimination on the basis of religion is not forfeited when the organization seeks or receives financial assistance from DHS for a social service program or otherwise participates in a DHS program.
(b) Where a DHS program contains independent statutory or regulatory provisions that impose nondiscrimination requirements on all grantees, those provisions are not waived or mitigated by this part. Accordingly, grantees should consult with the appropriate DHS program office to determine the scope of any applicable requirements.
(a) If a State, local, or Tribal government voluntarily contributes its own funds to supplement Federally supported activities, the State, local, or Tribal government has the option to segregate the Federal assistance or commingle it.
(b) If the State, local, or Tribal government chooses to commingle its own and Federal funds, the requirements of this part apply to all of the commingled funds.
(c) If a State, local, or Tribal government is required to contribute matching funds to supplement a Federally supported activity, the matching funds are considered commingled with the Federal assistance and therefore subject to the requirements of this part.
Name of Organization:
Name of Program:
Contact Information for Program Staff (name, phone number, and email address, if appropriate):
Because this program is supported in whole or in part by direct financial assistance from the Federal Government, we are required to let you know that—
• We may not discriminate against you on the basis of religion or religious belief, your refusal to hold a religious belief, or your refusal to attend or participate in a religious practice;
• We may not require you to attend or participate in any explicitly religious activities that are offered by us, and any participation by you in these activities must be purely voluntary;
• We must separate in time or location any privately funded explicitly religious activities from activities supported with direct Federal financial assistance under this program;
• If you object to the religious character of our organization, we must make reasonable efforts to identify and refer you to an alternative provider to which you have no objection; however, we cannot guarantee that in every instance, an alternative provider will be available; and
• You may report violations of these protections, including any denials of services or benefits, by contacting or filing a written complaint with the Department of Homeland Security, Office for Civil Rights and Civil Liberties:
E-mail:
Fax: 202-401-4708.
U.S. Mail: U.S. Department of Homeland Security Office for Civil Rights and Civil Liberties, Compliance Branch, 245 Murray Lane SW., Building 410, Mail Stop #0190, Washington, DC 20528.
{Where the program involves an intermediary, the recipient or intermediary should add where feasible:
You may also report violations of these protections, including any denials of services or benefits, to:
[Name and contact information for the intermediary]}
We must give you this written notice before you enroll in our program or receive services from the program.
If you object to receiving services from us based on the religious character
Please check if applicable:
If you checked above that you wish to be referred to another service provider, please check one of the following:
Accordingly, for the reasons described in the preamble, USDA amends 7 CFR part 16 as follows:
5 U.S.C. 301; E.O. 13279, 67 FR 77141; E.O. 13280, 67 FR 77145; E.O. 13559, 75 FR 71319.
(b) Except as otherwise specifically provided in this part, the policy outlined in this part applies to all recipients and subrecipients of USDA assistance to which 2 CFR part 400 applies, and to recipients and subrecipients of Commodity Credit Corporation assistance that is administered by agencies of USDA.
As used in this part:
(a) USDA direct assistance is Federal financial assistance provided by USDA and means that the Federal Government or an intermediary (under this part) selects the provider and either purchases services from that provider (
(b)(1) USDA indirect assistance is Federal financial assistance provided indirectly by USDA and means that the choice of the service provider is placed in the hands of the beneficiary, and the cost of that service is paid through a voucher, certificate, or other similar means of government-funded payment. Federal financial assistance provided to an organization is considered “indirect” within the meaning of the Establishment Clause of the First Amendment to the U.S. Constitution when
(i) The government program through which the beneficiary receives the voucher, certificate, or other similar means of government-funded payment is neutral toward religion;
(ii) The organization receives the assistance as a result of a decision of the beneficiary, not a decision of the government; and
(iii) The beneficiary has at least one adequate secular option for the use of the voucher, certificate, or other similar means of government-funded payment.
(2) The recipients of sub-grants that receive Federal financial assistance through State-administered programs (
(c) Intermediary means an entity, including a non-governmental organization, acting under a contract, grant, or other agreement with the Federal Government or with a State or local government that accepts USDA direct assistance and distributes that assistance to other organizations that, in turn, provide government-funded services. If an intermediary, acting under a contract, grant, or other agreement with the Federal Government or with a State or local government that is administering a program supported by Federal financial assistance, is given the authority under the contract, grant, or agreement to select non-governmental organizations to provide services funded by the Federal Government, the intermediary must ensure compliance with the provisions of Executive Order 13559 and any implementing rules or guidance by the recipient of a contract, grant, or agreement. If the intermediary is a non-governmental organization, it retains all other rights of a non-governmental organization under the program's statutory and regulatory provisions.
(a) A religious organization is eligible, on the same basis as any other eligible private organization, to access and participate in USDA assistance programs. Neither the Federal Government nor a State or local government receiving USDA assistance shall, in the selection of service providers, discriminate for or against a religious organization on the basis of the organization's religious character or affiliation. Additionally, decisions about awards of USDA direct assistance or USDA indirect assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of the religious affiliation of a recipient organization or lack thereof.
(b) A religious organization that participates in USDA assistance programs will retain its independence and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use USDA direct assistance to support any explicitly religious activities, including activities that involve overt religious content such as worship, religious instruction, or proselytization. Among other things, a religious organization may:
(a) Any organization that participates in a program funded by USDA financial assistance shall not, in providing services, discriminate against a current or prospective program beneficiary on the basis of religion, religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice. However, an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program.
(b) Organizations that receive USDA direct assistance under any USDA program may not engage in explicitly religious activities, including activities that involve overt religious content such as worship, religious instruction, or proselytization, as part of the programs or services supported with USDA direct assistance. If an organization conducts such activities, the activities must be offered separately, in time or location, from the programs or services supported with USDA direct assistance, and participation must be voluntary for beneficiaries of the programs or services supported with such USDA direct assistance.
(d)(1) USDA direct assistance may be used for the acquisition, construction, or rehabilitation of structures only to the extent that those structures are used for conducting USDA programs and activities and only to the extent authorized by the applicable program statutes and regulations. USDA direct assistance may not be used for the acquisition, construction, or rehabilitation of structures to the extent that those structures are used by the USDA funding recipients for explicitly religious activities. Where a structure is used for both eligible and explicitly religious activities, USDA direct assistance may not exceed the cost of those portions of the acquisition, construction, or rehabilitation that are attributable to eligible activities in accordance with the cost accounting requirements applicable to USDA funds. Sanctuaries, chapels, or other rooms that an organization receiving direct assistance from USDA uses as its principal place of worship, however, are ineligible for USDA-funded improvements. Disposition of real property after the term of the grant or any change in use of the property during the term of the grant is subject to government-wide regulations governing real property disposition (see 2 CFR part 400).
(2) Any use of USDA direct assistance funds for equipment, supplies, labor, indirect costs, and the like shall be prorated between the USDA program or activity and any use for other purposes by the religious organization in accordance with applicable laws, regulations, and guidance.
(3) Nothing in this section shall be construed to prevent the residents of housing who are receiving USDA direct assistance funds from engaging in religious exercise within such housing.
(e) USDA direct assistance under any USDA program may not be used for explicitly religious activities, speech, and materials generated or controlled by the administrators, instructors, or officials of the organization receiving USDA direct assistance.
(f)
(i) The organization may not discriminate against beneficiaries on the basis of religion or religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(ii) The organization may not require beneficiaries to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by beneficiaries in such activities must be purely voluntary;
(iii) The organization must separate in time or location any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
(iv) If a beneficiary objects to the religious character of the organization, the organization will undertake reasonable efforts to identify and refer the beneficiary to an alternate provider to which the prospective beneficiary has no objection; the organization may not be able to guarantee, however, that in every instance, an alternate provider will be available; and
(v) Beneficiaries may report violations of these protections (including denials of services or benefits) by an organization to, USDA (or, the intermediary, if applicable).
(2) This written notice must be given to beneficiaries prior to the time they enroll in the program or receive services from such programs. When the nature of the service provided or exigent circumstances make it impracticable to provide such written notice in advance of the actual service, service providers must advise beneficiaries of their protections at the earliest available opportunity.
(g)
(1) A referral may be made to another faith-based organization, if the beneficiary has no objection to that provider. But if the beneficiary requests a secular provider, and a secular provider is available, then a referral must be made to that provider.
(2) Except for services provided by telephone, Internet, or similar means, the referral must be to an alternate provider that is in reasonable geographic proximity to the organization making the referral and that offers services that are similar in substance and quality to those offered by the organization, if one is available. The alternate provider also should have the capacity to accept additional clients, if one with capacity to accept additional clients is available.
(3) If the organization determines that it is unable to identify an alternate provider, the organization shall promptly notify the awarding entity, and the awarding entity shall determine whether there is any other suitable alternate provider to which the beneficiary may be referred. An intermediary that receives a request for assistance in identifying an alternate provider may request assistance from USDA or a State or local government receiving USDA direct assistance.
(4) In some cases, USDA may require that the awarding entity provide the organization with information regarding alternate providers. Such information regarding alternative providers should include providers (including secular organizations) within a reasonable geographic proximity that offer services that are similar in substance and quality and that would reasonably be expected to have the capacity to accept additional clients, provided any such organizations exist. An organization which relies on such information provided by the awarding entity shall be considered to have undertaken reasonable efforts to identify an alternate provider under this subpart.
(h) The requirements in paragraphs (b) through (g) of this section do not apply where USDA funds or benefits are provided to religious organizations as a result of a genuine and independent private choice of a beneficiary or through other indirect funding mechanisms, provided the religious organizations otherwise satisfy the requirements of the program.
If a State or local government voluntarily contributes its own funds to supplement activities carried out under programs governed by this part, the State or local government has the option to separate out the USDA direct assistance funds or comingle them. If the funds are comingled, the provisions of this part shall apply to all of the comingled funds in the same manner, and to the same extent, as the provisions apply to the USDA direct assistance.
Name of Organization:
Name of Program:
Contact Information for Program Staff (name, phone number, and email address, if appropriate): Because this program is supported in whole or in part by financial assistance from the Federal Government, we are required to let you know that—
• We may not discriminate against you on the basis of religion or religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
• We may not require you to attend or participate in any explicitly religious activities that are offered by us, and any participation by you in these activities must be purely voluntary;
• We must separate in time or location any privately funded explicitly religious activities from activities supported with USDA direct assistance;
• If you object to the religious character of our organization, we must make reasonable efforts to identify and refer you to an alternate provider to which you have no objection. We cannot guarantee, however, that in every instance, an alternate provider will be available; and
• You may report violations of these protections (including denials of services or benefits) to _____.
If you object to receiving services from us based on the religious character of our organization, please complete this form and return it to the program contact identified above. Your use of this form is voluntary.
If you object to the religious character of our organization, we must make reasonable efforts to identify and refer you to an alternate provider to which you have no objection. We cannot guarantee, however, that in every instance, an alternate provider will be available. With your consent, we will follow up with you or the organization to which you are referred to determine whether you have contacted that organization.
Please provide the following information if you want us to follow up with you:
Your Name:
Best way to reach me (phone/address/email):
Please provide the following information if you want us to follow up with the service provider only.
Your Name:
You are permitted to withhold your name, though if you choose to do so, we will be unable to follow up with you or the service provider about your referral.
1. Date of Objection: _/_/_
2. Referral (check one):
3. Follow-up date: _/_/_
4. Staff name and initials:
For the reasons stated in the preamble, USAID amends chapter II of title 22 of the Code of Federal Regulations as follows:
22 U.S.C. 2381(a).
(b) Organizations that receive direct financial assistance from USAID under any USAID program (including through a prime award or sub-award) may not engage in explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization), as part of the programs or services directly funded with direct financial assistance from USAID. If an organization conducts such activities, the activities must be offered separately, in time or location, from the programs or services funded with direct financial assistance from USAID, and participation must be voluntary for beneficiaries of the programs or services funded with such assistance. Nothing in this part restricts USAID's authority under applicable federal law to fund activities, such as the provision of chaplaincy services, that can be directly funded by the Government consistent with the Establishment Clause.
(c) A religious organization that applies for, or participates in, USAID-funded programs or services (including through a prime award or sub-award) may retain its independence and may continue to carry out its mission, including the definition, development, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from USAID (including through a prime award or sub-award) to support or engage in any explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization), or in any other manner prohibited by law. Among other things, a religious organization that receives financial assistance from USAID may use space in its facilities, without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from USAID retains its authority over its internal governance, and it may retain religious terms in its organization's name, select its board members on a religious basis, and include religious references in its organization's mission statements and other governing documents.
(e) An organization that participates in programs funded by financial assistance from USAID (including through a prime award or sub-award) shall not, in providing services, discriminate against a program beneficiary or potential program
(f) No grant document, contract, agreement, covenant, memorandum of understanding, policy, or regulation that is used by USAID shall require only religious organizations to provide assurances that they will not use monies or property for explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization). Any such restrictions shall apply equally to religious and secular organizations. All organizations that participate in USAID programs (including through a prime award or subaward), including religious ones, must carry out eligible activities in accordance with all program requirements and other applicable requirements governing the conduct of USAID-funded activities, including those prohibiting the use of direct financial assistance from USAID to engage in explicitly religious activities. No grant document, agreement, covenant, memorandum of understanding, policy, or regulation that is used by USAID shall disqualify religious organizations from participating in USAID's programs because such organizations are motivated or influenced by religious faith to provide social services, or because of their religious character or affiliation.
(j) Decisions about awards of USAID financial assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of the religious affiliation of a recipient organization, or lack thereof.
Accordingly, for the reasons described in the preamble, HUD amends 24 CFR parts 5, 92, 570, 574, 576, 578, and 1003 as follows:
42 U.S.C. 1437a, 1437c, 1437f, 1437n, 3535(d), Sec. 327, Pub. L. 109-115, 119 Stat. 2936, Sec. 607, Pub. L. 109-162, 119 Stat. 3051, E.O. 13279, and E.O. 13559.
