| Page Range | 9985-10321 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 10321 - Determination and Waiver Pursuant to Section 1209 of the Carl Levin and Howard P. ``Buck'' McKeon National Defense Authorization Act for Fiscal Year 2015 Regarding the Provision of Assistance to Appropriately Vetted Elements of the Syrian Opposition | |
| 80 FR 10313 - Establishment of the Pullman National Monument | |
| 80 FR 10283 - Employment Authorization for Certain H-4 Dependent Spouses | |
| 80 FR 10162 - Government in the Sunshine Act Meeting Notice | |
| 80 FR 10209 - Call for Nominations for Treasury Secretary Appointments to Tribal Advisory Committee | |
| 80 FR 10171 - Sunshine Act Meeting | |
| 80 FR 10003 - Clothianidin; Pesticide Tolerances for Emergency Exemptions | |
| 80 FR 10203 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Airport Noise Compatibility Planning | |
| 80 FR 10091 - Notice of Receipt of Requests for Amendments To Terminate Uses in Certain Pesticide Registrations | |
| 80 FR 10146 - Guidelines for State Courts and Agencies in Indian Child Custody Proceedings | |
| 80 FR 10087 - Proposed Information Collection Request; Comment Request; Participation by Disadvantaged Business Enterprises in Procurements Under EPA Financial Assistance Agreements (Renewal) | |
| 80 FR 10090 - Notification of a Public Teleconference of the Great Lakes Advisory Board | |
| 80 FR 10165 - Concentration Averaging and Encapsulation Branch Technical Position | |
| 80 FR 10045 - Submission for OMB Review; Comment Request | |
| 80 FR 10046 - Submission for OMB Review; Comment Request | |
| 80 FR 10074 - Submission for OMB Review; Comment Request | |
| 80 FR 10007 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Amendment 20B; Correction | |
| 80 FR 10075 - Judicial Proceedings Since Fiscal Year 2012 Amendments Panel (Judicial Proceedings Panel); Notice of Federal Advisory Committee Meeting | |
| 80 FR 10165 - Entergy Nuclear Vermont Yankee, LLC and Entergy Nuclear Operations, Inc.; Establishment of Atomic Safety and Licensing Board | |
| 80 FR 10088 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Iron and Steel Foundry Area Sources (Renewal) | |
| 80 FR 10089 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Primary Lead Smelters (Renewal) | |
| 80 FR 10123 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting | |
| 80 FR 10165 - James Chaisson; Notice of Atomic Safety and Licensing Board Reconstitution | |
| 80 FR 10053 - Trade Mission to South Africa, Kenya and Mozambique | |
| 80 FR 10051 - Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan: Final Results of Antidumping Duty Administrative Review; 2012-2013 | |
| 80 FR 10249 - Fisheries of the Exclusive Economic Zone Off Alaska; Gulf of Alaska; Final 2015 and 2016 Harvest Specifications for Groundfish | |
| 80 FR 10051 - Foreign-Trade Zone 45-Portland, Oregon; Revision to Production Authority; Epson Portland, Inc., Subzone 45F; (Inkjet Cartridges and Bulk Ink); Hillsboro, Oregon | |
| 80 FR 10058 - Atlantic Highly Migratory Species; Meeting of the Atlantic Highly Migratory Species Advisory Panel | |
| 80 FR 10094 - Notice of Agreement Filed | |
| 80 FR 10059 - Caribbean Fishery Management Council: Scoping Meetings | |
| 80 FR 10083 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Shipbuilding and Ship Repair Facilities-Surface Coating (Renewal) | |
| 80 FR 10085 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Reporting and Recordkeeping Requirements for Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles (Renewal) | |
| 80 FR 10001 - Automobile or Other Conveyance and Adaptive Equipment Certificate of Eligibility for Veterans or Members of the Armed Forces With Amyotrophic Lateral Sclerosis | |
| 80 FR 10114 - Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Disability and Rehabilitation Research Projects Program | |
| 80 FR 10161 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 80 FR 10125 - National Medical Device Postmarket Surveillance System Planning Board Report; Availability, Web Site Location and Request for Comments | |
| 80 FR 10103 - Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training Centers | |
| 80 FR 10026 - Over-the-Counter Sunscreen Drug Products-Regulatory Status of Enzacamene | |
| 80 FR 10035 - Over-the-Counter Sunscreen Drug Products-Regulatory Status of Ecamsule | |
| 80 FR 10111 - Proposed priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training Centers | |
| 80 FR 10117 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals | |
| 80 FR 10106 - Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training Centers | |
| 80 FR 10099 - Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training Centers | |
| 80 FR 10169 - Joint Industry Plan; Order Approving the Eighth Amendment to the National Market System Plan To Address Extraordinary Market Volatility by BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, The Nasdaq Stock Market LLC, National Stock Exchange, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and NYSE Arca, Inc. | |
| 80 FR 10201 - In the Matter of Akesis Pharmaceuticals, Inc., Stellar Resources, Ltd., and Thwapr, Inc.; Order of Suspension of Trading | |
| 80 FR 10201 - In the Matter of Revonergy Inc., Siberian Energy Group Inc., Tao Minerals Ltd., (n/k/a Canam Gold Corp.), and Todays Alternative Energy Corp.; Order of Suspension of Trading | |
| 80 FR 10201 - In the Matter of Innovative Software Technologies, Inc., National Health Partners, Inc., The Laguna Group, Inc. (a/k/a Eco Energy Pumps, Inc.), and TYIN Group Holdings Limited; Order of Suspension of Trading | |
| 80 FR 10200 - In the Matter of Calypte Biomedical Corporation, EC Development, Inc., and Information Architects Corporation (n/k/a Dakota Creative Group Corporation); Order of Suspension of Trading | |
| 80 FR 10050 - Submission for OMB Review; Comment Request | |
| 80 FR 10164 - Advisory Committee for Cyberinfrastructure; Notice of Meeting | |
| 80 FR 10085 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Petroleum Refineries (Renewal) | |
| 80 FR 10084 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Municipal Solid Waste Landfills (Renewal) | |
| 80 FR 10082 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Calciners and Dryers in Mineral Industries (Renewal) | |
| 80 FR 10086 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Metal Coil Surface Coating (Renewal) | |
| 80 FR 10089 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Certification of Pesticide Applicators (Renewal) | |
| 80 FR 10162 - Tetrahydrofurfuryl Alcohol From China; Scheduling of an Expedited Five-Year Review | |
| 80 FR 10077 - Advisory Committee on Arlington National Cemetery Honor Subcommittee Meeting Notice | |
| 80 FR 10076 - Advisory Committee on Arlington National Cemetery Remember Subcommittee Meeting Notice | |
| 80 FR 10137 - Port Access Route Study: In the Chukchi Sea, Bering Strait and Bering Sea | |
| 80 FR 10131 - Policy Letters: Guidance for the Use of Liquefied Natural Gas as a Marine Fuel | |
| 80 FR 10060 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to San Francisco Bay Area Water Emergency Transportation Authority Central Bay Operations and Maintenance Facility Project in Alameda, California | |
| 80 FR 10066 - Takes of Marine Mammals Incidental to Specified Activities; Seabird Research Activities in Central California, 2015-2016 | |
| 80 FR 10047 - Request for Information: Software Vendors of State and Local Management Information Systems (MIS) and Other Technology Solutions for the National School Lunch and School Breakfast Programs | |
| 80 FR 10159 - Draft Environmental Impact Statement for Alcatraz Ferry Embarkation Plan, San Francisco County, California. | |
| 80 FR 10126 - Request for Information on Specific Areas of Public Health Concern Related to Racial/Ethnic Demographic Subgroups for Additional Research by the Office of Minority Health | |
| 80 FR 10093 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
| 80 FR 10092 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 80 FR 10122 - Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 80 FR 10144 - Notice of Public Meetings on the Proposed Revised Guidelines for Implementing Executive Order 11988, Floodplain Management, as Revised Through the Federal Flood Risk Management Standard | |
| 80 FR 9987 - Authorization To Seize Property Involved in Drug Offenses for Administrative Forfeiture (2012R-9P) | |
| 80 FR 10138 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; National Fire Incident Reporting System (NFIRS) v5.0 | |
| 80 FR 10140 - Final Flood Hazard Determinations | |
| 80 FR 10138 - Final Flood Hazard Determinations | |
| 80 FR 10163 - Petitions for Modification of Application of Existing Mandatory Safety Standards | |
| 80 FR 10022 - Position Limits for Derivatives and Aggregation of Positions | |
| 80 FR 10121 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient | |
| 80 FR 10098 - Proposed Information Collection Activity; Comment Request | |
| 80 FR 10168 - New Postal Product | |
| 80 FR 10203 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 80 FR 10096 - Proposed Data Collections Submitted for Public Comment and Recommendations | |
| 80 FR 10095 - Proposed Data Collections Submitted for Public Comment and Recommendations | |
| 80 FR 10051 - Submission for OMB Review; Comment Request | |
| 80 FR 10202 - Data Collection Available for Public Comments | |
| 80 FR 10175 - Self-Regulatory Organizations; ISE Gemini, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Extend the Limit Up-Limit Down Obvious Error Pilot | |
| 80 FR 10192 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Exchange Rule 6.25 | |
| 80 FR 10179 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify and Reorganize Chapter VI (Trading Systems), Section 8 (BX Opening and Halt Cross) of the Exchange's Options Rules | |
| 80 FR 10198 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Extending the Pilot Period Applicable to Rule 953.1NY(c), Obvious and Catastrophic Errors, Until October 23, 2015 | |
| 80 FR 10187 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Extending the Pilot Period Applicable to Rule 6.65A(c), Obvious and Catastrophic Errors, Until October 23, 2015 | |
| 80 FR 10196 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Period Applicable to Rule 530 Relating To Limit Up/Limit Down | |
| 80 FR 10177 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Program That Suspends Certain Obvious Error Provisions During Limit Up-Limit Down States in Securities That Underlie Options Traded on the Exchange | |
| 80 FR 10194 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Order Disapproving Proposed Rule Changes To List and Trade Options on Shares of the iShares ETFs and Market Vectors ETFs | |
| 80 FR 10189 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change Relating to the Listing and Trading of the Shares of the Tuttle Tactical Management U.S. Core ETF of ETFis Series Trust I | |
| 80 FR 10171 - Self-Regulatory Organizations; the Options Clearing Corporation; Order Approving Proposed Rule Change To Clarify That OCC Would not Treat a Futures Transaction That Is an Exchange-for-Physical or Block Trade as a Non-Competitively Executed Trade if the Exchange on Which Such Trade Is Executed Has Provided OCC With Representations That it Has Policies or Procedures Requiring That Such Trades Be Executed at Reasonable Prices and That Such Price Is Validated by the Exchange | |
| 80 FR 10173 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 404 | |
| 80 FR 10203 - Regulatory Fairness Hearing; Region VIII-Salida, Colorado | |
| 80 FR 10202 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 80 FR 10044 - Notice of Renewal of Charter of the Global Development Council | |
| 80 FR 10094 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 80 FR 10169 - Product Change-Priority Mail Negotiated Service Agreement | |
| 80 FR 10049 - Codex Alimentarius Commission: Meeting of the Codex Committee on General Principles | |
| 80 FR 10210 - Public Meeting: Citizens Coinage Advisory Committee | |
| 80 FR 10145 - Enforcement Actions Summary | |
| 80 FR 10080 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 21st Century Community Learning Centers Annual Performance Report | |
| 80 FR 10077 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Report on Appeals Process RSA-722 | |
| 80 FR 10078 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Charter Schools Program (CSP) Grant Award Database | |
| 80 FR 10079 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Quarterly Cumulative Caseload Report | |
| 80 FR 10079 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; HBCU All Star Student Program | |
| 80 FR 10072 - Compliance Bulletin-Treatment of Confidential Supervisory Information | |
| 80 FR 10127 - Submission for OMB Review; 30-Day Comment Request Division of Cancer Epidemiology and Genetics (DCEG) Fellowship Program and Summer Student Applications (NCI) | |
| 80 FR 10128 - Submission for OMB Review; 30-Day Comment Request; Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries (NCI) | |
| 80 FR 10206 - Petition for Waiver of Compliance | |
| 80 FR 10204 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System | |
| 80 FR 10073 - Proposed Collection; Comment Request | |
| 80 FR 10053 - Export Trade Certificate of Review | |
| 80 FR 10205 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System | |
| 80 FR 10207 - Petition for Waiver of Compliance | |
| 80 FR 10146 - Rental Assistance Demonstration (RAD)-Alternative Requirements or Waivers: Waiving and Specifying Alternative Requirements for the 20 Percent Portfolio Cap on Project-Basing and Certain Tenant Protection and Participation Provisions for the San Francisco Housing Authority's RAD Projects | |
| 80 FR 10129 - Government-Owned Inventions; Availability for Licensing | |
| 80 FR 10130 - Center for Scientific Review; Notice of Closed Meetings | |
| 80 FR 10124 - Robotically-Assisted Surgical Devices: Challenges and Opportunities; Public Workshop; Request for Comments | |
| 80 FR 10208 - Petition for Waiver of Compliance | |
| 80 FR 10081 - Combined Notice of Filings #1 | |
| 80 FR 10050 - Notice of Proposed New Fee Site; Federal Lands Recreation Enhancement Act | |
| 80 FR 9985 - Airworthiness Directives; Sikorsky Aircraft Corporation (Sikorsky) Helicopters | |
| 80 FR 10080 - National Advisory Committee on Institutional Quality and Integrity Meeting | |
| 80 FR 10008 - Part 400-General Administrative Regulation-Subpart V-Submission of Policies, Provisions of Policies and Rates of Premium | |
| 80 FR 10211 - Energy Conservation Program: Test Procedures for Portable Air Conditioners | |
| 80 FR 9989 - Definition of Spouse Under the Family and Medical Leave Act | |
| 80 FR 10162 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Family and Medical Leave Act of 1993, as Amended |
Administrative Order, Libya; Continuation of National Emergency (Notice of February 23, 2015) at 80 FR 9983 was published in the printed version of the
Federal Crop Insurance Corporation
Food and Nutrition Service
Food Safety and Inspection Service
Forest Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Wage and Hour Division
Federal Energy Regulatory Commission
Presidential Documents
Centers for Disease Control and Prevention
Children and Families Administration
Community Living Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Transportation Security Administration
Indian Affairs Bureau
National Park Service
Mine Safety and Health Administration
Wage and Hour Division
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Federal Railroad Administration
Transportation Security Administration
United States Mint
Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for certain Sikorsky Model S-76A, B, C, and D helicopters. This AD requires inspecting the tail rotor drive shaft (TDS) flange-to-shaft attachment hardware for correct assembly and correct torque of the fasteners. If there is a discrepancy, this AD requires, before further flight, applying an index mark to the flange and TDS, inspecting the flange and shaft for a crack, fracture, wear, and certain measurements, and replacing any part that does not meet the approved criteria before further flight. This AD is prompted by a partial loss of tail rotor drive resulting in a forced landing. The actions specified by this AD are intended to prevent failure at the flange-to-shaft attachment, loss of a tail rotor drive, and subsequent loss of control of the helicopter.
This AD becomes effective March 12, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain document as of March 12, 2015.
We must receive comments on this AD by April 27, 2015.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
For service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
Michael Schwetz, Aviation Safety Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate, FAA, 12 New England Executive Park, Burlington, Massachusetts 01803; telephone (781) 238-7761; email
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.
We are adopting a new AD for certain Sikorsky Model S-76A, B, C, and D helicopters. This AD requires inspecting the TDS flange-to-shaft attachment hardware at four locations for correct installation and correct torque of the fasteners. If there is movement, misalignment of the torque stripe, a misassembled part, or torque of less than 105 inch-pounds on any nut, this AD requires applying an index mark to the flange and shaft to make sure the flange is reinstalled in the same position to maintain shaft balance, and, before further flight, inspecting the flange and shaft for a crack, fracture, wear on the mounting hole, and diameter measurements, and replacing the TDS if the flange or stub does not meet the inspection criteria. This AD is prompted by a partial loss of tail rotor drive resulting in a forced landing, and instances where TDS flange-to-shaft attachment hardware was found to be loose or fractured. The actions specified by this AD are intended to detect loose or fractured hardware and prevent failure of the TDS at the flange-to-shaft attachment, loss of a tail rotor drive, and
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.
Sikorsky issued Alert Service Bulletin ASB 76-66-52, Basic Issue, on April 1, 2014, which specifies a one-time inspection of the TDS flange-to-shaft attachment hardware for proper installation and torque. If there is movement, torque stripe misalignment, or misassembled hardware, the ASB specifies removing and returning the hardware to Sikorsky with certain forms and replacing hardware with airworthy TDS hardware before returning the helicopter to service. The ASB also specifies either replacing the TDS or inspecting the flange and shaft for a crack, fracture, wear of the mounting hole, and diameter and replacing any part that does not meet the approved criteria. The ASB states there were instances where the TDS flange-to-shaft attachment hardware was found loose or fractured. This service information is reasonably available; see
This AD requires, within 30 days:
• Inspecting each TDS flange attachment hardware at all four locations for looseness and torque stripe misalignment, inspecting each nut to determine whether it can be rotated by hand, determining whether the hardware is assembled correctly, and determining the torque of each nut.
• If there is no looseness, torque stripe misalignment, incorrect hardware assembly, and if no nut can be rotated by hand and the torque of any nut is not less than 105 inch-pounds, no further action is required by this AD.
• If there is looseness, torque stripe misalignment, incorrect hardware assembly, a nut rotated by hand, or the torque of any nut is less than 105 inch-pounds:
○ Applying an index mark to the flange and shaft, unbolting and removing the flange from the shaft, visually inspecting each radius washer for wear or fretting, and replacing any washer with wear or fretting.
○ Inspecting the flange and shaft for a crack, fracture, wear on the mounting hole, and diameter, and replacing the TDS with an airworthy TDS if the flange and shaft fail any of the inspection criteria.
○ Aligning index marks, installing the flange on the shaft, and coating the grip length of each bolt and the contact surfaces on each radius washer and washer with epoxy polyamide primer.
○ Torquing each nut.
The AD does not require returning the unairworthy parts with certain forms to the manufacturer as does the service information.
We estimate that this AD affects 260 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. We estimate $85 per work-hour for labor. We estimate 2.2 work-hours to inspect the hardware assembly and torque at a cost of $187 per helicopter and $48,620 for the fleet. We estimate 2.2 work-hours if the hardware is replaced and $1,200 for the required parts, for a total cost of $1,387 per helicopter.
Providing an opportunity for public comments before adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we find that the risk to the flying public justifies waiving notice and comment before adopting this rule because the required corrective actions must be done within 30 days, a very short time period based on the average flight-hour utilization rate of these helicopters used for commuter, air ambulance, and offshore operations.
Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in less than 30 days.
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, 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.
We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
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 applies to Model S-76A, S-76B, S-76C, and S-76D helicopters, serial numbers (S/N) up to and including 761050, certificated in any category, with a tail drive shaft (TDS) part number (P/N) and S/N as follows:
(a) P/N 76361-04004 (all dash numbers) with an S/N up to and including A127-01092; or
(b) P/N 76361-04604 (all dash numbers) with an S/N with a prefix A240 or B240, or with an S/N C240-00001 through C240-00880.
This AD defines the unsafe condition as loose or fractured TDS flange-to-shaft attachment hardware. This condition could result in loss of a tail rotor drive and subsequent loss of control of the helicopter.
This AD becomes effective March 12, 2015.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
Within 30 hours time-in-service:
(1) Inspect each TDS flange attachment hardware at all four locations for looseness and torque stripe misalignment as depicted in Figure 1 and shown in Figure 2 of Sikorsky Aircraft Corporation Alert Service Bulletin ASB 76-66-52, Basic Issue, dated April 1, 2014 (ASB). Inspect each nut to determine whether it can be rotated by hand. Determine whether the hardware is assembled correctly by following the Accomplishment Instructions, paragraph B.(3)(a) through B.(3)(b) of the ASB. Determine the torque of each nut.
(2) If there is no looseness, torque stripe misalignment, incorrect hardware assembly, and if no nut can be rotated by hand and the torque of any nut is not less than 105 inch-pounds, no further action is required by this AD.
(3) If there is looseness, torque stripe misalignment, incorrect hardware assembly, a nut rotated by hand, or the torque of any nut is less than 105 inch-pounds, do the following:
(i) Apply an index mark to the flange and shaft to make sure the flange is reinstalled in the same position and to maintain shaft balance, unbolt and remove the flange from the shaft, and visually inspect each radius washer for wear or fretting. Replace any washer with wear or fretting.
(ii) Inspect the flange and shaft for a crack, fracture, wear on the mounting hole, and diameter by following the Accomplishment Instructions, paragraph 3.D.(5)(a) through 3.D.(5)(e), of the ASB. If the flange and shaft fail any of the inspection criteria, before further flight, replace the TDS with an airworthy TDS.
(iii) Align index marks, install the flange on the shaft, and coat the grip length of each bolt and the contact surfaces on each radius washer and washer with epoxy polyamide primer.
(iv) Torque each nut by following either paragraph D.(9) or D.(10) of the Accomplishment Instructions of the ASB.
(1) The Manager, Boston Aircraft Certification Office, FAA, may approve AMOCs for this AD. Send your proposal to: Michael Schwetz, Aviation Safety Engineer, Engine & Propeller Directorate, FAA, 12 New England Executive Park, Burlington, Massachusetts 01803; telephone (781) 238-7761; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
Joint Aircraft Service Component (JASC) Code: 6510 Tail Rotor Drive Shaft.
(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) Sikorsky Aircraft Corporation Alert Service Bulletin ASB 76-66-52, Basic issue, dated April 1, 2014.
(ii) Reserved.
(3) For Sikorsky Aircraft Corporation service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference 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:
Department of Justice.
Final rule.
The Department of Justice is amending its regulations to delegate to the Director of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) authority to seize and administratively forfeit property involved in controlled substance offenses.
This rule is effective February 25, 2015.
Denise Brown, Enforcement Programs and Services, Bureau of Alcohol, Tobacco, Firearms, and Explosives, U.S. Department of Justice, 99 New York Avenue NE., Washington, DC 20226, telephone: (202) 648-7070.
After the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) became part of the Department of Justice (DOJ) in January 2003, pursuant to the Homeland Security Act of 2002 (Pub. L. 107-296), the Attorney General delegated to ATF the authority to investigate, seize, and forfeit property involved in a violation or attempted violation within its investigative jurisdiction.
The Department believes that forfeiting the assets of criminals is an essential tool in combating criminal activity that provides law enforcement with the ability to dismantle criminal organizations, deprive wrongdoers of the proceeds of their crimes, and deter crime. The Department further believes that administrative forfeiture permits the expedient and effective use of this valuable law enforcement tool.
An uncontested administrative forfeiture can be perfected in 60-90 days for minimal cost, including the personal notice to interested parties and the notice by publication required by statute. Conversely, the costs associated with judicial forfeiture can amount to hundreds or thousands of dollars and the judicial process generally can take anywhere from 6 months to years. In the meantime, the government incurs additional costs if the property requires storage or maintenance until a final order of forfeiture can be obtained.
One of the primary missions of ATF is to combat firearm-related violent crime. The nexus between drug trafficking and firearm violence is well established. Upon review of the current role and mission of ATF within DOJ, the Attorney General decided to authorize a temporary delegation of title 21 seizure and forfeiture authority to determine whether such authority can enhance the effectiveness of ATF in the investigation of violent crimes involving firearms. On August 21, 2012, the Attorney General signed a final rule delegating seizure and forfeiture authority under 21 U.S.C. 881 to the ATF for a trial period of one year, effective February 25, 2013. 77 FR 51698 (Aug. 27, 2012). By subsequent action, the Attorney General extended the same authority to ATF for an additional one-year period to give ATF more time to refine its process, fully hire and train all necessary staff, and further demonstrate the effectiveness of the delegation in the investigation of violent crimes involving firearms. 79 FR 12060 (Mar. 4, 2014).
ATF has refined its title 21 asset forfeiture process, and strengthened the overall asset forfeiture program, by changing organizational structure, adding experienced personnel and resources to review and more efficiently process all of ATF's administrative forfeitures, and providing additional asset forfeiture training to all agency personnel involved in the forfeiture process, together with a renewed focus on the proper execution of all phases of ATF's asset forfeiture mission to ensure that all interested parties are afforded due process under the law, that all seized assets are accounted for and properly maintained, and that all forfeited property is disposed of according to law in a timely and cost-efficient manner.
This authority has given ATF the ability to process drug-related property seized in criminal investigations in which firearms and explosives also are seized. From February 25, 2013, to September 30, 2014, ATF used its authority under title 21 to seize more than 1,700 assets with a total value in excess of $19,300,000.
The delegation of authority has afforded cost savings to the United States government by streamlining the forfeiture process to prevent unnecessary burden on the judicial system and the public and by permitting the government to process forfeitures within a single agency. The grant of title 21 seizure and forfeiture authority will permit ATF to continue its use of asset forfeiture as a valuable tool in support of its law enforcement mission and enable the Department to further increase the speed and efficiency of uncontested forfeiture actions.
This rule amends the regulations in 28 CFR part 0 to delegate to the Director of ATF the authority to seize, forfeit, and remit or mitigate the forfeiture of property in accordance with 21 U.S.C. 881.
Forfeiting the assets of criminals is an essential tool in combating criminal activity and provides law enforcement with the capacity to dismantle criminal organizations, deprive wrongdoers of the proceeds of their illegal activities, and deter crime. Therefore, the Attorney General has decided to delegate to the Director of ATF without a time limit administrative seizure and forfeiture authority under title 21 to permit expedient and effective use of this valuable law enforcement tool in the investigation of violent crime involving firearms.
Notice and comment rulemaking is not required for this final rule. Under the APA, “rules of agency organization, procedure or practice,” 5 U.S.C. 553(b)(A), that do not “affect[] individual rights and obligations,”
The Attorney General, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Department. Further, a Regulatory Flexibility Analysis is not required for this final rule because the Department was not required to publish a general notice of proposed rulemaking for this matter.
This rule has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation, and with Executive Order 13563, “Improving Regulation and Regulatory Review.” This rule is limited to agency organization, management, or personnel matters as described by Executive Order 12866, section 3(d)(3) and, therefore, is not a “regulation” or “rule” as defined by that Executive Order.
This rule will not have an annual effect on the economy of $100 million or more, nor will it adversely affect in a material way the economy, a sector of the economy, productivity, competition,
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, “Civil Justice Reform.”
This rule will not 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. Therefore, in accordance with Executive Order 13132, “Federalism,” the Department has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501
This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
This action pertains to agency management, personnel, and organization and does not substantially affect the rights or obligations of non-agency parties. Accordingly, it is not a rule for purposes of the reporting requirement of 5 U.S.C. 801.
Authority delegations (Government agencies), Government employees, Organization and functions (Government agencies), Privacy, Reporting and recordkeeping requirements, Whistleblowing.
Accordingly, by virtue of the authority vested in me as Attorney General, including 5 U.S.C. 301 and 28 U.S.C. 509, 510, and for the reasons set forth in the preamble, part 0 of title 28 of the Code of Federal Regulations is amended as follows:
5 U.S.C. 301; 28 U.S.C. 509, 510, 515-519.
Wage and Hour Division, Department of Labor.
Final rule.
The Department of Labor's (Department) Wage and Hour Division (WHD) revises the regulation defining “spouse” under the Family and Medical Leave Act of 1993 (FMLA or the Act) in light of the United States Supreme Court's decision in
This Final Rule is effective March 27, 2015.
Mary Ziegler, Director of the Division of Regulations, Legislation, and Interpretation, U.S. Department of Labor, Wage and Hour Division, 200 Constitution Avenue NW., Room S-3502, Frances Perkins Building, Washington, DC 20210; telephone: (202) 693-0406 (this is not a toll-free number). Copies of this Final Rule may be obtained in alternative formats (large print, braille, audio tape or disc), upon request, by calling (202) 693-0675 (this is not a toll-free number). TTY/TDD callers may dial toll-free 1-877-889-5627 to obtain information or request materials in alternative formats.
Questions of interpretation and/or enforcement of the agency's current regulations may be directed to the nearest WHD district office. Locate the nearest office by calling WHD's toll-free help line at (866) 4US-WAGE ((866) 487-9243) between 8 a.m. and 5 p.m. in your local time zone, or log onto WHD's Web site for a nationwide listing of WHD district and area offices at
The Family and Medical Leave Act of 1993, 29 U.S.C. 2601
FMLA leave may be taken in a block, or under certain circumstances, intermittently or on a reduced leave schedule.
Title I of the FMLA is administered by the U.S. Department of Labor and applies to private sector employers of 50 or more employees, private and public elementary and secondary schools, public agencies, and certain federal employers and entities, such as the U.S. Postal Service and Postal Regulatory Commission. Title II is administered by the U.S. Office of Personnel Management and applies to civil service employees covered by the annual and sick leave system established under 5 U.S.C. Chapter 63 and certain employees covered by other federal leave systems.
The FMLA generally covers employers with 50 or more employees. To be eligible to take FMLA leave, an employee must meet specified criteria, including employment with a covered employer for at least 12 months, performance of a specified number of hours of service in the 12 months prior to the start of leave, and work at a location where there are at least 50 employees within 75 miles.
The FMLA required the Department to issue initial regulations to implement Title I and Title IV of the FMLA within 120 days of enactment (by June 5, 1993) with an effective date of August 5, 1993. The Department published a Notice of Proposed Rulemaking (NPRM) in the
After publication, the Department invited further public comment on the interim regulations. 58 FR 45433. During this comment period, the Department received a significant number of substantive and editorial comments on the interim regulations from a wide variety of stakeholders. Based on this second round of public comments, the Department published final regulations to implement the FMLA on January 6, 1995. 60 FR 2180. The regulations were amended February 3, 1995 (60 FR 6658) and March 30, 1995 (60 FR 16382) to make minor technical corrections. The final regulations went into effect on April 6, 1995.
The Department published a Request for Information (RFI) in the
The Department published an NPRM in the
The Department commenced the current rulemaking by publishing an NPRM in the
The FMLA provides eligible employees with leave to care for a spouse in the following situations: (1) When needed to care for a spouse due to the spouse's serious health condition; (2) when needed to care for a spouse who is a covered servicemember with a serious illness or injury; and (3) for a qualifying exigency related to the covered military service of a spouse. The FMLA defines “spouse” as “a husband or wife, as the case may be.” 29 U.S.C. 2611(13). In the 1993 Interim Final Rule, the Department defined spouse as “a husband or wife as defined or recognized under state law for purposes of marriage, including common law marriage in states where it is recognized.” 58 FR 31817, 31835 (June 4, 1993). In commenting on the Interim Final Rule, both the Society for Human Resource Management and William M. Mercer, Inc., questioned which state law would apply when an employee resided in one State but worked in another State. 60 FR 2190. In response to these comments, the 1995 Final Rule clarified that the law of the State of the employee's residence would control for determining eligibility for FMLA spousal leave.