(a)
(b)
(c)
(d)
(1) A faith-based organization that applies for, or participates in, a HUD program or activity supported with Federal financial assistance retains its independence and may continue to carry out its mission, including the definition, development, practice, and expression of its religious beliefs, provided that it does not use direct Federal financial assistance that it receives (
(2) A faith-based organization that receives direct Federal financial
(e)
(f)
(g)
(1)
(i) The organization may not discriminate against a beneficiary or prospective beneficiary on the basis of religion, religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(ii) The organization may not require beneficiaries to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by beneficiaries in such activities must be purely voluntary;
(iii) The organization must separate, in time or location, any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
(iv) If a beneficiary objects to the religious character of the organization, the organization must undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no such objection; and
(v) Beneficiaries or prospective beneficiaries may report an organization's violation of these protections, including any denial of services or benefits by an organization, by contacting or filing a written complaint to HUD or the intermediary, if applicable.
(2)
(3)
(ii) A referral may be made to another faith-based organization, if the beneficiary or prospective beneficiary has no objection to that provider based on the provider's religious character. But if the beneficiary or prospective beneficiary requests a secular provider, and a secular provider is available, then a referral must be made to that provider.
(iii) Except for activities carried out by telephone, Internet, or similar means, the referral must be to an alternative provider that is in reasonable geographic proximity to the organization making the referral and that carries out activities that are similar in substance and quality to those offered by the organization. The alternative provider also must have the capacity to accept additional beneficiaries.
(iv) If the organization determines that it is unable to identify an alternative provider, the organization shall promptly notify the intermediary or, if there is no intermediary, HUD. If HUD or an intermediary is notified that an organization is unable to identify an alternative provider, HUD or the intermediary, as appropriate, shall promptly determine whether there is any other suitable alternative provider to which the beneficiary or prospective beneficiary may be referred. An intermediary that receives a request for assistance in identifying an alternative provider may request assistance from HUD.
(4)
(h)
(j)
(k)
42 U.S.C. 3535(d) and 12701-12839.
The HUD program requirements in § 5.109 apply to the HOME program, including the requirements regarding disposition and change in use of real property by a faith-based organization.
42 U.S.C. 3535(d) and 5301-5320.
(j)
42 U.S.C. 3535(d) and 12901-12912.
(c)
42 U.S.C. 11371
The HUD program requirements in § 5.109 of this title apply to the ESG program, including the requirements regarding disposition and change in use of real property by a faith-based organization.
42 U.S.C. 11371
(b)
42 U.S.C. 3535(d) and 5301
The HUD program requirements in § 5.109 of this title apply to the ICDBG program, including the requirements regarding disposition and change in use of real property by a faith-based organization.
28 U.S.C. 509; 5 U.S.C. 301; E.O. 13279, 67 FR 77141, 3 CFR, 2002 Comp., p. 258, Dec. 12. 2002; 18 U.S.C. 4001, 4042, 5040; 42 U.S.C. 14045b; 21 U.S.C. 871; 25 U.S.C. 3681; Pub. L. 107-273, 116 Stat. 1758, Nov. 2, 2002; Pub. L. 109-162, 119 Stat.
The purpose of this part is to implement Executive Order 13279 and Executive Order 13559.
(a) A faith-based or religious organization that applies for, or participates in, a social service program supported with Federal financial assistance may retain its independence and may continue to carry out its mission, including the definition, development, practice, and expression of its religious beliefs, provided that it does not use direct Federal financial assistance, whether received through a prime award or sub-award, to support or engage in any explicitly religious activities, including activities that involve overt religious content such as worship, religious instruction, or proselytization.
(b) The use of indirect Federal financial assistance is not subject to this restriction.
(c) Nothing in this part restricts the Department's authority under applicable Federal law to fund activities, such as the provision of chaplaincy services, that can be directly funded by the Government consistent with the Establishment Clause.
As used in this part:
(a)(1) “Direct Federal financial assistance” or “Federal financial assistance provided directly” refers to situations where the Government or an intermediary (under this part) selects the provider and either purchases services from that provider (
(2) Recipients of sub-grants that receive Federal financial assistance through State administering agencies or State-administered programs are recipients of “direct Federal financial assistance” (or recipients of “Federal financial assistance provided directly”).
(b) “Indirect Federal financial assistance” or “Federal financial assistance provided indirectly” refers to situations where the choice of the service provider is placed in the hands of the beneficiary, and the cost of that service is paid through a voucher, certificate, or other similar means of government-funded payment. Federal financial assistance provided to an organization is considered “indirect” when
(1) The government program through which the beneficiary receives the voucher, certificate, or other similar means of government-funded payment is neutral toward religion;
(2) The organization receives the assistance as a result of a decision of the beneficiary, not a decision of the Government; and
(3) The beneficiary has at least one adequate secular option for the use of the voucher, certificate, or other similar means of government-funded payment.
(c)(1) “Intermediary” or “pass-through entity” means an entity, including a nonprofit or nongovernmental organization, acting under a contract, grant, or other agreement with the Federal Government or with a State or local government, such as a State administering agency, that accepts Federal financial assistance as a primary recipient or grantee and distributes that assistance to other organizations that, in turn, provide government-funded social services.
(2) When an intermediary, such as a State administering agency, distributes Federal financial assistance to other organizations, it replaces the Department as the awarding entity. The intermediary remains accountable for the Federal financial assistance it disburses and, accordingly, must ensure that any providers to which it disburses Federal financial assistance also comply with this part.
(d) “Department program” refers to a grant, contract, or cooperative agreement funded by a discretionary, formula, or block grant program administered by or from the Department.
(e) “Grantee” includes a recipient of a grant, a signatory to a cooperative agreement, or a contracting party.
(f) The “Office for Civil Rights” refers to the Office for Civil Rights in the Department's Office of Justice Programs.
(a)
(b)
(a) Organizations that receive direct financial assistance from the Department may not engage in explicitly religious activities, including activities that involve overt religious content such as worship, religious instruction, or proselytization, as part of the programs or services funded with direct financial assistance from the Department. If an organization conducts such explicitly religious activities, the activities must be offered separately, in time or location, from the programs or services funded with direct financial assistance from the Department, and participation must be voluntary for beneficiaries of the programs or services funded with such assistance.
(b) A faith-based or religious organization that participates in the Department-funded programs or services shall retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from the Department to support any explicitly religious activities, including activities that involve overt religious content such as worship, religious instruction, or proselytization. Among other things, a faith-based or religious organization that receives financial assistance from the Department may use space in its facilities without removing religious art, icons, messages, scriptures, or symbols. In addition, a faith-based or religious organization that receives financial assistance from the Department retains its authority over its internal governance, and it may retain religious terms in its organization's name, select its board members on a religious basis, and include religious references in its mission statements and other governing documents.
(c) Any organization that participates in programs funded by Federal financial assistance from the Department shall not, in providing services, discriminate
(d) No grant document, agreement, covenant, memorandum of understanding, policy, or regulation that the Department or a State or local government uses in administering financial assistance from the Department shall require only faith-based or religious organizations to provide assurances that they will not use monies or property for explicitly religious activities. All organizations, including religious ones, that participate in Department programs must carry out eligible activities in accordance with all program requirements and other applicable requirements governing the conduct of Department-funded activities, including those prohibiting the use of direct financial assistance from the Department to engage in explicitly religious activities. No grant document, agreement, covenant, memorandum of understanding, policy, or regulation that is used by the Department or a State or local government in administering financial assistance from the Department shall disqualify faith-based or religious organizations from participating in the Department's programs because such organizations are motivated or influenced by religious faith to provide social services, or because of their religious character or affiliation.
(e)
(f) If an intermediary, acting under a contract, grant, or other agreement with the Federal Government or with a State or local government that is administering a program supported by Federal financial assistance, is given the authority under the contract, grant, or agreement to select organizations to provide services funded by the Federal Government, the intermediary must ensure the compliance of the recipient of a contract, grant, or agreement with the provisions of Executive Order 13279, as amended by Executive Order 13559, and any implementing rules or guidance. If the intermediary is a nongovernmental organization, it retains all other rights of a nongovernmental organization under the program's statutory and regulatory provisions.
(g) In general, the Department does not require that a grantee, including a religious organization, obtain tax-exempt status under section 501(c)(3) of the Internal Revenue Code to be eligible for funding under Department programs. Many grant programs, however, do require an organization to be a “nonprofit organization” in order to be eligible for funding. Individual solicitations that require organizations to have nonprofit status will specifically so indicate in the eligibility sections of the solicitations. In addition, any solicitation that requires an organization to maintain tax-exempt status shall expressly state the statutory authority for requiring such status. Grantees should consult with the appropriate Department program office to determine the scope of any applicable requirements. In Department programs in which an applicant must show that it is a nonprofit organization, the applicant may do so by any of the following means:
(1) Proof that the Internal Revenue Service currently recognizes the applicant as an organization to which contributions are tax deductible under section 501(c)(3) of the Internal Revenue Code;
(2) A statement from a State taxing body or the State secretary of state certifying that:
(i) The organization is a nonprofit organization operating within the State; and
(ii) No part of its net earnings may lawfully benefit any private shareholder or individual;
(3) A certified copy of the applicant's certificate of incorporation or similar document that clearly establishes the nonprofit status of the applicant; or
(4) Any item described in paragraphs (g)(1) through (g)(3) of this section if that item applies to a State or national parent organization, together with a statement by the State or parent organization that the applicant is a local nonprofit affiliate.
(h) Grantees should consult with the appropriate Department program office to determine the applicability of this part in foreign countries or sovereign lands.
(a)
(b) To the extent otherwise permitted by Federal law, the restrictions on explicitly religious activities set forth in this section do not apply to indirect Federal financial assistance.
(c)
(i) The organization may not discriminate against beneficiaries or prospective beneficiaries on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(ii) The organization may not require beneficiaries or prospective beneficiaries to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by beneficiaries in such activities must be purely voluntary;
(iii) The organization must separate in time or location any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
(iv) If a beneficiary or prospective beneficiary objects to the religious character of the organization, the organization will undertake reasonable efforts to identify and refer the beneficiary or prospective beneficiary to an alternative provider to which the beneficiary or prospective beneficiary has no objection; and
(v) Beneficiaries or prospective beneficiaries may report an organization's violation of these
(2) This written notice must be given to prospective beneficiaries prior to the time they enroll in the program or receive services from the program. When the nature of the service provided or exigent circumstances make it impracticable to provide such written notice in advance of the actual service, organizations must advise beneficiaries of their protections at the earliest available opportunity.
(3) The notice that a faith-based or religious organization may use to notify beneficiaries or prospective beneficiaries of their protections under paragraph (g)(1) of this section is specified in appendix A to this part.
(d)
(2) An organization may refer a beneficiary or prospective beneficiary to another faith-based or religious organization that provides comparable services, if the beneficiary or prospective beneficiary has no objection to that provider based on the organization's religious character. But if the beneficiary or prospective beneficiary requests a secular provider, and a secular provider is available, then a referral must be made to that provider.
(3) Except for services provided by telephone, Internet, or similar means, the referral must be to an alternative provider that is in reasonable geographic proximity to the organization making the referral and that offers services that are similar in substance and quality to those offered by the organization. The alternative provider also must have the capacity to accept additional clients.
(4) When the organization makes a referral to an alternative provider, the organization shall maintain a record of that referral for review by the awarding entity. When the organization determines that it is unable to identify an alternative provider, the organization shall promptly notify and maintain a record for review by the awarding entity. If the organization is unable to identify an alternative provider, the awarding entity shall determine whether there is any other suitable alternative provider to which the beneficiary may be referred. An intermediary that receives a request for assistance in identifying an alternative provider may request assistance from the Department.
(a) Every application submitted to the Department for direct Federal financial assistance subject to this part must contain, as a condition of its approval and the extension of any such assistance, or be accompanied by, an assurance or statement that the program is or will be conducted in compliance with this part.
(b) Every intermediary must provide for such methods of administration as are required by the Office for Civil Rights to give reasonable assurance that the intermediary will comply with this part and effectively monitor the actions of its recipients.
(a) The Office for Civil Rights is responsible for reviewing the practices of recipients of Federal financial assistance to determine whether they are in compliance with this part.
(b) The Office for Civil Rights is responsible for investigating any allegations of noncompliance with this part.
(c) Recipients of Federal financial assistance determined to be in violation of any provisions of this part are subject to the enforcement procedures and sanctions, up to and including suspension and termination of funds, authorized by applicable laws.
(d) An allegation of any violation or discrimination by an organization, based on this regulation, may be filed with the Office for Civil Rights or the intermediary that awarded the funds to the organization.
Name of Organization:
Name of Program:
Contact Information for Program Staff (name, phone number, and email address, if appropriate):
Because this program is supported in whole or in part by financial assistance from the Federal Government, we are required to let you know that—
• We may not discriminate against you on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
• We may not require you to attend or participate in any explicitly religious activities that we offer, and your participation in these activities must be purely voluntary;
• We must separate in time or location any privately funded explicitly religious activities from activities supported with direct Federal financial assistance;
• If you object to the religious character of our organization, we must make reasonable efforts to identify and refer you to an alternative provider to which you have no objection; and
• You may report violations of these protections to the U.S. Department of Justice, Office of Justice Programs, Office for Civil Rights or to [name of intermediary that awarded funds to the organization].
We must give you this written notice before you enroll in our program or receive services from the program.
Appendix B to Part 38—Beneficiary Referral Request
If you object to receiving services from us based on the religious character of our organization, please complete this form and return it to the program contact identified above. If you object, we will make reasonable efforts to refer you to another service provider. We cannot guarantee, however, that in every instance, an alternative provider will be available. With your consent, we will follow up with you or the organization to which you were referred to determine whether you contacted that organization.
Please check if applicable:
If you checked above that you wish to be referred to another service provider, please check one of the following:
For the reasons discussed in the preamble, the Department of Labor amends 29 CFR part 2 as follows:
5 U.S.C. 301; Executive Order 13198, 66 FR 8497, 3 CFR 2001 Comp., p. 750; Executive Order 13279, 67 FR 77141, 3
(a) The term
(1) The term
(2) The term
(i) The Government program through which the beneficiary receives the voucher, certificate, or other similar means of Government-funded payment is neutral toward religion;
(ii) The organization receives the assistance as a result of a decision of the beneficiary, not a decision of the government; and
(iii) The beneficiary has at least one adequate secular option for the use of the voucher, certificate, or other similar means of Government-funded payment.