The Defense of Marriage Act (DOMA) was enacted in 1996. Public Law 104-199, 110 Stat. 2419. Section 3 of DOMA restricted the definitions of “marriage” and “spouse” for purposes of federal law, regulations, and administrative interpretations: “the word `marriage' means only a legal union between one man and one woman as husband and wife, and the word `spouse' refers only to a person of the opposite sex who is a husband or a wife.” 1 U.S.C. 7. For purposes of employee leave under the FMLA, the effect of DOMA was to limit the availability of FMLA leave based on a spousal relationship to opposite-sex marriages. While the Department did not revise the FMLA regulatory definition of “spouse” to incorporate DOMA's restrictions, in 1998 WHD issued an opinion letter that addressed, in part, the limitation section 3 of DOMA imposed on the availability of FMLA spousal leave.
Under the FMLA (29 U.S.C. 2611(13)), the term “spouse” is defined as a husband or wife, which the regulations (29 CFR
On June 26, 2013, the Supreme Court held in
Because of the Supreme Court's holding in
The Department commenced this rulemaking by publishing an NPRM on June 27, 2014. 79 FR 36445. In the NPRM the Department proposed to change the definition of spouse to look to the law of the jurisdiction in which the marriage was entered into (including for common law marriages), as opposed to the law of the State in which the employee resides, and to expressly reference the inclusion of same-sex marriages in addition to common law marriages. The Department proposed to change the definition of spouse to ensure that all legally married couples, whether opposite-sex or same-sex, will have consistent federal family leave rights regardless of where they live. The Department received 77 comment submissions on the NPRM, representing over 18,000 individuals, which are available for review at the Federal eRulemaking Portal,
The Department has carefully considered all of the relevant and timely comments. The major comments received on the proposed regulatory changes are summarized below, together with a discussion of the Department's responses. The Final Rule adopts the changes to the regulations as proposed in the NPRM.
In the NPRM the Department proposed to change the regulatory definition of spouse in §§ 825.102 and 825.122(b) to mean the other person with whom an individual entered into marriage. The Department proposed to look to the law of the jurisdiction in which the marriage was entered into (including for common law marriages), as opposed to the law of the State in which the employee resides, and to expressly reference the inclusion of same-sex marriages in addition to common law marriages. The Department also proposed to include in the definition same-sex marriages entered into abroad by including marriages entered into outside of any State as long as the marriage was legally valid in the place where it was entered into and could have been entered into legally in at least one State.
The proposed definition included the statutory language defining spouse as a husband or wife but made clear that these terms included all individuals in lawfully recognized marriages. As noted in the NPRM, the Department is aware that the language surrounding marriage is evolving and that not all married individuals choose to use the traditional terms of husband or wife when referring to their spouse. 79 FR 36448. The Department intended the proposed definition to cover all spouses in legally valid marriages as defined in the regulation regardless of whether they use the terms husband or wife. The Department adopts the definition of spouse as proposed.
The Department is moving from a state of residence rule to a rule based on the jurisdiction where the marriage was entered into (place of celebration) to ensure that all legally married couples, whether opposite-sex or same-sex, will have consistent federal family leave rights regardless of where they live. 79 FR 36448. The Department noted in the proposed rule that while many States and foreign countries currently legally recognize same-sex marriage, not all do. As of February 13, 2015, thirty-two States and the District of Columbia
The vast majority of commenters, including the HRC letter-writing campaign commenters, applauded the Department's proposed use of a place of celebration rule. As the Maine Women's Lobby, A Better Balance, the 9to5 National Association of Working Women, the American Federation of Teachers, the North Carolina Justice Center, the Women's Law Project, the Religious Action Center for Reform Judaism, and many other commenters noted, under a state of residence rule, employees in legally valid same-sex marriages who live in a State that does not recognize their marriage are often forced to risk their jobs and financial wellbeing when they need time off to care for their ill or injured spouse or to address qualifying exigencies relating to their spouse's military service. These commenters stated that a place of celebration rule will provide security to all legally married same-sex spouses in knowing that they will be able to exercise their FMLA rights when the need arises. An individual similarly commented that, as the mother of a daughter in a same-sex marriage, she supported the rule because it would provide comfort to her as a parent who lives far from her daughter in knowing that, should her daughter need care, her daughter's same-sex spouse would be able to care for the daughter without having to worry that she would lose her job. Commenters such as the Family Equality Council (Family Equality), the National Partnership for Women & Families (National Partnership), the National Minority AIDS Council (NMAC), and twenty-three United States Senators who submitted a joint comment, also noted that nationally consistent and uniform access to leave as provided by the proposed rule will further the original purpose of the FMLA.
Many commenters, including the National Center for Transgender Equality, Family Values @Work, the National Employment Lawyers Association, the National Partnership, the Feminist Majority Foundation, the National Council of Jewish Women, and Equal Rights Advocates approved of the proposed place of celebration rule because it would provide certainty to same-sex couples regarding their FMLA leave rights, which would encourage worker mobility. The National Partnership commented that “[g]eographic mobility is a significant part of economic mobility for American workers . . . . By ensuring that [lesbian, gay, bisexual, and transgender (LGBT)] couples receive the same federal family leave protections if they move to a state that does not recognize their marriage, the rule makes it easier for workers to accept promotions or new jobs . . . .” This commenter also observed that the rule would provide important protections for LGBT military families who relocate due to military assignment.
Commenters also noted that a place of celebration rule will benefit employers as well as employees. The National Partnership observed that, by securing federal family leave rights to legally married same-sex spouses regardless of the State in which they reside, employers will be able to fill job positions with the most qualified workers. The National Business Group on Health expressed support for this rule because it will reduce the administrative burden on employers that operate in more than one State or have employees who move between States. The National Consumers League and the National Women's Law Center, among other commenters, echoed this observation that a place of celebration rule will simplify FMLA administration for employers that operate in multiple States.
The Department concurs with these comments. A place of celebration rule provides consistent federal family leave rights for legally married couples regardless of the State in which they reside, thus reducing barriers to the mobility of employees in same-sex marriages in the labor market and ensuring employees in same-sex marriages will be able to exercise their FMLA leave rights. Moreover, such a rule also reduces the administrative burden on employers that operate in more than one State, or that have employees who move between States with different marriage recognition rules; such employers will not have to consider the employee's state of residence and the laws of that State in determining the employee's eligibility for FMLA leave.
Several commenters were appreciative that the proposed place of celebration rule would be consistent with the interpretations adopted by other federal government agencies, such as the Department of Defense and the Internal Revenue Service, as this would create greater uniformity for employees and employers.
SHRM, the U.S. Conference of Catholic Bishops (USCCB), and the National Automobile Dealers Association (NADA) expressed concern regarding the potential burden on employers to know the marriage laws of jurisdictions beyond those in which they operate. NADA and SHRM requested that the Department provide guidance on how to determine if a same-sex marriage is legally valid, perhaps with a chart on the Department's Web site with current information on the status of same-sex marriage in the States and foreign jurisdictions.
The Department does not believe that further guidance on state and foreign marriage laws is necessary at this time. Employers do not need to know the marriage laws of all 50 States and all foreign countries. Rather, employers will only need to know the same-sex marriage laws of a specific State or country in situations where an employee has requested leave to care for a spouse, child, or parent and the basis for the family relationship is a same-sex marriage. In such a situation, for purposes of confirming the qualifying basis of the leave, the employer would need to know the marriage laws of only the individual State or country where the marriage at issue was entered into. The Department believes that making this determination will not be burdensome. There are a number of organizations focused on providing up-to-date information on the status of same-sex marriages in the 50 States within the United States and foreign jurisdictions. Some examples of organizations that provide this information include
A few commenters addressed common law marriages as referenced in the proposed definition of spouse. Family Equality questioned whether the wording of the proposed definition could be interpreted to exclude an individual in a same-sex common law marriage. This commenter requested that the definition be modified to make clear that same-sex common law spouses are included in the definition. SHRM and the Food Marketing Institute (FMI) expressed concern that knowing the common law marriage standards of numerous States will be particularly burdensome for employers.
The Department has retained the proposed language regarding common law marriage in the Final Rule. The Department believes that the language regarding common law marriage in the definition of “spouse” in the Final Rule will not result in a significant change in employers' administration of the FMLA. Common law marriages have been included in the definition of spouse under the FMLA since 1995. § 825.113(a) (1995).
The only change from the current definition of spouse to the definition in the Final Rule in regards to common law marriage is that in States that permit same-sex common law marriages, employees who have entered into a same-sex common law marriage in those States will now be eligible to take FMLA spousal leave regardless of the State in which they reside. In response to Family Equality's comment above, the Department believes that the language used in the proposed definition and adopted in the Final Rule already encompasses spouses in same-sex common law marriages.
Moreover, under both the current and revised definitions of spouse, an employer would only need to know the common law marriage standards for a particular State for confirmation purposes in the event that an eligible employee requests FMLA leave to care for a spouse, child, or parent and the basis for the family relationship is a common law marriage. The Department does not believe that this will be burdensome and notes that there are organizations that provide information to the public on the status of common law marriages in the 50 States within the United States. Some examples of organizations that provide this information include
A few commenters addressed the documentation that employers may require from employees to confirm a family relationship. SHRM recommended that the Department clarify the type of proof an employer may require to confirm that an employee has a valid marriage, and permit employers to ask for documentation of proof of marriage on a case-by-case basis. FMI commented that it will be burdensome for employers to determine whether a common law marriage is valid, and requested guidance on how to confirm the existence of a common law marriage. Due to these concerns, this commenter recommended that the definition of spouse be revised to apply only to those who have a valid, government-issued document recognizing the marriage, such as a marriage certificate, court order, or letter from a federal agency such as the Social Security Administration. The National Women's Law Center urged the Department to modify the regulation at § 825.122(k) to require that employers request documentation of a family relationship in a consistent and non-discriminatory manner so that employees in same-sex marriages are not singled out with special burdens when they attempt to exercise their FMLA rights.
The Department declines to modify the regulation at § 825.122(k). That regulation permits employers to require employees who take leave to care for a family member to provide reasonable documentation of the family relationship. Reasonable documentation may take the form of either a simple statement from the employee or documentation such as a birth certificate or court document.
In response to the comments, the Department believes that the current regulation adequately addresses the nature of the documentation that employers may require. An employee may satisfy an employer's requirement to confirm a family relationship by providing either a simple statement asserting that the requisite family relationship exists, or documentation such as a child's birth certificate, a court document, etc. It is the employee's choice whether to provide a simple statement or another type of documentation. Thus, in all cases, a simple statement of family relationship is sufficient under the regulation to satisfy the employer's request. In response to FMI's comment, the Department does not believe that it is necessary or that it would be appropriate to require government-issued documentation to confirm common law marriages when an employee can document all other
Two commenters raised concerns about a tension between the proposed definition and state laws prohibiting the recognition of same-sex marriages. USCCB commented that it believed the proposed definition of spouse is “at odds” with the Supreme Court's decision in
The Department believes that using a place of celebration rule in the definition of spouse under the FMLA is consistent with the Court's decision in
The Department noted in the NPRM that the proposed change to a place of celebration rule for the definition of spouse under the FMLA would also have some impact beyond spousal leave. 79 FR 36448. Specifically, the Department noted that under the Department's proposed rule, an employee in a legal same-sex marriage would be able to take leave to care for a stepchild (
Several commenters addressed the interplay between the proposed rule and the Administrator's Interpretation FMLA 2010-3 (June 22, 2010) that addresses in loco parentis.
The Department did not intend for the proposed rule to have any impact on the standards for in loco parentis set out in the Administrator's Interpretation and this Final Rule has no impact on the standards for determining the existence of an in loco parentis relationship set out in Administrator's Interpretation FMLA 2010-3. Rather, the place of celebration rule means that employees in same-sex marriages, regardless of the State in which they reside, do not need to establish the requirements for in loco parentis for their spouse's child (the employee's stepchild) in order to take leave to care for the child. Only one type of relationship need apply for an employee to satisfy the requisite family relationship under the FMLA.
A few commenters also expressed concern about the regulatory definition of “parent” in § 825.122(c), which provides that a parent means a biological, adoptive, step or foster father or mother, or any other individual who stood in loco parentis to the employee when the employee was a son or daughter as defined in paragraph (d) of this section.
The Department declines to modify the definition of parent as suggested. The Department believes that the definition of parent as currently worded is not causing confusion. Nonetheless, the Department understands that further clarification may be useful. As an initial matter, the Department notes that the definition of parent in § 825.122(c) is relevant only to instances of an employee needing FMLA leave to care for a parent or to attend to a qualifying exigency arising out of the parent's military service. It is not relevant to instances of an employee needing to take leave to care for the employee's child. The regulatory definition of parent lists various types of parents, separated by commas. §§ 825.102, 825.122(c). The term “any other individual who stood in loco parentis to the employee when the employee was a son or daughter as defined in paragraph (d) of this section” is set off by a comma from the list of other types of parents (
Two commenters addressed the publication and effective date of the Final Rule. FMI requested that the Department delay publication of the Final Rule until the Department provides guidance on how employers can confirm the existence of an employee's common law marriage. The National Business Group on Health requested that the Department delay the effective date of the Final Rule for at least 12 months to allow employers time to modify their policies and procedures. The Department does not believe that any delay is warranted given the limited scope of this Final Rule. Therefore, the Final Rule will become effective 30 days after publication.
Lastly, notwithstanding the Final Rule's definition of spouse as including all legally married couples according to the law of the place of celebration, an employer may, of course, offer an employment benefit program or plan that provides greater family or medical leave rights to employees than the rights established by the FMLA.
Minor editorial changes were proposed to §§ 825.120, 825.121, 825.122, 825.127, 825.201 and 825.202 to make references to husbands and wives, and mothers and fathers gender neutral where appropriate so that they apply equally to opposite-sex and same-sex spouses. The Department proposed using the terms “spouses” and “parents,” as appropriate, in these regulations. As stated in the NPRM, these editorial changes do not change the availability of FMLA leave but simply clarify its availability for all eligible employees who are legally married. 79 FR 36449. The Department received no comments on these changes and adopts them as proposed.
The Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
OMB has assigned control number 1235-0003 to the FMLA information collections. As required by the PRA (44 U.S.C. 3507(d)), the Department has submitted these proposed information collection amendments to OMB for its review. The Department will publish a notice in the
The Department's Final Rule revises the regulation defining “spouse” under the FMLA, in light of the United States Supreme Court's holding that section 3 of the Defense of Marriage Act is unconstitutional. Amending the definition of spouse to include all legally married spouses as recognized under state law for purposes of marriage in the State where the marriage was entered into or, in the case of a marriage entered into outside of any State, if the marriage is valid in the place where entered into and could have been entered into in at least one State, expands the availability of FMLA leave to legally married same-sex spouses regardless of the State in which they reside. Under the revised definition of spouse, eligible employees are able to take FMLA leave based on a same-sex marital relationship regardless of the state in which they reside.
In light of the June 26, 2013
Covered, eligible employees in same-sex marriages are already eligible to take FMLA leave for certain FMLA qualifying reasons (
Accordingly, the Department developed an estimate that focuses on FMLA leave that employees can currently and will be able to take to care for a family member based on a same-sex marital relationship. The final regulations, which do not substantively alter the FMLA but instead allow FMLA leave to be taken on the basis of an employee's same-sex marriage regardless of their state of residence, will create additional burdens on some of the information collections.
The Department's authority for the collection of information and the required disclosure of information under the FMLA stems from the statute and/or the implementing regulations.
Aside from the general requirement that third-party notifications be in writing, with a possible exception for the employee's FMLA request that depends on the employer's leave policies, there are no restrictions on the method of transmission. Respondents may meet many of their notification obligations by using Department-prepared publications available on the WHD Web site,
Other Respondent Cost Burden (capital/start-up): 0.$
The PRA requires agencies to consider public comments on information collections and to explain in final rules how public engagement resulted in changes from proposed rules. The Department discussed public comments regarding comments on documentation requirements related to establishing a family relationship earlier in this rulemaking.
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. Although this rule is not economically significant within the meaning of Executive Order 12866, it has been reviewed by OMB.
The Department revised the regulatory definition of “spouse” for the purpose of the FMLA to allow all legally married employees to take leave to care for their spouse regardless of whether their state of residence recognizes their marriage. As a result of this Final Rule, covered and eligible employees will be entitled to take FMLA leave regardless of their state of residence to care for their same-sex spouse with a serious health condition; to care for a stepchild with a serious health condition to whom the employee does not stand in loco parentis; to care for their parent's same-sex spouse with a serious health condition who did not stand in loco parentis to the employee when the employee was a child; for qualifying exigency reasons related to the covered active duty of their same-sex spouse; and to care for their same-sex spouse who is a covered servicemember with a serious injury or illness. This Final Rule will not expand coverage under the FMLA; that is, the coverage and eligibility provisions of the FMLA are unchanged by this rule and employees who were not previously eligible and employed by a covered establishment will not become eligible as a result of this Final Rule.
Estimates of the number of individuals in same-sex marriages vary widely due to issues with state level data tracking, reliance on self-reporting, and changes in survey formatting. The Department bases its estimate of same-sex marriages on the 2013 American Community Survey (ACS), conducted by the U.S. Census Bureau. The 2013 ACS showed 251,695 self-reported same-sex marriages, which represents 503,390 individuals. The Department estimates, based on the 2013 ACS, that in 45.2 percent of same-sex marriages both partners are employed and, for the purposes of this analysis, the Department assumes that one spouse is employed in the remaining 54.8 percent of same-sex marriages.
The Department recently surveyed employers and employees nationwide on FMLA leave taking,
365,461 employees × 59.2 percent = 216,353 covered, eligible employees.
216,353 × 16.8 percent = 36,347 covered, eligible employees taking leave.
In past rulemakings the Department has estimated that covered, eligible employees taking leave take 1.5 instances of leave per year for traditional FMLA purposes, 13 instances of leave per year for qualifying exigency purposes, 44 instances of leave per year for military caregiver leave to care for an active-duty servicemember, and 51 instances of leave per year for military caregiver leave to care for a covered veteran. The Department uses those same estimates for this analysis. The Department estimates a weighted average for an employee who takes military caregiver leave at 45.4 instances of leave per year ((29,100 respondents × 44 responses) + (6,966 respondents × 51 responses) → 1,280,400 + 355,266 = 1,635,666 → 1,635,666/(29,100 + 6,966) = 45.4).
To determine total new instances of leave, the Department first totaled the number of respondents per type of leave, then determined the percentage that respondents for each type of leave represent of all total respondents, and lastly, applied these percentages and the averages of instances of leave per type of leave to the Department's estimate of 36,347 same-sex, married employees who are FMLA-covered, FMLA-eligible and actually take FMLA leave per year. These calculations are as follows:
Traditional FMLA leave respondents: 7,000,000 + 5,950 = 7,005,950
Qualifying Exigency leave respondents: 110,000 + 30,900 = 140,900
Military Caregiver (all) leave respondents: 29,100 + 6,966 = 36,066
Total respondents: 7,182,916.
Percentage that each type of leave represents of all total respondents:
Traditional FMLA leave respondents: 7,005,950/7,182,916 = 0.9754 or 97.54 percent.
Qualifying Exigency leave respondents: 140,900/7,182,916 = 0.0196 or 1.96 percent.
Military Caregiver (all) leave respondents: 36,066/7,182, 916 = 0.0050 or 0.50 percent.
36,347 employees × 0.9754 × 1.5 = 53,180 instances of traditional leave
36,347 employees × 0.0196 × 13 = 9,256 instances of qualifying exigency leave
36,347 employees × 0.0050 × 45.4 = 8,263 instances of military caregiver leave
Total instances of leave or responses taken by individuals in same-sex marriages: 70,699.
70,699 × 17.6 percent = 12,443 instances of leave to care for a parent, spouse, or child.
70,699 × 1.4 percent = 990 instances of leave for qualifying exigency reasons.
70,699 × 1.4 percent = 990 instances of leave for military caregiver reasons.
The Department assumes that half (6,222) of the 12,443 instances of leave for the employee's parent, child, or spouse would be taken for the employee's same-sex spouse, stepchild, or stepparent, in recognition of the fact that an employee with a same-sex partner is already able to take leave to care for the employee's parent or child.
6,222 + 990 + 990 = 8,202 new instances of FMLA leave.
Because FMLA leave is unpaid leave, the costs to employers resulting from this Final Rule are: regulatory familiarization, maintenance of preexisting employee health benefits during FMLA leave, and administrative costs associated with providing required notices to employees, requesting certifications, reviewing employee requests and medical certifications, and making necessary changes to employer policies. The costs related to requesting and reviewing employee requests for leave and certifications and of providing required notices to employees are discussed in the Paperwork Reduction Act section of this Final Rule. The Department expects the remaining costs to be minimal to employers. The Department has determined that this rule will not result in an annual effect on the economy of $100 million or more. No comments were received on the Department's regulatory impact analysis.
The Regulatory Flexibility Act of 1980 (RFA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), hereafter jointly referred to as the RFA, requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations and small governmental jurisdictions.
The Department certifies that this Final Rule does not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. Therefore, a final regulatory flexibility analysis is not required. The factual basis for this certification is set forth below.
This Final Rule amending the FMLA regulations' definition of spouse will not substantively alter current FMLA regulatory requirements, but instead will allow more employees to take leave based on a same-sex marital relationship. The Department estimates that this definitional revision will result in 6,222 new instances of FMLA leave taken to care for an employee's same-sex spouse, stepchild, or stepparent; 990 new instances for qualifying exigency purposes; and 990 new instances for military caregiver purposes. These numbers reflect the Department's estimate that a total of 8,202 new instances of FMLA leave might be taken as a result of this Final Rule, as detailed in the Executive Orders 12866 and 13563 section of this Final Rule preamble. This likely overestimates the number of new instances of leave-taking as covered and eligible employees in same-sex marriages are already entitled in most cases to take FMLA leave to care for a parent or child with a serious health condition.
Because the FMLA does not require the provision of paid leave, the costs of this rule are limited to the cost of hiring replacement workers, maintenance of employer-provided health insurance to the employee while on FMLA leave, compliance with the FMLA's notice requirements, and regulatory familiarization.
The need to hire replacement workers represents a possible cost to employers. In some businesses employers are able to redistribute work among other employees while an employee is absent on FMLA leave, but in other cases the employer may need to hire temporary replacement workers. This process involves costs resulting from recruitment of temporary workers with needed skills, training the temporary workers, and lost or reduced productivity of these workers. The cost to compensate the temporary workers is in most cases offset by the amount of wages not paid to the employee absent on FMLA leave, when the employee's FMLA leave is unpaid (
In the first FMLA rulemaking, the Department drew upon available research to suggest that the cost per employer to adjust for workers who are on FMLA leave is fairly small. 58 FR 31810. Subsequent rulemakings have not produced evidence to the contrary; therefore, for the purpose of this discussion, the Department will continue to assume that these costs are fairly small. Furthermore, most employers subject to this Final Rule have been subject to the FMLA for some time and have already developed internal systems for work redistribution and recruitment of temporary workers.
Additionally, one cost to employers consists of the health insurance benefits maintained by employers during employees' FMLA leave. Based on the Department's recent survey on FMLA leave,
Further, based on methodology used in the 2008 Final Rule, which first implemented the FMLA's military leave provisions, the Department estimates that a covered, eligible employee will take 200 hours of FMLA leave for qualifying exigency leave under § 825.126 in a given year. Additionally, using the same methodology, the Department estimates that a covered, eligible employee will take 640 hours of FMLA leave for military caregiver leave in a given year under § 825.127. 73 FR 68051.
To calculate the costs of providing health insurance, the Department utilizes data from the BLS Employer Costs for Employee Compensation survey. According to BLS' March, 2014 report, employers spend an average of $2.45 per hour on insurance.
Estimated annual employer benefits cost for FMLA leave taken for employee's same-sex spouse, stepchild, or stepparent: $3,353,658 (6,222 new instances × 220 hours
Estimated annual employer benefit cost for FMLA leave taken for qualifying
Estimated annual employer benefit cost for FMLA leave taken for military caregiver leave: $1,552,320 (990 new instances × 640 hours × $2.45).
Assuming that all covered, eligible employees taking FMLA leave receive employer-provided health insurance benefits, the estimated total cost to employers for providing benefits is $5,391,078 ($3,353,658 + $485,100 + $1,552,320).
Further, employers will incur costs related to the increase in the number of required notices and responses to certain information collections due to this Final Rule. As explained in the Paperwork Reduction Act section of this Final Rule preamble, the Department has estimated the paperwork burden cost associated with this regulatory change to be $233,096 per year.
Lastly, in response to this Final Rule, each employer will need to review the definitional change, determine what revisions are necessary to their policies, and update their handbooks or other leave-related materials to incorporate any needed changes. This is a one-time cost to each employer, calculated as 30 minutes at the hourly wage of a Human Resources Specialist. The median hourly wage of a Human Resources Specialist is $27.23 plus 40 percent in fringe benefits, which results in a total hourly rate of $38.12 (($27.23 × 0.40) + $27.23).
Therefore, the Department estimates the total cost of this Final Rule to be $12,886,034 ($5,391,078 in employer provided health benefits + $233,096 in paperwork burden cost + $7,261,860 in regulatory familiarization costs).
The Department believes this to be an overestimate. The FMLA applies to public agencies and to private sector employers that employ 50 or more employees for each working day during 20 or more calendar weeks in the current or preceding calendar year. 29 U.S.C. 2611(4). In addition, the FMLA excludes employees from eligibility for FMLA leave if the total number of employees employed by that employer within 75 miles of that employee's worksite is less than 50. 29 U.S.C. 2611(2)(B)(ii). Therefore, changes to the FMLA regulations by definition will not impact small businesses with fewer than 50 employees. The Department acknowledges that some small employers that are within the SBA definition of small business (50-500 employees) will still have to comply with the regulation and incur costs.
In its 2012 proposed rule, the Department estimated there were 381,000 covered firms and government agencies with 1.2 million establishments subject to the FMLA. 77 FR 8989. Applying the SBA size definitions for small entities, the Department estimated that approximately 83 percent, or 314,751 employers, are small entities subject to the FMLA. 77 FR 9004. Dividing the total cost of this Final Rule by the Department's estimate for the number of affected small entities results in an annual cost per small entity of $40.77 ($12,831,808/314,751 small entities). This is not deemed a significant cost. In addition, if the Department assumed that all covered employers were small entities, the annual cost per small entity would only be $33.82 ($12,886,034/381,000 small entities). This also is not deemed a significant cost.
The Department received no comments on its determination that the proposed rule would not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. The Department certifies to the Chief Counsel for Advocacy that this Final Rule will not have a significant economic impact on a substantial number of small entities.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments as well as on the private sector. Under section 202(a) of UMRA, the Department must generally prepare a written statement, including a cost-benefit analysis, for proposed and final regulations 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” in excess of $100 million in any one year ($141 million in 2012 dollars, using the Gross Domestic Product deflator).
State, local, and tribal government entities are within the scope of the regulated community for this regulation. The Department has determined that this Final Rule contains a federal mandate that is unlikely to result in expenditures of $141 million or more for state, local, and tribal governments, in the aggregate, or the private sector in any one year.
This Final Rule does not have federalism implications as outlined in E.O. 13132 regarding federalism. Although States are covered employers under the FMLA, this Final Rule does not 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.
This Final Rule was reviewed under the terms of E.O. 13175 and determined not to have “tribal implications.” This Final Rule also does not 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.” As a result, no tribal summary impact statement has been prepared.
The undersigned hereby certifies that this Final Rule will not adversely affect the well-being of families, as discussed under section 654 of the Treasury and General Government Appropriations Act, 1999.
E.O. 13045 applies to any rule that (1) is determined to be “economically significant” as defined in E.O. 12866, and (2) concerns an environmental health or safety risk that the promulgating agency has reason to believe may have a disproportionate effect on children. This Final Rule is not subject to E.O. 13045 because it is not economically significant as defined in Executive Order 12866 and, although the rule addresses family and medical leave provisions of the FMLA, it does not concern environmental health or safety risks that may disproportionately affect children.
A review of this Final Rule in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321
This Final Rule is not subject to E.O. 13211. It will not have a significant adverse effect on the supply, distribution, or use of energy.
This Final Rule is not subject to E.O. 12630, because it does not involve implementation of a policy “that has takings implications” or that could impose limitations on private property use.
This rule was drafted and reviewed in accordance with E.O. 12988 and will not unduly burden the federal court system. This Final Rule was: (1) Reviewed to eliminate drafting errors and ambiguities; (2) written to minimize litigation; and (3) written to provide a clear legal standard for affected conduct and to promote burden reduction.
Employee benefit plans, Health, Health insurance, Labor management relations, Maternal and child health, Teachers.
For the reasons set forth in the preamble, the Department amends Title 29, Part 825 of the Code of Federal Regulations as follows:
29 U.S.C. 2654.
(1) Was entered into in a State that recognizes such marriages; or
(2) If entered into outside of any State, is valid in the place where entered into and could have been entered into in at least one State.
The revisions to read as follows:
(a) * * *
(1) Both parents are entitled to FMLA leave for the birth of their child.
(2) Both parents are entitled to FMLA leave to be with the healthy newborn child (
(3) Spouses who are eligible for FMLA leave and are employed by the same covered employer may be limited to a combined total of 12 weeks of leave during any 12-month period if the leave is taken for birth of the employee's son or daughter or to care for the child after birth, for placement of a son or daughter with the employee for adoption or foster care or to care for the child after placement, or to care for the employee's parent with a serious health condition. This limitation on the total weeks of leave applies to leave taken for the reasons specified as long as the spouses are employed by the same employer. * * * Where spouses both use a portion of the total 12-week FMLA leave entitlement for either the birth of a child, for placement for adoption or foster care, or to care for a parent, the spouses would each be entitled to the difference between the amount he or she has taken individually and 12 weeks for FMLA leave for other purposes. * * * Note, too, that many state pregnancy disability laws specify a period of disability either before or after the birth of a child; such periods would also be considered FMLA leave for a serious health condition of the birth mother, and would not be subject to the combined limit.
(4) The expectant mother is entitled to FMLA leave for incapacity due to pregnancy, for prenatal care, or for her own serious health condition following the birth of the child. * * * The expectant mother is entitled to leave for incapacity due to pregnancy even though she does not receive treatment from a health care provider during the absence, and even if the absence does not last for more than three consecutive calendar days. * * *
(5) A spouse is entitled to FMLA leave if needed to care for a pregnant spouse who is incapacitated or if needed to care for her during her prenatal care, or if needed to care for her following the birth of a child if she has a serious health condition. * * *
(6) Both parents are entitled to FMLA leave if needed to care for a child with a serious health condition if the requirements of §§ 825.113 through 825.115 and 825.122(d) are met. Thus, spouses may each take 12 weeks of FMLA leave if needed to care for their newborn child with a serious health condition, even if both are employed by the same employer, provided they have not exhausted their entitlements during the applicable 12-month FMLA leave period.
(b) * * * The employer's agreement is not required for intermittent leave required by the serious health condition of the expectant mother or newborn child. * * *
The revisions to read as follows:
(a) * * *
(3) Spouses who are eligible for FMLA leave and are employed by the same covered employer may be limited to a combined total of 12 weeks of leave during any 12-month period if the leave is taken for the placement of the employee's son or daughter or to care for the child after placement, for the birth of the employee's son or daughter or to care for the child after birth, or to care for the employee's parent with a serious health condition. This limitation on the total weeks of leave applies to leave taken for the reasons specified as long as the spouses are employed by the same employer. * * * Where spouses
(4) * * * Thus, spouses may each take 12 weeks of FMLA leave if needed to care for an adopted or foster child with a serious health condition, even if both are employed by the same employer, provided they have not exhausted their entitlements during the applicable 12-month FMLA leave period.
(b)
(1) Was entered into in a State that recognizes such marriages; or
(2) If entered into outside of any State, is valid in the place where entered into and could have been entered into in at least one State.
(f) Spouses who are eligible for FMLA leave and are employed by the same covered employer may be limited to a combined total of 26 workweeks of leave during the single 12-month period described in paragraph (e) of this section if the leave is taken for birth of the employee's son or daughter or to care for the child after birth, for placement of a son or daughter with the employee for adoption or foster care, or to care for the child after placement, to care for the employee's parent with a serious health condition, or to care for a covered servicemember with a serious injury or illness. This limitation on the total weeks of leave applies to leave taken for the reasons specified as long as the spouses are employed by the same employer. * * *
(b)
(c) * * * The employer's agreement is not required, however, for leave during which the expectant mother has a serious health condition in connection with the birth of her child or if the newborn child has a serious health condition. * * *
Department of Veterans Affairs.
Interim final rule.
The Department of Veterans Affairs (VA) is amending its adjudication regulation regarding certificates of eligibility for financial assistance in the purchase of an automobile or other conveyance and adaptive equipment. The amendment authorizes automatic issuance of a certificate of eligibility for financial assistance in the purchase of an automobile or other conveyance and adaptive equipment to all veterans with service-connected amyotrophic lateral sclerosis (ALS) and members of the Armed Forces serving on active duty with ALS.
Written comments may be submitted through
Randy A. McKevitt, Legal Consultant, Regulations Staff (211D), Compensation Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9700. (This is not a toll-free number.)
In a document published in the
Section 3901(1), title 38, United States Code (U.S.C.), provides specific criteria for determining eligibility for an automobile and adaptive equipment allowance. To be eligible for an automobile and adaptive equipment allowance, a veteran must be in receipt of compensation under chapter 11 of title 38 U.S.C. for (or a member of the Armed Forces serving on active duty must have) loss or permanent loss of use of one or both feet; loss or permanent loss of use of one or both hands; permanent impairment of vision of both eyes with central visual acuity of 20/200 or less in the better eye with the use of corrective glasses or central visual acuity of more than 20/200 if there is a field defect in which the peripheral field has contracted to such an extent that the widest diameter of visual field subtends an angular distance no greater than twenty degrees in the better eye; or a severe burn injury. 38 U.S.C. 3901(1). These disabilities must be the result of an injury incurred or disease contracted in or aggravated by active military, naval, or air service.
VA's automobile and adaptive equipment allowance eligibility regulation, 38 CFR 8.808 Automobiles or other conveyances and adaptive equipment; certification, which was promulgated to implement 38 U.S.C. 3901 and 3902, includes the same criteria for entitlement to a certificate of eligibility as 38 U.S.C. 3901. Because ALS is a rapidly progressive, totally debilitating, and irreversible disease, VA has determined that progression of ALS will routinely, and quickly, satisfy these existing certificate of eligibility criteria. This interim final rule permits VA to determine entitlement to a certificate of eligibility for an automobile or other conveyance and adaptive equipment as soon as a veteran establishes service connection for ALS, or a member of the Armed Forces serving on active duty is diagnosed with ALS, eliminating the need for additional development and reducing wait times. By streamlining the eligibility process, this regulatory amendment will allow veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS to receive and utilize to maximum advantage the automobile or other conveyance and adaptive equipment benefit, without unnecessary delay.
From the standpoint of entitlement to a certificate of eligibility for automobile or other conveyance and adaptive equipment qualification procedures, the effect of this regulatory amendment is to allocate resources more efficiently and ensure a better lifestyle for veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS who want to purchase and adapt an automobile or other conveyance and adaptive equipment so they can remain mobile as long as possible. In this regard, as the ALS progresses, the need for assistive devices adapting an automobile or other conveyance and adaptive equipment so that the veteran or member of the Armed Forces serving on active duty can continue to be mobile, including attending examinations and treatment by medical personnel, while remaining in their home for as long as possible, will be greatly assisted. Without these benefits, a veteran or member of the Armed Forces serving on active duty may be required to be institutionalized sooner than otherwise necessary to receive medical treatment.
Thus, there exists an immediate need for VA to focus this regulatory change upon the entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment process. Because the prognosis of the progression of ALS is typically established after a brief period of observation, in most cases less than 3 months, VA has determined that it is fair and reasonable to provide a certificate of eligibility for automobile or other conveyance and adaptive equipment upon determination of service connection for ALS in a veteran or on diagnosis and receipt of an application from a member of the Armed Forces serving on active duty.
VA, therefore, intends to establish entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment eligibility for eligible veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS. VA is doing so by adding a new provision to 38 CFR 3.808, which governs eligibility for entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment under 38 U.S.C. 3901 and 3902. This new provision adds ALS as a qualifying disability for eligibility to this benefit and will allow eligible individuals to access this benefit without further development and delay. VA incorporates this new category of criteria in § 3.808 as new paragraph (b)(5). Current paragraph (b)(5) will be redesignated as paragraph (b)(6).
Pursuant to 5 U.S.C. 553(b)(B) and (d)(3), we find that there is good cause to dispense with advance public notice and opportunity to comment on this rule and good cause to publish this rule with an immediate effective date. This interim final rule is necessary to implement immediately the Secretary's decision to establish entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment for all veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS. Delay in the implementation of this rule would be impracticable and contrary to the public interest, particularly to veterans and members of the Armed Forces serving on active duty.
Because the survival period for persons suffering from ALS is generally 18-48 months or less from the onset of symptoms, any delay in establishing entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment eligibility is extremely detrimental to veterans and members of the Armed Forces serving on active duty who are currently afflicted with ALS. Any delay in implementation until after a public-comment period could delay modifying the regulated certificate of eligibility
For the foregoing reasons, the Secretary is issuing this rule as an interim final rule with immediate effect.
This interim final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The Secretary hereby certifies that this interim 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. This interim final rule will not affect any small entities. Only VA beneficiaries will be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this interim final rule is exempt from the final regulatory flexibility analysis requirements of section 604.
Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule 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; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact 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 set forth in this Executive Order.”
The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector.
The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces and 64.109, Veterans Compensation for Service-Connected Disability.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jose D. Riojas, Chief of Staff, approved this document on February 12, 2015, for publication.
Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Veterans.
For the reasons set out in the preamble, VA amends 38 CFR part 3 as follows:
38 U.S.C. 501(a), unless otherwise noted.
(b) * * *
(5) Amyotrophic lateral sclerosis.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes a time-limited tolerance for residues of clothianidin,
This regulation is effective February 25, 2015. Objections and requests for hearings must be received on or before April 27, 2015, and must be filed in accordance with the instructions provided in 40 CFR part
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0253, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; 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).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0253 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 27, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0253, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement of a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative,
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b) (2) (C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . . ”
Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.
The Florida Department of Agriculture and Consumer Services requested the EPA Administrator to issue a specific exemption for the use of clothianidin as a soil drench application on immature citrus trees to control the transmission of Huanglongbing (HLB) disease vectored by the Asian Citrus Psyllid (ACP). The applicant asserts that clothianidin is needed to control HLB disease due to the lack of effective available alternatives for season long control practices, and that significant economic losses will occur if this
Further, the Applicant asserts that an emergency condition exists in accordance with the criteria for approval of an emergency exemption, and issued a crisis exemption under FIFRA section 18 to allow the use of clothianidin on immature citrus trees for control of the transmission of HLB disease vectored by the ACP in Florida. After having reviewed the submission, EPA concurred that an emergency condition exists for Florida citrus growers and authorized a specific emergency exemption under FIFRA section 18 for control of clothianidin on immature citrus trees to control the transmission of HLB disease vectored by the ACP.
As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of clothianidin in or on citrus. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although this time-limited tolerance expires on December 31, 2017, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on fruit, citrus, group 10-10 after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by the time-limited tolerance at the time of that application. EPA will take action to revoke this time-limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether clothianidin meets FIFRA's registration requirements for use on fruit, citrus, group 10-10 or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of clothianidin by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Florida to use this pesticide on the applicable crop under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for clothianidin contact the Agency's Registration Division at the address provided under
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of clothianidin in or on citrus. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2) and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18.
Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this emergency action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption and the time-limited tolerance for residues of clothianidin in or on fruit, citrus, group 10-10 at 0.07 ppm.
EPA recently evaluated the currently approved uses of clothianidin when establishing tolerances for residues of clothianidin in three non-citrus commodity groups in the March 29, 2013
EPA has also recently evaluated the dietary exposure that would result from a similar use of clothianidin on citrus that would result in clothianidin residues of 0.60 ppm. This is significantly higher than the 0.07 ppm time-limited tolerance level established in today's final rule. In order to expedite this time-limited tolerance rule, EPA has relied on its previous dietary risk assessment assuming clothianidin residues of 0.60 ppm on citrus. The higher application rates and concentrations assure that exposure and risk resulting from the emergency use are not underestimated. In addition, the estimated drinking water concentrations based on the clothianidin use on citrus resulted in higher acute drinking water estimates than those previously assessed. The chronic analysis drinking water estimate remains the same as it was in the previous dietary assessment. Even with these conservative assumptions, the revised acute dietary risk estimates from exposure to clothianidin through food and water are below the Agency's level of concern for all population subgroups.
In its aggregate assessment of exposures and risk associated with clothianidin, including use on citrus which was assessed at a significantly higher use rate, EPA concluded that the acute dietary exposure from food and water to clothianidin would occupy 28% of the acute population adjusted dose (aPAD) for children 1-2 years old, the population subgroup receiving the greatest exposure; and that chronic exposure to clothianidin from food and water would utilize 28% of the chronic population adjusted dose (cPAD) for children 1-2 years old, the population subgroup receiving the greatest exposure. These population adjusted doses represent the levels below which exposure is not of health concern. Because these levels of dietary exposures for the most exposed subpopulations would be well below the aPAD and cPAD, the expected lower levels of dietary exposures are not of concern.
There are no new residential uses of clothianidin at this time. However, existing uses of clothianidin on turf, ornamental plants, and/or indoor surfaces for bed bug control may result in human exposure in a residential setting. Such exposures may occur during application of products containing clothianidin (handler exposure) as well as following application (post-application exposure) and are expected to be of short-term (1-30 days) duration.
For clothianidin, residential handler and post-application risk estimates are considered to be of potential concern when the dermal margin of exposure (MOE) is less than 100, the inhalation MOE is less than 1,000, and/or the aggregate risk index (ARI), reflecting combined dermal and inhalation exposure, is less than one. The residential handler and post-application risk estimates are not of concern (ARIs range from 1.9 to 990). The aggregate ARIs, which combine residential and dietary exposure, ranged from 1.2 to 6.5, which are not of concern (
Therefore, EPA concluded there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to clothianidin residues as a result of existing uses and the proposed section 18 use pattern.
Refer to the March 29, 2013 final rule, available at
An adequate enforcement methodology, based on solvent extraction and liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) separation, identification, and quantification, is available for plant (Morse Method#Meth-164-modified, RM-39C-1, or Bayer Method 00552) matrices to enforce the tolerance expression. The limit of quantitation (LOQ) for clothianidin in plant commodities is 0.01 ppm. Clothianidin and its major metabolites are not adequately recovered using any of the United States Food and Drug Administration (FDA) multi-residue methods.
The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has established MRLs for clothianidin in or on citrus fruits at 0.07 ppm, the same level the U.S. is establishing for the time-limited-tolerance.
Therefore, a time-limited tolerance is established for residues of clothianidin, in or on fruit, citrus, group 10-10 at 0.07 ppm. This tolerance expires on December 31, 2017.
This final rule establishes tolerances under FFDCA sections 408(e) and 408(l)(6). The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(b)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; correction.
This document contains a correction to the final rule to implement Amendment 20B to the Fishery Management Plan for the Coastal Migratory Pelagic Resources in the exclusive economic zone of the Gulf of Mexico and Atlantic Region (Amendment 20B) that was published in the
This correction is effective March 1, 2015.
Anik Clemens, 727-551-5611; email:
On January 27, 2015, (80 FR 4216), NMFS published an incorrect annual catch limit (ACL) value for Atlantic migratory group Spanish mackerel in § 622.388(d)(1)(iii). The commercial ACL for Atlantic migratory group Spanish mackerel is equal to the commercial quota. The commercial quota value was published correctly in § 622.384(c)(2), however, the commercial ACL value was published incorrectly in § 622.388(d)(1)(iii). This document corrects the commercial ACL value for Atlantic migratory group Spanish mackerel.
1. On page 4223, in the first column, § 622.388(d)(1)(iii) is correctly revised to read as follows:
(d) * * *
(1) * * *
(iii) The commercial ACL for the Atlantic migratory group Spanish mackerel is 3.33 million lb (1.51 million kg).
Federal Crop Insurance Corporation, USDA.
Proposed rule.
The Federal Crop Insurance Corporation (FCIC) proposes to replace the General Administrative Regulation—Subpart V—Submission of Policies, Provisions of Policies and Rates of Premium. The intended effect of this action is to incorporate legislative changes to the Federal Crop Insurance Act (Act) stemming from the Agricultural Act of 2014, clarify existing regulations, lessen the burden of submitters of crop insurance policies, provisions of policies, or rates of premium under section 508(h) of the Act, provide guidance on the submission and payment for concept proposals under section 522 of the Act, and to incorporate changes that are consistent with those made in the Common Crop Insurance Policy Basic Provisions (Basic Provisions).
Written comments and opinions on this proposed rule will be accepted until close of business April 27, 2015 and will be considered when the rule is to be made final.
FCIC prefers that comments be submitted electronically through the Federal eRulemaking Portal. You may submit comments, identified by Docket ID No. FCIC-13-0006 by any of the following methods:
•
•
All comments must include the agency name and docket number or Regulatory Information Number (RIN) for this rule. For detailed instructions on submitting comments and additional information, see
Tim Hoffmann, Product Administration and Standards Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-7730.
This rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, it has not been reviewed by the OMB.
Pursuant to the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the collections of information in this rule have been approved by the Office of Management and Budget (OMB) under control number 0563-0064.
FCIC is committed to complying with the E-Government Act of 2002, 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.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.
It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.
FCIC certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation does not require any more action on the part of the small entities than is required on the part of large entities. No matter the size of the submitter, all submitters are required to
This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.
This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115, June 24, 1983.
This proposed rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. With respect to any direct action taken by FCIC or to require the insurance provider to take specific action under the terms of the crop insurance policy, the administrative appeal provisions published at 7 CFR part 11 must be exhausted before any action against FCIC for judicial review may be brought.
This action is not expected to have a significant economic impact on the quality of the human environment, health, or safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.
FCIC makes available standard policies for producers to insure certain agricultural commodities against various agricultural production risks and perils. Under the provisions of section 508(h) of the Act, any person may submit or propose other crop insurance policies, plans of insurance, provisions of policies, or rates of premium to the FCIC Board of Directors (Board) for approval for reinsurance and subsidy. These policies may be submitted without regard to certain limitations contained in the Act. Section 508(h) of the Act also requires that FCIC issue regulations to establish guidelines for the submission and Board review of policies or other material submitted to the Board under the Act. These regulations were published at 7 CFR part 400, subpart V (Subpart V) and provided the process for making submissions, its contents, the approval process, and the procedures for requests for reimbursement of research and development costs and maintenance. Section 522 of the Act authorizes the advance payment of research and development costs for concept proposals and this proposed rule includes the procedures for requesting such advanced payment.
The Agricultural Act of 2014 amended parts of section 508(h) as well as other sections of the Act. One such change requires FCIC to develop procedures for submitting index-based weather plans of insurance. Another change mandated by the Agricultural Act of 2014 requires submitters of products for specialty crops to follow certain consultation requirements with grower groups in the major producing areas. The Agricultural Act of 2014 also contains amendments that require changes to review criteria and establish approval priorities and considerations of submissions under section 508(h) of the Federal Crop Insurance Act.
In addition to the changes required by the Agricultural Act of 2014, other changes are being proposed to provide clarity or lessen the burden on submitters or FCIC. This rule contains proposed revisions to definitions to clarify the meaning of terms used in Subpart V as well as new definitions for terms that were either not defined or not previously used. This rule also contains proposed changes to clarify FCIC and submitter responsibilities with respect to timing, content, approval, reimbursement for research and development costs and maintenance costs, and potential user fees for such submissions. To lessen the burden on submitters, this rule proposes to reduce the number of printed copies of the submission that must be provided to FCIC. This rule proposes to provide additional guidance for submitting concept proposals, including confidentially standards and advance payment provisions. This rule also proposes changes to guidelines for non-reinsured supplemental policies to be submitted to FCIC including a proposed provision to decrease the burden on FCIC by increasing the time FCIC has to review such policies from 120 to 150 days.
Administrative practice and procedure, Crop insurance.
Accordingly, as set forth in the preamble, FCIC proposes to amend 7 CFR part 400 by replacing subpart V in its entirety as set forth below:
Revise subpart V to read as follows:
7 U.S.C. 1506(l), 1506(o), 1508(h), 1522(b), 1523(i).
This subpart establishes guidelines, the approval process, and responsibilities of FCIC and the applicant for policies, provisions of policies, and rates of premium submitted to the Board as authorized under section 508(h) of the Act. It also provides procedures for reimbursement of research and development costs and maintenance costs for concept proposals and approved submissions. Guidelines for submitting concept proposals and the standards for approval and advance payments are provided in this subpart. This subpart also provides guidelines and reference to procedures for submitting index-based weather plans of insurance as authorized under section 523(i) of the Act. The procedures for
(1) Does not have any familial relationship (parents, brothers, sisters, children, spouse, grandchildren, aunts, uncles, nieces, nephews, first cousins, or grandparents, related by blood, adoption or marriage, are considered to have a familial relationship) with the submitter;
(2) Who will not benefit financially from the submission, concept proposal, or index-based weather plan of insurance if approved, or from the administration of any approved policy or plan of insurance; or
(3) Must not be employed by or work under contract or be associated in any similar manner to the applicant on a regular basis.
(a) Pursuant to section 508(h)(4)(A) of the Act, prior to approval by the Board, any submission submitted to the Board under section 508(h) of the Act, concept proposal submitted under section 522 of the Act, or index-based weather plan of insurance submitted under section 523(i) of the Act, including any information generated from the submission, concept proposal, or index-based weather plan of insurance, will be considered confidential commercial or financial information for purposes of 5 U.S.C. 552(b)(4) and will not be released by FCIC to the public, unless the applicant authorizes such release in writing.
(b) Once the Board approves a submission or an index-based weather plan of insurance, information provided with the submission (including information from the concept proposal) or the index-based weather plan of insurance, or generated in the approval process, may be released to the public, as applicable, including any mathematical modeling and data, unless it remains confidential business information under 5 U.S.C. 552(b)(4). While the expert reviews are releasable once the submission or an index-based weather plan of insurance has been approved, the names of the expert reviewers may be redacted to prevent any harassment or undue pressure on the expert reviewers.
(c) Any submission, concept proposal, or index-based weather plan of insurance disapproved by the Board will remain confidential commercial or financial information in accordance with 5 U.S.C. 552(b)(4) and no information related to such submission, concept proposal, or index-based weather plan of insurance will be released by FCIC unless authorized in writing by the applicant.
(d) All submissions, concept proposals, and index-based weather plans of insurance, will be kept confidential until approved by the Board and will be given an identification number for tracking purposes, unless the applicant advises otherwise.
(a) A submission, concept proposal, or index-based weather plan of insurance may only be provided to FCIC during the first five business days in January, April, July, and October.
(b) A submission, concept proposal, or index-based weather plan of insurance must be provided to FCIC in the following format:
(1) Electronic format, sent to the address in paragraph (d)(1) of this section by the due date in paragraph (a) of this section. The electronic copy must be provided as a single document so that when printed the order and content exactly match the hard copy; and
(2) Two hard copies, mailed to the addresses in paragraph (d)(2) of this section and postmarked by the due date in paragraph (a) of this section. The hard copies must exactly match the electronic copy.
(c) Any submission, concept proposal, or index-based weather plan of insurance not provided within the first 5 business days of a month stated in paragraph (a) of this section will be considered to have been provided in the next month stated in paragraph (a). For example, if an applicant provides a submission on January 10, it will be considered to have been received on April 1.
(d) Any submission, concept proposal, or index-based weather plan of insurance must be provided:
(1) In electronic format to the Deputy Administrator for Product Management (or successor) at
(2) In hard copy format, with one hard copy provided to the Deputy Administrator for Product Management (or any successor position), USDA/Risk Management Agency, Beacon Facility Mail Stop 0812, 9240 Troost Ave., Kansas City, MO 64131-3055, and one identical hard copy must be provided to the Administrator, Risk Management Agency, 1400 Independence Ave., Stop 0801, Room 3053 South Building, Washington, DC 20250-0801.
(e) In addition to the requirements in paragraph (a) of this section, a submission must be received not later than 240 days prior to the earliest proposed sales closing date to be considered for sale in the requested crop year.
(f) To be offered for sale in a crop year, there must be at least sixty days between the date the policy has been approved by the Board and ready to be made available for sale and the earliest sales closing date, unless this requirement is waived by the Board.
(g) Notwithstanding, paragraph (f) of this section, the Board, or RMA if authorized by the Board, shall determine when sales can begin for a submission approved by the Board.
(a) An applicant may submit to the Board, in accordance with § 400.705, a submission that is:
(1) A policy or plan of insurance not currently reinsured by FCIC;
(2) One or more proposed revisions to a policy or plan of insurance authorized under the Act; or
(3) Rates of premium for any policy or plan of insurance authorized under the Act.
(b) An applicant must submit to the Board, any significant change to a previously approved submission, including requests for expansion, prior to making the change in accordance with § 400.705.
(c) An applicant may submit a concept proposal to the Board prior to developing a full submission, in accordance with this subpart and the Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses, which can be found on the RMA Web site at
(d) An applicant who is an approved insurance provider may submit an index-based weather plan of insurance for consideration as a pilot program in accordance with this subpart and the Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance, which can be found on the RMA Web site at
(e) An applicant must submit a non-reinsured supplemental policy or endorsement to RMA in accordance with § 400.713.
(a) A complete submission must contain the following material, as
(b) The first section will contain general information numbered as follows (1, 2, 3, etc.), including, as applicable:
(1) The applicant's name(s), address or primary business location, phone number, and email address;
(2) The type of submission (see § 400.704) and a notation of whether or not the submission was approved by the Board as a concept proposal;
(3) A statement of whether the applicant is requesting:
(i) Reinsurance;
(ii) Risk subsidy;
(iii) A&O subsidy;
(iv) Reimbursement for research and development costs, as applicable and, if the submission was previously submitted as a concept proposal, the amount of the advance payment for expected research and development costs; or
(v) Reimbursement for expected maintenance costs, if applicable;
(4) The proposed agricultural commodities to be covered, including types, varieties, and practices covered by the submission;
(5) The crop or insurance year and reinsurance year in which the submission is proposed to be available for purchase by producers;
(6) The proposed sales closing date, if applicable, or if not applicable, the earliest date the applicant expects to release the product to the public;
(7) The proposed area for the plan of insurance and if applicable, the reasons why the submission is not being proposed for other areas producing the commodity;
(8) Any known or anticipated future expansion plans;
(9) Identification, including names, addresses, telephone numbers, and email addresses, of the person(s) responsible for:
(i) Addressing questions regarding the policy, underwriting rules, loss adjustment procedures, rate and price methodologies, data processing and record-keeping requirements, and any other questions that may arise in implementing or administering the program if it is approved; and
(ii) Annual reviews to ensure compliance with all requirements of the Act, this subpart, and any agreements executed between the applicant and FCIC; and
(10) A statement of whether the submission will be filed with the applicable office responsible for regulating insurance in each state proposed for insurance coverage, and if not, reasons why the submission will not be filed for review.
(c) The second section must contain the benefits of the plan, including, as applicable, a summary that includes:
(1) How the submission offers coverage or other benefits not currently available from existing public or private programs;
(2) The projected demand for the submission, including support for and against development from market research, producers or producer groups, agents, lending institutions, and other interested parties that provide verifiable evidence of demand;
(3) Potential impacts the submission may have on producers both where the new plan will and will not be available (include both positive and negative impacts);
(4) How the submission meets public policy goals and objectives consistent with the Act and other laws, as well as policy goals supported by USDA and the Federal Government; and
(5) A detailed description of the coverage provided by the submission and its applicability to all producers, including targeted producers.
(d) Except as provided in this section, the third section must contain the policy, that is clearly written in plain language in accordance with the Plain Writing Act of 2010 (5 U.S.C. 301) such that producers will be able to understand the coverage being offered. The policy language permits actuaries to form a clear understanding of the payment contingencies for which they will set rates. The policy language does not encourage an excessive number of disputes or legal actions because of misinterpretations.
(1) If the submission involves a new insurance policy or plan of insurance:
(i) All applicable policy provisions; and
(ii) A list of any additional coverage that may be elected by the insured in conjunction with the submission such as applicable endorsements (include a description of the coverage and how such coverage may be obtained).
(2) If the submission involves a change to a previously approved policy, plan of insurance, or rates of premium, the proposed revisions, rationale for each change, data and analysis supporting each change, the impact of each change, and the impact of all changes in aggregate.
(e) The fourth section must contain a marketing plan, including, as applicable:
(1) A list of counties and states where the submission is proposed to be offered;
(2) The amount of commodity (acres, head, board feet, etc.), the amount of production, and the value of each agricultural commodity proposed to be covered in each proposed county and state;
(3) A reasonable estimate of expected liability and premium, for each proposed county and state and total expected liability and premium by crop year based on the marketing plan and an estimate of the market penetration of other similar products;
(4) If available, any insurance experience for each year and in each proposed county and state in which the policy has been previously offered for sale including an evaluation of the policy's performance and, if data are available, a comparison with other similar insurance policies reinsured under the Act;
(5) Focus group results, both positive and negative reactions;
(6) Market research studies that include:
(i) Evidence the proposed submission will be positively received by producers; and
(ii) Market estimates that show demand and level of coverage for which producers are willing to pay;
(7) For submissions proposing products for specialty crops a consultation report must be provided that includes a summary and analysis of discussions with groups representing producers of those agricultural commodities in all major producing areas for commodities to be served or potentially impacted, either directly or indirectly, and the expected impact of the proposed submission on the general marketing and production of the crop from both a regional and national perspective including evidence that the submission will not create adverse market distortions;
(8) Effects upon the delivery system or participants including:
(i) Estimated computer system impacts and costs;
(ii) Estimated administrative and training costs; and
(iii) What, if any, efficiency will be gained;
(9) Correspondence from producers expressing the need for such policy or plan of insurance; and
(10) A commitment in writing from at least one approved insurance provider to sell and support the policy or plan of insurance.
(f) The fifth section must contain the information related to the underwriting and loss adjustment of the submission, including as applicable:
(1) Detailed rules for determining insurance eligibility, including all producer reporting requirements;
(2) Relevant dates;
(3) Step by step examples of the data and calculations needed to establish the insurance guarantee (liability) and premium per acre or other unit of measure, including worksheets that provide the calculations in sufficient detail and in the same order as presented in the policy to allow verification that the premiums charged for the coverage are consistent with policy provisions;
(4) Step-by-step examples of calculations used to determine indemnity payments for all probable situations where a partial or total loss may occur;
(5) A detailed description of the causes of loss covered by the policy or plan of insurance and any causes of loss excluded;
(6) Any statements to be included in the actuarial documents including any intended Special Provisions statements that may change any underlying policy terms or conditions; and
(7) The loss adjustment standards handbook for the policy or plan of insurance that includes:
(i) A table of contents and introduction;
(ii) A section containing abbreviations, acronyms, and definitions;
(iii) A section containing insurance contract information (insurability requirements; Crop Provisions not applicable to catastrophic risk protection; specific unit division guidelines, if applicable; notice of damage or loss provisions; quality adjustment provisions; etc.);
(iv) A section that thoroughly explains appraisal methods, if applicable;
(v) Illustrative samples of all the applicable forms needed for insuring and adjusting losses in regards to the submission, plus detailed instructions for their use and completion;
(vi) Instructions, examples of calculations, and loss adjustment procedures that are necessary to establish the amounts of coverage and loss;
(vii) A section containing any special coverage information (
(viii) A section containing all applicable reference material (
(g) The sixth section must contain information related to prices and rates of premium, including, as applicable:
(1) A detailed description of the specific premium rating methodology proposed to be used and the basis for selection of the rating methodology;
(2) A list of all assumptions made in the premium rating and commodity pricing methodologies, and the basis for these assumptions;
(3) A detailed description of the pricing and rating methodologies, including:
(i) Supporting documentation;
(ii) All mathematical formulas and equations;
(iii) Data and data sources used in determining rates and prices and a detailed assessment of the data and how it supports the proposed rates and prices;
(iv) A detailed explanation of how the rates account for each of the risks covered by the policy; and
(v) A detailed explanation of how the prices are applicable to the policy;
(4) An example of both a rate calculation and a price calculation;
(5) A discussion of the applicant's objective evaluation of the accuracy of the data, the short and long term availability of the data, and how the data will be obtained (if the data source is confidential or proprietary explain the cost of obtaining the data); and
(6) An analysis of the results of simulations or modeling showing the performance of proposed rates and commodity prices, as applicable, based on one or more of the following (Such simulations must use all years of experience available to the applicant and must reflect both partial losses and total losses):
(i) A recalculation of total premium and losses compared to a similar or comparable insurance plan offered under the authority of the Act with modifications, as needed, to represent the components of the submission;
(ii) A simulation that shows liability, premium, indemnity, and loss ratios for the proposed insurance product based on the probability distributions used to develop the rates and commodity prices, as applicable, including sensitivity tests that demonstrate price or yield extremes, and the impact of inappropriate assumptions; or
(iii) Any other comparable simulation that provides results indicating both aggregate and individual performance of the submission including expected liability, premium, indemnity, and loss ratios for the proposed insurance product, under various scenarios depicting good and poor actuarial experience.