(3) The recipient of sub-awards received through programs administered by States or other intermediaries that are themselves recipients of Federal financial assistance (
(f) The term
(b) A religious organization that is a DOL social service provider retains its independence from Federal, State, and local governments and must be permitted to continue to carry out its mission, including the definition, development, practice, and expression of its religious beliefs, subject to the provisions of § 2.33. Among other things, such a religious organization must be permitted to:
(c) A grant document, contract or other agreement, covenant, memorandum of understanding, policy, or regulation that is used by DOL, a State or local government administering DOL support, or a DOL social service intermediary provider must not require only religious organizations to provide assurances that they will not use direct DOL support for explicitly religious activities (including activities that involve overt religious content, such as worship, religious instruction, or proselytization). Any such requirements must apply equally to both religious and other organizations. All organizations, including religious ones, that are DOL social service providers must carry out DOL-supported activities in accordance with all applicable legal and programmatic requirements, including those prohibiting the use of direct DOL support for explicitly religious activities (including activities that involve overt religious content, such as worship, religious instruction, or proselytization). A grant document, contract or other agreement, covenant, memorandum of understanding, policy, or regulation that is used by DOL, a State or local government, or a DOL social service intermediary provider in administering a DOL social service program must not disqualify organizations from receiving DOL support or participating in DOL programs on the grounds that such organizations are motivated or influenced by religious faith to provide social services, have a religious character or affiliation, or lack a religious component.
(a) Any organization that participates in a program funded by federal financial assistance shall not, in providing services or in outreach activities related to such services, discriminate against a current or prospective program beneficiary on the basis of religion, religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice. However, an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program. This requirement does not preclude DOL, DOL social service intermediary providers, or State or local governments administering DOL support from accommodating religion in a manner consistent with the Establishment Clause of the First Amendment to the Constitution.
(b)(1) DOL, DOL social service intermediary providers, DOL social service providers, and State and local governments administering DOL support must ensure that they do not use direct DOL support for explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization). DOL social service providers must be permitted to offer explicitly religious activities so long as they offer those activities separately in time or location from social services receiving direct DOL support, and participation in the explicitly religious activities is voluntary for the beneficiaries of social service programs receiving direct DOL support. For example, participation in an explicitly
(3) Notwithstanding the requirements of paragraph (b)(1) of this section, and to the extent otherwise permitted by Federal law (including constitutional requirements), direct DOL support may be used to support explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization), and such activities need not be provided separately in time or location from other DOL-supported activities, under the following circumstances:
(c) If a DOL social service intermediary provider, acting under a contract, grant, or other agreement with the Federal Government or with a State or local government that is administering a program supported by Federal financial assistance, is given the authority under the contract, grant, or agreement to select non-governmental organizations to provide services funded by the Federal Government, the DOL social service intermediary provider must ensure compliance with the provisions of Executive Order 13279, as amended by Executive Order 13559, and any implementing rules or guidance, by the recipient of a contract, grant or agreement. If the DOL social service intermediary provider is a non-governmental organization, it retains all other rights of a non-governmental organization under the program's statutory and regulatory provisions.
(a)
(1) The organization may not discriminate against a beneficiary or prospective beneficiary on the basis of religion or religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(2) The organization may not require beneficiaries to attend or participate in any explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization) that are offered by our organization, and any participation by beneficiaries in such activities must be purely voluntary;
(3) The organization must separate out in time or location any privately-funded explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization) from activities supported with direct Federal financial assistance;
(4) If a beneficiary objects to the religious character of the organization, the organization must make reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection. The organization cannot guarantee, however, that in every instance, an alternative provider will be available; and
(5) Beneficiaries or prospective beneficiaries may report violations of these protections to, or file a written complaint of any denials of services or benefits by an organization with, the U.S. Department of Labor's Civil Rights Center. The required language of the notice is set forth in appendix A to these regulations and may be downloaded from the Civil Rights Center's Web site at
(b)
(c)
(a) If a beneficiary or prospective beneficiary of a social service program supported by direct DOL financial assistance objects to the religious character of an organization that provides services under the program, that organization must promptly undertake reasonable efforts to identify and refer the beneficiary or prospective beneficiary to an alternative provider to which the beneficiary or the prospective beneficiary has no objection.
(b) A referral may be made to another religious organization, if the beneficiary has no objection to that provider. But if the beneficiary requests a secular provider, and a secular provider is available, then a referral must be made to that provider.
(c) Except for services provided by telephone, internet, or similar means, the referral must be to an alternative provider that is in reasonable geographic proximity to the organization making the referral and that offers services that are similar in substance and quality to those offered by that organization. The alternative provider also must have the capacity to accept additional clients.
(d) When the organization makes a referral to an alternative provider, the organization shall maintain a record of that referral for review by the awarding entity. When the organization determines that it is unable to identify an alternative provider, the organization shall promptly notify and maintain a record for review by the awarding entity. If the organization is unable to identify an alternative provider, the awarding entity shall determine whether there is any other suitable alternative provider to which the beneficiary may be referred.
(e) A DOL social service intermediary provider that receives a request for assistance in identifying an alternative provider may request assistance from DOL.
(f) The obligations in this section apply only to religious organizations providing services under social service programs administered in the United States.
Decisions about awards of Federal financial assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of religion or religious belief or lack thereof.
[Insert Name of Organization]:
[Insert Name of Program]:
[Insert Contact information for Program Staff (name, phone number, and email address, if appropriate)]:
(1) We may not discriminate against you on the basis of religion or religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(2) We may not require you to attend or participate in any explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization) that are offered by our organization, and any participation by beneficiaries in such activities must be purely voluntary;
(3) We must separate out in time or location any privately-funded explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization) from activities supported with direct Federal financial assistance;
(4) If you object to the religious character of an organization, we must make reasonable efforts to identify and refer you to an alternative provider to which you have no objection. We cannot guarantee, however, that in every instance, an alternative provider will be available; and
(5) You may report violations of these protections to, or file a written complaint of any denials of services or benefits by an organization, with the U.S. Department of Labor's Civil Rights Center, 200 Constitution Ave. NW., Room N-4123, Washington, DC 20210, or by email to
This written notice must be given to you prior to the time you enroll in the program or receive services from such programs, unless the nature of the service provided or urgent circumstances makes it impracticable to provide such notice in advance of the actual service. In such an instance, this notice must be given to you at the earliest available opportunity.
If you object to receiving services from us based on the religious character of our organization, please complete this form and return it to the program contact identified above. If you object, we will make reasonable efforts to refer you to another service provider. With your consent, we will follow up with you or the organization to which you were referred to determine whether you contacted that organization.
Please check if applicable:
If you checked above that you wish to be referred to another service provider, please check one of the following:
For the reasons set out in the preamble, the Department of Veterans Affairs adds 38 CFR part 50 and amends parts 61 and 62 as follows:
38 U.S.C. 501 and as noted in specific sections.
(a) A faith-based organization that applies for, or participates in, a social service program (as defined in Executive Order 13279) supported with Federal financial assistance (as defined in Executive Order 13279) may retain its independence and may continue to carry out its mission, including the definition, development, practice, and expression of its religious beliefs, provided that it does not use direct Federal financial assistance that it receives (including through a prime or sub-award) to support or engage in any explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization), or in any other manner prohibited by law. Direct Federal financial assistance may not be used to pay for equipment or supplies to the extent they are allocated to such activities. The use of indirect Federal financial assistance is not subject to this restriction. Nothing in this part restricts the VA's authority under applicable Federal law to fund activities, such as the provision of chaplaincy services, that can be directly funded by the Government consistent with the Establishment Clause.
(b)(1) Direct Federal financial assistance or Federal financial assistance provided directly means that the government or an intermediary as defined in paragraph (d) of this section selects the provider and either purchases services from that provider (
(2) Indirect Federal financial assistance or Federal financial assistance provided indirectly means that the choice of the service provider is placed in the hands of the beneficiary, and the cost of that service is paid through a voucher, certificate, or other similar means of government-funded payment.
(3) Federal financial assistance provided to an organization is considered indirect when:
(i) The government program through which the beneficiary receives the voucher, certificate, or other similar means of government funded payment is neutral toward religion;
(ii) The organization receives the Federal financial assistance as a result of a decision of the beneficiary, not a decision of the government; and
(iii) The beneficiary has at least one adequate secular option for the use of the voucher, certificate, or other similar means of government-funded payment.
(c) The recipients of sub-grants that receive Federal financial assistance through State-administered programs are not considered recipients of indirect Federal financial assistance (or recipients of Federal funds provided indirectly) as those terms are used in Executive Order 13559.
(d) Intermediary means an entity, including a non-governmental organization, acting under a contract, grant, or other agreement with the Federal Government or with a State or local government, that accepts Federal financial assistance and distributes that assistance to other organizations that, in turn, provide government-funded social
(e) If an intermediary, acting under a contract, grant, or other agreement with VA or with a State or local government that is administering a program supported by VA financial assistance, is given the authority under the contract, grant, or agreement to select non-governmental organizations to provide services funded by VA, the intermediary must select any providers to receive direct financial assistance in a manner that does not favor or disfavor organizations on the basis of religion or religious belief and ensure compliance with the provisions of Executive Order 13279, as amended by Executive Order 13559, and any implementing rules or guidance by the recipient of a contract, grant or agreement. If the intermediary is a non-governmental organization, it retains all other rights of a non-governmental organization under the program's statutory and regulatory provisions.
(f) Any organization that participates in a program funded by Federal financial assistance shall not, in providing services or in outreach activities related to such services, discriminate against a program beneficiary or prospective program beneficiary on the basis of religion, religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice. However, an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program.
(a) Faith-based or religious organizations providing social services to beneficiaries under a VA program supported by direct VA financial assistance must give written notice to beneficiaries and prospective beneficiaries of certain protections. Such notice must be given in a manner prescribed by VA. The notice will state that:
(1) The organization may not discriminate against beneficiaries on the basis of religion or religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(2) The organization may not require beneficiaries to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by beneficiaries in such activities must be purely voluntary;
(3) The organization must separate in time or location any privately funded explicitly religious activities from activities supported by direct VA financial assistance;
(4) If a beneficiary objects to the religious character of the organization, the organization will undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the prospective beneficiary has no objection; and
(5) Beneficiaries or perspective beneficiaries may report an organization's violations of these protections, including any denials of services or benefits by an organization, by contacting or filing a written complaint with, VA or an intermediary that awarded funds to the organization.
(b) This written notice must be given to beneficiaries prior to the time they enroll in the program or receive services from such program. When the nature of the service provided or exigent circumstances make it impracticable to provide such written notice in advance of the actual service, service providers must advise beneficiaries of their protections at the earliest available opportunity.
(c) Faith-based or religious organizations providing social services to beneficiaries under a VA program supported by indirect VA financial assistance are not required to give written notice to beneficiaries and prospective beneficiaries of the protections specified in subsection (a).
(a) If a beneficiary or prospective beneficiary of a social service programs supported by VA objects to the religious character of an organization that provides services under the program, that organization must promptly undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the prospective beneficiary has no objection.
(b) A referral may be made to another faith-based organization if the beneficiary has no objection to that provider. If the beneficiary requests a secular provider, and a secular provider is available, then a referral must be made to that provider.
(c) Except for services provided by telephone, internet, or similar means, the referral must be to an alternative provider that is in reasonable geographic proximity to the organization making the referral and that offers services that are similar in substance and quality to those offered by the organization. The alternative provider also must have the capacity to accept additional clients.
(d) If the organization determines that it is unable to identify an alternative provider, the organization shall promptly notify VA or the intermediary. If the organization is unable to identify an alternative provider, VA shall determine whether there is any other suitable alternative provider to which the beneficiary may be referred. An intermediary that receives a request for assistance in identifying an alternative provider may request assistance from VA.
Decisions about awards of Federal financial assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of religion or religious belief or lack thereof.
38 U.S.C. 501, 2001, 2002, 2011, 2012, 2061, 2064.
The revisions read as follows:
(a) * * * Decisions about awards of Federal financial assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of religion or religious belief or lack thereof.
(b) * * *
(2) * * * “Direct financial assistance” means that VA or an intermediary as defined in 38 CFR 50.1(d) selects the
38 U.S.C. 501, 2044, and as noted in specific sections.
The revisions read as follows:
(a) * * * Decisions about awards of Federal financial assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of religion or religious belief or lack thereof.
(b) * * *
(2) * * * “Direct financial assistance” means that VA or an intermediary as defined in 38 CFR 50.1(d) selects the provider and either purchases services from that provider (
For the reasons stated in the preamble, under the authority of 5 U.S.C. 301, the Department of Health and Human Services and the Administration for Children and Families, respectively, propose to amend 45 CFR parts 87 and 1050 as set forth below:
5 U.S.C. 301.
(a) These are the definitions for terms used in this part. Different definitions may be found in Federal statutes or regulations that apply more specifically to particular program or activities.
(b) The terms
(c) The term
(1) Federal financial assistance provided to an organization is considered indirect when:
(i) The Government program through which the beneficiary receives the voucher, certificate, or other similar means of Government-funded payment is neutral toward religion;
(ii) The organization receives the assistance as a result of a decision of the beneficiary, not a decision of the government; and
(iii) The beneficiary has at least one adequate secular option for the use of the voucher, certificate, or other similar means of Government-funded payment.
(2) The recipients of sub-grants that receive Federal financial assistance through State-administered programs are not considered recipients of “indirect Federal financial assistance” [or recipients of “Federal funds provided indirectly”] as those terms are used in this part.
(d)
(e)
This part applies to grants awarded in HHS social service programs governed by either the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 CFR part 75 or Block Grant regulations at 45 CFR part 96, except as provided in paragraphs (a) and (b) of this section.