(h) The seventh section must contain forms, instructions for completing forms, and statements for all forms applicable to the submission in a format compatible with the Document and Supplemental Standards Handbook (FCIC 24040) found at
(i) The eighth section must contain the following:
(1) A statement certifying that the submitter and any approved insurance provider or its affiliates will not solicit or market the submission until at least 60 days after all policy materials are released to the public by RMA, unless otherwise specified by the Board;
(2) An explanation of any provision of the policy not authorized under the Act and identification of the portion of the rate of premium due to these provisions; and
(3) If applicable, agent and loss adjuster training plans.
(j) The ninth section must contain a statement from the submitter that, if the submission is approved, the submitter will work with RMA and its computer programmers as needed to assure an effective and efficient implementation process. The applicant must consult with RMA to determine whether or not the submission can be effectively and efficiently implemented and administered through the current information technology standards and systems.
(1) If FCIC approves the submission and determines that its information technology systems have the capacity to implement and administer the submission, the applicant must provide a document detailing acceptable computer processing requirements consistent with those used by RMA as shown on the RMA Web site in the Appendix III/M-13 Handbook. This information details the acceptable computer processing requirements in a manner consistent with that used by RMA to facilitate the acceptance of producer applications and related data.
(2) Any computer systems, requirements, code and software must be consistent with that used by RMA and comply with the standards established in Appendix III/M-13 Handbook, or any successor document, of the SRA or other reinsurance agreement as specified by FCIC.
(3) These requirements are available from the USDA/Risk Management Agency, Beacon Facility Mail Stop 0812, 9240 Troost Ave., Kansas City, MO 64131-3055, or on RMA's Web site at
(k) The tenth section submitted on separate pages and in accordance with §§ 400.712 must specify:
(1) On one page, the amount received for an advance payment, an estimate of the total amount of reimbursement for research and development costs (new products only) or an estimate for maintenance costs for the year that the submission will be effective (for products that are within the maintenance period); and
(2) On another page, a detailed estimate of maintenance costs for future years of the maintenance period and the basis that such maintenance costs will be incurred, including, but not limited to:
(i) Any anticipated expansion;
(ii) Anticipated changes or updates to policy materials;
(iii) The generation of premium rates;
(iv) The determination of prices; and
(v) Any other costs that the applicant anticipates will be requested for reimbursement of maintenance costs or expenses;
(l) The eleventh section must contain executed (signed) certification statements in accordance with the following:
(1) “{Applicant's Name} hereby claim that the basis and amounts set forth in this section and § 400.712 are correct and due and owing to {Applicant's Name} by FCIC under the Federal Crop Insurance Act”; and
(2) “{Applicant Name} understands that, in addition to criminal fines and imprisonment, the submission of false or fraudulent statements or claims may result in civil and administrative sanctions.”
(m) The contents required for concept proposals are found in the Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses. In addition, the proposal must provide a detailed description of why the concept provides insurance:
(1) In a significantly improved form;
(2) To a crop or region not traditionally served by the Federal crop insurance program; or
(3) In a form that addresses a recognized flaw or problem in the program;
(n) The contents required for index-based weather plans of insurance are found in the Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance. In accordance with the Board approved procedures, the approved insurance provider that submits the index-based weather plan of insurance must provide evidence they have:
(1) Adequate experience underwriting and administering policies or plans of insurance that are comparable to the proposed policy of plan of insurance;
(2) Sufficient assets or reinsurance to satisfy the underwriting obligations of the approved insurance provider, and possess a sufficient insurance credit rating from an appropriate credit rating bureau; and
(3) Applicable authority and approval from each State in which the approved insurance provider intends to sell the insurance product.
(a) Prior to providing a submission, concept proposal, or index-based weather plan of insurance to the Board, RMA will:
(1) Review the submission, concept proposal, or index-based weather plan of insurance to determine if all required documentation is included in accordance with § 400.705;
(2) Review the submission, concept proposal, or index-based weather plan of insurance to determine whether it is of sufficient quality to conduct a meaningful review such that the Board will be able to make an informed decision regarding approval or disapproval;
(3) In accordance with section 508(h)(1)(B) of the Act, at its sole discretion, determine if the policy or plan of insurance:
(i) Will likely result in a viable and marketable policy;
(ii) Will provide crop insurance coverage in a significantly improved form; and
(iii) Adequately protect the interests of producers.
(4) Except for submissions developed from a concept proposal funded for advanced payment by the Board, reject and return any submission, concept proposal, or indexed based weather plan of insurance that:
(i) Does not contain all the required information or is not of sufficient quality to conduct a meaningful review;
(ii) Is unlikely result in a viable and marketable policy;
(iii) Will not provide crop insurance coverage in a significantly improved form; and
(iv) Will not adequately protect the interests of producers.
(5) Except as provided in paragraph (a)(4) of this section or if the submission was developed from an approved concept proposal, forward the submission, concept proposal, or index-based weather plan of insurance, and the results of RMA's initial review, to the Board for its determination of completeness.
(b) Upon the Board's receipt of a submission, the Board will:
(1) Determine if the submission is complete (The date the Board votes to contract with the expert reviewers is the date the submission is deemed to be complete for the start of the 120 day time-period for approval);
(2) Unless the submission makes non-significant changes to a policy or plan of insurance, or involves policy provisions that have already undergone expert review, forward the complete submission to at least five expert reviewers to review the submission:
(i) Of the five expert reviewers, no more than one will be employed by the Federal Government, and none may be employed by any approved insurance provider or their representative; and
(ii) The expert reviewers will each provide their individual assessment of whether the submission:
(A) Protects the interests of agricultural producers and taxpayers;
(B) Is actuarially appropriate;
(C) Follows appropriate insurance principles;
(D) Meets the requirements of the Act;
(E) Does not contain excessive risks;
(F) Follows sound, reasonable, and appropriate underwriting principles;
(G) Will provide a new kind of coverage that is likely to be viable and marketable;
(H) Will provide crop insurance coverage in a manner that addresses a clear and identifiable flaw or problem in an existing policy;
(I) Will provide a new kind of coverage for a commodity that previously had no available crop insurance, or has demonstrated a low level of participation or coverage level under existing coverage;
(J) May have a significant adverse impact on the crop insurance delivery system;
(K) Contains a marketing plan that reasonably demonstrates the product would be viable and marketable;
(L) If applicable, contains a consultation report that provides evidence the submission will not create adverse market distortions; and
(M) Meets any other criteria the Board may deem necessary;
(3) Return to the applicant any submission the Board determines is not complete, along with an explanation of the reason for the determination and:
(i) With respect to submissions developed from approved concept proposals, the provisions in § 400.712(c)(1) shall apply; and
(ii) Except for submissions developed from concept proposals, if the
(4) For complete submissions:
(i) Request review by RMA to provide its assessment of whether the submission:
(A) Meets the criteria listed in subsections (b)(2)(ii)(A) through (M);
(B) Is consistent with USDA's public policy goals;
(C) Does not increase or shift risk to any other FCIC reinsured policy;
(D) Can be implemented, administered, and delivered effectively and efficiently using RMA's information technology and delivery systems; and
(E) Contains requested amounts of government reinsurance, risk subsidy, and administrative and operating subsidies that are reasonable and appropriate for the type of coverage provided by the policy submission; and
(ii) Seek review from the Office of the General Counsel (OGC) to determine if the submission conforms to the requirements of the Act and all applicable Federal statutes and regulations.
(5) Unless all the requirements for approval for submissions in this subsection are met or reasons for notice of disapproval exist as specified in subsection (k), provide a notice of intent to disapprove, including the reasons for the intent to disapprove.
(c) Upon the Board's receipt of a concept proposal, the Board will:
(1) Determine whether the concept proposal is complete (The date the Board votes to contract with expert reviewers is the date the concept proposal is deemed to be a complete concept proposal for the start of the 120 day time-period for approval);
(2) If complete, forward the complete concept proposal to at least two expert reviewers with underwriting or actuarial experience to review the concept in accordance with section 522(b)(2) of the Act, this subpart, and Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses;
(3) Return to the applicant any concept proposal the Board determines is not complete, along with an explanation of the reason for the determination (If the concept proposal is resubmitted at a later date, it will be considered a new concept proposal solely for the purposes of determining the amount of time that the Board must take action);
(4) Determine whether the concept proposal, if developed into a policy or plan of insurance would, in good faith, would meet the requirement of being likely to result in a viable and marketable policy consistent with section 508(h);
(5) At its sole discretion, determine whether the concept proposal, if developed into a policy or plan of insurance would meet the requirement of providing coverage:
(i) In a significantly improved form;
(ii) To a crop or region not traditionally served by the Federal crop insurance program; or
(iii) In a form that addresses a recognized flaw or problem in the program;
(6) Determine whether the proposed budget and timetable are reasonable;
(7) Determine whether the concept proposal meets all other requirements imposed by the Board or as otherwise specified in Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses;
(8) Provide a date by which the submission must be provided in consultation with the applicant; and
(9) Unless all the requirements for approval of concept proposals in this subsection are met or reasons for disapproval exist as specified in subsection (l), provide a notice of disapproval, including the reasons for disapproval.
(d) Upon the Board's receipt of an index-based weather plan of insurance, the Board will:
(1) Determine whether the index-based weather plan of insurance is complete (The date the Board votes to contract with expert reviewers is the date the index-based weather plan of insurance is deemed to be a complete for the start of the 120 day time-period for approval);
(2) If determined to be complete, contract with five expert reviewers and review the index-based weather plan of insurance in accordance with section 523(i) of the Act, this subpart, and Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance;
(3) Return to the applicant any index-based weather plan of insurance the Board determines is not complete, along with an explanation of the reason for the determination (If the index-based weather plan of insurance is resubmitted at a later date, it will be considered a new index-based weather plan of insurance solely for the purposes of determining the amount of time that the Board must take action);
(4) Give the highest priority for approval of index-based weather plans of insurance that provide a new kind of coverage for specialty crops and livestock commodities that previously had no available crop insurance, or has demonstrated a low level of participation under existing coverage; and
(5) Unless all the requirements for approval of index-based weather plans of insurance in this subsection are met or reasons for notice of disapproval exist as specified in paragraph (m) of this section, provide a notice of intent to disapprove including the reasons for the intent to disapprove.
(e) All comments and evaluations will be provided to the Board by a date determined by the Board to allow the Board adequate time for review.
(f) The Board will consider all comments, evaluations, and recommendations in its review process. Prior to making a decision, the Board may request additional information from RMA, OGC, the expert reviewers, or the applicant.
(g) In considering whether to approve a submission and when such submission will be offered for sale, the Board will:
(1) First, consider policies or plans of insurance that address underserved commodities, including commodities for which there is no insurance;
(2) Second, consider existing policies or plans of insurance for which there is inadequate coverage or there exists low levels of participation; and
(3) Last, consider all policies or plans of insurance submitted to the Board that do not meet the criteria described in paragraph (g)(1) or (2) of this section.
(h) At any time an applicant may request a time delay after the submission, concept proposal, or index-based weather plan of insurance has been placed on the Board meeting agenda. The Board is not required to agree to such an extension.
(1) With respect to submissions from concept proposals approved by the Board for advanced payment, the applicant must provide good cause why consideration should be delayed.
(2) Any requested time delay is not limited in the length of time unless a date is set by the Board by which all revisions to the submission, concept proposal or indexed-based weather plan of insurance must be made. However, delays may make implementation of the submission for the targeted crop year impractical or impossible as determined by the Board.
(3) The time period during which the Board will make a decision to approve or disapprove the submission, concept proposal or indexed-based weather plan of insurance shall be extended
(i) The applicant may withdraw a submission, concept proposal, index-based weather plan of insurance, or a portion of a submission or concept proposal, at any time by presenting a request to the Board. A withdrawn submission, concept proposal or index-based weather plan of insurance that is resubmitted will be deemed a new submission, concept proposal, or index-based weather plan of insurance solely for the purposes of determining the amount of time that the Board must take action.
(j) The Board will render a decision on a submission, concept proposal, or indexed-based weather plan of insurance, with or without revision within 90 days after the date the submission, concept proposal, or indexed-based weather plan of insurance is considered complete by the Board, unless the Board agrees to a time delay in accordance with paragraph (h) of this section. Failure to approve a submission, concept proposal, or indexed-based weather plan of insurance constitutes intent to give of intent to disapprove a submission or index-based weather plan of insurance or disapproval of a concept proposal.
(k) The Board may provide a notice of intent to disapprove a submission if it determines:
(1) The interests of producers and taxpayers are not protected, including but not limited to:
(i) The submission does not provide adequate coverage or treats producers disparately;
(ii) The applicant has not presented sufficient documentation that the submission will provide a new kind of coverage that is likely to be viable and marketable;
(iii) Coverage would be similar to another policy or plan of insurance that has not demonstrated a low level of participation or does not contain a clear and identifiable flaw, and the producer would not significantly benefit from the submission;
(iv) The submission may create adverse market distortions or adversely impact other crops or agricultural commodities if marketed;
(v) The submission will have a significant adverse impact on the private delivery system; or
(vi) The submission cannot be implemented, administered, and delivered effectively and efficiently using RMA's information technology and delivery systems;
(2) The premium rates are not actuarially appropriate;
(3) The submission does not conform to sound insurance and underwriting principles;
(4) The risks associated with the submission are excessive or it increases or shifts risk to another reinsured policy;
(5) The submission does not meet the requirements of the Act; or
(6) The 90 day deadline under subsection (i) will expire before the Board has time to make an informed decision to approve or disapprove the submission.
(l) The Board may disapprove a concept proposal if it determines:
(1) The concept, in good faith, will not likely result in a viable and marketable policy consistent with section 508(h);
(2) At the sole discretion of the Board, the concept, if developed into a policy and approved by the Board, would not provide crop insurance coverage:
(i) In a significantly improved form;
(ii) To a crop or region not traditionally served by the Federal crop insurance program; or
(iii) In a form that addresses a recognized flaw or problem in the program;
(3) The proposed budget and timetable are not reasonable, as determined by the Board; or
(4) The concept proposal fails to meet one or more requirements established by the Board.
(m) The Board may provide a notice of intent to disapprove an index-based weather plan of insurance if it determines there is not:
(1) Adequate experience underwriting and administering policies or plans of insurance that are comparable to the proposed policy or plan of insurance;
(2) Sufficient assets or reinsurance to satisfy the underwriting obligations of the approved insurance provider, and possess a sufficient insurance credit rating from an appropriate credit rating bureau, in accordance with Board procedures; and
(3) Applicable authority and approval from each State in which the approved insurance provider intends to sell the insurance product.
(n) Unless otherwise provided for in this section:
(1) If the Board intends to disapprove a submission or index-based weather plan of insurance or disapproves a concept proposal, the Board will provide the applicant with a written explanation outlining the basis for the intent to disapprove or disapproval; and
(2) Any approval or disapproval of a submission, concept proposal, or index-based weather plan of insurance must be made by the Board in writing not later than 120 days after the Board has determined it to be complete.
(o) If a notice of intent to disapprove all or part of a submission or index-based weather plan of insurance has been provided by the Board, the applicant must provide written notice to the Board not later than 30 days after the Board provides such notice if the submission or index-based weather plan of insurance will be modified. If the applicant does not respond within the 30-day period, the Board will send the applicant a letter stating the submission or index-based weather plan of insurance is disapproved.
(p) If the applicant elects to modify the submission or index-based weather plan of insurance:
(1) The applicant must advise the Board of a date by which the modified submission or index-based weather plan of insurance will be presented to the Board; and
(2) The remainder of the time left between the Board's notice of intent to disapprove and the expiration of the 120 day deadline is tolled until the modified submission or index-based weather plan of insurance is received by the Board.
(3) The Board will disapprove a modified submission or index-based weather plan of insurance if the:
(i) Causes for disapproval stated by the Board in its notification of intent to disapprove the submission or index-based weather plan of insurance are not satisfactorily addressed;
(ii) Board determines there is insufficient time for the Board to finish its review before the expiration of the 120-day deadline for disapproval of a submission or index-based weather plan of insurance, unless the applicant grants the Board an extension of time to adequately consider the modified submission or index-based weather plan of insurance (If an extension of time is agreed upon, the time period during which the Board must act on the modified submission or index-based weather plan of insurance will tolled during the extension); or
(iii) Applicant does not present a modification of the submission or index-based weather plan of insurance to the Board on the date the applicant specified and the applicant does not request an additional time delay.
(q) If the Board fails to render a decision on a new submission or index-based weather plan of insurance within the time periods specified in paragraph (j) or (n) of this section, such submission or index-based weather plan of insurance will be deemed approved by the Board for the initial reinsurance year designated for the submission or index-based weather plan of insurance. The
(a) The Board will inform the applicant of the date, time, and place of the Board meeting.
(b) The applicant will be given the opportunity and is encouraged to present the submission, concept proposal, or index-based weather plan of insurance to the Board in person. The applicant must confirm in writing, email or fax whether the applicant will present in person to the Board.
(c) If the applicant elects not to present the submission, concept proposal, or index-based weather plan of insurance to the Board, the Board will make its decision based on the information provided in accordance with § 400.705 and § 400.706.
(a) After a submission is approved by the Board, and prior to it being made available for sale to producers:
(1) The following must be executed, as applicable:
(i) If required by FCIC, an agreement between the applicant and FCIC that specifies:
(A) In addition to the requirements in § 400.709, responsibilities of each with respect to the implementation, delivery and maintenance of the submission; and
(B) The required timeframes for submission of any information and documentation needed to administer the approved submission;
(ii) A reinsurance agreement if terms and conditions differ from the available existing reinsurance agreements; and
(iii) A training package to facilitate implementation of the approved submission;
(2) The Board may limit the availability of coverage, for any policy or plan of insurance developed under the authority of the Act and this regulation, on any farm or in any county or area;
(3) A submission approved by the Board under this subpart will be made available to all approved insurance providers under the same reinsurance, subsidy, and terms and conditions as received by the applicant;
(4) Any solicitation, sales, marketing, or advertising of the approved submission by the applicant before FCIC has made the policy materials available to all interested parties through its official issuance system will result in the denial of reinsurance, risk subsidy, and A&O subsidy for those policies affected; and
(5) The property rights to the submission will automatically transfer to FCIC if the applicant elects not to maintain the submission under § 400.712(a)(3) or fails to notify FCIC of its decision to elect or not elect maintenance of the program under § 400.712(l).
(b) Requirements and procedures for approved index-based weather plans of insurance are contained in Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance. In accordance with the Board approved procedures, index-based weather plans of insurance are not eligible for federal reinsurance, but may be approved for risk subsidy and A&O subsidy.
(a) With respect to the applicant:
(1) The applicant is responsible for:
(i) Preparing and ensuring that all policy documents, rates of premium, prices, and supporting materials, including actuarial documents, are submitted by the deadline specified by FCIC, in the form approved by the Board, and are in compliance with Section 508 of the Rehabilitation Act;
(ii) Annually updating and providing maintenance changes no later than 180 days prior to the earliest contract change date for the commodity in all counties or states in which the policy or plan of insurance is sold;
(iii) Timely addressing responses to procedural issues, questions, problems or clarifications in regard to a policy or plan of insurance (all such resolutions for approved submissions will be communicated to all approved insurance providers through FCIC's official issuance system); and
(iv) If requested by the Board, providing an annual review of the policy's performance, in writing to the Board, 180 days prior to the contract change date for the plan of insurance (The first annual report will be submitted one full year after implementation of an approved policy or plan of insurance, as agreed to by the submitter and RMA);
(2) Only the applicant may make changes to the policy, plan of insurance, or rates of premium approved by the Board:
(i) Any changes to approved submissions, both non-significant and significant, must be submitted to FCIC in the form of a submission for review in accordance with this subpart no later than 180 days prior to the earliest contract change date for the commodity in all counties or states in which the policy or plan of insurance is sold; and
(ii) Significant changes will be considered a new submission;
(3) Except as provided in paragraph (a)(4) of this section, the applicant is solely liable for any mistakes, errors, or flaws in the submitted policy, plan of insurance, their related materials, or the rates of premium that have been approved by the Board unless the policy or plan of insurance is transferred to FCIC in accordance with § 400.712(l) (The applicant remains liable for any mistakes, errors, or flaws that occurred prior to transfer of the policy or plan of insurance to FCIC);
(4) If the mistake, error, or flaw in the policy, plan of insurance, their related materials, or the rates of premium is discovered more than 45 days prior to the cancellation or termination date for the policy or plan of insurance, the applicant may request in writing that FCIC withdraw the approved policy, plan of insurance, or rates of premium:
(i) Such request must state the discovered mistake, error, or flaw in the policy, plan of insurance, or rates of premium, and the expected impact on the program; and
(ii) For all timely received requests for withdrawal, no liability will attach to such policies, plans of insurance, or rates of premium that have been withdrawn and no producer, approved insurance provider, or any other person will have a right of action against the applicant;
(5) Notwithstanding the policy provisions regarding cancellation, any policy, plan of insurance, or rates of premium that have been withdrawn by the applicant, in accordance with paragraph (a)(4) of this section is deemed canceled and applications are deemed not accepted as of the date that FCIC publishes the notice of withdrawal on its Web site at
(i) Approved insurance providers will be notified in writing by FCIC that the policy, plan of insurance, or premium rates have been withdrawn; and
(ii) Producers will have the option of selecting any other policy or plan of insurance authorized under the Act that is available in the area by the sales closing date for such policy or plan of insurance; and
(6) Failure of the applicant to perform all of the applicant's responsibilities may result in the withdrawal of approval for the policy or plan of insurance.
(b) With respect to FCIC:
(1) FCIC is responsible for:
(i) Conducting a review of the submission in accordance with § 400.706 and providing its recommendations to the Board;
(ii) With respect to submissions:
(A) Ensuring that all approved insurance providers receive the approved policy or plan of insurance, and related material, for sale to producers in a timely manner (All such information shall be communicated to all approved insurance providers through FCIC's official issuance system);
(B) As applicable, ensuring that approved insurance providers receive reinsurance under the same terms and conditions as the applicant (Approved insurance providers should contact FCIC to obtain and execute a copy of the reinsurance agreement) if required; and
(C) Reviewing the activities of approved insurance providers, agents, loss adjusters, and producers to ensure that they are in accordance with the terms of the policy or plan of insurance, the reinsurance agreement, and all applicable procedures;
(2) FCIC will not be liable for any mistakes, errors, or flaws in the policy, plan of insurance, their related materials, or the rates of premium and no cause of action may be taken against FCIC as a result of such mistake, error, or flaw in a submission or index-based weather plan of insurance submitted under this subpart;
(3) If at any time prior to the cancellation date, FCIC discovers there is a mistake, error, or flaw in the policy, plan of insurance, their related materials, or the rates of premium, or any other reason for withdrawal of approval contained in § 400.706(k) exists, FCIC will deny reinsurance for such policy or plan of insurance (If reinsurance is denied, a written notice will be provided to on RMA's Web site at
(4) If maintenance of the policy or plan of insurance is transferred to FCIC in accordance with § 400.712(l), FCIC will assume liability for the policy or plan of insurance for any mistake, error, or flaw that occur after the date the policy is transferred.
(c) If approval by the Board is withdrawn or reinsurance is denied for any submission, the approved insurance provider must cancel the policy or plan of insurance in accordance with its terms.
A policy or plan of insurance that is approved by the Board for FCIC reinsurance is preempted from state and local taxation. This preemption does not apply to index-based weather plans of insurance approved for premium subsidy or A&O subsidy under this part.
(a) At any time after approval, the Board may review any policy, plan of insurance, related material, or rates of premium approved under this subpart, including index-based weather plans of insurance and request additional information to determine whether the policy, plan of insurance, related material, or rates of premium comply with the requirements of this subpart.
(b) The Board will notify the applicant of any problem or issue that may arise and allow the applicant an opportunity to make any needed change. If the contract change date has passed, the applicant will be liable for such problems or issues for the crop year in accordance with § 400.709 until the policy may be changed.
(c) The Board may withdraw approval for the applicable policy, plan of insurance or rate of premium, including index-based weather plans of insurance, as applicable, if:
(1) The applicant fails to perform the responsibilities stated under § 400.709(a);
(2) The applicant does not timely and satisfactorily provide materials or resolve any issue to the Board's satisfaction so that necessary changes can be made prior to the earliest contract change date;
(3) The Board determines the applicable policy, plan of insurance or rate of premium, including index-based weather plans of insurance is not in conformance with the Act, these regulations or the applicable procedures;
(4) The policy, plan of insurance, or rates of premium are not sufficiently marketable according to the applicant's estimate in the submission or fails to perform sufficiently as determined by the Board; or
(5) The interest of producers or tax payers is not protected or the continuation of the program raises questions or issues of program integrity.
(a) For submissions approved by the Board for reinsurance under section 508(h) of the Act:
(1) The submission may be eligible for a one-time payment of research and development costs and reimbursement of maintenance costs for up to four reinsurance years, as determined by the Board;
(2) Reimbursement of research and development costs or maintenance costs will be considered as payment in full by FCIC for the submission, and no additional amounts will be owed to the applicant if the submission is transferred to FCIC in accordance with paragraph (l) of this section; and
(3) If the applicant elects at any time not to continue to maintain the submission, it will automatically become the property of FCIC and the applicant will no longer have any property rights to the submission and will not receive any user fees for the plan of insurance;
(b) The Board approved procedures and time-frames must be followed, or research and development costs and maintenance costs may not be reimbursed, unless otherwise determined by the Board.
(1) After a submission has been approved by the Board for reinsurance, to be considered for reimbursement of:
(i) Research and development costs, the applicant must submit the total amount requested and all supporting documentation to FCIC by electronic method or by hard copy and such information must be received by FCIC on or before August 1 immediately following the date the submission was released to approved insurance providers through FCIC's issuance system; or
(ii) Maintenance costs, the applicant must submit the total amount requested and all supporting documentation to FCIC by electronic method or by hard copy and such information must be received by FCIC on or before August 1 of each year of the maintenance period.
(2) Given the limitation on funds, regardless of when the request is received, no payment will be made prior to September 15 of the applicable fiscal year.
(c) Applicants submitting a concept proposal may request an advance payment of up to 50 percent of the projected total research and development costs, and after the applicant has begun research and development activities, the Board may at its sole discretion provide up to an additional 25 percent advance payment of the estimated research and development costs, if requested in accordance with Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses.
(1) If a concept proposal is approved by the Board for advance payment, the applicant is responsible for independently developing a submission that is complete and of sufficient quality as specified in this subpart by the deadline set by the Board.
(i) If an applicant fails to fulfill the obligation to provide a submission that is complete and of sufficient quality by the deadline set by the Board, the Board shall provide a notice of non-compliance to the applicant and allow not less than 30 days for the applicant to respond;
(ii) If the applicant fails to respond, to the satisfaction of the Board, with just cause as to why a submission that is complete and of sufficient quality was not provided by the deadline set by the Board, the applicant shall return the amount of the advance payment plus interest at the rate of 1.25 percent simple interest per calendar month;
(iii) If the applicant responds, to the satisfaction of the Board, with just cause as to why a submission that is complete and of sufficient quality was not provided by the deadline set by the Board, the applicant will be given a new deadline by which to provide a submission that is complete and of sufficient quality; and
(iv) If the applicant fails to provide a submission that is complete and of sufficient quality by the deadline, no additional extensions will be approved by the Board and the applicant shall return the amount of the advance payment plus interest at the rate of 1.25 percent simple interest per calendar month.
(2) If an applicant receives an advance payment for a portion of the expected research and development costs for a concept proposal that is developed into a submission and determined by the Board to be complete and of sufficient quality, but the submission is not approved by the Board following expert review, the Board will not:
(i) Seek a refund of any advance payments for research and development costs; and
(ii) Make any further research and development cost reimbursements associated with the submission.
(d) Under section 522 of the Act, there are limited funds available on an annual fiscal year basis to pay for reimbursements of research and development costs (including advance payments for concept proposals) and maintenance costs. Consistent with paragraphs (e) through (j) of this section if all applicants' requests for reimbursement of research and development costs (including advance payments for concept proposals) and maintenance costs in any fiscal year:
(1) Do not exceed the maximum amount authorized by law, the applicants may receive the full amount of reimbursement determined reasonable by the Board; or
(2) Exceed the amount authorized by law, each applicant's reimbursement determined reasonable by the Board will be determined by dividing the total amount of each individual applicant's reimbursable costs authorized in paragraphs (e) through (j) of this section by the total amount of the aggregate of all applicants' reimbursable costs authorized in paragraphs (e) through (j) for the year and multiplying the result by the amount of reimbursement authorized under the Act.
(e) The amount of reimbursement for research and development costs requested by the applicant may be reduced based on:
(1) The complexity of the policy, plan of insurance, or rates of premium, so requests for reimbursements for submissions:
(i) Adding commodities to existing plans of insurance (
(ii) Using existing rating methodologies or commodity prices or a price methodology may be reduced by as much as 10 percent;
(iii) Using existing policy provisions, procedures, etc., may be reduced by as much as 10 percent; and
(2) The scope as measured by the agricultural commodities proposed to be covered or geographic area the proposed submission will cover, as determined by FCIC so requests for reimbursements for submissions:
(i) That cover a single commodity may be reduced by 10 percent; and
(ii) That cover a small geographic area compared to the total growing area for the commodity may be reduced by 10 percent.
(f) Research and development and maintenance costs must be supported by itemized statements and supporting documentation (copies of contracts, billing statements, time sheets, travel vouchers, accounting ledgers, etc.).
(1) Actual costs submitted will be examined for reasonableness and may be adjusted at the sole discretion of the Board.
(2) Allowable research and development costs and maintenance costs (directly related to research and development or maintenance of the submission only) may include the following:
(i) Wages and benefits, exclusive of bonuses, overtime pay, or shift differentials;
(A) One line per employee or contractor, include job title, total hours, and total dollars;
(B) The rates charged must be commensurate with the tasks performed (For example, a person performing the task of data entry should not be paid at the rate for performing data analysis);
(C) The wage rate and benefits shall not exceed two times the hourly wage rate plus benefits provided by the Bureau of Labor Statistics; and
(D) The applicant must report any familial or business relationship that exists between the applicant and the contractor or employee (Reimbursement may be limited or denied if the contractor or employee is associated to the applicant and they may be considered as one and the same. This includes a separate entity being created by the applicant to conduct research and development. Reimbursement may be limited or denied if the contractor is paid a salary or other compensation);
(ii) Travel and transportation (One line per event, include the job title, destination, purpose of travel, lodging cost, mileage, air or other identified transportation costs, food and miscellaneous expenses, other costs, and the total cost);
(iii) Software and computer programming developed specifically to determine appropriate rates, prices, or coverage amounts (Identify the item, include the purpose, and provide receipts or contract or straight-time hourly wage, hours, and total cost. Software developed to send or receive data between the producer, agent, approved insurance provider or RMA or such other similar software may not be included as an allowable cost);
(iv) Miscellaneous expenses such as postage, telephone, express mail, and printing (Identify the item, cost per unit, number of items, and total dollars); and
(v) Training costs expended to facilitate implementation of a new approved submission (Include instructor(s) hourly rate, hours, and cost of materials and travel) conducted at a national level, directed to all approved insurance providers interested in selling the submission, and approved prior to the training by RMA).
(3) The following expenses are specifically not eligible for research and development and maintenance cost reimbursement:
(i) Copyright fees, patent fees, or any other charges, costs or expenses related to the use of intellectual property;
(ii) Training costs, excluding training costs to facilitate implementation of the approved submission in accordance with subsection (f)(2)(v);
(iii) State filing fees and expenses;
(iv) Normal ongoing administrative expenses or indirect overhead costs (for example, costs associated with the management or general functions of an organization, such as costs for internet service, telephone, utilities, and office supplies);
(v) Paid or incurred losses;
(vi) Loss adjustment expenses;
(vii) Sales commission;
(viii) Marketing costs;
(ix) Lobbying costs;
(x) Product or applicant liability resulting from the research, development, preparation or marketing of the policy;
(xi) Copyright infringement claims resulting from the research, development, preparation or marketing of the policy;
(xii) Costs of making program changes as a result of any mistakes, errors or flaws in the policy or plan of insurance;
(xiii) Costs associated with building rents or space allocation;
(xiv) Costs in paragraphs (i) and (j) of this section determined by the Board to be ineligible for reimbursement; and
(xv) Local, State, or Federal taxes.
(g) Requests for reimbursement of maintenance costs must be supported by itemized statements and supporting documentary evidence for each reinsurance year in the maintenance period.
(1) Actual costs submitted will be examined for reasonableness and may be adjusted at the sole discretion of the Board.
(2) Maintenance costs for the following activities may be reimbursed:
(i) Expansion of the original submission into additional crops, counties or states;
(ii) Non-significant changes to the policy and any related material;
(iii) Non-significant or significant changes to the policy as necessary to protect program integrity or as required by Congress; and
(iv) Any other activity that qualifies as maintenance.
(h) Projected costs for research and development for concept proposals shall be based on a reasonable estimate of the costs allowed in paragraph (f) of this section.
(i) If a submission is determined to be of insufficient quality to refer to expert review, or is considered incomplete and is subsequently resubmitted and approved, the costs to perfect the submission may not be considered reimbursable costs depending on the level of insufficiency or incompleteness of the submission, as determined at the sole discretion of the Board.
(j) Reimbursement of costs associated with addressing issues raised by the Board, expert reviewers and RMA will be evaluated based on the substance of the issue and the amount of time reasonably necessary to address the specific issue raised. Delays and additional costs caused by the inability or refusal to adequately address issues may not be considered reimbursable, as determined at the sole discretion of the Board.
(k) If the Board withdraws its approval for reinsurance at any time during the period that reimbursement for maintenance is being made or user fees are being collected, no maintenance reimbursement shall be made nor any user fee be owed after the date of such withdrawal.
(l) Not later than 180 days prior to the end of the last reinsurance year in which a maintenance reimbursement will be paid for the approved submission, the applicant must notify FCIC in writing regarding its decision on future ownership and maintenance of the policy or plan of insurance.
(1) The applicant must notify FCIC in writing whether it intends to:
(i) Continue to maintain the policy or plan of insurance and charge approved insurance providers a user fee to cover maintenance expenses for all policies earning premium; or
(ii) Transfer responsibility for maintenance to FCIC.
(2) If the applicant fails to notify FCIC in writing by the deadline, the policy or plan of insurance will automatically transfer to FCIC beginning with the next reinsurance year.
(3) If the applicant elects to:
(i) Continue to maintain the policy or plan of insurance, the applicant must submit a request for approval of the user fee by the Board at the time of the election; or
(ii) Transfer the policy or plan of insurance to FCIC, FCIC may at its sole discretion, continue to maintain the policy or plan of insurance or elect to withdraw the availability of the policy or plan of insurance.
(4) Requests for approval of the user fee must be accompanied by written documentation to support the amount requested will only cover direct costs to maintain the plan of insurance. Costs that are not eligible for research and development and maintenance reimbursements under this section are not eligible to be considered for determining the user fee.
(5) The Board will approve the amount of user fee, including the maximum amount of total maintenance that may be collected per year, that is payable to the applicant by approved insurance providers unless the Board determines that the user fee charged:
(i) Is unreasonable in relation to the maintenance costs associated with the policy or plan of insurance; or
(ii) Unnecessarily inhibits the use of the policy or plan of insurance by approved insurance providers.
(6) If the total user fee exceeds the maximum amount determined by the Board, the maximum amount determined by the Board will be divided by the number of policies earning premium to determine the amount to be paid by each approved insurance provider.
(7) Reasonableness of the initial request to charge a user fee will be determined by the Board based on a comparison of the amount of reimbursement for maintenance previously received, the number of policies, the number of approved insurance providers, and the expected total amount of user fees to be received in any reinsurance year.
(8) A user fee unnecessarily inhibits the use of a policy or plan of insurance if it is so high that approved insurance providers will not sell the policy.
(9) The user fee charged to each approved insurance provider will be considered payment in full for the use of such policy, plan of insurance or rate of premium for the reinsurance year in which payment is made.
(10) It is the sole responsibility of the applicant to collect such fees from an approved insurance provider and any indebtedness for such fees must be resolved by the applicant and approved insurance provider.
(i) Applicants may request that FCIC provide the number of policies sold by each approved insurance provider.
(ii) Such information will be provided not later than 90 days after such request is made or not later than 90 days after the requisite information has been provided to FCIC by the approved insurance provider, whichever is later.
(11) Every two years after approval of a user fee, or if the applicant has made a significant change to the approved submission, applicants must submit documentation to the Board for review in determining if the user fee should be revised.
(12) The Board may review the amount of the user fee at any time at its sole discretion.
(m) The Board may consider information from the Equal Access to Justice Act, 5 U.S.C. 504, the Bureau of Labor Statistic's Occupational Employment Statistics Survey, the Bureau of Labor Statistic's Employment Cost Index, and any other information determined applicable by the Board, in making a determination whether to approve a submission for
(n) For purposes of this section, rights to, or obligations of, research and development cost reimbursement, maintenance cost reimbursement, or user fees cannot be transferred from any individual or entity unless specifically approved in writing by the Board.
(o) Applicants requesting reimbursement for research and development costs, maintenance costs, or user fees, may present their request in person to the Board prior to consideration for approval.
(p) Index-based weather plans of insurance are not eligible for reimbursement from FCIC for maintenance costs or research and development costs. Submitters of approved index-based weather plans of insurance may collect user fees from other approved insurance providers in accordance with Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance.
(a) Unless otherwise specified by FCIC, any NRS policy that covers the same agricultural commodity as any policy reinsured by FCIC under the Act must be provided to RMA to ensure it does not shift any loss under the FCIC reinsured policy. Failure to provide such NRS policy or endorsement to RMA prior to its issuance shall result in the denial of reinsurance, A&O subsidy and risk subsidy on the underlying FCIC reinsured policy for which such NRS policy was sold.
(b) Three hard copies, and an electronic copy in a format approved by RMA, of the new or revised NRS policy and related materials must be submitted at least 150 days prior to the first sales closing date applicable to the NRS policy. At a minimum, examples that demonstrate how liability and indemnities are determined under differing scenarios must be included.
(1) Hard copies of the NRS must be sent to the Deputy Administrator for Product Management (or successor), USDA/Risk Management Agency, Beacon Facility Mail Stop 0812, 9240 Troost Ave., Kansas City, MO 64131-3055.
(2) Electronic copies of the NRS must be sent to the Deputy Administrator for Product Management (or successor) at
(c) RMA will review the NRS policy. If any of the conditions found in paragraphs (c)(1) through (5) of this section are found to occur, FCIC will deny reinsurance, A&O subsidy and risk subsidy on the underlying FCIC reinsured policy for which such NRS policy was sold.
(1) If the NRS policy materially increases or shifts risk to the underlying policy or plan of insurance reinsured by FCIC.
(i) An NRS policy will be considered to materially increase or shift risk to the underlying policy or plan of insurance reinsured by FCIC if it creates an incentive for moral hazard such as a financial incentive to increase the number or size of losses or, allows for aggregate indemnities in excess of the expected value of the insured commodity.
(ii) The NRS must include language that clearly states no indemnity will be paid in excess of the initial value of the insured commodity.
(2) The NRS reduces or limits the rights of the insured with respect to the underlying policy or plan of insurance reinsured by FCIC. An NRS policy will be considered to reduce or limit the rights of the insured with respect to the underlying policy or plan of insurance if it alters the terms or conditions of the underlying policy or otherwise preempts procedures issued by FCIC.
(3) The NRS disrupts the marketplace. An NRS policy will be considered to disrupt the marketplace if it encourages planting more acres of the insured commodity in excess of normal market demand, adversely affects the sales or administration of reinsured policies, undermines producers' confidence in the Federal crop insurance program, or harms public perception of the Federal crop insurance program.
(4) The NRS is an impermissible rebate. An NRS may be considered to be an impermissible rebate if FCIC determines that the premium rates charged are insufficient to cover the expected losses and a reasonable reserve or it offers other benefits that are generally provided at a cost.
(5) The NRS policy is conditioned upon or provides incentive for the purchase of the underlying policy or plan of insurance reinsured by FCIC with a specific agent or approved insurance provider.
(d) RMA will respond not less than 60 days before the first sales closing date or provide notice why RMA is unable to respond within the time frame allotted.
(e) NRS policies reviewed by RMA will not need to be submitted for a five year period unless a change is made to the NRS or the underlying policy or the loss ratio for the NRS policy exceeds 2.0. Once any changes are made to either policy or the five year period has concluded, the NRS must be resubmitted for review.
Commodity Futures Trading Commission.
Notice of proposed rulemaking; provision of Table 11a; and reopening of comment periods.
On December 12, 2013, the Commodity Futures Trading Commission (“Commission”) published in the
The comment periods for the Aggregation Proposal published November 15, 2013, at 78 FR 68946, and for the Position Limits Proposal published December 12, 2013, at 78 FR 75680, will reopen on February 26, 2015, and will close on March 28, 2015.
You may submit comments, identified by RIN 3038-AD99 for the Position Limits Proposal or RIN 3038-AD82 for the Aggregation Proposal, by any of the following methods:
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•
•
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Please submit your comments using only one method. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
Stephen Sherrod, Senior Economist, Division of Market Oversight, (202) 418-5452,
The Commission has long established and enforced speculative position limits for futures and options contracts on various agricultural commodities as authorized by the Commodity Exchange Act (“CEA”).
The Commission published the Position Limits Proposal and the Aggregation Proposal separately because it believes that the proposed amendments regarding aggregation of positions could be appropriate regardless of whether the Position Limits Proposal is finalized.
In order to provide interested parties with an opportunity to comment on the Aggregation Proposal during the comment period on the Position Limits Proposal, the Commission extended the comment period for the Aggregation Proposal to February 10, 2014, the same end date as the comment period for the Position Limits Proposal.
Subsequent to publication of the Position Limits Proposal and the Aggregation Proposal, the Commission directed staff to schedule a June 19, 2014, public roundtable to consider certain issues regarding position limits for physical commodity derivatives. The roundtable focused on hedges of a physical commodity by a commercial enterprise, including gross hedging, cross-commodity hedging, anticipatory hedging, and the process for obtaining a non-enumerated exemption. Discussion included the setting of spot month limits in physical-delivery and cash-settled contracts and a conditional spot-month limit exemption. Further, the roundtable included discussion of: The aggregation exemption for certain ownership interests of greater than 50 percent in an owned entity; and aggregation based on substantially identical trading strategies. As well, the Commission invited comment on whether to provide parity for wheat contracts in non-spot month limits. In conjunction with the roundtable, staff questions regarding these topics were posted on the Commission's Web site.
To provide commenters with a sufficient period of time to respond to questions raised and points made at the roundtable, the Commission published a document in the
The Commission's Agricultural Advisory Committee met on December 9, 2014. The agenda adopted for the meeting included consideration, among other matters, of two issues associated with the Position Limits rulemaking: Deliverable supply and exemptions for bona fide hedging positions. In conjunction with the meeting of the Commission's Agricultural Advisory Committee, the Commission posted questions and presentation materials on the Commission's Web site; additionally, access to a video webcast of the meeting was added to the Web site.
Comment letters received on the Position Limits Proposal are available at
The Commission's Energy and Environmental Markets Advisory Committee has scheduled a meeting on February 26, 2015. The agenda adopted for the meeting includes consideration of exemptions for bona fide hedging positions. In conjunction with the meeting of the Commission's Energy and Environmental Markets Advisory Committee, the Commission will post associated materials on the Commission's Web site; additionally, access to a video webcast of the meeting will be added to the Web site. To provide interested persons with a sufficient period of time to respond to questions raised and points made at the Energy and Environmental Markets Advisory Committee meeting, the Commission is reopening both the Position Limit Proposal and the Aggregation Proposal for an additional 30-day comment period. The Commission is providing notice that, in addition to commenting on the agenda issues, comments may be made on the issues addressed at the meeting or in associated materials posted to the Commission's Web site, as they pertain to energy commodities, including hedges of a physical commodity by a commercial enterprise, as pertains to energy commodities.
In addition, and in connection with the Energy and Environmental Markets Advisory Committee meeting, the Commission is providing counts of the unique persons exceeding the 28 proposed position limit levels (currently provided in Table 11 of the Positions Limits Proposal based on counts from the period of January 1, 2011, to December 31, 2012 period
Both comment periods will reopen on February 26, 2015, and will close on March 28, 2015.
The following appendix will not appear in the Code of Federal Regulations.
On this matter, Chairman Massad and Commissioners Wetjen, Bowen, and Giancarlo voted in the affirmative. No Commissioner voted in the negative.
Food and Drug Administration, HHS.
Proposed order; request for comments.
The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that enzacamene is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the-counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.
Submit either electronic or written comments on this proposed order by April 13, 2015. Sponsors may submit written requests for a meeting with FDA to discuss this proposed order by March 27, 2015. See section VI for the proposed effective date of a final order based on this proposed order.
You may submit comments by any of the following methods:
Submit electronic comments in the following way:
•
Submit written submissions in the following ways:
•
Submit requests for a meeting with FDA to discuss this proposed order to Kristen Hardin (see
Kristen Hardin, Division of Nonprescription Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5491, Silver Spring, MD 20993-0002, 240-402-4246.
The data and information addressed in this proposed order were originally submitted for review under FDA's Time and Extent Application (TEA) regulation, § 330.14 (21 CFR 330.14), a process that has since been supplemented with new statutory procedures established in the SIA (Pub. L. 113-195), enacted November 26, 2014. The discussion that follows briefly describes and compares the pre- and post-SIA processes as they apply to the regulatory status of enzacamene.
The TEA regulation established a process through which a sponsor could request that an active ingredient or other OTC condition,
Critical steps in a proceeding under the TEA regulation include the following: (1) FDA's determination that an active ingredient had been marketed for the proposed OTC use for a material time and to a material extent (eligibility determination), and public call for submission of safety and efficacy data, followed by; (2) review of safety and efficacy data submitted by the sponsor or other interested parties; and (3) FDA's initial determination that the data show the active ingredient to be either GRASE or not GRASE for OTC use under the applicable monograph conditions (including any new conditions rising from FDA's review) (GRASE determination). Under the TEA regulation, FDA's GRASE determinations are effectuated through notice and comment rulemaking to amend or establish the appropriate monograph.
The TEA process in FDA regulations was supplemented by Congress's enactment of the SIA. Among other amendments it makes to the FD&C Act, the SIA creates new procedures specifically for reviewing the safety and effectiveness of nonprescription sunscreen active ingredients, including those, such as enzacamene, that were the subject of pending TEA proceedings at the time the SIA was enacted. Like the TEA regulation, the SIA calls for an initial eligibility determination phase for nonprescription sunscreen active ingredients, followed by submissions of safety and efficacy data and a GRASE determination phase. However, the SIA requires FDA to make proposed and final GRASE determinations for nonprescription sunscreen active ingredients in the form of administrative orders rather than the multistep public rulemaking required by the TEA regulation, and establishes strict timelines for the necessary administrative actions.
Among other requirements, no later than 90 days after the SIA was enacted (
A proposed sunscreen order under the SIA is an order containing FDA's tentative determination proposing that a nonprescription sunscreen active ingredient or combination of ingredients: (1) Is GRASE and is not misbranded when marketed in accordance with the proposed order; (2) is not GRASE and is misbranded; or (3) is not GRASE and is misbranded because the data are insufficient to classify the active ingredient or combination of ingredients as GRASE and not misbranded, and additional information is necessary to allow FDA to determine otherwise (section 586(7) of the FD&C Act, as amended by the SIA). Publication of a proposed sunscreen order triggers several timelines under the SIA, including a 45-day public comment period, and a 30-day period in which a sponsor may request a meeting with FDA to discuss the proposed order.
Buchanan Ingersoll submitted a TEA in 2002 on behalf of Merck KGaA under § 330.14(c) seeking OTC monograph status for the sunscreen active ingredient enzacamene (also known as 4-Methylbenzylidene Camphor (4-MBC) or Eusolex 6300) at concentrations up to 4 percent for use in OTC sunscreen products (enzacamene TEA) (Note 1). FDA issued a TEA notice of eligibility for enzacamene on July 11, 2003 (68 FR 41386), stating that enzacamene at concentrations of up to 4 percent is eligible to be considered for inclusion in the OTC sunscreen monograph (21 CFR part 352, currently stayed) and calling for submission of safety and effectiveness data for enzacamene. In response, a submission of data dated October 9, 2003, was made to the docket on behalf of Merck KGaA (enzacamene data submission) (Note 2), which referred to materials previously submitted to other dockets.
In accordance with new section 586C(b)(4) of the FD&C Act as amended by the SIA, we are issuing this notice as a proposed order for enzacamene. Based on our review of the available safety and efficacy data, we have made a tentative determination that enzacamene is not GRASE and is misbranded because the data are insufficient to classify it as GRASE and not misbranded for use in OTC sunscreens, and additional information is necessary to allow us to determine otherwise. The remainder of this proposed sunscreen order describes our review of the available safety and efficacy data, identifies additional data needed to demonstrate that enzacamene is GRASE for the requested use, and explains our rationale for specific conclusions and data requirements.
This proposed order will be open for public comment (see
In evaluating the safety of a proposed monograph active ingredient, FDA applies the following regulatory standard: Safety means a low incidence of adverse reactions or significant side effects under adequate directions for use and warnings against unsafe use as well as low potential for harm which may result from abuse under conditions of widespread availability. Proof of safety shall consist of adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use. This proof shall include results of significant human experience during marketing. General recognition of safety shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data (§ 330.10(a)(4)(i) (21 CFR 330.10(a)(4)(i))).
FDA's OTC drug regulations generally identify the types of information that may be submitted as evidence that an active ingredient or other OTC drug condition is safe, as part of the consideration of whether an active ingredient or other condition is GRASE (§ 330.10(a)(2)). For convenience, this order uses the term “generally recognized as safe (GRAS)” to refer to that aspect of the GRASE determination. To apply the general OTC safety standard to each potential new condition, FDA uses its scientific expertise to determine what constitutes “adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use.” In assessing what specific testing or other data are needed to adequately demonstrate the safety of enzacamene for use in sunscreen, FDA considers the circumstances under which OTC sunscreen products that could contain enzacamene would be used by consumers.
When used as directed with other sun protection measures, broad spectrum OTC sunscreen products with a sun protection factor (SPF) value of 15 or higher strongly benefit the public health by decreasing the risk of skin cancer and premature skin aging associated with solar ultraviolet (UV) radiation, as well as by helping to prevent sunburn. (Sunscreens with lower SPF values, or without broad spectrum protection, also help prevent sunburn.) When used as directed by the required labeling, all OTC sunscreen products are applied liberally to the skin and reapplied frequently throughout the day (§ 201.327(e) (21 CFR 201.327(e))). Because the effects of UV exposure are cumulative, to obtain the maximum benefit, users of broad spectrum sunscreens with an SPF value of 15 or higher are directed to use such products regularly—on a routine basis (
The purpose of the safety testing described in this section II is to establish whether an OTC sunscreen product containing enzacamene and otherwise marketed under the conditions described in a final sunscreen order and in accordance with all requirements applicable to nonprescription drugs would be GRAS for use as labeled. To demonstrate that these requirements are met for enzacamene, initial safety testing should be performed using enzacamene as the sole active ingredient up to the highest concentration for which marketing status is sought and eligibility has been established: 4 percent. If initial testing suggests a particular safety concern associated with enzacamene (
Studies of skin irritation, sensitization, and photosafety are standard elements in the safety evaluation of topical drug products that, like enzacamene-containing sunscreens, are applied to the skin repeatedly over long periods of time. FDA recommends separate studies for skin irritation and sensitization. Skin irritation studies should generally include at least 30 evaluable subjects and should evaluate the test formulation (
FDA recommends that photosafety evaluation generally involve studies of skin photoirritation (phototoxicity) and skin photosensitization (photoallergenicity). General principles for designing and conducting photosafety studies are described in FDA guidance (Ref. 1). Photosafety studies, like sensitization and irritation studies, should be conducted using enzacamene 4 percent in an appropriate test vehicle, the vehicle alone, and a negative control. In addition, phototoxicity studies should include at least 30 evaluable subjects and photoallerginicity studies should include at least 45 evaluable subjects.
We reviewed the submitted study reports for human safety studies, including a skin irritation and sensitization study of enzacamene 5 percent in 30 subjects (Note 3); skin
FDA concludes that the data submitted are not sufficient to assess the dermal safety of enzacamene and specifically its potential to cause irritation, sensitization, photoirritation, or photoallergenicity. We recommend submission of additional data from human irritation, sensitization, and photosafety studies to demonstrate that an OTC sunscreen containing up to 4 percent enzacamene is not an irritant, sensitizer, photosensitizer, or photoirritant.
Because sunscreens are topically applied, another important safety consideration for enzacamene for use in sunscreens is whether dermal application may result in skin penetration and systemic exposure to enzacamene, and if so, to what extent. A well-designed and -conducted human dermal pharmacokinetic study can be expected to detect and quantify the presence of enzacamene and/or any metabolites in blood or other bodily fluids that may have a bearing on safety, using recognized parameters such as bioavailability percentage, maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), total area under the plasma concentration versus time curve (AUC), half-life, clearance, and volume of distribution. This information can help identify potential safety concerns and help determine whether an adequate safety margin for sunscreens containing enzacamene exists. FDA recommends that the pharmacokinetic studies performed on enzacamene also collect additional safety-related data from regularly scheduled physical examinations, collection of vital signs, and other measures, which may help capture adverse skin events or other potential safety signals. To ensure that maximum penetration of enzacamene has taken place and chances of it being detected are optimal, studies should continue until steady state is reached.
General information and recommendations on the design and conduct of human pharmacokinetic studies can be found in FDA guidance (Ref. 2). To support a GRAS determination for enzacamene (up to 4 percent), such a study should be conducted under maximal use conditions using enzacamene 4 percent in various vehicles, including vehicles that would be expected to enhance absorption. We encourage study sponsors to consult with us before conducting pharmacokinetic studies, because the properties of enzacamene bear on the optimal design.
We reviewed three submitted reports of dermal absorption studies in humans in which percutaneous absorption was estimated using radiolabeled (
A review of the published literature identified more recent studies related to the extent of absorption of enzacamene in humans after dermal application. A 2004 article from Janjua et al. (Ref. 3) reports on the absorption from a formulation containing 10 percent enzacamene and 2 other active sunscreen ingredients after whole body application for 4 days in 15 healthy males and 17 postmenopausal females. The article provides only summary bioavailability information but claims that the maximum plasma concentrations were 20 milligrams (mg)/milliliter (mL) in both men and women and that increasing plasma levels of enzacamene and metabolites were seen, suggesting the presence of accumulation. It is noted that thyroid function was also assessed during this study, but results are confounded by the simultaneous application of three active sunscreen ingredients. A 2006 article from Shauer et al. (Ref. 4) includes in vivo pharmacokinetic data from six healthy volunteers exposed to 4 percent enzacamene applied over 90 percent body surface area for a 12-hour period. The data are limited by the small number of subjects included; however, there was gender-related difference observed in those males who had blood levels that were approximately twice that of females. A 2008 article by Janjua et al. contains a more complete analysis of in vivo absorption for enzacamene in a 10 percent enzacamene formulation (Ref. 5). The levels of absorption were generally low but accumulation was observed. However, the age of the females enrolled in the study was 2 to 3 times that of the males, confounding the interpretation of age or gender effects.
Overall, the data available are incomplete for the assessment of human bioavailability (dermal absorption) of enzacamene. Accordingly, we request data from human pharmacokinetic studies to assess potential for and extent of systemic absorption. These studies should be performed under expected maximal-use conditions with the proposed maximum concentration as discussed previously.
In addition to the bioavailability data described previously, three reports of clinical pharmacology studies were submitted that evaluate the potential effect of enzacamene on thyroid function. The first was a pilot study in which a 5 percent enzacamene formulation was applied twice, at 3-hour intervals, to the abdomen and back
A second study evaluated the effect on thyroid function of topical application of 5 percent enzacamene (6 grams (g) applied twice, at 3-hour intervals) in nine healthy volunteers (Note 12). This was a double-blind, placebo-controlled, crossover design study, and investigators reported that there was a statistically significant lowering of mean T3 and T4 values in the active treatment group at 24 hours after application. Although larger than the pilot study, this is a small single-dose study and the changes reported were small relative to placebo and were of questionable clinical significance. Interpretation of the results is also hampered by the fact that some analytes (TSH and free T4) were below normal levels at baseline.
A third study was a parallel-group, placebo-controlled design in which 48 subjects received treatment with either enzacamene (5 g of a 6 percent enzacamene formulation per dose) or placebo twice daily for 14 days (Note 13). According to the investigators, the results of the study did not reveal any significant differences in thyroid function tests between enzacamene and placebo, although there was a small between-group difference in thyroid volume gland decrease (a 1.7 percent reduction in the enzacamene arm and an increase of 3.1 percent in the placebo group). The quality of the study report submitted is inadequate to be used to verify the analyses, but no adverse events of hypothyroidism or hyperthyroidism or abnormal thyroid function tests were reported.
The three clinical pharmacology studies submitted are insufficient either to substantiate or dismiss clinical concerns related to potential thyroid effects from enzacamene. We request submission of any additional clinical thyroid function data or analyses that have not yet been submitted to us, including any provided to the European Scientific Committee on Cosmetic Products and Nonfood Products (SCCNFP) to support its 2008 conclusion that enzacamene at a concentration up to 4 percent is safe for use in finished cosmetic products for whole body application (Ref. 6). If, after full review of nonclinical toxicology data (discussed in section I.B of this proposed order) and any additional clinical data, concerns exist regarding enzacamene's thyroid safety, we will recommend that additional clinical study be carried out. It is recommended that we be consulted regarding the study protocols prior to commencement of such investigations.
An evaluation of safety information from adverse event reports and other safety-related information derived from commercial marketing experience of sunscreen products containing enzacamene, as well as from other sources, is a critical aspect of FDA's safety review for enzacamene. The TEA regulation under which the original request for enzacamene was submitted specifically calls for submission of information on all serious adverse drug experiences, as defined in 21 CFR 310.305(a) and 314.80(a), from each country where the active ingredient or other condition has been or is currently marketed as either a prescription or OTC drug; in addition, it calls for submission of all data generally specified in § 330.10(a)(2), which includes documented case reports and identification of expected or frequently reported side effects (§ 330.14(f)(1) and (f)(2)). To evaluate enzacamene, FDA continues to seek individual adverse drug experience reports, a summary of all serious adverse drug experiences, and expected or frequently reported side effects of the condition (
• A summary of all available reported adverse events potentially associated with enzacamene;
• All available documented case reports of serious side effects
• Any available safety information from studies of the safety and effectiveness of enzacamene in humans; and
• Relevant medical literature describing adverse events associated with enzacamene. Submissions of adverse event data should also include a description of how each country's system identifies and collects adverse events, unless this information has been previously submitted as part of enzacamene's TEA package.
Although we recognize that adverse event data from foreign marketing experience may reflect patterns of use and regulatory reporting requirements that differ from those in the United States, we nonetheless consider such information to be strongly relevant both to our overall GRASE assessment of enzacamene for use in sunscreens and to our consideration of potential product labeling. FDA recognizes that such information may not be available from all countries; where that is the case, please provide a written explanation for the lack of data. Overall, we seek sufficient data to characterize enzacamene's adverse event profile.