(a)
(b)
(a) Faith-based or religious organizations are eligible, on the same basis as any other organization, to participate in any HHS awarding agency program for which they are otherwise eligible. Neither the HHS awarding agency, nor any State or local government and other pass-through entity receiving funds under any HHS awarding agency program shall, in the selection of service providers, discriminate for or against an organization on the basis of the organization's religious character or affiliation. As used in this section, “program” refers to activities supported by discretionary, formula or block grants.
(b) Organizations that apply for or receive direct financial assistance from an HHS awarding agency may not support or engage in any explicitly religious activities (including activities that involve overt religious content such
(c) A faith-based or religious organization that participates in HHS awarding agency-funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from an HHS awarding agency (including through a prime or sub-award) to support or engage in any explicitly religious activities (including activities that involve overt religious content such as worship, religious instruction, or proselytization). A faith-based or religious organization may use space in its facilities to provide programs or services funded with financial assistance from the HHS awarding agency without removing religious art, icons, scriptures, or other religious symbols. In addition, a faith-based or religious organization that receives financial assistance from the HHS awarding agency retains its authority over its internal governance, and it may retain religious terms in its organization's name, select its board members on a religious basis, and include religious references in its organization's mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of HHS funded activities.
(d) An organization that participates in any programs funded by financial assistance from an HHS awarding agency shall not, in providing services or in outreach activities related to such services, discriminate against a program beneficiary or prospective program beneficiary on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice. However, an organization that participates in a program funded by indirect financial assistance need not modify its program activities to accommodate a beneficiary who chooses to expend the indirect aid on the organization's program.
(e) No grant document, agreement, covenant, memorandum of understanding, policy, or regulation that is used by an HHS awarding agency or a State or local government in administering financial assistance from the HHS awarding agency shall require only faith-based or religious organizations to provide assurances that they will not use monies or property for explicitly religious activities. Any restrictions on the use of grant funds shall apply equally to religious and non-religious organizations. All organizations that participate in HHS awarding agency programs, including organizations with religious character or affiliations, must carry out eligible activities in accordance with all program requirements and other applicable requirements governing the conduct of HHS awarding agency-funded activities, including those prohibiting the use of direct financial assistance to engage in explicitly religious activities. No grant document, agreement, covenant, memorandum of understanding, policy, or regulation that is used by the HHS awarding agency or a State or local government in administering financial assistance from the HHS awarding agency shall disqualify faith-based or religious organizations from participating in the HHS awarding agency's programs because such organizations are motivated or influenced by religious faith to provide social services, or because of their religious character or affiliation.
(f) A faith-based or religious organization's exemption from the Federal prohibition on employment discrimination on the basis of religion, set forth in section 702(a) of the Civil Rights Act of 1964, 42 U.S.C. 2000e-1, is not forfeited when the faith-based or religious organization receives direct or indirect financial assistance from an HHS awarding agency. Some HHS awarding agency programs, however, contain independent statutory provisions requiring that all recipients agree not to discriminate in employment on the basis of religion. Accordingly, recipients should consult with the appropriate HHS awarding agency program office if they have questions about the scope of any applicable requirement.
(g) In general, the HHS awarding agency does not require that a recipient, including a faith-based or religious organization, obtain tax-exempt status under section 501(c)(3) of the Internal Revenue Code to be eligible for funding under HHS awarding agency programs. Many grant programs, however, do require an organization to be a “nonprofit organization” in order to be eligible for funding. Funding announcements and other grant application solicitations that require organizations to have nonprofit status will specifically so indicate in the eligibility section of the solicitation. In addition, any solicitation that requires an organization to maintain tax-exempt status will expressly state the statutory authority for requiring such status. Recipients should consult with the appropriate HHS awarding agency program office to determine the scope of any applicable requirements. In HHS awarding agency programs in which an applicant must show that it is a nonprofit organization, the applicant may do so by any of the following means:
(1) Proof that the Internal Revenue Service currently recognizes the applicant as an organization to which contributions are tax deductible under section 501(c)(3) of the Internal Revenue Code;
(2) A statement from a State or other governmental taxing body or the State secretary of State certifying that:
(i) The organization is a nonprofit organization operating within the State; and
(ii) No part of its net earnings may benefit any private shareholder or individual;
(3) A certified copy of the applicant's certificate of incorporation or similar document that clearly establishes the nonprofit status of the applicant; or
(4) Any item described in paragraphs (g)(1) through (3) of this section, if that item applies to a State or national parent organization, together with a statement by the State or parent organization that the applicant is a local nonprofit affiliate.
(h) If a recipient contributes its own funds in excess of those funds required by a matching or grant agreement to supplement HHS awarding agency-supported activities, the recipient has the option to segregate those additional funds or commingle them with the Federal award funds. If the funds are commingled, the provisions of this section shall apply to all of the commingled funds in the same manner, and to the same extent, as the provisions apply to the Federal funds. With respect to the matching funds, the provisions of
(i)(1) Faith-based or religious organizations providing social services in the United States to beneficiaries under an HHS program that is supported by direct Federal financial assistance must give written notice to beneficiaries or prospective beneficiaries of certain protections. This written notice must be given to beneficiaries prior to the time they enroll in the program or receive services from such programs. Notice must be given in a manner prescribed by the HHS awarding agency. This notice must state that:
(i) The organization may not discriminate against beneficiaries or prospective beneficiaries on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
(ii) The organization may not require beneficiaries to attend or participate in any explicitly religious activities that are offered by the organization, and any participation by beneficiaries in such activities must be purely voluntary;
(iii) The organization must separate in time or location any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
(iv) If a beneficiary or prospective beneficiary objects to the religious character of the organization, the organization will undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection; however, the organization cannot guarantee that in every instance an alternative provider will be available; and
(v) Beneficiaries or prospective beneficiaries may report violations of these protections, including any denials of services or benefits that violate these regulations, by contacting or filing a written complaint with the HHS awarding entity.
(2) When the nature of the service provided or exigent circumstances make it impracticable to provide such written notice in advance of the actual service, service providers must advise beneficiaries of their protections at the earliest available opportunity.
(j) If a beneficiary or prospective beneficiary of a social service program supported by the HHS awarding agency objects to the religious character of an organization that provides services in the United States under the program, that organization must promptly undertake reasonable efforts to identify and refer the beneficiary to an alternative provider to which the beneficiary has no objection. A referral may be made to another faith-based or religious organization, if the beneficiary has no objection to that provider. But if the beneficiary requests a secular provider, and a secular provider is available, then a referral must be made to that provider. Except for services provided by telephone, internet, or similar means, the referral must be to an alternative provider that is in reasonable geographic proximity to the organization making the referral and that offers services that are similar in substance and quality to those offered by the organization. The alternative provider also must have the capacity to accept additional beneficiaries.
(k) When the organization determines that it is unable to identify an alternative provider, the organization must promptly notify the prime recipient entity from which it has received funds. The prime recipient of Federal financial assistance must notify the HHS awarding agency when a sub-recipient is unable to identify an alternative provider. If the organization is successful in making a referral, it shall maintain a record of the referral.
(l) Decisions about awards of Federal financial assistance must be free from political interference or even the appearance of such interference and must be made on the basis of merit, not on the basis of the religious affiliation, or lack thereof, of a recipient organization.
(m) If a pass-through entity, acting under a contract, grant, or other agreement with the Federal Government or with a State or local government that is administering a program supported by Federal financial assistance, is given the authority under the contract, grant, or agreement to select non-governmental organizations to provide services funded by the Federal Government, the pass-through entity must ensure compliance with the provisions of this part and any implementing regulations or guidance by the sub-recipient. If the pass-through entity is a non-governmental organization, it retains all other rights of a non-governmental organization under the program's statutory and regulatory provisions.
42 U.S.C. 9901
(h) If a nongovernmental pass-through entity, acting under a grant, contract, or other agreement with the Federal, State or local government, is given the authority to select nongovernmental organizations to provide services under an applicable program, then the intermediate organization must ensure that the service provider complies with these Charitable Choice provisions and 45 CFR 87.1 and 87.3(i) through (l). The pass-through entity retains all other rights of a nongovernmental organization under the Charitable Choice provisions.
Name of Organization:
Name of Program:
Contact Information for Program Staff (name, phone number, and email address, if appropriate):
Because this program is supported in whole or in part by direct Federal financial assistance from the Federal Government, we are required to let you know that:
• We may not discriminate against you on the basis of religion, religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
• We may not require you to attend or participate in any explicitly religious activities that are offered by us, and any participation by you in these activities must be purely voluntary;
• We must separate, in time or location, any privately funded explicitly religious activities from activities supported by direct Federal financial assistance;
• If you object to the religious character of our organization, we must make reasonable efforts to identify and refer you to an alternative provider to which you have no such objection; and
• You may report an organization's violations of these protections, including any denial of services or benefits, by contacting or filing a written complaint to HUD [or the intermediary, if applicable].
We must give you this written notice before you enroll in our program or activity, as required by 24 CFR 5.109.
If you object to receiving services from us based on the religious character of our organization, please complete this form and return it to the program contact identified above. Your use of this form is voluntary.
If you object to the religious character of our organization, we must make reasonable efforts to identify and refer you to an alternative provider to which you have no such objection. We cannot guarantee, however, that in every instance, an alternative provider will be available. With your consent, we will follow up with you or the organization to which you are referred to determine whether you have contacted that organization.
Please provide the following information if you want us to follow up with you:
Your Name:
Best way to reach you (phone/address/email):
Please provide the following information if you want us to follow up with the provider only.
Your Name:
Date of Objection:
Referral (check one):
1. Follow-up date:
2. Staff name and initials:
Name of Organization:
Name of Program:
Contact Information for Program Staff (name, phone number, and email address, if appropriate):
Because this program is supported in whole or in part by financial assistance from the Federal Government, we are required to let you know that—
• We may not discriminate against you on the basis of religion, religious belief, refusal to hold a religious belief, or a refusal to attend or participate in a religious practice;
• We may not require you to attend or participate in any explicitly religious activities that are offered by us, and any participation by you in these activities must be purely voluntary;
• We must separate in time or location any privately funded explicitly religious activities from activities supported with direct Federal financial assistance;
• If you object to the religious character of our organization, we must make reasonable efforts to identify and refer you to an alternative provider to which you have no objection, we cannot guarantee, however, that in every instance an alternate provider will be available; and
• You may report violations of these protections including any denials of services or benefits to VA or the [awarding entity].
We must give you this written notice before you enroll in our program or receive services from the program.
If you object to receiving services from us based on the religious character of our organization, please complete this form and return it to the program contact identified above. If you object, we will make reasonable efforts to refer you to another service provider. With your consent, we will follow up with you or the organization to which you were referred to determine whether you contacted that organization.
Please check all that apply:
This information will be used by VA National Grant & Per Diem Program Office to identify those beneficiaries who object to the religious character of the faith-based organization providing services; and to provide them with services from another faith-based or community organization. Once the beneficiaries complete and submit this form to the faith-based organization, then the form will be submitted to VA National Grant & Per Diem Program Office, 10770 N. 46th Street, Suite C-200 Tampa, FL 33617. The VA National Program Office will notify the faith-based organization that the form has been received via email or U.S. Mail. This form will be kept on internal file at VA for the purpose identifying the beneficiaries' treatment location and for data collection/metrics.
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Federal Communications Commission.
Final rule.
In this document, the Commission refines the collection of data reported on FCC Form 323, Ownership Report for Commercial Broadcast Stations, and FCC Form 323-E, Ownership Report for Noncommercial Broadcast Stations. Specifically, the Commission implements a Restricted Use FRN (RUFRN) within the Commission's Registration System (CORES) that individuals may use solely for the purpose of broadcast ownership report filings; eliminates the availability of the Special Use FRN (SUFRN) for broadcast station ownership reports, except in very limited circumstances; prescribes revisions to Form 323-E that conform reporting for noncommercial educational (NCE) broadcast stations more closely to those for commercial stations; and makes a number of significant changes to its reporting requirements that reduce the filing burdens on broadcasters, streamline the process, and improve data quality. These enhancements will enable the Commission to obtain data reflecting a more useful, accurate, and thorough assessment of minority and female broadcast station ownership in the United States while reducing certain filing burdens.
Effective May 4, 2016 The amendments to §§ 73.3615 and 74.797 contain new or revised information collection requirements that are not effective until approved by the Office of Management and Budget (OMB). The Commission will publish a document in the
Jake Riehm, Industry Analysis Division, Media Bureau, FCC, (202) 418-2330. For additional information concerning the information collection requirements contained in the
This is a summary of the Commission's Report and Order, Second Report and Order, and Order on Reconsideration (
This document contains information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. The requirements will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other Federal agencies will be invited to comment on the information collection requirements contained in this proceeding. The Commission will publish a separate document in the
1. The Commission has a long-standing goal of promoting diversity in ownership of broadcast stations to ensure that diverse viewpoints and perspectives are available to the American people in the content they receive over the broadcast airwaves. In pursuit of this goal, the Commission has a long history of promulgating rules and regulations designed to foster diversity in terms of minority and female ownership in particular. In this
2. A necessary precursor to the Commission's policy-making efforts in this area is the collection of comprehensive, reliable data reflecting the race, gender, and ethnicity of the owners and other interest holders in broadcast stations. Such data are essential to effectively study and analyze ownership trends, to assess the impact of Commission rules, and to provide a foundation for the adoption of new rules, among other things. To be useful for this purpose, to the greatest extent possible the data must be capable of being read, verified, searched, aggregated, and cross-referenced electronically. Moreover, for the Commission's broadcast ownership data to be complete, reliable, and usable for study and analysis, individuals reported on Forms 323 and 323-E must be uniquely identified. The enhancements described herein enable the Commission to obtain data reflecting a more useful, accurate, and thorough assessment of minority and female broadcast station ownership in the United States while reducing certain filing burdens. These improvements also address the directive from the U.S. Court of Appeals for the Third Circuit that the Commission obtain more and better data concerning broadcast ownership to support its rulemaking decisions.
3. Accordingly, pursuant to the Commission's statutory mandate contained in section 257 of the Telecommunications Act of 1996 (the 1996 Act) and section 309(j) of the Communications Act of 1934 (the Act) to promote opportunities for small businesses and women and minorities in the broadcasting industry, the Commission implements a Restricted
4. The Commission has been engaged in a sustained effort to improve the quality, utility, and reliability of its broadcast ownership data. In 2009, the Commission substantially revised the biennial Form 323 to facilitate longitudinal comparative studies of broadcast station ownership. The changes also addressed flaws in the data collection process identified by the United States Government Accountability Office (GAO) and by researchers who had attempted to use the data submitted on previous versions of Form 323. GAO cited several shortcomings with the Commission's data collection process: (1) Exemptions from the biennial filing requirement for certain types of broadcast stations; (2) inadequate data quality procedures; and (3) problems with storage and retrieval. GAO noted that “more accurate, complete, and reliable [broadcast ownership] data would allow FCC to better assess the impact of its rules and regulations and allow the Congress to make more informed legislative decisions,” and it “recommend[ed] that FCC take steps to improve the reliability and accessibility of its data on the gender, race, and ethnicity of broadcast outlet owners.”
5. To improve the quality of its broadcast ownership data, the Commission adopted several significant changes to Form 323 in the
6. In the
7. Accompanying the
8. On August 11, 2009, the Commission submitted a revised Form 323 to the Office of Management and Budget (OMB) for approval pursuant to the Paperwork Reduction Act (PRA) requirements and published the
9. On October 6, 2009, the Office of the Managing Director (OMD) at the Commission submitted a letter to OMB addressing the comments filed in response to the revised Form 323. OMD explained that requiring CORES FRNs on Form 323 is an integral part of the Commission's effort to improve the quality, reliability, and usability of the collected data by eliminating inconsistencies and inadequacies in the data submitted. The Reply Letter rejected allegations that the Commission failed to comply with the notice requirements of the PRA or ran afoul of the Privacy Act. OMD also disputed commenters' objections that the CORES FRN requirement raised security and identity theft concerns. The Commission utilizes a “robust security architecture . . . for CORES that exceeds Federal guidelines and recommendations” and has deployed operational controls that comply with National Institute of Standards and Technology guidance.
10. The
11. On October 19, 2009, OMB approved the revised Form 323, which included the requirement that filers provide a CORES FRN for individuals holding an attributable interest in the licensee. On October 16, 2009, the Commission sent a subsequent letter to OMB acknowledging the Commission's action in the
12. In November 2009, Koerner & Olender, P.C., and Fletcher, Heald & Hildreth, P.L.C., filed petitions seeking reconsideration of the requirement to obtain CORES FRNs for individuals holding attributable interests, arguing that the CORES FRN requirement is overly burdensome and raises privacy and data security issues and that the Commission provided inadequate notice of the CORES FRN requirement. In the
13. In June 2010, the Media Bureau initiated the
14. In December 2010, the Commission initiated another separate rulemaking proceeding in which it proposed to update CORES to enhance the Commission's data collection efforts and to improve customer interface with CORES. In the
15. In July 2011, the U.S. Court of Appeals for the Third Circuit, as part of its review of the Commission's media ownership rules, vacated and remanded certain aspects of the
16. On November 14, 2012, the Media Bureau released the first electronic analysis of commercial broadcast ownership data submitted pursuant to the revised biennial reporting requirements for 2009 and 2011 (
17. The Commission also sought public comment on both reports. On December 3, 2012, the Commission issued a Public Notice in the
18. On January 3, 2013, the Commission released its
19. The Commission received significant opposition in response to the
20. The Commission reiterated its position that it must be able to uniquely identify all parties, including individuals, reported on broadcast ownership reports and tentatively concluded that the RUFRN “will provide reasonable assurance of unique identification” of attributable individuals and is a superior method of uniquely identifying individuals than the existing SUFRN. The Commission sought comment on what additional information, if any, the Commission could require to ensure that the data collected on the ownership reports will be reliable.
21. The Commission also acknowledged that commenters to the
22. The Commission sought comment on these subjects and its conclusions that the RUFRN proposal will improve the reliability and usability of the broadcast report data. The
23. The Commission also sought comment on extending the RUFRN to Form 323-E in the event that changes proposed in the pending
24. Finally, the
25. By the actions the Commission here, the Commission advances its commitment to improving the comprehensiveness and reliability of the ownership data collected on Forms 323 and 323-E to enable more effective analysis of ownership trends in support of policy initiatives promoting diversity in ownership of broadcast stations. Accordingly, the Commission will no longer allow filers to use SUFRNs on biennial ownership reports, except in limited cases, and instead will require that on such forms filers provide a CORES FRN or RUFRN for any reportable individual attributable interest holder. In addition, the Commission updates its reporting requirements for NCE stations to more closely parallel the requirements for commercial stations. The Commission also makes certain changes to its Form 323 and Form 323-E aimed at reducing the filing burdens on broadcasters and improving data collection. Finally, the Commission declines to adopt certain proposals detailed in comments in this proceeding as redundant, unnecessary, technically infeasible, or unsupported.
26. The Commission concludes that the RUFRN is important to the Commission's ongoing mission to improve, streamline, and modernize the way it collects and uses data. The Commission continues to believe that it must be able to uniquely identify parties reported on broadcast ownership reports for purposes of creating reliable and usable data in support of the Commission's policy initiatives promoting diverse ownership. The Commission has recognized that the TIN/SSN backed CORES FRNs offer a unique identifier and therefore play an important role in promoting the integrity of the data collected on Form 323. The Commission, however, is also sensitive to concerns that have been expressed regarding a mandate that every individual attributable interest holder of a broadcast station submit his or her SSN to the Commission for purposes of broadcast ownership reporting. The creation of the new RUFRN mechanism within CORES, allowing individuals to obtain a unique identification number without submitting a full SSN, properly balances
27.
28. Similarly, pursuant to section 309(j), the Commission must award licenses in a manner that “promot[es] economic opportunity and competition and ensur[es] that new and innovative technologies are readily accessible to the American people by avoiding excessive concentration of licenses and by disseminating licenses among a wide variety of applicants, including small businesses, rural telephone companies, and businesses owned by members of minority groups and women.” Congress directed the Commission to regulate in a manner that ensures that “small businesses, rural telephone companies, and businesses owned by members of minority groups and women” are represented in licensed activities. The statute further requires that the Commission “ensure that small businesses, rural telephone companies, and businesses owned by members of minority groups and women are given the opportunity to participate in the provision of spectrum-based services.” As the Commission has previously determined, section 309(j) is evidence of a congressional policy in support of the grant of broadcast licenses to a wide variety of groups, including minorities and women.
29. In the
30. The Commission finds that flaws in the current practices related to the reporting of SUFRNs for individuals listed on Form 323 compromise the integrity of the data collected and thereby frustrate the Commission's attempts to fulfill its statutory mandates under section 257 and section 309(j). The SUFRN was devised as merely a computer-generated number to be created by clicking a button within Form 323 itself and not backed by any identifying information. The Commission collects no information when the system generates a new SUFRN, and there is no database analogous to CORES that contains uniquely identifying information associated with SUFRNs. The SUFRN therefore offers the Commission no way to cross reference or trace back reported information to a single individual. It was intended only as an interim measure. Based on the Commission's experience reviewing the ownership reports submitted during three separate biennial reporting cycles, it is clear that SUFRNs have been used in a manner that is inconsistent with the Commission's direction and that undermines the integrity of the data. On the one hand some SUFRNs have been used in conjunction with multiple individuals, and on the other hand individuals have used multiple SUFRNs. Because the Commission currently cannot determine whether two SUFRNs identify one or more individuals, it cannot reliably examine the complete attributable holdings of an individual reported with an SUFRN (either at a specific time or over time), or search, aggregate, and cross reference the ownership data. Any attempt at such analysis would require manual analysis of every single entry where an SUFRN appears together with a subjective analysis of other textual information contained on the form or available from other public sources. The Media Bureau cannot confidently determine the number of individuals reporting SUFRNs. In the 2011 biennial ownership reports, the Bureau found that 3,326 unique SUFRNs were reported, and, because some were reported multiple times, SUFRNs were used in 8,719 instances. Because it is possible for filers to improperly report SUFRNs for individuals—either reporting multiple SUFRNs for a single individual on multiple reports or using the same SUFRN for multiple individuals on multiple reports—despite instructions to the contrary, the Bureau concluded that the number of unique SUFRNs reported during the 2011 filing period cannot be relied on to accurately determine the number of individuals using SUFRNs. Manual, subjective analysis of thousands of Form 323 entries using various sources of information compromises data integrity and data utility. Consequently, the Commission cannot rely on the SUFRNs reported to provide reliable ownership data.
31. In the
32. In contrast, in the
33. Some commenters disagree that the RUFRN proposal is superior to the existing SUFRN system. Although these commenters focus primarily on issues related to NCE attributable interest holders, which are addressed in detail below, some of the arguments suggest that the use of RUFRNs will not substantially and meaningfully improve the quality of the Commission's broadcast ownership data generally. These commenters assert that if SUFRNs are being misused, it is either due to mistakes or conscious decisions not to comply with Bureau guidance. According to these commenters, either remains possible with the proposed RUFRN system. The Alabama Educational Television Commission (AETC) et al. argue that users could accidentally enter information incorrectly, forget to enter a previously used SUFRN or FRN, or intentionally violate the Commission's rules, and that errors could also stem from data entry problems on Form 323 itself, such as inadvertent or intentional mistyping of RUFRNs, SUFRNs, or FRNs. AETC et al. urge the Commission to retain the SUFRN for individual attributable interest holders that refuse to obtain a CORES FRN or RUFRN, without imposing substantiation requirements, and to specifically exclude “NCE and non-profit licensees” from the new RUFRN requirement. The Commission addresses these two requests below and addresses here the more general assertion. In addition, commenters state, insofar as the Commission intends to allow use of ownership data by third-party researchers, much of the benefit that comes from the use of RUFRNs is negated by the Commission's proposal to hold securely and confidentially within CORES all identifying information used to obtain RUFRNs, except for names and the RUFRNs themselves.
34. The Commission finds that its policy initiatives are dependent on the quality of the data collected. The Commission concludes that having reasonable assurance that attributable interest holders are uniquely identified on ownership reports in a manner that ensures that the data can be meaningfully searched, aggregated, and cross referenced electronically is crucial to the quality and usability of the Commission's ownership data. The Commission concludes that the SUFRN cannot provide unique identification of individual attributable interest holders on broadcast ownership reports, and the Commission concludes that requiring an FRN generated by CORES, either through existing mechanisms or via the RUFRN method, for all attributable interest holders on broadcast ownership reports is essential to improve the quality and usability of the data collected. The Commission therefore adopts the RUFRN as an alternative mechanism within CORES that will allow an individual (not entities) to obtain an RUFRN by submitting an alternate set of identifying information that does not include a full SSN: Full name, residential address, date of birth, and the last four digits of the individual's SSN.
35. The identifying information provided by the individual will be stored confidentially within CORES, as other sensitive information is stored in CORES to support CORES FRNs issued pursuant to existing functionalities. Only the individual's name and RUFRN will be available publicly. Both the RUFRN and the associated ownership information will be entirely machine readable and will not require manual consideration of each biennial ownership form to analyze whether various Form 323 entries might identify the same individual or different individuals. The same is true for the CORES FRN and underlying TIN. The CORES system will be programmed to verify that the information submitted by the applicant is complete and does not duplicate any information that is already associated with an RUFRN in CORES. The Commission concludes that, since RUFRNs will be backed by identifying information, and since CORES will not issue multiple RUFRNs for the same identifying information, RUFRNs can be relied on to identify individuals uniquely. When the applicant obtains an RUFRN, the applicant will be asked to list all CORES FRNs registered to the individual and all SUFRNs the individual previously used in any broadcast ownership report filings since the 2009 biennial reporting cycle. The Commission concludes that such disclosures will allow it to identify CORES FRNs, RUFRNs, and SUFRNs that identify the same individual, promoting the usefulness of the broadcast ownership data for purposes of electronic searching, aggregating, and cross-referencing and for trend analysis. RUFRNs may be used only on broadcast ownership reporting forms and only for individuals (not entities) reported as attributable interest holders. Once an RUFRN is issued, any ownership report filing that lists the individual associated with that RUFRN will be required to include that RUFRN. However, an individual may opt to use a traditional CORES FRN instead of obtaining and using an RUFRN. In the
36. The Commission does not believe that the existence of possible situations or limitations some commenters identified in objecting to the RUFRN compel the Commission to abandon its conclusion that RUFRNs offer superior data quality to SUFRNs for the purpose of broadcast ownership reports. As the Commission stated in the
37.
38.
39. In response, NAB states that RUFRNs, because they create a unique identifier without requiring individuals to submit full SSNs to the Commission, provide a “safety valve” for individuals who might be reluctant to obtain a CORES FRN due to data privacy and security concerns. NAB claims this is accomplished without compromising the quality of the Commission's ownership data. Thus, states NAB, the RUFRN proposal for commercial broadcasters reflects a better balancing of affected interests than simply eliminating the SUFRN and mandating CORES FRNs in all cases.
40. NCE commenters, on the other hand, continue to express concerns about identity theft, even though the RUFRN does not require the disclosure of full SSNs. NCE commenters state that the existence of an individual's name, address, date of birth, and the last four digits of an SSN would permit hackers to predict a full SSN. Some commenters cite a study conducted by researchers at Carnegie Mellon University. In that study, researchers were able 44 percent of the time to predict the first five digits of individual SSNs for persons born after 1989.
41. Even if the Commission's systems have not been breached to date, NCE commenters argue, there is no assurance that a successful breach will not occur in the future. They again point to the Information Security GAO Report and cite to reports of recent breaches at the White House and other Federal offices. Some commenters claim that the risk of breach would increase if the Commission begins storing in CORES information about NCE board members because some are public officials or other prominent individuals. Although it is sometimes necessary to collect personal information that can be used for identity theft, AETC et al. assert, to provide maximum protection, the collection of such information must be limited to situations where there is no alternative.