The 1999 enzacamene submission states that no complaints from customers concerning tolerance or adverse reactions had been reported for enzacamene by the cosmetic industry during the prior 10 years (Note 14). This information was referred to in the 2002 TEA submission and the 2003 enzacamene data submission. The 1999 enzacamene submission also included a literature search for adverse reactions to enzacamene from the following databases: Medline (1966-1998), Derwent Drug File (1983-1998), and CCSearch (week 3 1998-week 48 1998) (Note 15). There were 17 articles reviewed which had been published or translated into English. Of these, 10 articles describe contact dermatitis and resultant positive photopatch testing in one or two patients. The 7 other articles are literature or case series reviews of up to 400 patients, describing dermatologic adverse reactions to sunscreen use and subsequent photopatch testing. On the whole, these reports suggest that enzacamene has the potential to cause contact allergy and photocontact allergy. However, data from this literature have limitations. In some cases, the testing methodology used to determine that enzacamene is an allergen is not described. Also, some of the test formulations used are not described. It is conceivable that the observed reactions may have been specific to particular test formulations, including formulations containing other active ingredients.
The submitted information and literature do not fulfill the criteria described previously. To support the evaluation of safety of enzacamene for
Another important element of FDA's GRAS review of enzacamene for use in sunscreens is an assessment of data from nonclinical (animal) studies that characterize the potential long-term dermal and systemic effects of exposure to enzacamene. Even if the bioavailability data discussed in section II.A.2 suggest that dermal application is unlikely to result in skin penetration and systemic exposure to enzacamene, FDA still considers data on the effects of systemic exposure to be an important aspect of our safety evaluation of enzacamene. A determination that enzacamene up to 4 percent is GRASE for use in sunscreens would permit its use in as-yet-unknown product formulations, which might in turn alter the skin penetration of the active ingredient. Therefore, an understanding of the effects of enzacamene, were systemic exposure to occur, is critical to determine whether and how regulatory parameters can be defined to assure that all conforming enzacamene-containing sunscreens would be GRASE as labeled.
FDA recommends animal testing of the potential long-term dermal and systemic effects of exposure to enzacamene because these effects cannot be easily assessed from previous human use. Taken together, the carcinogenicity studies, developmental and reproductive toxicity studies, and toxicokinetic studies described in sections II.B.1 through II.B.3 should provide the information needed to characterize both the potential dermal and systemic toxic effects and the levels of exposure at which they occur. These data, when viewed in the context of human exposure data, can be used to determine a margin of safety for use of enzacamene in OTC sunscreens.
The enzacamene submissions included data from the following types of nonclinical safety studies:
Based on the submitted studies, acute toxicity was low. However, the standard battery of tests detected findings that we will consider further as additional data become available to inform our GRAS assessment. Studies submitted by the sponsor showed an increase in thyroid weight and changes in thyroid function that included an increase in T3 and TSH, along with a decrease in T4. Other thyroid findings included follicular epithelium hypertrophy and hyperplasia. A decrease in adrenal and prostate weights, and alterations in ovarian weights (an increase was seen in some studies while decreased weight was noted in others), was documented with a no observed adverse effect level (NOAEL) of 25-30 mg/kilograms (kg)/day (Note 33).
To followup on these findings, we identified published literature that describes related enzacamene activity. A number of these articles indicate that exposure to enzacamene at high doses has been associated with hormonal changes. Among the in vitro findings (Refs. 7 through 16), a number of articles described the in vitro binding activity of enzacamene to estrogen (ER) and androgen (AR) receptors where it was able to bind to ERß but showed inconsistent binding activity at ERα receptors. No androgenic activity and mixed results for antiandrogenic activity were also documented.
Other effects of enzacamene included in vivo alterations of reproductive tissues and behavior in rats (Refs. 17 through 25). Findings include decreased testis weight; increased prostate volume and altered duct development; delayed preputial separation; decreased prostate weight in males; and increased uterine weight, decreased ovarian weight, and altered sexual behavior in females. Overall, we cannot arrive at a final determination about the findings described in the literature until we receive a complete nonclinical assessment as described in sections II.B.1 through II.B.3.
We did not receive data from toxicokinetic or dermal or systemic carcinogenicity studies. Upon assessment of all available information for enzacamene and based on the nonclinical studies currently recommended to support sunscreen development, the following nonclinical studies are recommended to support the safety of enzacamene:
• Dermal and systemic carcinogenicity
• Fertility
• Prenatal/postnatal toxicity
• Toxicokinetics
Additional discussion of study findings and data gaps are provided in the following subsections.
FDA guidance recommends that carcinogenicity studies be performed for any pharmaceutical that is expected to be clinically used continuously for at least 6 months or “repeatedly in an intermittent manner” (Refs. 26, 27, and 28). Because the proposed use of enzacamene in OTC sunscreens falls within this category, these studies should be conducted to help establish that enzacamene is GRAS for its proposed use. Carcinogenicity studies assist in characterizing potential dermal and systemic risks by identifying the type of toxicity observed, the level of exposure at which toxicity occurs, and the highest level of exposure at which no adverse effects occur (
Systemic carcinogenicity studies can also help to identify other systemic or organ toxicities that may be associated with enzacamene, such as hormonal effects. For example, the effect of persistent disruption of particular endocrine gland systems (
Enzacamene showed no evidence of DNA mutations in one standard Ames test. A chromosomal aberration assay using a Chinese hamster V79 cell line
We did not receive dermal or systemic carcinogenicity studies. Assessments of both dermal and systemic carcinogenicity are recommended because sunscreen products containing enzacamene are expected to be applied over large portions of the body with multiple daily applications. In addition, as discussed previously, marketing of this product according to a final sunscreen order might permit its formulation in a variety of as-yet-unknown vehicles that might have an impact on systemic absorption. Consequently, FDA seeks information on dermal and system carcinogenicity, in case of the possibility that systemic absorption could occur.
FDA recommends conducting DART studies to evaluate the potential effects that exposure to enzacamene may have on developing offspring throughout gestation and postnatally until sexual maturation, as well as on the reproductive competence of sexually mature male and female animals. Gestational and neonatal stages of development may also be particularly sensitive to active ingredients with hormonal activity. For this reason, we recommend that these studies include assessments of endpoints such as vaginal patency, preputial separation, anogenital distance, and nipple retention, which can be incorporated into traditional DART study designs to assess potential hormonal effects of enzacamene on the developing offspring. We also recommend conducting behavioral assessments (
Potential reproductive and developmental effects from enzacamene were evaluated in two embryotoxicity studies and one teratogenicity study. Enzacamene did not show evidence of embryotoxicity in a pilot rabbit test and hen's egg assay. In a teratogenicity study in rats with oral administration of single daily doses of 10, 30, and 100 mg/kg of enzacamene administered on days 6 to 15 after conception, enzacamene was not found to be teratogenic in any of the treated groups. Additional DART testing is recommended to assess fertility and prenatal and postnatal development in a rodent model.
We recommend conducting animal toxicokinetic studies because they provide an important bridge between toxic levels seen in animal studies and potential human exposure. Data from these studies can be correlated to potential human exposure via clinical dermal pharmacokinetic study findings. Toxicokinetic data could be collected as part of animal studies being conducted to assess one or more of the safety parameters described previously.
No toxicokinetic data were submitted as part of any of the nonclinical studies, thus it is difficult to bridge from animal findings to potential human exposure. Toxicokinetic data should be collected as part of the animal studies to allow exposure comparisons between animals and humans.
Toxicokinetic data are particularly important to the evaluation of enzacamene's safety for use in sunscreens because enzacamene appears to have the potential to affect some endocrine-responsive endpoints. We need toxicokinetic data to develop more information about exposure parameters, in order to understand whether a margin of safety exists between the exposures that cause the effects in animals and estimated human exposures. Should we find, after review of a more complete nonclinical program, that additional clinical studies are warranted, we will provide additional recommendations regarding the design of the studies.
FDA's evaluation of the effectiveness of active ingredients under consideration for inclusion in an OTC drug monograph is governed by the following regulatory standard: Effectiveness means a reasonable expectation that, in a significant proportion of the target population, the pharmacological effect of the drug, when used under adequate directions for use and warnings against unsafe use, will provide clinically significant relief of the type claimed. Proof of efficacy shall consist of controlled clinical investigations as defined in 21 CFR 314.126(b). Investigations may be corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing. Isolated case reports, random experience, and reports lacking the details that permit scientific evaluation will not be considered. General recognition of effectiveness shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data (§ 330.10(a)(4)(ii)). For convenience, this order uses the term “generally recognized as effective” (GRAE) when referring to this aspect of the GRASE determination.
To evaluate the efficacy of enzacamene for use in OTC sunscreen products, FDA requests evidence from at least two adequate and well-controlled SPF studies showing that enzacamene effectively prevents sunburn. To determine that enzacamene is GRAE for use in OTC sunscreens at concentrations in a range with the proposed maximum strength of 4 percent as requested, two adequate and well-controlled SPF studies of enzacamene at a lower concentration should be conducted according to established standards.
The current standard procedure for SPF testing is described in FDA's regulations in § 201.327(i).
Although current sunscreen testing and labeling regulations also specify a “broad spectrum” testing procedure to support related labeling claims for certain OTC sunscreen products marketed without approved new drug
A total of 11 efficacy studies were submitted. Two studies, an in vitro assessment and a field study, both dated from the 1970s, did not use study designs that we consider valid for SPF assessment for a GRASE determination (Docket No. 78N-0038, OTC Volume 060083, submitted December 18, 1973; Docket No. 78N-0038, OTC Volume 060130, submitted November 1974). The other nine studies all tested enzacamene as the only active ingredient. These included two studies of 1.25 percent enzacamene and three studies of 2.5 percent enzacamene, concentrations within the range found eligible for consideration of GRASE status in the Agency's 2003 eligibility determination, and three studies of 5 percent enzacamene and one study of 10 percent enzacamene, concentrations above the maximum established to be eligible for consideration, which studies we do not further address in this proposed order. (FDA-1978-N-0018-0766, Citizen Petition (CP1), submitted December 17, 1980.) In each of the five studies addressing enzacamene at concentrations of 1.25 percent and 2.5 percent, enzacamene achieved a mean SPF of 2, but there is substantial variability in the data and it cannot be confirmed that that efficacy was established at any of the concentrations tested. In addition, none of these study reports specified the use of appropriate standard controls to validate the test results. Currently, there are insufficient data to support a finding that enzacamene is GRAE at concentrations up to 4 percent.
To support a finding that enzacamene is GRAE at concentrations up to 4 percent, we request data from two adequate and well-controlled SPF studies conducted according to established standards to demonstrate that the lowest selected concentration provides an SPF of 2 or more. Because no study has been identified that establishes that enzacamene is effective at a concentration of 4 percent, we also recommend that such a study be conducted and submitted.
Based on our review of the available safety and efficacy data as discussed previously, we request the types of data listed in this section of the proposed order, at minimum, for us to reverse our tentative determination that enzacamene is not GRASE and is misbranded because the data are insufficient to classify enzacamene as GRASE and not misbranded, and additional data are necessary to allow us to determine otherwise. For additional information about the purpose and design of studies recommended to address these data gaps, please refer to the earlier sections of this proposed order referenced in parentheses. We welcome discussions on design of any of the studies prior to their commencement. We request the following types of data:
The need for additional human safety studies (
Alternatively, the results of a literature search that found no reports of adverse events may be provided. In that case, detailed information on how the search was conducted should be provided.
In order for concentrations of enzacamene up to 4 percent to be found to be GRASE for use in nonprescription sunscreen products as requested, at least two SPF studies showing effectiveness of a selected concentration lower than 4 percent should be conducted. An efficacy study of enzacamene at 4 percent is also recommended.
A copy of this proposed order will be filed in the Division of Dockets Management in Docket Numbers FDA-2003-N-0196, FDA-1978-N-0018, and FDA-1996-N-0006. To inform FDA's evaluation of whether this ingredient is GRASE and not misbranded for use in sunscreen products, we encourage the sponsor and other interested parties to submit additional data regarding the safety and effectiveness of this ingredient for use as an OTC sunscreen product. We also encourage the sponsor and other interested parties to notify us in writing of their intent to submit additional data. However, as noted previously, because the data submitted to date are not sufficient to support a determination that enzacamene is GRASE for use as an active ingredient in OTC sunscreen drug products, at present, OTC sunscreen products containing enzacamene may not be marketed without approval of an NDA (see section 586C(e)(1)(A) of the FD&C Act, as amended by the SIA). Data submissions relating to this proposed order should be submitted to Docket Numbers FDA-2003-N-0196, FDA-1978-N-0018, and FDA-1996-N-0006 at the Division of Dockets Management (see
Section 586C(b)(7) of the FD&C Act, as amended by the SIA, provides that
FDA proposes that any final administrative order based on this proposal become effective on the date of publication of the final order in the
Similarly, section 586C(b)(6) of the FD&C Act, as amended by the SIA, establishes that a proposed sunscreen order shall provide 45 days for public comment. Interested persons wishing to comment on this proposed order may submit either electronic comments to
1. FDA-2003-N-0196-0056, Time and Extent Application (TEA) Request to Reopen the Rulemaking Record; submitted August 21, 2002.
2. FDA-2003-N-0196-0028, C1, dated October 9, 2003.
3. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 10, dated November 27, 1972.
4. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 20, dated September 8, 1982.
5. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 11, dated February 20, 1980.
6. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 12, dated February 20, 1980.
7. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 21, dated June 5, 1985.
8. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 14, dated November 29, 1982.
9. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 15, dated July 17, 1984.
10. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 16, dated July 8, 1984.
11. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 19, dated August 1, 1981.
12. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 18, dated July 2, 1982.
13. FDA-1978-N-0018-0762 (Sup 28), Volume 5, Report 29, Study no. 43/20792, dated October 18, 1995.
14. FDA-1978-N-0018-0754 (Sup 24), dated April 12, 1999.
15. FDA-1978-N-0018-0755 (Sup 24), Attachment 1, dated April 12, 1999.
16. FDA-1978-N-0018-0758 (Sup 24), Volume 1, Reports 1, 2, 3 and 4, Study no. 4/83/71, 4/130/73, 4/131/73, 4/52/80.
17. FDA-1978-N-0018-0758 (Sup 24), Volume 1, Reports 2 and 3, Study no. 4/130/73 and 4/131/73.
18.
19.
20.
21. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 8, dated October 16, 1978.
22. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 9, dated October 16, 1978.
23. FDA-1978-N-0018-0758 (Sup 24), Volume 1, Report 5, dated May 5, 1983.
24.
25. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 7, dated April 26, 1984.
26. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 17, dated May 1, 1984.
27. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 22, Study no. LMP166, dated April 25, 1986.
28. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 13, Study no. 4/56/80, dated June 2, 1980.
29. FDA-1978-N-0018-0761 (Sup 27), Volume 4, Report 28, Study no. 40/13/93, dated April 14, 1993.
30. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 23, Study no. 4/20/84, Experiment No. T9207.
31. FDA-1978-N-0018-0761 (Sup 27), Volume 4, Report 24 and 25, dated October 23, 1987, and October 26, 1987.
32. FDA-1978-N-0018-0761 (Sup 27), Volume 4, Report 26, Study no. 4/43/88, Experiment No. T9305, dated September 14, 1983.
33. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 7, dated April 26, 1984.
The following references have been placed on display in the Division of Dockets Management (see
Food and Drug Administration, HHS.
Proposed order; request for comments.
The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that ecamsule (also known as terephthalylidene dicamphor sulfonic acid) at concentrations up to 10 percent is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the-counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.
Submit either electronic or written comments on this proposed order by April 13, 2015. Sponsors may submit written requests for a meeting with FDA to discuss this proposed order by March 27, 2015. See section VI for the proposed effective date of a final order based on this proposed order.
You may submit comments by any of the following methods:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
Submit written submissions in the following ways:
•
Submit requests for a meeting with FDA to discuss this proposed order to Kristen Hardin (see
Kristen Hardin, Division of Nonprescription Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5491, Silver Spring, MD 20993-0002, 240-402-4246.
The data and information addressed in this proposed order were originally submitted for review under FDA's Time and Extent Application (TEA) regulation, § 330.14 (21 CFR 330.14), a process that has since been supplemented with new statutory procedures established in the SIA (Pub. L. 113-195), enacted November 26, 2014. The discussion that follows briefly describes and compares the TEA and SIA processes as they apply to the regulatory status of ecamsule.
The TEA regulation established a process through which a sponsor could request that an active ingredient or other OTC condition,
Critical steps in a proceeding under the TEA regulation include the following: (1) FDA's determination that an active ingredient had been marketed for the proposed OTC use for a material time and to a material extent (eligibility determination), and public call for submission of safety and efficacy data, followed by; (2) review of safety and efficacy data submitted by the sponsor or other interested parties; and (3) FDA's initial determination that the data show the active ingredient to be either GRASE or not GRASE for OTC use under the applicable monograph conditions (including any new conditions rising from FDA's review) (GRASE determination). Under the TEA regulation, FDA's GRASE determinations are effectuated through notice and comment rulemaking to amend or establish the appropriate monograph.
The TEA process in FDA regulations was supplemented by Congress's enactment of the SIA. Among other amendments it makes to the FD&C Act, the SIA creates new procedures specifically for reviewing the safety and effectiveness of nonprescription sunscreen active ingredients, including those, such as ecamsule, that were the subject of pending TEA proceedings at the time the SIA was enacted. Like the TEA regulation, the SIA calls for an initial eligibility determination phase for nonprescription sunscreen active ingredients, followed by submissions of safety and efficacy data and a GRASE determination phase. However, the SIA requires FDA to make proposed and final GRASE determinations for nonprescription sunscreen active ingredients in the form of administrative orders rather than the multistep public rulemaking required by the TEA regulation, and establishes strict timelines for the necessary administrative actions.
Among other requirements, no later than 90 days after the SIA was enacted (
A proposed sunscreen order under the SIA is an order containing FDA's tentative determination proposing that a nonprescription sunscreen active ingredient or combination of ingredients: (1) Is GRASE and is not misbranded when marketed in accordance with the proposed order; (2) is not GRASE and is misbranded; or (3) is not GRASE and is misbranded because the data are insufficient to classify the active ingredient or combination of ingredients as GRASE and not misbranded, and additional information is necessary to allow FDA to determine otherwise (section 586(7) of the FD&C Act, as amended by the SIA). Publication of a proposed sunscreen order triggers several timelines under the SIA, including a 45-day public comment period, and a 30-day period in which a sponsor may request a meeting with FDA to discuss the proposed order.
L'Oreal asked FDA to include ecamsule in concentrations up to 10 percent as an active ingredient in the OTC sunscreen monograph in a TEA submitted September 19, 2007. FDA announced on September 12, 2008, that ecamsule had been found eligible in concentrations up to 10 percent to be considered for inclusion in the OTC sunscreen monograph (21 CFR part 352, currently stayed), and requested submissions of safety and effectiveness data to support a GRASE determination for the requested OTC use (73 FR 53029). L'Oreal submitted safety and efficacy data on ecamsule to the designated docket (FDA-2008-N-0474) on November 14, 2008 (ecamsule data submission). At the time the SIA was enacted, FDA had not issued a TEA feedback letter or otherwise responded to that submission.
In accordance with new section 586C(b)(4) of the FD&C Act as amended by the SIA, we are issuing this notice as a proposed order for ecamsule. Based on our review of the ecamsule data submission, we have made a tentative determination that ecamsule is not GRASE for OTC sunscreen use and is misbranded because the data are insufficient to classify it as GRASE and not misbranded, and additional
This proposed order will be open for public comment (see
In evaluating the safety of a proposed monograph active ingredient, FDA applies the following regulatory standard: Safety means a low incidence of adverse reactions or significant side effects under adequate directions for use and warnings against unsafe use as well as low potential for harm which may result from abuse under conditions of widespread availability. Proof of safety shall consist of adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use. This proof shall include results of significant human experience during marketing. General recognition of safety shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data (§ 330.10(a)(4)(i) (21 CFR 330.10(a)(4)(i))).
FDA's OTC drug regulations generally identify the types of information that may be submitted as evidence that an active ingredient or other OTC drug condition is safe, as part of the consideration of whether an active ingredient or other condition is GRASE (§ 330.10(a)(2)). For convenience, this order uses the term “generally recognized as safe (GRAS)” to refer to that aspect of the GRASE determination. To apply the general OTC safety standard to each potential new condition, FDA uses its scientific expertise to determine what constitutes “adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use.” In assessing what specific testing or other data are needed to adequately demonstrate the safety of ecamsule for use in sunscreen, FDA considers the circumstances under which OTC sunscreen products that could contain ecamsule would be used by consumers.
When used as directed with other sun protection measures, broad spectrum OTC sunscreen products with a sun protection factor (SPF) value of 15 or higher strongly benefit the public health by decreasing the risk of skin cancer and premature skin aging associated with solar ultraviolet (UV) radiation, as well as by helping to prevent sunburn. (Sunscreens with lower SPF values, or without broad spectrum protection, also help prevent sunburn.) When used as directed by the required labeling, all OTC sunscreen products are applied liberally to the skin and reapplied frequently throughout the day (§ 201.327(e) (21 CFR 201.327(e))). Because the effects of UV exposure are cumulative, to obtain the maximum benefit, users of broad spectrum sunscreens with an SPF value of 15 or higher are directed to use such products regularly—on a routine basis (
The purpose of the safety testing described in this section II is to establish whether an OTC sunscreen product containing ecamsule and otherwise marketed under the conditions described in a final sunscreen order and in accordance with all requirements applicable to nonprescription drugs would be GRAS for use as labeled. To demonstrate that these requirements are met for ecamsule, initial safety testing should be performed using ecamsule as the sole active ingredient up to the highest concentration for which marketing status is sought and eligibility has been established: 10 percent. If initial testing suggests a particular safety concern associated with ecamsule (
Studies of skin irritation, sensitization, and photosafety are standard elements in the safety evaluation of topical drug products that, like ecamsule-containing sunscreens, are applied to the skin repeatedly over long periods of time. FDA recommends separate studies for skin irritation and sensitization. Skin irritation studies should generally include at least 30 evaluable subjects and should evaluate the test formulation (
FDA recommends that photosafety evaluation generally involve studies of skin photoirritation (phototoxicity) and skin photosensitization (photoallergenicity). General principles for designing and conducting photosafety studies are described in FDA guidance (Ref. 1). Photosafety studies, like sensitization and irritation studies, should be conducted using ecamsule 10 percent in an appropriate test vehicle, the vehicle alone, and a negative control. In addition, phototoxicity studies should include at least 30 evaluable subjects and photoallerginicity studies should include at least 45 evaluable subjects.
We received information regarding 26 non-U.S. human dermal safety studies evaluating formulations containing up to approximately 4 percent ecamsule with one or more other additional active ingredients (Note 1). These studies exposed a total of approximately 1,500 adults to formulations containing ecamsule. Reports of 21 of these studies were complete: 2 of these studies assessed primary cutaneous irritation, 7 assessed cumulative irritation and sensitization potential, 9 assessed phototoxicity potential, and 3 assessed photosensitizing potential. However, the information provided in the 21 complete study reports does not meet FDA's current standards to support the human dermal safety of ecamsule at any concentration. All of these studies assessed formulations containing more than one active ingredient and therefore provide only limited insight into the safety of ecamsule. Furthermore, the formulations used in these studies included ecamsule only in concentrations of between 0.33 percent and 3.96 percent, and therefore would
• Failure to provide individual skin reaction scores to negative controls in all studies.
• Failure to enroll a sufficient number of subjects in the sensitization, phototoxicity, and photoallergenicity studies.
• Although the cumulative irritation studies enrolled an adequate number of evaluable subjects, there was a failure to indicate whether positive controls were used, and only three study reports indicated a negative control was used.
• Failure to indicate whether or not investigators in the primary cutaneous irritation, phototoxicity, and photoallergenicity studies were blinded to patch applications.
• Failure to indicate whether the phototoxicity and photoallergenicity studies included vehicle controls.
The ecamsule data submission also included reports for 14 studies exposing a total of over 500 children primarily between 3 and 12 years of age to sunscreen formulations containing ecamsule in concentrations of 1.5 percent to 9 percent, with 1 or more other additional active ingredients (Note 2). Numerous dermatologic reactions were reported; however, none were considered serious.
Three human safety-related literature citations listed in the submission were limited to studies describing photoallergic reactions to combination sunscreen products formulated both with and without ecamsule (Note 3). One publication described a single case of photoallergy to an ecamsule-containing sunscreen product (Ref. 2). A second publication was a review that summarized published and unpublished data from a single center's experience with patch and photopatch testing in a consecutive series of 402 patients who presented to a photobiology unit from 1981 to 1996 with suspected clinical photosensitivity (Ref. 3). The authors did not observe allergy or photoallergy to 1 percent ecamsule, but experience with ecamsule was limited in this study because it was included in the sunscreen series beginning in 1995, towards the end of the 15-year study period. The third publication was a case report describing no photoallergy to an ecamsule-containing combination sunscreen drug product in a 71-year-old male patient with persistent photocontact allergy to other UV filters (Ref. 4). A literature search conducted by FDA did not identify additional publications regarding the human dermal safety of ecamsule in concentrations up to 10 percent for use as an OTC sunscreen.
FDA concludes that the data submitted are not sufficient to assess the dermal safety of ecamsule in concentrations up to 10 percent and specifically its potential to cause irritation, sensitization, photoirritation, or photoallergenicity. Submission of data from human irritation, sensitization, and photosafety studies that meet FDA standards (see section II.A.1) is recommended to demonstrate that an OTC sunscreen product containing up to 10 percent ecamsule is not an irritant, sensitizer, photosensitizer, or photoirritant.
Because sunscreens are topically applied, another important safety consideration for ecamsule for use in sunscreens is whether dermal application may result in skin penetration and systemic exposure to ecamsule, and if so, to what extent. A well-designed and -conducted human dermal pharmacokinetic study can be expected to detect and quantify the presence of ecamsule and/or any metabolites in blood or other bodily fluids that may have a bearing on safety, using recognized parameters such as bioavailability percentage, maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), total area under the plasma concentration versus time curve (AUC), half-life, clearance, and volume of distribution. This information can help identify potential safety concerns and help determine whether an adequate safety margin for sunscreens containing ecamsule exists. FDA recommends that the pharmacokinetic studies performed on ecamsule also collect additional safety-related data from regularly scheduled physical examinations, collection of vital signs, and other measures, which may help capture adverse skin events or other potential safety signals. To ensure that maximum penetration of ecamsule has taken place and chances of it being detected are optimal, studies should continue until steady state is reached.
General information and recommendations on the design and conduct of human pharmacokinetic studies can be found in FDA guidance (Ref. 5). To support a GRAS determination for ecamsule (up to 10 percent), such a study should be conducted under maximal use conditions using ecamsule up to 10 percent in various vehicles, including vehicles that would be expected to enhance absorption. We encourage study sponsors to consult with us before conducting pharmacokinetic studies, because the properties of ecamsule bear on the optimal design.
Human dermal pharmacokinetic studies for ecamsule were submitted in response to our call for data. We reviewed one in vitro study that evaluated the potential for dermal penetration of topically applied ecamsule from human skin samples (Note 4). Because this study was not designed to detect or quantify ecamsule in the blood or other body fluids, it provides no useful information about systemic exposure. One urinary excretion study conducted with a 4.95 percent ecamsule test formulation suggested minimal systemic absorption in seven male volunteers dosed over an extensive body surface area for a total of 5 days (Note 5). A study in which radiolabeled 2 percent ecamsule was topically applied to the forearms of five male volunteers and retained for 4 hours detected a minimal level of radiation above background in urine after dosing but radiation levels above background were not detected in blood (Note 6). Although this study suggests that ecamsule is minimally absorbed following dermal application, the study formulation contained ecamsule at a concentration much lower than the requested 10 percent maximum and only a small number of subjects were dosed over a limited surface area. The last human dermal pharmacokinetic study assessed the absorption of 3 percent ecamsule from a formulation containing a total of four active ingredients (Note 7). The formulation was applied to an extensive body surface area of six male subjects twice daily for 8 days. Results showed that there were quantifiable plasma concentrations of ecamsule at several time points, suggesting that ecamsule is absorbed via dermal application. None of the submitted human dermal pharmacokinetic studies assessed an adequate number of subjects, or tested ecamsule at the maximum requested concentration of 10 percent.
Our literature search found no additional publications regarding human pharmacokinetics of ecamsule. Accordingly, we request data from human pharmacokinetic studies to assess the potential for and the extent of systemic absorption. These studies should be performed under expected
An evaluation of safety information from adverse event reports and other safety-related information derived from commercial marketing experience of sunscreen products containing ecamsule, as well as from other sources, is a critical aspect of FDA's safety review for ecamsule. The TEA regulation under which the original request for ecamsule was submitted specifically calls for submission of information on all serious adverse drug experiences, as defined in 21 CFR 310.305(a) and 314.80(a), from each country where the active ingredient or other condition has been or is currently marketed as either a prescription or an OTC drug; in addition, it calls for submission of all data generally specified in § 330.10(a)(2), which includes documented case reports and identification of expected or frequently reported side effects (§ 330.14(f)(1) and (f)(2)). To evaluate ecamsule, FDA continues to seek individual adverse drug experience reports, a summary of all serious adverse drug experiences, and expected or frequently reported side effects of the condition (
• A summary of all available reported adverse events potentially associated with ecamsule;
• All available documented case reports of serious side effects;
• Any available safety information from studies of the safety and effectiveness of ecamsule in humans; and
• Relevant medical literature describing adverse events associated with ecamsule. Submissions of adverse event data should also include a description of how each country's system identifies and collects adverse events, unless this information has been previously submitted as part of ecamsule's TEA package.
Although we recognize that adverse event data from foreign marketing experience may reflect patterns of use and regulatory reporting requirements that differ from those in the United States, we nonetheless consider such information to be strongly relevant both to our overall GRASE assessment of ecamsule for use in sunscreens and to our consideration of potential product labeling. FDA recognizes that such information may not be available from all countries; where that is the case, please provide a written explanation for the lack of data. Overall, we seek sufficient data to characterize ecamsule's adverse event profile.
The submission describes the marketing history of ecamsule and provides eight case report forms (Form FDA 3500A) that have been submitted to FDA's MedWatch program in association with marketed sunscreen products containing ecamsule in combination with other active ingredients (Note 8). Our review of the FDA Adverse Event Reporting System (FAERS) identified one additional case report associated with such a sunscreen product. These case reports describe serious allergic reactions such as redness, swelling and urticaria, breathing difficulties, and anaphylaxis. The role, if any, of ecamsule in these cases cannot be fully assessed due in part to the presence of multiple active ingredients in the associated sunscreen products. To support the evaluation of the safety of ecamsule for use in OTC sunscreens, we request that the sponsor either supplement the information already submitted with adverse event or other safety-related data derived from commercial marketing experience, or explain why such information cannot be provided.