42. As stated in the
43. No commercial entity has contested the Commission's proposal to implement the RUFRN system for individual attributable interest holders in commercial broadcast stations, and NCE commenters have offered no compelling reason why the Commission must conclude that the system security needs or risks of NCE attributable interest holders are greater than those of commercial attributable interest holders. Indeed, the quality of the information is similar or exactly the same. The observation that NCE attributable interest holders may be public officials or other prominent individuals is also true in the commercial realm. The Commission takes its data security obligations to all entities and individuals that have confidential
44. To enhance the completeness of the Commission's data collection, promote data integrity, and ensure that data are electronically readable and aggregable, the Commission revises Form 323-E for NCE stations to collect race, gender, and ethnicity information for attributable interest holders, require that CORES FRNs or RUFRNs be used, and conform the biennial filing deadline for NCE broadcast ownership reports with the biennial filing deadline for commercial station ownership reports. In limited circumstances there may be additional parties—other than officers or directors—that hold attributable interests in an NCE station. For example, some states allow non-profit organizations to issue voting stock or the equivalent thereto. Holders of five percent or more of the voting stock of such entities are attributable owners pursuant to section 73.3555, Note 2(a), and must be reported on Form 323-E in the same manner as officers and directors (including the provision of a CORES FRN and, in the case of individuals, race, gender, and ethnicity information). As noted below, the Commission's revisions to Form 323-E and its instructions confirm this point. Attached to this
45.
46. The Commission has previously found that, in order to adopt policies or regulations to promote minority and female ownership of broadcast stations, it is imperative to have information about female and minority ownership in broadcasting as a whole—specifically including “the entire universe of NCE stations.” In light of this, commenters who assert that there is no policy justification for the Commission to collect ownership data from NCE stations are incorrect. Similarly, the Commission disagrees with commenters who suggest that collection of ownership data from NCE licensees is unnecessary because, pursuant to section 73.3555(f) of the Commission's rules, NCE stations are not subject to the Commission's multiple ownership restrictions. The GAO and outside researchers have criticized the Commission specifically for its failure to collect data concerning ownership of NCE stations, and many have described prior data collections as incomplete.
47. The
48. Officers and directors of NCE stations already are defined as attributable interest holders in NCE stations and they already are reported on Form 323-E. The Commission finds that the additional requirements it imposes here—including requiring race, gender, and ethnicity information, and a CORES FRN or RUFRN—do not involve crafting or imposing a new legal definition of “ownership” with respect to NCE stations. For Form 323 and Form 323-E purposes, the concept of ownership relies on the attribution standards set forth in section 73.3555 of the Commission's rules, which generally do not depend on equity interests but instead “seek to identify those interests . . . that confer . . . a degree of influence or control such that the holders have a realistic potential to affect the programming decisions of licensees or other core operating functions.” The National Federation of Community Broadcasters and the Prometheus Radio Project ask what percentage voting interest standard is applicable to Form 323-E. Revised Form 323-E relies on the standards set forth in section 73.3555. Arguments that the Commission should not impose these additional requirements for NCE stations because the individuals have no equity ownership therefore are not compelling.
49. Individuals or entities that hold attributable ownership interests in commercial broadcast stations often do
50. The observation that NCE board members are often governmental officials, governmental appointees, individuals elected by station members, or volunteers does not lead the Commission to a different conclusion. The Commission's attribution standards depend not on the manner in which an individual came to be a member of a station's board of directors or other governing body, but rather on the ability to influence station programming or operations that his or her membership confers. Similarly, because a party can exert influence over a station without being involved in the day-to-day operations of that station, the Commission's attribution rules do not depend on—or even reference—such involvement. Instead, officers and directors are attributable owners because holders of such positions
51. The Commission's rules do, however, allow officers and directors to be exempted from attribution in limited circumstances. Specifically, an officer or director can be exempted from attribution in an entity that is involved in businesses other than broadcasting, provided that his or her duties are
52. The
53.
54. While some commenters support the Commission's conclusion that RUFRNs are essential to allow analysis of the data, other commenters dispute that position. For instance, AETC et al. claim that the Commission has failed to demonstrate why the proposed RUFRN requirement is necessary to track broadcast ownership. Similarly, the University of Utah and the Utah State Board of Regents et al. argue that the benefits derived from the use of RUFRNs on Form 323-E filings “would be marginal, at best.” The University of Utah and the Utah State Board of Regents et al. assert that, in the noncommercial context, the Commission has not identified a diversity problem that additional reporting requirements would help to solve. Noncommercial stations are already required to implement numerous diversity initiatives in order to receive funding from CPB, and unlike commercial stations, NCEs are also subject to political pressures to promote diversity, state the University of Utah and the Utah State Board of Regents et al. Diversity is also identified as an explicit goal in the governing documents of many NCE broadcast licensees, the commenters assert. Further, the University of Utah and the Utah State Board of Regents et al. argue, even if the new reporting requirements enable the Commission to identify a diversity problem, it is unclear what remedial measures the Commission could take in the noncommercial context. Any remedial measures would presumably rely on market-based incentives to lower the economic or regulatory cost of ownership, which would be irrelevant to NCEs given that board membership is not determined by the cost of investment in broadcast properties or prospective financial gain from broadcast station ownership, state the University of Utah and the Utah State Board of Regents et al. According to the Public Broadcast Licensees, the ability to cross reference based on a unique identifier “has little or no relevance to the NCE industry,” where the existence of multiple broadcast interests is “quite rare” in the case of NCE board members and directors. Similarly, Public Broadcast Licensees assert that the proposal to eliminate a filer's obligation to disclose other attributable broadcast interests of attributable parties listed in the filing has “little or no relevance” to NCE stations, because unlike commercial stations, “where individuals often have multiple commercial broadcast interests, the existence of such interests is in fact quite rare in the case of NCE board members and officers.”
55. The Commission disagrees. The Commission believes a unique identifier for each individual attributable interest holder is necessary to make the NCE data aggregable, machine readable, and searchable in the same manner as commercial broadcast station information. As the GAO recognized, to
56.
57. In the
58. The Commission confirms that SUFRNs will remain available for the limited purpose of protecting the position of filers in the case of interest holders that refuse to obtain an FRN or provide the licensee with the information necessary to generate an FRN for the interest holder. The Commission expects that, where an individual interest holder does not already have a CORES FRN, filers will acquire an RUFRN or CORES FRN for such individuals after obtaining the requisite identifying information, or will instruct the individual to obtain his or her own RUFRN or CORES FRN and to provide the FRN to the filer for reporting on the biennial ownership report form. As previously noted, the RUFRN method will avoid the need for individuals to disclose their full SSNs to the Commission. In order for the Commission's RUFRN system to be effective, the Commission believes it is necessary to ensure that filers are using reasonable and good-faith efforts to obtain RUFRNs from individuals with reportable interests (or from CORES on behalf of such individuals). Therefore, the Commission concludes that filers should be required to take specific steps to substantiate that they are making such efforts. The Commission finds that instructing an individual about his or her obligations and about potential enforcement action are specific steps that demonstrate “reasonable and good-faith efforts.” No commenters proposed alternative steps that would show that such efforts are being made. The Commission expects that filers will inform reportable individuals of their obligations and the risk of enforcement action for failing to provide an RUFRN or CORES FRN or to permit an RUFRN or CORES FRN to be obtained on their behalf. An SUFRN may be obtained only if an individual still refuses to provide a means of reporting a valid RUFRN or CORES FRN after the filer has taken such steps. In the event that an SUFRN is used, the Commission may take enforcement action against the filer and/or the recalcitrant individual. The commenters have offered no evidence in the record that the prospect of enforcement action for failing to comply with the RUFRN requirements adopted herein will have a chilling effect on participation in public broadcasting. Enforcement decisions will be made on a case-by-case basis based on the facts and circumstances of each unique case before the Commission. However, the filer itself will be exempt from enforcement action if the filer substantiates that it has used reasonable and good-faith efforts as described herein.
59. The Commission directs the Media Bureau to include instructions for Forms 323 and 323-E and post language on its Form 323 and 323-E Web site, informing reportable interest holders of their obligation to obtain and provide an RUFRN or CORES FRN, or to permit an RUFRN or CORES FRN to be acquired on their behalf, and to alert interest holders of the risk of enforcement action for the failure to provide an RUFRN or CORES FRN or to permit an RUFRN or CORES FRN to be
60. To make sound legislative, regulatory, and policy determinations, the Commission must have complete and reliable broadcast ownership data. Both GAO and the Third Circuit have highlighted the importance of comprehensive and reliable data. At the same time, the Commission is mindful of the burden ownership reporting represents for the industry. The Commission's experience with Form 323 submissions for 2009, 2011, and 2013 reveals that many filings contained errors. Such errors undermine the Commission's ability to electronically process ownership data and make it difficult for the Commission and outside analysts to evaluate the data. Accordingly, the Commission finds that certain improvements to the forms will greatly reduce the burden on filers, significantly streamline the filing process, and increase the quality and usability of the data submitted to the Commission. These changes include extending the biennial filing deadline for Forms 323 and 323-E, reducing the number of filings required, modifying the reporting of other broadcast and daily newspaper interests, and additional improvements described below. The Commission believes they will greatly reduce the burden on filers and increase the quality and usability of submitted ownership data. Section and question references in this
61.
62. Despite these efforts, many ownership reports submitted to the Commission contained errors in 2009, 2011, and 2013. As discussed above, the Commission's experience reviewing those submissions revealed numerous filing mistakes that prevented accurate electronic processing of submitted reports. In preparing the
63. The Commission has solicited a wide variety of input concerning potential further modifications to Form 323 and Form 323-E, including changes designed to decrease filing burdens and reduce errors in ownership filings. For
64. The Commission has received extensive public input as a result of these requests. NAB in particular identifies burdens that complicate the ownership report filing process for both Form 323 and Form 323-E. As the Commission noted in the
65.
66. The Commission declines to adopt proposals for different filing deadlines. While some commenters argue that a December 1 deadline is inconvenient for filers and Commission staff due to the date's proximity to the Thanksgiving holiday and other Commission filing deadlines, those commenters fail to suggest an alternative date. Further, the Commission finds that the 60-day period between the “as of” date and the filing date should provide sufficient flexibility for filers such that other deadlines or holidays do not complicate compliance. Filers can file any time from October 1 through December 1. MMTC asks that the Commission impose an annual, rather than biennial, ownership reporting obligation. At this time, the Commission believes that any marginal benefit of having an annual rather than a biennial snapshot of ownership data is outweighed by the additional burden such a requirement would place on licensees to undertake the full reporting obligation twice as often.
67. The
68. Some commenters suggest that, to reduce the burden on NCE broadcasters and their counsel, any uniform filing date for Form 323-E should be in the first quarter, to correspond to a date that certain NCE stations submit similar data to CPB. This suggestion would not allow the Commission to obtain the synchronized data needed to evaluate minority and female participation in broadcasting over all the services over time. Moreover, since not all NCE stations submit data to CPB, efforts by the Commission to coordinate with CPB would not fully address the filing deadline issue.
69.
70. The Commission believes that modifying Form 323 to allow a parent entity with multiple licensee subsidiaries to file one report that covers all of those licensees will greatly reduce the burden on many filers with no negative impact on the quality of the Commission's ownership data. In some cases, an entity is both a licensee and the parent of one or more licensees. Such an entity must file two separate reports—one as a licensee and one as a parent company. The Commission therefore makes the following three changes to Form 323: (1) The Commission modifies the form to allow parent filers to list multiple subsidiary licensees and the stations associated with those licensees, (2) the Commission deletes the portion of section II-A, question 3(a) (non-biennial), and section II-B, question 3(a) (biennial), asking filers to identify the relationship that each reportable individual or entity has to the licensee, and (3) the Commission deletes section II-B, question 4 (biennial), asking each parent filer to identify the entity or entities directly below it in the licensee's ownership chain. The revised version of Form 323-E is consistent with these modifications as well. The Commission makes the second change to allow a parent entity to file a consolidated ownership report even if an individual listed in response to question 3(a) on the parent's report does not have the same direct interests in all of the parent's licensee subsidiaries. For example, an individual might hold officer positions in the parent and its radio licensee subsidiaries, but not in the parent's television licensee subsidiaries. Because the responses to question 3(a) on the report for each licensee include information concerning the relationship between each attributable party and that licensee, this modification will have no impact on the completeness of the Commission's ownership data. The third change will ensure that a parent entity can file a consolidated report in situations where it holds interests in some of its licensee subsidiaries directly and some indirectly and/or it holds its various subsidiary licensees through different intermediate entities. The Commission added section II-B, question 4 (biennial), to the revised version of Form 323 in an effort to improve the ability of researchers and others to cross reference ownership report data and construct complete ownership structures. Experience has demonstrated, however, that information provided in response to section II-A, question 3(a) (non-biennial), and section II-B, question 3(a) (biennial), is sufficient for these purposes.
71.
72. As discussed in more detail below, the Commission declines to eliminate section II-B, question 3(c), entirely. Nevertheless, the Commission believes that modifications to the reporting requirements for other attributable broadcast and daily newspaper interests will reduce filing burdens and improve both the quality and the usability of the Commission's ownership data. Specifically, the Commission takes the following actions with respect to the reporting of other broadcast interests on Form 323: (1) The Commission deletes the broadcast interests portion section II-B, question 3(c); (2) the Commission adds simple yes/no buttons to the relevant subforms; and (3) the Commission modifies the public search capabilities of its electronic filing system to allow users to search ownership report filings by FRN and output the results as either a list of reports or a list of stations. Several commenters requested that the Commission add search capabilities of this type. Taken together, these three changes will simplify reporting and allow interested parties to determine the other broadcast interests held by reported individuals and entities, if any, in a straightforward manner.
73. Two factors make these changes possible. First, the Commission's implementation of the RUFRN requirement will make the FRN information in the Commission's ownership database more useful as a means to cross reference information across multiple filings. Second,
74. Section II-B, question 3(c), in the biennial section of Form 323 also requires the respondent to provide information concerning the attributable daily newspaper interests held by parties that hold attributable interests in the respondent. The Commission will not delete this portion of the question. Unlike information about broadcast interests, information concerning daily newspaper interests does not appear anywhere on Form 323 except in responses to question 3(c). In other words, an interest holder's daily newspaper interests cannot be ascertained except in direct response to this question. The Commission therefore cannot remove the newspaper interests portion of section II-B, question 3(c), without sacrificing the quality and completeness of the Commission's data. The Commission notes that, because reported newspaper interests generally are significantly fewer than the broadcast interests implicated in the first part of the question, eliminating the daily newspaper inquiry would be of limited value in reducing filing burdens. Moreover, the Commission believes that a slight modification to this question will improve the quality of the Commission's Form 323 data collection and enhance the ability of parties to search, aggregate, and cross reference the Commission's broadcast ownership data. Specifically, the Commission modifies the relevant subforms and attachments to require filers to provide an FRN for each person and entity listed. Any FRN reported in response to question 3(c) is already required in response to question 3(a). Accordingly, this modification to question 3(c) does not mandate the submission of any additional information or require any person or entity to obtain an RUFRN or CORES FRN that is not already required to do so.
75. Finally, the reasoning in support of the modifications to the reporting of broadcast interests discussed above applies equally well to both the biennial and the non-biennial sections of Form 323, as well as to Form 323-E. Accordingly, the Commission applies these changes to both sections of Form 323, and includes parallel modifications to both sections of the revised version of Form 323-E. Moreover, the Commission applies its modifications to the reporting of newspaper interests to both the biennial and non-biennial sections of Form 323, because they share a common underlying rationale. The Commission believes these changes will further reduce filing burdens and improve the quality of its ownership data. As part of making these modifications, the Commission will eliminate the relevant inconsistencies between the forms and the instructions noted by NAB in the
76.
77. The Commission agrees that collecting information on a biennial basis concerning participation of Tribal Nations and Tribal entities in broadcasting will help the Commission evaluate service to underserved and minority populations. Moreover, such data will help inform the Commission's ongoing efforts to expand broadcast opportunities for Tribal Nations and Tribal entities, as developed in the Commission's
78.
79. First, the Commission reduces burdens and improves both the quality and usability of the Commission's ownership data by clarifying the manner in which filers should report contracts and other instruments that must be filed pursuant to section 73.3613 of the Commission's rules. As part of this clarification, the Commission will eliminate the relevant inconsistencies between the forms and the instructions noted by NAB in the
80. To address these issues, the Commission modifies the relevant questions on Form 323 and Form 323-E to require all section 73.3613 documents for a station to be listed on the report for that station's licensee. Under the Commission's rules, a full-power television station, Class A television station, AM radio station, or FM radio station must have an up-to-date list of all section 73.3613 documents, or copies of all such documents, in its public file at all times. Accordingly, licensee entities are often in the best position to produce the information necessary to respond to this question. It is therefore sensible to require licensees' filings to include a complete document list. This clarification will reduce filing burdens, because filers will be able to enter all required information on the licensee report and simply check “N/A” for all parent filings. Moreover, to the extent that filers may have been providing different document lists on various reports for the same parent entity, this modification helps ensure that parent entities can file consolidated reports for all of their subsidiary licensees. This clarification also will improve public access to and use of the Commission's ownership data, because parties reviewing ownership reports will need to examine only one of a station's filings to construct a full list of that station's section 73.3613 documents. As a result of this clarification, the section 73.3613 documents question mirrors section II-B, question 5, which directs parties to provide an ownership chart (or similar information) on the licensee's ownership report and to check “N/A” on all parent filings. To further improve public review and use of the Commission's ownership data, the ownership report search results screen in LMS will indicate, for each report listed, whether that report was submitted for a licensee/permittee or a parent entity. This will help users quickly identify the filings that contain summary contracts and ownership structure information.
81. Second, the Commission improves data quality by adding a category to Form 323 for limited liability companies. Section I, question 8, of Form 323 requires the filer to identify the nature of the respondent, and currently allows the filer to choose between categories for sole proprietorships, for-profit corporations, not-for-profit corporations, general partnerships, and limited partnerships. Respondents that do not fit into one of these categories must select the “other” category and provide an explanatory exhibit. The parallel question on the revised version of Form 323-E includes different categories. Accordingly, the modification the Commission makes here applies only to Form 323. Over the years, limited liability companies have become increasingly common in the ownership structures of commercial broadcast stations. The Commission believes it is prudent to add a separate category allowing parties to identify filing entities that are limited liability companies. The “other” option will remain on the form, along with the ability to upload an exhibit, for respondents that do not fit into one of the provided categories. Adding this category will reduce burdens on limited liability company filers by eliminating the need to type an exhibit. It will also improve the Commission's data by placing more ownership information into machine-readable data fields and, thereby, improving the ability of parties to electronically search, aggregate, and cross reference the Commission's ownership data.
82. Third, the Commission reduces burdens by eliminating Form 323, section II-A, question 2 (non-biennial), and section II-B, question 2 (biennial), which requires filers to provide capitalization information for any respondent that is a licensee, permittee, or entity that has a majority interest in, or otherwise exercises
83. Fourth, in addition to the Commission's general desire to improve the quality of its broadcast ownership
84. In certain circumstances, two or more parties hold a voting interest in a licensee or other respondent jointly. Two parties may, for example, hold 100 percent of the voting interest in an entity together, as joint tenants (as opposed to each individual holding 50 percent of the voting interests). Similarly, agreements for partnerships or limited liability companies may provide that two or more individuals exercise voting power together, such that any of the relevant parties can fully exercise the voting interest. Because the current version of Form 323 provides no mechanism for parties to identify situations in which voting interests are jointly held, it is likely that filers report such interests in different ways, which leads to errors and inconsistencies in the Commission's data. For example, faced with a situation in which parties A and B hold a 50 percent voting interest jointly, one filer might report both as having a 50 percent interest while another filer might report A and B as holding 25 percent of the voting interests each. Neither of these options accurately captures the voting rights at issue. When preparing the
85. Finally, the subforms for Form 323 section II-A, question 3(a) (nonbiennial) and section II-B, question 3(a) (biennial) provide categories for filers to identify each attributable party's positional interest in the respondent. To increase the usability of the Commission's ownership data, and in light of the Commission's recent decision concerning attribution of television joint sales agreements (JSAs), the Commission will add a new positional interest category that will allow filers to identify reported parties that are attributable by virtue of a JSA or Local Marketing Agreement. One commenter proposes additional reporting requirements for parties that operate a station pursuant to a local marketing agreement (LMA). As an initial matter, the Commission notes that any party that has an attributable interest in a commercial broadcast station by virtue of an attributable LMA or JSA is already required to comply with Form 323 filing requirements for that station. This existing requirement captures any minority and female ownership interests in commercial broadcast stations that result from the operation of a station pursuant to an attributable agreement. The Commission declines to extend the reporting requirement to nonattributable operating agreements because there is no information on the current record that reflects that a data collection focused on this category of nonattributable interest holders would meaningfully improve the data set.
86. Commenters in this proceeding provide several additional suggestions relating to Form 323, Form 323-E, procedures related to those forms, and the Commission's Consolidated Database System (CDBS) that the Commission declines to implement at this time. The Commission discusses those proposals briefly below. As noted above, the Commission intends to move Forms 323 and 323-E from CDBS to LMS. Comments and arguments presented herein with respect to CDBS are equally applicable to the Commission's future LMS implementation of the forms and the associated public search capabilities. Additional rejected proposals are addressed elsewhere in this
87. MMTC asks the Commission to create a separate filing category for transfers to bankruptcy trustees, debtors-in-possession, or trusts, arguing that this would help identify business failures. The Commission declines to do so, because the suggestion is outside the scope of this proceeding, would be burdensome and costly, and similar information is available already. Creating a new filing category would require changes to Form 323 and Form 323-E, the associated database elements in CDBS, and also changes to the Commission's forms for assignments and transfers of broadcast authorizations, the database infrastructure associated with those forms, and the Public Access portion of CDBS. The record does not demonstrate sufficient utility of the information to justify these costly undertakings. In any event, parties can use the public access portion of CDBS to obtain information concerning individual transactions, including those that involve assignments or transfers to bankruptcy trustees, debtors-in-possession, or trusts. The Public Access portion of CDBS allows users to search for assignment and transfer applications based on multiple criteria, including call sign, Facility ID Number, service, station location (city and state), application file number, and applications status. This electronic system also gives users access to the full content of each assignment and transfer application, including the portions that describe the parties to the application and the nature of the underlying transaction(s), and provides information about legal actions pertaining to those applications. The Commission intends to implement these functions in LMS as well.
88. Several commenters ask the Commission to modify its electronic filing systems, the Public Access portion of CDBS, or the online instructions for CDBS. For example, parties ask the Commission to create new filing systems for parties with limited broadband access and/or update CDBS accounts to recognize the type of entity, list only reports applicable to that entity, indicate previous filings and dates, allow users to pre-populate entries in new reports based on prior reports (including forms of different types), and provide automated filing reminders. Several of these capabilities already exist in CDBS. For example, if a party uses the same CDBS account for all of its filings, that account already contains the station's prior filings as well as information about those filings, including submission dates. CDBS in many cases allows users to pre-populate new ownership reports by copying or prefilling data from another filing of the same type. CDBS pre-populates data in some other situations as well. For example, when a party launches a covering license application in CDBS, the system often pre-populates some information from the related permit application. Similarly, CDBS uses information in the Account Maintenance menu to prefill respondent, applicant, and contact representative information into applications. The Commission intends to implement similar functions in LMS
89. Finally, several commenters ask that the Commission not audit ownership data submitted by NCE stations and/or that NCE entities be subject to reduced compliance standards and/or forfeitures. The Commission believes that in order to maintain and improve the quality of both its commercial and noncommercial ownership data, the Commission must have the ability to audit broadcast ownership data and hold parties responsible for their submissions. Accordingly, the Commission declines to make any changes to its approach to ownership report data audits and related forfeitures at this time.
90. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission incorporated an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the
91. The
92. Accordingly, pursuant to the Commission's statutory mandate contained in section 257 of the Telecommunications Act of 1996 (the 1996 Act) and section 309(j) of the Communications Act of 1934 (the Act) to
93. The Commission received no comments in direct response to the IRFAs contained in the
94. The actions taken in the
95.
96. In the
97. The identifying information provided by the individual in order to obtain an RUFRN will be confidentially stored within CORES, and only the individual's name and RUFRN will be available publicly. The underlying information will be entirely machine readable and will not require the manual consideration of each biennial ownership form to compare associated name and address information to analyze whether Form 323 entries might identify the same individual or different individuals. When the individual applicant obtains an RUFRN, the applicant will be asked to list all CORES FRNs registered to the individual and all SUFRNs that the individual previously used in any broadcast ownership report filings since the 2009 biennial reporting cycle. The Commission concludes that this disclosure will allow the Commission to identify all CORES FRNs, RUFRNs, and SUFRNs that identify the same individual, which will promote the usefulness of the broadcast ownership data for purposes of electronic searching, aggregating and cross-referencing, and for trend analysis. Once an RUFRN is issued, an ownership report filing that lists the individual associated with that RUFRN will be required to include that RUFRN. However, an individual may opt to use a traditional CORES FRN instead of obtaining and using an RUFRN.
98. The Commission also concludes that permitting individual interest holders the ability to obtain and report an RUFRN in lieu of a traditional CORES FRN will impose minimal costs and burdens, if any, on individuals or filers. Those that already have a CORES FRN will be able to continue to use that existing number without the need to
99. Commenters also raise concerns about the security and integrity of CORES and argue that registering for a CORES FRN or an RUFRN may leave individuals vulnerable to identity theft. The Commission agreed with commenters that privacy and security with respect to personally identifiable information are paramount, and the Commission stated that it is confident that the steps taken and the procedures in place assure the security of the Commission's systems. In fact, the Commission stated that it is not aware of any breaches to CORES. In the
100.
101. The
102. The Commission finds that officers and directors of NCE stations already are defined as attributable interest holders in NCE stations and that such individuals are already identified on Form 323-E. The additional requirements imposed in the
103. The Commission is unconvinced that providing the race, gender, and ethnicity on Form 323-E is burdensome and would discourage board participation. Many NCE stations already provide similar information in an annual report to the Corporation for Public Broadcasting (CPB), and the record does not reflect that the CPB reporting is burdensome or discourages participation. The Commission does not believe that providing similar information to the Commission would have a significantly different impact,
104. The
105. The Commission also disagrees with commenters that argue that the CORES FRN and RUFRN requirements are unduly burdensome and would
106.
107. The Media Bureau is directed to include instructions for Forms 323 and 323-E and post language on its Form 323 and 323-E Web site, informing reportable interest holders of their obligation to obtain and provide an RUFRN or CORES FRN, or to permit an RUFRN or CORES FRN to be acquired on their behalf, and to alert interest holders of the risk of enforcement action for failure to provide an RUFRN or CORES FRN or to permit an RUFRN or CORES FRN to be obtained. The Commission anticipates that the 2017 filing period will be the first filing period that the requirement will be implicated, and the time frame mitigates any potential burden because filers will have ample time to ensure that they have a current and correct RUFRN or CORES FRN for the individuals and entities reported on the Forms 323 and 323-E.
108. Filing Burden Reductions and Improved Data Integrity. In the
109. To permit filers more time to file Form 323, the Commission moved the filing deadline from November 1 to December 1. The Commission found that the 60-day period between the October 1 “as of” date and the filing date should provide sufficient flexibility for filers such that other deadlines or holidays do not complicate compliance. The Commission also adopted a uniform filing date of December 1 for filing the Form 323-E biennial ownership report. In the
110. The current version of Form 323 allows parent-entity filers to list only one subsidiary licensee and its associated stations. As a result, parent entities with multiple licensee subsidiaries must file separate ownership reports for each of those licensees. In the
111. In the
112. Information concerning daily newspaper interests does not appear anywhere on Form 323 except in response to question 3(c). In other words, an interest holder's daily newspaper interests cannot be ascertained except in direct response to this question. The Commission determined that it therefore cannot remove the newspaper interests portion of section II-B, question 3(c), without sacrificing the quality and completeness of the data. However, to improve the quality of the data collected in response to this question and enhance the ability of parties to search, aggregate, and cross-reference that data, the Commission modified the subforms and the spreadsheet attachments for the newspaper interests portion of section II, question 3(c), to require filers to provide an FRN (either a CORES FRN or RUFRN, or an SUFRN, subject to the limitations addressed above) for each person and entity listed. In order to further reduce filing burdens and improve the quality of the ownership data, the Commission incorporated these changes into biennial and non-biennial versions of Form 323 and Form 323-E.