Another important element of FDA's GRAS review of ecamsule for use in sunscreens is an assessment of data from nonclinical (animal) studies that characterize the potential long-term dermal and systemic effects of exposure to ecamsule. Even if the bioavailability data discussed in section II.A.2 suggest that dermal application is unlikely to result in skin penetration and systemic exposure to ecamsule, FDA still considers data on the effects of systemic exposure to be an important aspect of our safety evaluation of ecamsule. A determination that ecamsule up to 10 percent is GRASE for use in sunscreens would permit its use in as-yet-unknown product formulations, which might in turn alter the skin penetration of the active ingredient. Therefore, an understanding of the effects of ecamsule, were systemic exposure to occur, is critical to determine whether and how regulatory parameters can be defined to assure that all conforming ecamsule-containing sunscreens would be GRASE as labeled.
FDA recommends animal testing of the potential long-term dermal and systemic effects of exposure to ecamsule because these effects cannot be easily assessed from previous human use. Taken together, the carcinogenicity studies, developmental and reproductive toxicity studies, and toxicokinetic studies described in sections II.B.1 through II.B.3 should provide the information needed to characterize both the potential dermal and systemic toxic effects and the levels of exposure at which they occur. These data, when viewed in the context of human exposure data, can be used to determine a margin of safety for use of ecamsule in OTC sunscreens.
The ecamsule submission included reports of the following types of nonclinical safety studies:
The submission includes summary reports of nonclinical studies that are of the types FDA requests as a basis for evaluating whether ecamsule is GRAS for use in sunscreen (chronic toxicity, carcinogenicity, reproductive and developmental toxicity, and toxicokinetics). However, the submission did not provide the full reports and full comprehensive data sets that would be needed for an adequate review of the data for these studies. Because the summary data provided can support only tentative conclusions about these studies, full final study reports and data sets need to be made available to support a final GRASE determination.
Additional discussion of study findings and data gaps are provided in the following subsections.
FDA guidance recommends that carcinogenicity studies be performed for any pharmaceutical that is expected to be clinically used continuously or “repeatedly in an intermittent manner” for a total of 6 months of exposure (Refs. 6, 7, and 8). Because the proposed use of ecamsule in OTC sunscreens falls within this category, these studies should be conducted to help establish that ecamsule is GRAS for its proposed use. Carcinogenicity studies assist in characterizing potential dermal and systemic risks by identifying the type of toxicity observed, the level of exposure at which toxicity occurs, and the highest level of exposure at which no adverse effects occur (
Systemic carcinogenicity studies can also help to identify other systemic or organ toxicities that may be associated with ecamsule, such as hormonal effects. For example, the effect of persistent disruption of particular endocrine gland systems (
The ecamsule submission included some information regarding genotoxicity studies. Based on the reviewable genotoxicity data included in the ecamsule data submission, ecamsule appears to be negative for causing genotoxic activity under the conditions studied (Notes 35 through 43). As we believe that data from the recommended systemic carcinogenicity and developmental and reproductive toxicology (DART) studies will provide an adequate and appropriate measure of potential long-term effects of systemic or dermal exposure to ecamsule, we do not request further genotoxicity studies.
We have reviewed study summaries for four dermal carcinogenicity and photocarcinogenicity studies, which appear to be negative (Notes 44 through 47). However, full final study reports need to be made available to support a final GRASE determination. In addition, we did not receive any systemic carcinogenicity data, which are recommended to support the safety of long-term use of ecamsule. We request that the sponsor provide a systemic carcinogenicity study, as well as make available full final study reports for the previously conducted carcinogenicity studies that were submitted in a summarized form.
FDA recommends conducting DART studies to evaluate the potential effects that exposure to ecamsule may have on developing offspring throughout gestation and postnatally until sexual maturation, as well as on the reproductive competence of sexually mature male and female animals. Gestational and neonatal stages of development may also be particularly sensitive to active ingredients with hormonal activity. For this reason, we recommend that these studies include assessments of endpoints such as vaginal patency, preputial separation, anogenital distance, and nipple retention, which can be incorporated into traditional DART study designs to assess potential hormonal effects of ecamsule on the developing offspring. We also recommend conducting behavioral assessments (
We received study summaries for five developmental and reproductive toxicity assays (Notes 48 through 52), which appear to be negative for the potential to cause adverse developmental or reproductive effects. However, comprehensive data sets were not provided.
We request that the sponsor make available full final study reports, including full comprehensive datasets, to support a final GRASE determination.
We recommend conducting animal toxicokinetic studies because they provide an important bridge between toxic levels seen in animal studies and potential human exposure. Data from these studies can be correlated to potential human exposure via clinical dermal pharmacokinetic study findings. Toxicokinetic data could be collected as part of animal studies being conducted to assess one or more of the safety parameters described previously.
We reviewed single-dose pharmacokinetic studies conducted in animal models which showed that systemic exposure was achieved under the conditions of the conducted studies (Notes 53 and 54). However, we did not receive any pharmacokinetic data reflecting drug levels following long-term exposure, which are usually collected from repeat toxicity studies such as chronic (systemic or dermal) studies. We recommend that a time course toxicokinetic study be conducted following repeat-dose exposure (via the oral and dermal routes) to evaluate the steady-state exposure level of ecamsule. Data obtained from this study could be used to compare drug levels in animals to those in humans under maximal exposure conditions to establish a margin of safety for human exposure.
FDA's evaluation of the effectiveness of active ingredients under consideration for inclusion in an OTC drug monograph is governed by the following regulatory standard: Effectiveness means a reasonable expectation that, in a significant proportion of the target population, the pharmacological effect of the drug, when used under adequate directions
To evaluate the efficacy of ecamsule for use in OTC sunscreen products, FDA requests evidence from at least two adequate and well-controlled SPF studies showing that ecamsule effectively prevents sunburn. To determine that ecamsule is GRAE for use in OTC sunscreens at concentrations in a range with the proposed maximum strength of 10 percent as requested, two adequate and well-controlled SPF studies of ecamsule at a lower concentration should be conducted according to established standards.
The current standard procedure for SPF testing is described in FDA's regulations in § 201.327(i).
Although current sunscreen testing and labeling regulations also specify a “broad spectrum” testing procedure to support related labeling claims for certain OTC sunscreen products marketed without approved new drug applications that contain specific ingredients included in the OTC sunscreen monograph, those additional claims are permitted, but not required, for these products (§ 201.327(c)(2) and (j)). Under current regulations, sunscreen active ingredients need only be effective for the labeled indication of sunburn prevention, for which the SPF test can provide sufficient evidence. Consistent with this approach, we here do not request broad spectrum testing for ecamsule. Broad spectrum protection is often, although not always, the result of the combined contribution of multiple active ingredients in a final sunscreen formulation. Thus, under the current regulations applicable to other sunscreens, the determination of whether an individual sunscreen product may be labeled as broad spectrum and bear the related additional claims is made on a product-specific basis, applying standard testing methods set forth in those regulations. If ecamsule is established to be GRASE for use in nonprescription sunscreens (based in part on the efficacy data requested here), the final sunscreen order can likewise address broad-spectrum testing and related labeling conditions for final sunscreen formulations containing ecamsule.
Study reports were submitted for two studies that assessed SPF of formulations containing ecamsule, at a concentration of either 2 percent or 3 percent (Notes 55 and 56, respectively), in combination with other active ingredients. Neither of these studies provides a direct evaluation of the efficacy of ecamsule alone. These studies were not adequately designed to provide evidence of efficacy on which to base a GRAE determination for ecamsule. No adequately designed studies of ecamsule efficacy were identified in our search of the published literature. To support the finding that ecamsule is GRAE when used at concentrations up to 10 percent, we request submission of data from two adequate and well-controlled SPF studies conducted according to established standards to demonstrate that the lowest selected concentration provides an SPF of 2 or more. Because no study has been identified that assesses the effectiveness of ecamsule at a concentration of 10 percent, it is recommended that such a study be conducted and submitted.
Based on our review of the available safety and efficacy data as discussed previously, we request the types of data listed in this section of the proposed order, at minimum, for us to reverse our tentative determination that ecamsule is not GRASE and is misbranded because the data are insufficient to classify ecamsule as GRASE and not misbranded, and additional data are necessary to allow us to determine otherwise. Note that, in some cases, as discussed in section II of this proposed order, the ecamsule data submission provided some information from nonclinical studies of the type FDA requests as part of the basis for a GRAS determination, but only in summary form. Were complete study data generally available from these previously conducted studies, they might address several aspects of our GRASE consideration. If data from these previously conducted studies are not made available, further studies of those types would be needed to support a finding that ecamsule is GRASE for use in sunscreens. Further, as summarized in the following subsections, some additional studies of other types are needed. For additional information about the purpose and design of studies recommended to address present data gaps, please refer to the earlier sections of this proposed order referenced in parentheses. We welcome discussions on the design of any of the studies prior to their commencement. We request the following types of data:
1. Skin irritation/sensitization, and photosafety (see section II.A.1)
2. Human dermal pharmacokinetic (bioavailability) studies (see section II.A.2)
1. A summary and analysis of all available reported adverse events potentially associated with ecamsule
2. A summary and analysis of all available documented case reports of serious side effects
3. A summary and analysis of any available safety information from studies of the safety and effectiveness of sunscreen products containing ecamsule in humans
4. A summary and analysis of relevant medical literature describing adverse events associated with ecamsule
Alternatively, the results of a literature search that found no reports of adverse events may be provided. In that case, detailed information on how the search was conducted should be provided.
Full study reports will be needed for the following studies:
1. Systemic and dermal carcinogenicity (see section II.B.1)
2. Reproductive and developmental toxicity studies (see section II.B.2)
3. Toxicokinetics (see section II.B.3)
For concentrations of ecamsule up to 10 percent to be found to be GRASE for use in nonprescription sunscreen products as requested, at least two SPF studies showing effectiveness of a selected concentration lower than 10 percent should be conducted. An efficacy study of ecamsule at 10 percent is also recommended.
A copy of this proposed order will be filed in the Division of Dockets Management in Docket No. FDA-2008-N-0474. To inform FDA's evaluation of whether this ingredient is GRASE and not misbranded for use in sunscreen products, we encourage the sponsor and other interested parties to submit additional data regarding the safety and effectiveness of this ingredient for use as an OTC sunscreen product. We also encourage the sponsor and other interested parties to notify us in writing of their intent to submit additional data. However, as noted previously, because the data submitted to date are not sufficient to support a determination that ecamsule is GRASE for use as an active ingredient in OTC sunscreen drug products, at present, OTC sunscreen products containing ecamsule may not be marketed without approval of an NDA or ANDA (see section 586C(e)(1)(A) of the FD&C Act, as amended by the SIA). Data submissions relating to this proposed order should be submitted to Docket No. FDA-2008-N-0474 at the Division of Dockets Management (see
Section 586C(b)(7) of the FD&C Act, as amended by the SIA, provides that the sponsor may, within 30 days of publication of a proposed order (see
FDA proposes that any final administrative order based on this proposal become effective on the date of publication of the final order in the
Similarly, section 586C(b)(6) of the FD&C Act, as amended by the SIA, establishes that a proposed sunscreen order shall provide 45 days for public comment. Interested persons wishing to comment on this proposed order may submit either electronic comments to
1. FDA-2008-N-0474-0012 and FDA-2008-N-0474-0013, Volumes 6 and 7, dated November 14, 2008.
2. FDA-2008-N-0474-0015 and FDA-2008-N-0474-0016, Volumes 9 and 10, dated November 14, 2008.
3. FDA-2008-N-0474-0007, Volume 1, dated November 14, 2008, FDA-2008-N-0474-0006, TEA submission.
4. FDA-2008-N-0474-0008, Volume 2, Study no. 16039/G2347.
5. FDA-2008-N-0474-0014, Volume 8, Study no. V3156.
6. FDA-2008-N-0474-0014, Volume 8, Study no. V99.1203.
7. FDA-2008-N-0474-0014, Volume 8, Study no. CG.03.SRE.2607.
8. FDA-2008-N-0474-0007, Volume 1, dated November 14, 2008.
9. FDA-2008-N-0474-0009, Volume 3, Study no. 3667-109/309, Study no. 1.CG.03.SRE.12160.
10. FDA-2008-N-0474-0009, Volume 3, Study no. 4222-109/310, Study no. 1.CG.03.SRE.12156.
11. FDA-2008-N-0474-0009, Volume 3, Study no. 1.CG.03.SRE.12158, Study no. 1.CG.03.SRE.12157.
12. FDA-2008-N-0474-0009, Volume 3, Study no. 712332, Volume 4, Study no. 712320.
13. FDA-2008-N-0474-0010, Volume 4, Study no. 802410, Study no. 3697-109/313.
14. FDA-2008-N-0474-0010, Volume 4, Study no. 1.CG.03.SRE.12163, Study no. 1.CG.03.SRE.12164.
15. FDA-2008-N-0474-0010, Volume 4, Study no. RDA.03.SRE.12268.
16. FDA-2008-N-0474-0009, Volume 3, Study no. 93/LOL/007/0971.
17. FDA-2008-N-0474-0009, Volume 3, Study no. 1.CG.03.SRE.12183.
18. FDA-2008-N-0474-0011, Volume 5, Study no. G185-109/314.
19. FDA-2008-N-0474-0011, Volume 5, Study no. G220-109/381, Study no. G220-109/381A, Study no. 12174MIC, Study no. 413/52-D6172.
20. FDA-2008-N-0474-0011, Volume 5, Study no. 12639MAR.
21. FDA-2008-N-0474-0011, Volume 5, Study no. EU1REBRP.031.
22. FDA-2008-N-0474-0011, Volume 5, Study no. LRL 170/921503.
23. FDA-2008-N-0474-0011, Volume 5, Study no. ICHUREBRP.031.
24. FDA-2008-N-0474-0010, Volume 4, Study no. 1.CG.03.SRE.12181.
25. FDA-2008-N-0474-0011, Volume 5, Study no. 1.CG.03.SRE.12182.
26. FDA-2008-N-0474-0011, Volume 5, Study no. 10297 RSL.
27. FDA-2008-N-0474-0010, Volume 4, Study no. 1412 RMR/064.89.
28. FDA-2008-N-0474-0011, Volume 5, RCC Project 682874.
29. FDA-2008-N-0474-0010, Volume 4, Study no. 95/LOL/008/1217, Study no. LOL/011/980150.
30. FDA-2008-N-0474-0010, Volume 4, Study no. C-1012-001, Study no. RDS.03.SRE.12215.
31. FDA-2008-N-0474-0009, Volume 3, Study no. 10225PAR, Study no. 1.CG.03.SRE.12269/RDS.03.SRE.12269.
32. FDA-2008-N-0474-0009, Volume 3, Study no. 10507 PAS, Study no. RDS.03.SRE 12268, Study no. RDS.03.SRE.12269/1.CG.03.SRE.12269.
33. FDA-2008-N-0474-0009, Volume 3, Study no. 2.CG.03.SRE.11029.
34. FDA-2008-N-0474-0009, Volume 3, Study no. 1.CG.03.SRE.12270.
35. FDA-2008-N-0474-0011, Volume 5, Study no. G185-109/314.
36. FDA-2008-N-0474-0011, Volume 5, Study no. G220-109/381.
37. FDA-2008-N-0474-0011, Volume 5, Study no. G220-109/381A.
38. FDA-2008-N-0474-0011, Volume 5, Study no. 12174MIC.
39. FDA-2008-N-0474-0011, Volume 5, Study no. 413/52-D6172.
40. FDA-2008-N-0474-0011, Volume 5, Study no. 12639MAR.
41. FDA-2008-N-0474-0011, Volume 5, Study no. EU1REBRP.031.
42. FDA-2008-N-0474-0011, Volume 5, Study no. LRL 170/921503.
43. FDA-2008-N-0474-0011, Volume 5, Study no. ICHUREBRP.031.
44. FDA-2008-N-0474-0010, Volume 4, Study no. 95/LOL/008/1217.
45. FDA-2008-N-0474-0010, Volume 4, Study no. LOL/011/980150.
46. FDA-2008-N-0474-0010, Volume 4, Study no. C-1012-001.
47. FDA-2008-N-0474-0010, Volume 4, Study no. RDS.03.SRE.12215.
48. FDA-2008-N-0474-1000, Volume 4, Study no. 1.CG.03.SRE.12181.
49. FDA-2008-N-0474-0011, Volume 5, Study no. 1.CG.03.SRE.12182, Study no. 1412 RMR/064.89.
50. FDA-2008-N-0474-0011, Volume 5, RCC Project 682874.
51. FDA-2008-N-0474-0011, Volume 5, RCC Project 682874.
52. FDA-2008-N-0474-0011, Volume 5, Study no. 1.CG.03.SRE.12182.
53. FDA-2008-N-0474-0009, Volume 3, Study no. 10225PAR.
54. FDA-2008-N-0474-0009, Volume 3, Study no. 1.CG.03.SRE.12269/RDS.03.SRE.12269.
55. FDA-2008-N-0474-0017, Volume 11, Study no. PEN.810.02.
56. FDA-2008-N-0474-0017, Volume 11, Study no. PEN.810.06.
The following references have been placed on display in the Division of Dockets Management (see
1. FDA, Guidance for Industry, “Photosafety Testing,” May 2003 (available at
2. Leonard, F., B. Kalis, H. Adamski, et al., “The New Standard Battery of Photopatch Test in France.”
3. Schauder, S., and H. Ippen, “Contact and Photocontact Sensitivity to Sunscreens. Review of a 15-Year Experience and of the Literature.”
4. Schmidt, T., J. Ring, and D. Abeck, “Photoallergic Contact Dermatitis Due to Combined UVB (4-Methylbenzylidene Camphor/Octyl Methoxycinnamate) and UVA (Benzophenone-3/Butyl Methoxydibenzoylmethane) Absorber Sensitization.”
5. FDA, Guidance for Industry, “Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application,” February 1987 (available at
6. International Conference on Harmonization (ICH), Guidance for Industry, “The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A,” March 1996 (available at
7. ICH, Guidance for Industry, “S1B Testing for Carcinogenicity of Pharmaceuticals,” July 1997 (available at
8. ICH, “S1C(R2) Dose Selection for Carcinogenicity Studies” (Revision 1), September 2008 (available at
9. ICH Harmonized Tripartite Guideline for Industry, “Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2),” 2005 (available at
10. ICH, Guideline for Industry, “Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A,” March 1995 (available at
United States Agency for International Development.
Notice of Charter Renewal.
Pursuant to the Federal Advisory Committee Act, notice is hereby given of the renewal of the Charter of the President's Global Development Council.
The President's Global Development Council brings together representatives of a variety of sectors, including, among others, institutions of higher education, non-profit and philanthropic organizations, civil society, and private industry to inform U.S. global development policy and programs and to support new and existing public-private partnerships to advance the global development policy agenda.
The Charter is being renewed for two years effective from the date of filing on February 20, 2015.
Jayne Thomisee, 202-712-5506
President's Global Development Council (Council).
Executive Order 13600 of February 9, 2012 provided the authority to establish the President's Global Development Council. The Council is established in accordance with the provisions of the Federal Advisory Committee Act (FACA) as amended, 5.U.S.C. App.
Executive Order 13652, Continuation of Certain Federal Advisory Committees, dated September 30, 2013, authorized the continuation of the Global Development Council until September 30, 2015.
To advise and support the President, through the National Security Staff/National Economic Council staff, in furtherance of the policy set forth in the Executive Order establishing the Global Development Council and the President's Policy Directive on Global Development.
To inform the policy and practice of U.S. global development policy and programs by providing advice to the President and other senior officials on issues including:
(i) Innovative, scalable approaches to development with proven demonstrable impact, particularly on sustainable economic growth and good governance;
(ii) Areas for enhanced collaboration between the Federal Government and public and private sectors to advance development policy;
(iii) Best practices for and effectiveness of research and development in low and middle income economies; and
(iv) Long-term solutions to issues central to strategic planning for U.S. development efforts.
To support new and existing public-private partnerships by:
(i) Identifying key areas for enhanced collaboration and any barriers to collaboration; and
(ii) Recommending concrete efforts that the private and public sectors together can take to promote economic development priorities and initiatives; and
(iii) Increase awareness and action in support of development by soliciting public input on current and emerging issues in the field of global development as well as bringing to the President's attention concerns and ideas that would inform policy options.
The Council reports to the President through the National Security Staff and the National Economic Council.
Support to the Council is provided by staff of the Office of the Administrator at USAID.
The annual operating costs in dollars and person-years for the Council and subcommittees thereof are estimated to be approximately $250,000 and one staff year respectively.
The Designated Federal Officer (DFO) for the Council is the Executive Director of the President's Global Development Council. The Chair, in coordination with the National Security Staff/National Economic Staff, shall convene and preside at meetings, determine the agendas, and direct the Council's work. The DFO will assist the Chair and the National Security Staff/National Economic Staff in calling all of the advisory committee meetings, preparing all meeting agendas, attending Council meetings, and adjourning meetings.
It is expected that the Council will hold approximately two public meetings annually. It's subcommittees and/or working groups, as and if requested by the Council, will meet as determined necessary.
The need for this advisory committee is continuing; however, this charter is subject to renewal every two years.
The Council shall terminate on September 30, 2015, two years after the date of Executive Order 136562 unless renewed by the President.
The membership of the Council shall be as follows:
(a) The Council shall be composed of the officials described in paragraph (b) of this section and not more than 12 individuals from outside the Federal Government appointed by the President. Appointed members of the Council may serve as representatives of a variety of sectors, including, among others, institutions of higher education, non-profit and philanthropic organizations, civil society, and private industry.
(b) The Secretary of State, the Secretary of the Treasury, the Secretary of Defense, the USAID Administrator, the Chief Executive Officer of the Millennium Challenge Corporation, the United States Trade Representative, and the Chief Executive Officer of the Overseas Private Investment Corporation shall serve as non-voting members of the Council and may designate, to perform the Council functions of the member, a senior-level official who is part of the member's department, agency, or office, and who is a full-time officer or employee of the Federal Government.
The Council, in coordination with USAID, may create subcommittees and/or working groups as necessary. These subcommittees/working groups shall report back to the Council and not directly to a federal officer or agency.
The records of this Committee, all formally and informally established subcommittees/working groups shall be handled in accordance with General Records Schedule 26, Item 2, or other approved agency records disposition schedule. These records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552 and will be posted on the Council's Web site.
February 20, 2015.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the 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 burden 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 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.
Comments regarding this information collection received by March 27, 2015 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street, NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the 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 burden 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 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.
Comments regarding this information collection received by March 27, 2015 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street, NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the 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 burden 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 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.
Comments regarding this information collection received by March 27, 2015 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street, NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Food and Nutrition Service (FNS), USDA.
Notice; request for information.
This is a request for information from Management Information Systems (MIS) software and hardware vendors and developers (“vendors”) to learn about the functionality of State and School Food Authority National School Lunch and School Breakfast Program (NSLP/SBP) data management information systems. It is not a request for proposal and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned. All responses will become part of the public record and will not be held confidential.
The United States Department of Agriculture (USDA) is seeking information that will inform future data reporting requirements for the Department's oversight and management of NSLP/SBP. The Department is aware that all States and many school districts have installed and implemented MIS or other technology solutions to improve State and local program management. To better understand the availability and implementation of these solutions, USDA is requesting information from vendors about NSLP/SBP data systems they offer and have deployed at the State and local levels.
The objectives of this request for information (RFI) are to:
1. Obtain background data to inform later research on State and School Food Authority (SFA) NSLP/SBP data management information systems.
2. Describe the functionality and capabilities of systems currently in use by State agencies and SFAs, or available to States and SFA for purchase.
3. Describe the typical costs of system development, installation, maintenance, and upgrades.
4. Identify which States and SFAs are using particular systems.
To be assured of consideration, written comments must be submitted or postmarked on or before April 27, 2015.
The Food and Nutrition Service, USDA, invites the submission of the requested information through one of the following methods:
•
•
• Comments may also be emailed to
All information properly and timely submitted, using one of the three methods described above, in response to this request for information will be included in the record and will be made available to the public on the Internet at
All written comments will be open for public inspection at the FNS office located at 3101 Park Center Drive, Alexandria, Virginia, 22302, Room 1014, during regular business hours (8:30 a.m. to 5:00 p.m., Monday through Friday). All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will be a matter of public record.
Requests for additional information or copies of this request for information should be directed to Dennis Ranalli at
The current Food and Nutrition Service (FNS) routine data collection requirements for the National School Lunch Program and School Breakfast Program (NSLP/SBP) have their roots in the paper and early computer eras and reflect concerns with paperwork and reporting burden. Thus, data collected to administer and monitor these programs is typically reported at the State level, with detailed data collected at the service delivery point (
FNS recognizes that, in fact, managing a school food service program is a complex and data intensive operation, and that SFAs collect, generate, and maintain far more data than they report to their State child nutrition agencies. This includes data on costs, revenues, inventories, vendor management, and other business, administrative and regulatory activity. The same is true of State agencies that are responsible for monitoring the work of many SFAs. Some States and SFAs have developed more sophisticated data management systems to manage program data, however there is no comprehensive inventory of NSLP/SBP management information systems (MIS) in use, the number of States and SFAs that use MIS, or the data elements collected to support FNS reporting and general program management.
The
FNS requests that vendors respond in detail to the items below. Vendors are encouraged to provide any material that addresses the information requested or any other information that may be pertinent. Additional references or links to materials are welcome.
a. Name of Company
b. Address and Telephone Number
c. Vendor Representative, contact number and email address
Briefly describe your company, your products and services, history, and ownership; for example:
a. Web site address
b. Main product/services
c. Main market/customers
d. Company location(s)
e. Product deployment sites/school systems
1. Number of School District/schools currently deployed
2. Average/typical size of the school system
3. Year of first deployment
4. Years serving schools
a. List and describe the core modules provided by your product. For example:
1. Point of Sale/Service (POS)
2. Prepayment system(s) for parents
3. Nutrient Analysis and Menu Planning
4. Inventory Management
5. Purchasing/Vendor Management
6. Production Records
7. Financial Management
8. Free and Reduced-Price Meals Applications
• Scanning paper applications
• Processing On-line applications
• Making eligibility determinations
• Creating benefit issuance documents
• Conducting verification
9. Direct Certification
• SNAP recipients
• Extended SNAP household members
• Other direct certification—homeless, migrant, foster
10. Meal counting and claiming
11. Administrative Review
12. Reporting
13. Any other not listed above
b. Describe the capabilities and reporting functionalities of your product.
c. Describe your platform—site-based, central office w/satellite, cloud-based, etc.
d. For SFAs, are POS terminals proprietary or third-party?
e. Is your system a commercial off the shelf (COTS) product with application in multiple industry segments or school nutrition specific?
f. Does your firm rely on any `third party software products/systems' for implementation and/or operation?
g. Are any additional licenses required from `third party sources' to utilize your product?
h. What is your product's ability to interface with other vendor systems? What level of customization is available?
i. List the minimum and recommended hardware requirements to implement and utilize your product at each level of installation.
j. Describe the interface capabilities between your product and various within-district student data base systems.
k. Describe the interface capabilities between your product and State agency systems.
l. Does your system adhere to Schools Interoperability Framework (SIF) standards?
m. Please provide a list of data elements captured/stored by your product. For example:
1. Name of the data element
2. Description of the data element
3. Possible values
n. Describe the processes/procedures/steps associated with planning, installation, setup, data import and conversion, data migration, quality assurance, deployment, and roll-out for your product.
a. Describe your model for providing customer support, including charge/cost structure (
b. Describe your incident reporting and tracking systems, and the ability for customer staff to access those systems directly.
c. List the types of support access that are available (web, email, chat, telephone etc.).
d. Describe the communication and escalation processes/protocols in the event of failure, network outages, degraded service, and/or exceeded planned utilization.
e. Describe your replication, archival and retrieval processes, including your disaster recovery model.
f. Describe the warranty and maintenance plan(s) for your product. Have there been recent upgrades or updates to your product? How often do you typically develop and release upgrades?
g. Is your support agreement integrated into the license agreement?
h. Describe your understanding and system approach to privacy rules, specifically those related to children and students (Children's Online Privacy Protection Act, Family Educational Rights and Privacy Act, etc.).
i. Describe your process for upgrading your product to meet federal and state regulations.
j. Does your product support access through smartphones, tablets, laptops etc.?
a. Describe your pricing models relevant to each component of your product.
b. Is your pricing model based on purchasing the entire product or individual module(s), or is it based on usage/users?
c. Describe the upgrade process and cost to upgrade.
d. List any additional pricing/cost information that would be useful to evaluate the affordability of the product.
a. What type of technical training do you provide?
b. Describe your product's documentation and in-program help?
Office of the Under Secretary for Food Safety, USDA.
Notice of public meeting and request for comments.
The Office of the Under Secretary for Food Safety, U.S. Department of Agriculture (USDA) is sponsoring a public meeting on February 25, 2015. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 29th Session of the Codex Committee on General Principles (CCGP) of the Codex Alimentarius Commission (Codex), which will take place in Paris, France, March 9-13,2015. The Deputy Under Secretary for Food Safety recognizes the importance of providing interested parties the opportunity to obtain background information on the 29th Session of CCGP and to address items on the agenda.
The public meeting is scheduled for Wednesday, February 25, 2014 from 1-4 p.m.
The public meeting will take place at the South Building, United States Department of Agriculture (USDA), 1400 Independence Ave SW., Room 1160, Washington, DC 20250. Documents related to the 29th Session of CCGP will be accessible on-line at the following address:
Mary Frances Lowe, U.S. Delegate to the 29th Session of CCGP, invites interested U.S. parties to submit their comments electronically to the following email address:
If you wish to participate in the public meeting for the 29th Session of CCGP by conference call on February 25, 2015, please use the call-in number and participant code listed below:
Call-in Number: 1 (888) 844-9904
Participant code: 5126092
Attendees may register by emailing
Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
The CCGP is responsible for dealing with procedural and general matters referred to it by Codex, for proposing amendments to the Codex Procedural Manual, and for reviewing and endorsing procedural provisions and texts forwarded by Codex Committees for inclusion in the Procedural Manual.
The Committee is hosted by France.