113. In the
114. The Commission also opted to include in section I, question 8, of Form 323 the designation for limited liability companies. Currently, the question requires a filer to identify the nature of the respondent, and currently allows the filer to choose between the designations of sole proprietorship, for-profit corporation, not-for-profit corporation, general partnership, and limited partnership. Respondents that do not fit into one of these categories must select “other” and provide an explanatory exhibit. The Commission found that adding the limited liability company designation to this question will reduce burdens on limited liability company filers by eliminating the need to provide an exhibit.
115. The Commission also reduced burdens and improved the quality and usability of the ownership data by clarifying the manner in which filers should report contracts and other instruments that must be filed with the Commission, as described in 47 CFR 73.3613. Currently, Form 323 and Form 323-E require stations to list all contracts required to be filed with the Commission pursuant to § 73.3613. The respondent on any given report may or may not be a party to these contracts and instruments. Some filers list all relevant documents on the licensee's ownership report, while other filers opt to list different documents on different reports. The latter approach requires filers to include different, often overlapping, lists of documents on multiple reports and forces researchers and other parties to examine all of a station's ownership filings to construct a complete list of that station's required contracts and instruments. To address these issues, the Commission modified the relevant questions on Form 323 and Form 323-E to require all § 73.3613 documents for a station to be listed on the report for that station's licensee. The Commission determined that clarification will reduce filing burdens, because filers will be able to enter all required information on the licensee report and simply check “N/A” for all parent filings.
116. The Commission also reduced burdens by eliminating question 2 of section II-A and section II-B of Form 323, which requires filers to provide capitalization information for any respondent that is a licensee, permittee, or entity that has a majority interest in, or otherwise exercises
117. To improve the quality of the broadcast ownership data collections, the Commission added a “yes/no” question to each subform of Form 323, section II-A, question 3(a) (non-biennial), and section II-B, question 3(a) (biennial), to allow parties to identify jointly held voting interests. In certain circumstances, two or more parties hold a voting interest in a licensee or other respondent jointly. Two parties may, for example, hold 100 percent of the voting interest in an entity together, as joint tenants (as opposed to each individual holding 50 percent of the voting interests). Similarly, agreements for partnerships or limited liability companies may provide that two or more individuals exercise voting power together, such that any of the relevant parties can fully exercise the voting interest. Because the current version of Form 323 provides no mechanism for parties to identify situations in which voting interests are jointly held, it is likely that filers report such interests in different ways, which leads to errors and inconsistencies in the Commission's data. In reviewing submitted data, the Commission found
118. The Commission also modifies Form 323 section II-A, question 3(a) (non-biennial) and section II-B, question 3(a) (biennial) to add a new positional interest category that will allow filers to identify reported parties that are attributable by virtue of a joint sales agreement (JSA) or local marketing agreement (LMA). This change is designed to increase the usability of the Commission's ownership data and reflects the Commission's recent decision concerning attribution of television JSAs.
119. The
120. Several commenters asked the Commission to modify its electronic filing system, the Public Access portion of CDBS, or the online instructions for CDBS. For example, parties asked the Commission to create new filing systems for parties with limited broadband access and/or to update CDBS accounts to recognize the type of entity, list only reports applicable to that entity, indicate previous filings and dates, allow users to pre-populate entries in new reports based on prior reports (including forms of different types), and provide automated filing reminders. Several of these capabilities already exist in CDBS. For example, if a party uses the same CDBS account for all of its filings, that account already contains the station's prior filings as well as information about those filings, including submission dates. CDBS in many cases allows users to pre-populate new ownership reports by copying or prefilling data from another filing of the same type. To utilize these and other burden-reducing capabilities in CDBS, filers sometimes use different CDBS accounts for different types of filings and different entities. The Commission did not want filers to lose the ability to benefit from the ability to use the same CDBS account for all of its filings. The remaining suggestions were either technically infeasible or would impose significant costs on the Commission that appear to exceed any possible benefits at this time. Other commenters suggested various enhancements to search capabilities within the Public Access portion of CDBS, including searching ownership reports by gender, race, ethnicity, voting percentage, and equity percentage; displaying explanatory messages when searches produce no results; and alerting searchers about assignment and/or transfer applications. Researchers and other parties currently can download the data files from the Commission's Web site at any time and study, search, and manipulate the data in a wide variety of ways. This limits the need for the Commission to develop an extensive catalog of complex query options within the Public Access portion of CDBS. The Commission found that the costs of implementing these suggested modifications to CDBS at this time exceed the benefits.
121. Several commenters asked that the Commission not audit ownership data submitted by NCE stations and/or that NCE entities be subjected to reduced compliance standards and/or forfeitures. The Commission found that in order to maintain and improve the quality of both the commercial and noncommercial ownership data, the Commission must have the ability to audit broadcast ownership data and hold parties responsible for their submissions. Accordingly, the Commission declined to make any changes to its approach to ownership report data audits and related forfeitures.
122. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction” under section 3 of the Small Business Act. In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). The actions taken herein affect small television and radio broadcast stations. A description of these small entities, as well as an estimate of the number of such small entities, is provided below.
123.
124. Additionally, the Commission has estimated the number of licensed commercial television stations to be 1,391. According to Commission staff review of BIA/Kelsey, LLC's Media Access Pro Television Database on July 22, 2015, about 1,268 of an estimated 1,391 commercial television stations (or approximately 91 percent) had revenues of $38.5 million or less. The Commission has estimated the number of licensed noncommercial educational television stations to be 394. We do not have revenue data or revenue estimates for noncommercial stations. These stations rely primarily on grants and contributions for their operations, so we will assume that all of these entities qualify as small businesses. We note that in assessing whether a business entity qualifies as small under the above definition, business control affiliations must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by any changes to the filing requirements for FCC Form 323 or Form 323-E, because the revenue figures on which this estimate is based do not include or aggregate revenues from affiliated companies.
125. An element of the definition of “small business” is that the entity not be dominant in its field of operation. The Commission is unable at this time and in this context to define or quantify the criteria that would establish whether a specific television station is dominant in its market of operation. Accordingly, the foregoing estimate of small businesses to which the rules may apply does not exclude any television stations from the definition of a small business on this basis and is therefore over-inclusive to that extent. An additional element of the definition of “small business” is that the entity must be independently owned and operated. It is difficult at times to assess these criteria in the context of media entities, and our estimates of small businesses to which they apply may be over-inclusive to this extent.
126.
127. Further, according to Commission staff review of BIA/Kelsey, LLC's Media Access Pro Radio Database on July 22, 2015, about 11,354 (or about 99.9 percent) of 11,364 commercial radio stations in the United States have revenues of $38.5 million or less. The Commission has estimated the number of licensed noncommercial radio stations to be 4,091. We do not have revenue data or revenue estimates for these stations. These stations rely primarily on grants and contributions for their operations, so we will assume that all of these entities qualify as small businesses. We note that in assessing whether a business entity qualifies as small under the above definition, business control affiliations must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by any changes to filing requirements for FCC Form 323 or Form 323-E, because the revenue figures on which this estimate is based do not include or aggregate revenues from affiliated companies.
128. In this context, the application of the statutory definition to radio stations is of concern. An element of the definition of “small business” is that the entity not be dominant in its field of operation. We are unable at this time and in this context to define or quantify the criteria that would establish whether a specific radio station is dominant in its field of operation. Accordingly, the foregoing estimate of small businesses to which the rules may apply does not exclude any radio station from the definition of a small business on this basis and is therefore over-inclusive to that extent. An additional element of the definition of “small business” is that the entity must be independently owned and operated. We note that it is difficult at times to assess these criteria in the context of media entities, and our estimates of small businesses to which they apply may be over-inclusive to this extent.
129.
130. The
131. The RFA requires an agency to describe any significant alternatives that is has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.
132. The
133. The Commission has extended the filing deadline for Form 323 to permit all filers, including small businesses, an additional 30 days to file the ownership report. The Commission also set the filing deadlines for Form 323-E to coincide with the deadlines for Form 323. The Commission considered a proposal to set the uniform filing deadline for Form 323-E to the first quarter to coincide with the date that certain NCE stations submit similar data to CPB. The Commission found that this suggestion would not allow it to obtain the synchronized data needed to evaluate minority and female participation in broadcasting over all the services over time. Moreover, because not all NCE stations submit data to CPB, efforts by the Commission to coordinate with CPB would not fully address the filing deadline issue.
134. The
135. Commission will send a copy of the
136. The Commission will send a copy of this
137. Accordingly
138.
139.
140.
141.
142.
Radio broadcast services.
Experimental radio, Auxiliary, Special broadcast and other program distributional services.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 73 and 74 as follows:
47 U.S.C. 154, 303, 334, 336 and 339.
(a) The Ownership Report for Commercial Broadcast Stations (FCC Form 2100, Schedule 323) must be filed electronically every two years by each licensee of a commercial AM, FM, or TV broadcast station and any entity that holds an interest in the licensee that is attributable pursuant to § 73.3555 (each a “Respondent”). The ownership report shall be filed by December 1 in all odd-numbered years. Each ownership report shall provide all information required by, and comply with all requirements set forth in, the version of FCC Form
(b)(1) Each permittee of a commercial AM, FM or TV broadcast station and any entity that holds an interest in the permittee that is attributable pursuant to § 73.3555 (each a “Respondent”) shall file an ownership report on FCC Form 2100, Schedule 323 within 30 days of the date of grant by the FCC of an application by the permittee for original construction permit. Each ownership report shall provide all information required by, and comply with all requirements set forth in, the version of FCC Form 2100, Schedule 323 (including all instructions for the form and schedule) that is current on the date on which the ownership report is filed.
(2) Except as specifically noted below, each permittee of a commercial AM, FM or TV broadcast station and any entity that holds an interest in the permittee that is attributable pursuant to § 73.3555 (each a “Respondent”) shall file an ownership report on FCC Form 2100, Schedule 323 on the date that the permittee applies for a station license. Each ownership report shall provide all information required by, and comply with all requirements set forth in, the version of FCC Form 2100, Schedule 323 (including all instructions for the form and schedule) that is current on the date on which the ownership report is filed. If a Respondent has a current and unamended ownership report on file with the Commission that was filed pursuant to paragraphs (b)(1) or (c) of this section, was submitted using the version of FCC Form 2100, Schedule 323 that is current on the date on which the ownership report due pursuant to paragraph (b)(2) is filed, and is still accurate, the Respondent may certify that it has reviewed such ownership report and that it is accurate, in lieu of filing a new ownership report.
(c) Each permittee or licensee of a commercial AM, FM or TV broadcast station and any entity that holds an interest in the permittee or licensee that is attributable pursuant to § 73.3555 (each a “Respondent”), shall file an ownership report on FCC Form 2100, Schedule 323 within 30 days of consummating authorized assignments or transfers of permits and licenses. Each ownership report shall provide all information required by, and comply with all requirements set forth in, the version of FCC Form 2100, Schedule 323 (including all instructions for the form and schedule) that is current on the date on which the ownership report is filed.
(d) The Ownership Report for Noncommercial Broadcast Stations (FCC Form 2100, Schedule 323-E) must be filed electronically every two years by each licensee of a noncommercial educational AM, FM or TV broadcast station and any entity that holds an interest in the licensee that is attributable pursuant to § 73.3555 (each a “Respondent”). The ownership report shall be filed by December 1 in all odd-numbered years. Each ownership report shall provide all information required by, and comply with all requirements set forth in, the version of FCC Form 2100, Schedule 323-E (including all instructions for the form and schedule) that is current on October 1 of the year in which the ownership report is filed. The information provided on each ownership report shall be current as of October 1 of the year in which the ownership report is filed. A Respondent with a current and unamended biennial ownership report (
(e)(1) Each permittee of a noncommercial educational AM, FM or TV broadcast station and any entity that holds an interest in the permittee that is attributable pursuant to § 73.3555 (each a “Respondent”) shall file an ownership report on FCC Form 2100, Schedule 323-E within 30 days of the date of grant by the FCC of an application by the permittee for original construction permit. Each ownership report shall provide all information required by, and comply with all requirements set forth in, the version of FCC Form 2100, Schedule 323-E (including all instructions for the form and schedule) that is current on the date on which the ownership report is filed.
(2) Except as specifically noted below, each permittee of a noncommercial educational AM, FM or TV broadcast station and any entity that holds an interest in the permittee that is attributable pursuant to § 73.3555 (each a “Respondent”) shall file an ownership report on FCC Form 2100, Schedule 323-E on the date that the permittee applies for a station license. Each ownership report shall provide all information required by, and comply with all requirements set forth in, the version of FCC Form 2100, Schedule 323-E (including all instructions for the form and schedule) that is current on the date on which the ownership report is filed. If a Respondent has a current and unamended ownership report on file with the Commission that was filed pursuant to paragraphs (e)(1) or (f) of this section, was submitted using the version of FCC Form 2100, Schedule 323-E that is current on the date on which the ownership report due pursuant to this subsection is filed, and is still accurate, the Respondent may certify that it has reviewed such ownership report and that it is accurate, in lieu of filing a new ownership report.
(f) Each permittee or licensee of a noncommercial educational AM, FM or TV broadcast station, and any entity that holds an interest in the permittee or licensee that is attributable pursuant to § 73.3555 (each a “Respondent”), shall file an ownership report on FCC Form 2100, Schedule 323-E within 30 days of consummating authorized assignments or transfers of permits and licenses. Each ownership report shall provide all information required by, and comply with all requirements set forth in, the version of FCC Form 2100, Schedule 323-E (including all instructions for the form and schedule) that is current on the date on which the ownership report is filed.
47 U.S.C. 154, 302a, 303, 307, 309, 336 and 554.
The Ownership Report for Commercial Broadcast Stations (FCC Form 2100, Schedule 323) must be electronically filed by December 1 in all odd-numbered years by each licensee of
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