The following items on the agenda for the 29th Session of CCGP will be discussed during the public meeting:
• Matters Referred to the Committee
• Proposed amendments to the Terms of Reference of CCGP
• Proposed amendments to the Procedures for the Elaboration of Codex Standards and Related Texts
• Consistency of the Risk Analysis Texts across the Relevant Committees
• Codex Work Management and Functioning of the Executive Committee
• Other Business
Each issue listed will be fully described in documents distributed, or to be distributed, by the Secretariat prior to the Committee meeting. Members of the public may access or request copies of these documents (see
At the February 25, 2015, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Mary Frances Lowe, U.S. Delegate for the 29th Session of CCGP (see
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which is available accessed on-line at
U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
(202) 690-7442.
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Forest Service, USDA.
Notice of proposed fee increase on Christmas tree permits.
The Sawtooth National Forest is proposing to increase the fee for Christmas tree permits from $5.00 to $10.00 per tag. The fee is proposed and will be determined upon further analysis and public comment. Funds from fees would be used for the continued operation, visitor services, maps, and law enforcement while issuing and enforcing Christmas tree permits.
Comments will be accepted through May 30, 2015. Increased fees would begin November 2015 for Christmas tree permits.
Kit Mullen, Forest Supervisor, Sawtooth National Forest, 2647 Kimberly Road East, Twin Falls, Idaho 83301.
Jennifer Blake, Recreation Fee Coordinator, by phone at 208-737-3216 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 Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the
Once public involvement is complete, the fee increases will be reviewed by a Recreation Resource Advisory Committee prior to a final decision and implementation.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
The first round of the application process is completed via an on-line application through the Student Information System which collects basic biographical information about the student. This information is reviewed and finalists are invited to submit secondary materials via email to
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
On October 20, 2014, Epson Portland, Inc. (EPI) submitted a notification of proposed revision to existing production authority to the Foreign-Trade Zones (FTZ) Board for EPI's facility in Hillsboro, Oregon, within Subzone 45F.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce.
On August 21, 2014, the Department of Commerce (“the Department”) published its preliminary results of the administrative review of the antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET film) from Taiwan.
Milton Koch or Toni Page at (202) 482-2584, or (202) 482-1398, respectively; AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.
On August 21, 2014, the Department published the
The products covered by the antidumping duty order are all gauges of raw, pretreated, or primed polyethylene terephthalate film, sheet, and strip, whether extruded or coextruded. Excluded are metalized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer of more than 0.00001 inches thick. Imports of polyethylene terephthalate film, sheet, and strip are currently classifiable in the Harmonized Tariff Schedule of the United States (“HTSUS”) under item number 3920.62.00.90. HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the antidumping duty order is dispositive.
The sole issue raised in the case and rebuttal briefs by parties regarding differential pricing methodology is addressed in the Issues and Decision Memorandum, which is dated concurrently with these final results and incorporated herein by reference.
Based on our analysis of the comments received, we have made no adjustments to the margin calculations for Nan Ya.
We determine that Nan Ya's weighted-average dumping margin is 1.56 percent for entries of subject merchandise that were produced and/or exported by Nan Ya and that entered, or were withdrawn from warehouse, for consumption during the period July 1, 2012, through June 30, 2013.
The Department shall determine, and U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review. For any individually examined respondents whose weighted-average dumping margin is above
The following deposit requirements will be effective for all shipments of PET film from Taiwan entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided for by section 751(a)(2)(C) of the Tariff Act of 1930, as amended (“the Act”): (1) The cash deposit rate for Nan Ya will be the rate established in the final results of this review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and, (4) if neither the exporter nor the manufacturer is a firm covered in this or any previous review, the cash deposit rate will be the all others rate for this proceeding, 2.40 percent, as established in the less-than-fair-value investigation.
We will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
This notice is the only reminder to parties subject to the administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
These final results of administrative review and notice are published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).
Notice of Application to Amend the Export Trade Certificate of Review Issued to California Almond Export Association, LLC (“CAEA”), Application No. (99-8A005).
The Office of Trade and Economic Analysis (“OTEA”) of the International Trade Administration, Department of Commerce, has received an application to amend an Export Trade Certificate of Review (“Certificate”). This notice summarizes the proposed amendment and requests comments relevant to whether the amended Certificate should be issued.
Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) (“the Act”) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325 (2014). Section 302(b)(1) of the Export Trade Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the
Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.
An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Export Trading Company Affairs, International Trade Administration, U.S. Department of Commerce, Room 21028, Washington, DC 20230.
Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the amended Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 99-8A005.”
International Trade Administration, Department of Commerce.
Replacement of Trade Mission Statement.
The United States Department of Commerce, International Trade Administration is replacing a notice published June 14, 2014, at 79 FR 36290, for the Trade Mission to South Africa and Mozambique, With an Optional Stop in Kenya; February 23-27, 2015.
Replacement of Trade Mission Statement.
The United States Department of Commerce, International Trade Administration is replacing its Trade Mission to South Africa and
The U. S. Department of Commerce, International Trade Administration, is organizing a Trade Mission to Mozambique, Kenya and South Africa, June 18-26, 2015, which will be led by a senior executive of the U.S. Department of Transportation. The mission is designed to help U.S. firms find business partners and sell equipment and services. Target sectors holding high potential for U.S exporters include:
Transportation Infrastructure and Equipment, such as: road, bridge and dam construction and reconstruction; automatic fare collection systems, new and refurbished railroad locomotives, new bulk car and other dedicated rolling freight fleets, smart signaling and rail operation automation, rolling stock depot design, strategic route design and network planning, port mobile, weighbridges and quayside systems and upgrading of existing port equipment and oil and gas development infrastructure.
Energy Equipment and Services, such as: power generation (including renewable energy); transmission and distribution (including smart grid), energy efficiency, oil and gas exploration and production and project development.
Agricultural Equipment, such as: crop production equipment and machinery, irrigation equipment and technology, crop storage and handling, precision farming technologies and fertilizers.
Although focused on the sectors above, the mission also will consider participation from companies in other appropriate sectors as space permits.
This trade mission will include one-on-one business appointments with pre-screened potential buyers, agents, distributors and joint venture partners; meetings with national and regional government officials, chambers of commerce, and business groups; and networking receptions. The mission will help participating firms and trade associations gain market insights, make industry contacts, solidify business strategies, and advance specific projects, with the goal of increasing U.S. exports to Mozambique, Kenya and South Africa.
Mozambique, with a population of 23 million, grew its economy from 1994 to 2009 at an average rate of eight percent per year—one of the fastest rates of growth of any sub-Saharan African economy over this period. In 2013, GDP reached $15 billion. While the country was devastated after the civil war ended in 1992, it has since benefited from macroeconomic reforms and large foreign investment projects.
Though infrastructure remains weak and the population is still largely rural, the government is committed to building a strong commercial environment. The United States has traditionally been a relatively minor trading partner, but U.S. investment in the energy sector, particularly off-shore natural gas, is expected to grow tremendously in the next several years. External competition, local labor quotas, periodic flooding, and an often-contentious political situation present some challenges to doing business in Mozambique.
Kenya, with a population of 43 million, is the dominant economy in the East African Community. Given its position as the economic, commercial, and logistical hub of East Africa, more U.S. companies are investing in Kenya and setting up local and regional operations there. Kenya's first election under a new constitution with a devolved government structure was held in April 2013, and should position it for further growth. Investor confidence is high, as demonstrated by Kenya's record-breaking $2 billion debut sovereign bond offering in 2014.
Kenya also boasts a large number of well-educated English-speaking and multi-lingual professionals, and a strong entrepreneurial tradition. Doing business in Kenya includes a number of challenges, such as crime, unemployment, limited infrastructure, and corruption.
South Africa, a country of 52 million people, has the most advanced, broad-based industrial economy in Africa, enjoys relative macroeconomic stability and boasts sound financial, legal and accounting institutions; not to mention an English-speaking workforce. It remains the primary choice for U.S. companies wishing to develop the promising markets of sub-Saharan Africa, although it suffers from large disparities in income distribution and over 25 percent unemployment. In 2014 South Africa's GDP grew by less than two percent to $357 billion. Doing business in South Africa includes a number of challenges including corruption and power shortages, as well as a series of protectionist policies that has precipitated a series of downgrades by the major credit agencies.
Transport networks and infrastructure will be instrumental to developing Mozambique's growth potential in the near and long term. The recently concluded $500 million Millennium Challenge Corporation compact funded extensive rehabilitation of key roads, a dam, and a water supply project in two northern provinces. The Government of Mozambique is investing heavily in expanding rail and port capacity to manage the rising production of mineral resources. A rail line to the deepest natural port on the East Coast of Africa should significantly lower coal transport costs, and two foreign companies have recently been contracted to begin work on a new rail line ending at Macuze port. As total coal exports are projected to reach 40 million tons per year by 2015 and long term estimates are in the range of 100 million tons per year, infrastructure around this sector remains a priority. In addition, rapid investment in infrastructure to support planned liquefied natural gas (LNG) projects in northern Mozambique, one of its least developed regions, could bring vast opportunities to U.S. firms.
Kenya enjoys an extensive, but uneven, infrastructure that is still superior in many cases to that of its neighbors. Nairobi is the undisputed transportation hub of Eastern and Central Africa and the largest city between Cairo and Johannesburg. The Port of Mombasa is the most important deep-water port in the region, supplying the shipping needs of more than a dozen countries despite persistent deficiencies in equipment, inefficiency and corruption. As a result of these deficiencies, the Port of Mombasa has been earmarked for major expansion and re-habilitation.
Kenya's “Vision 2030” infrastructure development plans call for significant improvements to the provision of water, renewable energy, ICT, housing, roads, bridges, railways, seaports and airports over the next 20 years. The construction industry in Kenya is driven primarily by two key infrastructure sectors: Transportation and housing, given the large housing deficit that exists in Kenya. Construction and infrastructure development will also present new opportunities, especially with the
South Africa's Transnet, the largest State Owned Enterprise (SOE) within the Department of Public Enterprises (DPE) has announced and allocated funding for significant transportation infrastructure capital investments. In 2012, the government announced the allocation of funding for investments estimated at over $90 billion over 15 years. Though there have been complaints of slow implementation, leading some contractors to re-focus business elsewhere in the continent, in late 2013 and early 2014 commitments were made to procure passenger rolling stock, locomotives, signaling and track upgrades. Also, the development of the significant Durban phase 2 port extension (in the old Durban International Airport precinct) has been initiated.
The Passenger Rail Agency of South Africa (Prasa) of the SA Department of Transport (SADOT) in March 2012 announced a 20-year rail improvement program estimated at more than $13.6 billion. Of this, $1.3 billion will be invested in signaling, new depots, modern stations and integrated ticketing, while $1.1 billion is being spent on new locomotives.
SOE Transnet Freight Rail (TFR) and others are expanding logistics projects such as upgrading the Sishen-Saldanha Bay ore line, the Richard Bay coal line and other new coal line networks in the northwest. Transnet's rail and port projects are reportedly set to cost around $30 billion over seven years and include augmenting the tractive and bulk car fleet, signaling, maintenance, advanced train management systems and network expansion/concession models. For the second large diesel locomotive program of 465 units, one U.S. and one Chinese manufacturer were selected as preferred bidders in February 2014.
Transnet Port Terminals (TPT), the port operating SOE is set to invest $3.3 billion over the next seven years for the expansion and improvement of its bulk and container terminals. Significant capacity-creating projects included the expansion of the Durban Container Terminal's (DCT's) Pier 1 that would increase its capacity from 700,000 twenty-foot equivalent units (TEUs) to 820,000 TEUs by 2013 and 1.2 million TEUs by 2016/17. Other expansion projects include the Ngqura Container Terminal, Durban Ro-Ro and Maydon Wharf terminal, the iron-ore bulk terminal at the Port of Saldanha and the ageing Richards Bay Terminal where $370 million is set aside for mobile and quayside equipment, as well as weighbridges.
Mozambique is set to become one of the world's largest new suppliers of natural gas. The country's massive offshore discoveries have launched a scramble among exploration and production companies to develop these new-found resources. In early 2014, the Oil and Gas Journal raised Mozambique's proven reserves to 100 trillion cubic feet (Tcf), making it the third-largest proved natural gas holder in Africa. Although much of the Mozambique's offshore acreage still remains underexplored, one U.S. company already has announced recoverable finds totaling some 45-65 Tcf. The country's rich resources could support up to ten LNG trains in one province alone, and a floating LNG facility is under consideration. Developers focusing on Mozambique's LNG infrastructure expect to begin exporting as early as 2018. Additionally, although the United States exported only $25 million of oil and gas field equipment to Mozambique in 2013, this is up from $1 million only five years prior and comprises about 19 percent of the country's relatively small total of $132 million for that year. More than 80 percent of U.S. exports to Mozambique are in pipe products, indicating the early stages of the industry.
Mozambique is a net exporter of energy. But in order to support its growing economy the country requires significant investment to upgrade old infrastructure and conclude new generation projects. The majority of power produced in the country comes from the Cahora Bassa hydro-power scheme in central Mozambique, where the government plans a multi-million dollar “North Bank” expansion. It will add an additional 1,250 MW with transmission lines to South Africa, the South African Power Pool, Maputo, and Northern Mozambique. Planning for a second multi-billion dollar, 1,500-plus MW hydropower dam 35 miles downstream at Mphanda Nkuwa is well underway, and the operators are expected to finalize financing this year, with commercial operations due to start as early as 2017. The government of Mozambique recently approved new renewable feed-in tariffs as part of an ongoing strategy to promote private investment in renewable energy sources.
In response to strong economic growth and increasing demand for electricity, Kenya is focused on developing its power generation and transmission and distribution infrastructure. Today, Kenya is faced with brownouts, blackouts, and power surges that damage equipment and necessitate emergency power, driving up the cost of electricity. The supply deficit and costly short-term solutions impede economic growth, and reduce the competitiveness of Kenya's private sector in the region. With only 25 percent of the population connected to the grid, the Kenyan government is currently implementing a plan to connect an additional 5,000MW to the grid to meet growing demand and help reduce electricity tariffs by 40 percent by 2017, with a goal of achieving universal access by 2030.
In ITA's Renewable Energy Top Markets for U.S.-Exports 2014-2015, Kenya was ranked 13th most promising export market for U.S. renewable energy companies, and first in the geothermal sector, which makes up about 22 percent of Kenya's energy mix (about 583 MW). More than 40 wells per year currently are being drilled, with a target of developing over 5,000 MW, approximately half of its capacity, in the next two decades. Kenya has extensive plans to increase other renewables as well. The country is gradually diversifying its energy mix and is keen to wean off expensive thermal diesel power, whose supply is impacted by recurring droughts; and thermal power, which is sensitive to global fuel prices.
Kenya is also an increasingly promising player in the booming East Africa oil and gas market. The multiple onshore discoveries announced since 2012, largely in Turkana County, have led exploration and production companies to sound optimistic notes about the country's potential. The greatest enthusiasm surrounds offshore resources, where drillers hope to replicate Mozambique and Tanzania's vast natural gas discoveries. To date, Kenya's oil resources are estimated to be 600 million barrels, with at least one firm projecting that Kenya's resource base could amount to as much as 10 billion barrels, though exploration is still in the early stages. While movement on key planned infrastructure projects, such as the $25 billion Lamu Port, South Sudan Ethiopia, Transport (LAPSSET) Corridor, has been slow, if all goes smoothly, a Uganda-Kenya pipeline could be completed by as early as 2019.
Electricity supply constraints are significant and are expected to remain a feature of South Africa's social and economic landscape for several years to come. ESKOM, the government owned power utility, with a virtual monopoly on generation, transmission and distribution (responsible for around 95 percent of local generation) is experiencing budgetary and infrastructure challenges. As a result of these challenges, the government has put a renewed focus on the increased generation of power, increased energy efficiency and decreased consumption. ESKOM's reserve of power has recently become so low that it has been forced to utilize its contractual rights with large industrial users to require them to reduce consumption at critical times, and it has implemented scheduled brownouts or “load-shedding” outages for all users. It has also been forced to use expensive diesel to power generators at peak load periods. Though there is current and planned infrastructure investment to ensure future supply, there have been significant delays in bringing these planned power generation facilities on line.
ESKOM is currently investigating smart grid as an option to manage peak load demand. Renewable energy programs have also been introduced in order to facilitate clean renewable independent energy production. The government's Renewable Energy Independent Power Producer Procurement program (REIPPP) has been relatively successful and marks the first time independent power producers have been allowed to sell power back to the grid. In ITA's Renewable Energy Top Markets for U.S.-Exports 2014-2015, South Africa was ranked 12th; however, local content requirements, which have increased in recent months, may limit potential U.S. exports.
Further capital expenditure is ongoing with the two large scale coal-fired plants under construction—Medupi Power Station (4,800 MW) and Kusile Power Station (4800 MW)—as well as a pumped storage project (1,332 MW) and a wind energy facility (1,00MW). With on-going power outages, the government of South Africa has also recently opened bids to independent power producers for the provision of 2,500 MW of base-load (coal) power.
South Africa boasts the world's eighth largest supply of technically recoverable shale gas resources, according to the U.S. Department of Energy's Energy Information Administration. In 2012, the government lifted a moratorium on exploring the country's estimated 390 trillion cubic feet (tcf) of unconventional deposits. While licenses have yet to be issued, President Zuma announced in June 2014 that the government would proceed with shale gas development plans, indicating the government's willingness to move forward with development in the sector.
South Africa has announced plans to add 9,600 MW of nuclear power over the next twenty years and the government is in talks with multiple countries about resources to develop South Africa's civil nuclear energy program. The country currently has two nuclear reactors that generate 5 percent of its electricity.
Mozambique has vast needs and vast opportunities in the agriculture sector. Boasting a landmass about the size of Texas and Louisiana combined, a coastline longer than the eastern seaboard of the United States, and a geographic location well-positioned to export to burgeoning Asian markets, agriculture is still small-scale and subsistence. Growth in agriculture has lagged in relation to GDP growth, largely due to the lack of mechanization and irrigation. Opportunities for U.S. companies vary from cold storage, irrigation and food processing equipment.
Mozambique recognizes agriculture as the key to poverty reduction and employment and is focused on policy reforms to attract more private sector investment. The Government of Mozambique is committed to promoting the use of technology, irrigation, and improved methods to raise yields. This commitment has resulted in plans by U.S. and other foreign agribusiness companies to establish commercial farms.
Agriculture remains the backbone of Kenya's economy. It accounts for about 24 percent of GDP directly and 75 percent of the labor force indirectly. Cash crop (tea, coffee, and horticulture), food crops (maize, wheat and rice), and livestock dominate the agricultural sector. Kenyan agriculture faces many challenges. It is predominately rainfall dependent and thus subject to wide production variances. It is undercapitalized, implying low technological absorption resulting in low productivity. Small-scale farmers contribute about 75 percent to the country's total value of agricultural output and account for nearly 85 percent of total employment in the agricultural sector. These attributes, coupled with challenges arising from limited institutional capacity, poor infrastructure, and risks associated with liberalized markets, explain the relative stagnation of agricultural productivity and incomes.
Kenya's horticulture industry is a major export success in Africa. It is almost entirely dominated by the private sector and provides many opportunities for increased importation of fertilizers, pesticides and equipment. Similar opportunities lie in the floriculture industry in Kenya, which is the leading exporter of fresh cut flowers to the flower auction in Holland. Other important commodities include maize, tea, coffee, sugarcane and wheat, which will require additional use of fertilizers as production grows. The government has embarked on a mechanization program to increase use of more modern means of farming to increase output. In addition, the government has set aside 1.2 million acres of land for irrigation that for growing maize and wheat, and livestock farming. Agricultural equipment is tax exempt under the VAT Act 2013 to provide support to the sector.
Kenya imports virtually all of its agricultural chemicals because local production is insignificant. Kenya's fertilizer use has almost doubled since the liberalization of the market in the 1990s and the removal of government price controls and import licensing quotas. The growth in use has been noted especially among the smallholder farmers in growth of both food crops (maize, domestic horticulture) and export crops (tea, coffee). Growth in the industry is largely due to huge private investment in both importation and retailing of fertilizers. Fertilizer is also tax exempted under the new VAT Act.
South Africa has by far the most modern, productive and diverse agricultural economy in Sub Saharan Africa. Agriculture in South Africa remains an important sector despite its relatively small contribution to the GDP. The sector plays an important role in terms of job creation, especially in rural areas, but is also a foremost earner of foreign exchange.
South Africa has a market-oriented agricultural economy that is highly diversified, including production of all the major grains (except rice), oilseeds, deciduous and subtropical fruits, sugar, citrus, wine and most vegetables. Livestock production includes cattle, dairy, pigs, sheep, and a well-developed broiler and egg industry. Value-added
South Africa offers U.S. exporters in the agricultural equipment and technology sector a wide range of opportunities. Five percent of all new agriculture equipment is being produced locally; 95 percent of all agriculture equipment and parts are being sourced from international markets, and at least 20 percent of new equipment and technologies are currently being sourced from the U.S.
The goal of this trade mission is to provide U.S. participants with first-hand market information, and one-on-one meetings with business contacts, including potential agents, distributors and partners so they can position themselves to enter or expand their presence in these markets.
This mission will visit Maputo, Mozambique, Nairobi, Kenya and Johannesburg, South Africa allowing participants to access the largest markets and business centers in these countries.
All parties interested in participating in the trade mission must complete and submit an application package for consideration by the U.S. Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. A minimum of 15 and maximum of 20 firms and/or trade associations or organizations will be selected from the applicant pool to participate in the mission.
After a company or trade association/organization has been selected to participate on the mission, a payment to the U.S. Department of Commerce in the form of a participation fee is required. The participation fee for the mission is $4,600 for small or medium-sized enterprises (SME),
The mission fee does not include any personal travel expenses such as lodging, most meals, local ground transportation and air transportation. Delegate members will however, be able to take advantage of U.S. Government rates for hotel rooms. Government fees and processing expenses to obtain such visas are also not included in the mission costs. However, the U.S. Department of Commerce will provide instructions to each participant on the procedures required to obtain necessary business visas.
Applicants must submit a completed and signed mission application and supplemental application materials, including adequate information on the company's or association/organization's products and/or services, primary market objectives, and goals for participation by April 17, 2015. If the Department of Commerce receives an incomplete application, the Department may either: reject the application, request additional information/clarification, or take the lack of information into account when evaluating the applications.
Each applicant must also certify that the products and services it seeks to export through the mission are either produced in the U.S., or, if not, are marketed under the name of a U.S. firm and have at least fifty-one percent U.S. content. In the case of a trade association or organization, the applicant must certify that for each company to be represented by the association/organization, the products and/or services the represented
In addition, each applicant must:
Certify that the products and services that it wishes to market through the mission would be in compliance with U.S. export controls and regulations;
Certify that it has identified to the Department of Commerce for its evaluation any business pending before the Department that may present the appearance of a conflict of interest;
Certify that it has identified any pending litigation (including any administrative proceedings) to which it is a party that involves the Department of Commerce; and
Sign and submit an agreement that it and its affiliates (1) have not and will not engage in the bribery of foreign officials in connection with a company's/participant's involvement in this mission, and (2) maintain and enforce a policy that prohibits the bribery of foreign officials.
Targeted mission participants are U.S. companies and trade associations/organizations providing or promoting products and services that have interest in entering or expanding their business in markets of Mozambique, Kenya and South Africa. The following criteria will be used in selecting participants:
Suitability of a company's (or in the case of a trade association/organization, represented companies') products or services to these markets.
Company's (or in the case of a trade association/organization, represented companies') potential for business in the markets, including likelihood of exports resulting from the mission.
Consistency of the applicant company's (or in the case of a trade association/organization, represented companies') goals and objectives with the stated scope of the mission.
Referrals from political organizations and any documents, including the application, containing references to partisan political activities (including political contributions) will be removed from an applicant's submission and not considered during the selection process.
Mission recruitment will be conducted in an open and public manner, including publication in the
Recruitment for this mission will begin immediately and conclude April 17, 2015. We will inform applicants of selection decisions as soon as possible after April 17, 2015. Applications received after April 17, 2015 will be considered only if space and scheduling constraints permit.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting and webinar/conference call.
NMFS will hold a 3-day Atlantic Highly Migratory Species (HMS) Advisory Panel (AP) meeting in March 2015. The intent of the meeting is to consider options for the conservation and management of Atlantic HMS. The meeting is open to the public.
The AP meeting and webinar will be held from 10:30 a.m. to 5 p.m. on Tuesday, March 10, 2015; from 8:30 a.m. to 5 p.m. on Wednesday, March 11, 2015; and from 8:30 a.m. to 12 p.m. on Thursday, March 12, 2015. There will be an introduction for new AP members at 9 a.m. on Tuesday, March 10, 2015.
The meeting will be held at the DoubleTree by Hilton Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting presentations will also be available via WebEx webinar/conference call.
On Tuesday, March 10, 2015, the conference call information is phone number 1-800-857-6552; Participant Code: 8099565; and the webinar event address is:
On Wednesday, March 11, 2015, the conference call information is phone number 1-800-857-6552; Participant Code: 8099565; and the webinar event address is:
On Thursday, March 12, 2015, the conference call information is phone number 1-800-857-6552; Participant Code: 8099565; and the webinar event address is:
Participants are strongly encouraged to log/dial in fifteen minutes prior to the meeting. NMFS will show the presentations via webinar and allow public comment during identified times on the agenda.
Peter Cooper or Margo Schulze-Haugen at (301) 427-8503.
The Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801
The AP has previously consulted with NMFS on: Amendment 1 to the Billfish FMP (April 1999); the HMS FMP (April 1999); Amendment 1 to the HMS FMP (December 2003); the Consolidated HMS FMP (October 2006); and Amendments 1, 2, 3, 4, 5a, 5b, 6, 7, 8, and 9 to the 2006 Consolidated HMS FMP (April and October 2008, February and September 2009, May and September 2010, April and September 2011, March and September 2012, January and September 2013, April and September 2014), among other things.
The intent of this meeting is to consider alternatives for the conservation and management of all Atlantic tunas, swordfish, billfish, and shark fisheries. We anticipate discussing
Additional information on the meeting and a copy of the draft agenda will be posted prior to the meeting at:
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Peter Cooper at (301) 427-8503 at least 7 days prior to the meeting.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of scoping meetings on Caribbean Federal permits.
The harvest activities of all fishing sectors must be understood to the greatest degree possible to assure that societal goals encompassed in the Magnuson-Stevens Fishery Conservation and Management Act are met. Thus, the need for timely, effective, and efficient means to monitor harvest from all sectors is fundamental. The goal of this Scoping Hearing is to allow the public to comment on the scoping document and to provide alternative options and ideas not yet considered by the Council and NMFS.
Written comments can be sent to the Council not later than April 10th, 2015, by regular mail to the address below, or via email to
Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 766-5926.
The Caribbean Fishery Management Council is considering establishing federal permits for fishing in the U.S. Caribbean exclusive economic zone (EEZ), and is conducting scoping meetings to obtain public comments regarding this matter.
A permitting system provides a comprehensive method to achieve this goal. Permitting supports professionalization of individual fisheries, identifying and acknowledging those fishers dedicated to and reliant upon a specific component of the commercial fishery. Permits also allow for direct communication with fishing entities, enabling focused outreach and education opportunities.
A permitting system allows fishery scientists and managers to gather more accurate data, decreasing both scientific and management uncertainty. Scientific uncertainty can be mitigated to some degree by increasing knowledge of the fishery and the health of the fish populations that support that fishery. A permit system that identifies the universe of fishers operating within a fishing sector and allows tracking of the disposition and characteristics of harvested resources would substantially enhance knowledge of the fishery. Data derived from a comprehensive permit system would also contribute to reducing management uncertainty by providing better estimates of harvesting effort and the timing of harvest, thereby improving management design and responsiveness. More accurate and reliable catch data allows for more informed management.
The absence of a federal permit system, or mandatory federal reporting requirements, has been identified as a major contributor to the lack of fishing effort information in the U.S. Caribbean EEZ. A permitting system would allow better estimates for measuring fishing effort for the Council-managed fisheries while shedding light on the effectiveness of regulations implemented to manage that effort.
Some of the needs and Issues that a permitting system could address in the EEZ:
1. Provide accurate and timely data on landings.
2. Allow estimation of catch per unit of fishing effort.
3. Identify spatial and temporal trends in effort, including the relative importance of fishing to individual communities.
4. Manage competing interests for the resource.
5. Identify trends in the health of targeted fish stocks.
6. Quantify the socioeconomic importance of permitted fishing sectors and mitigate negative impacts of management to fishing communities.
7. Provide permitted fishers with a better understanding of their fishery and the opportunities and implications of management to that fishery.
There are many aspects to implementing fishing permits in the U.S. Caribbean exclusive economic zone (EEZ) and many options regarding the design of a permit system. Options for developing and designing a permit system include, but are not limited to:
1. Require commercial fishers to obtain a federal permit to fish in the U.S. Caribbean EEZ;
2. Require commercial fishers to obtain a commercial fishing license from either Puerto Rico or the U.S. Virgin Islands (USVI) to fish in the U.S. Caribbean EEZ;
3. Require commercial fishers to obtain a federal permit or a commercial fishing license from either Puerto Rico or the USVI to fish in the U.S. Caribbean EEZ
4. Require a species/species group/fishery-specific permit in the U.S. Caribbean EEZ;
5. Require a gear-specific permit in the U.S. Caribbean EEZ;
6. Require a dealer permit to purchase fish harvested from the U.S. Caribbean EEZ;
7. Conduct a pilot study with some or all fishers from some or all island groups to evaluate the practicality of permits in the U.S. Caribbean EEZ.
The goal of these scoping meetings is to allow the public to comment on the options listed above and to provide alternative options not yet considered by the Council and NMFS.
Copy of the Scoping Document to address the Development of Federal Permits in the U.S. Caribbean Exclusive Economic Zone can be found at
These meetings are physically accessible to people with disabilities. For more information or request for sign language interpretation and other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone (787) 766-5926, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental take authorization.
In accordance with the Marine Mammal Protection Act (MMPA) regulations, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to the San Francisco Bay Area Water Emergency Transportation Authority (WETA) to take, by harassment, small numbers of two species of marine mammals incidental to pile driving and removal associated with the Central Bay Operations and Maintenance Facility Project in the City of Alameda, California, between December 1, 2015, through November 30, 2016.
Effective December 1, 2015, through November 30, 2016.
A copy of the application containing a list of the references used in this document, NMFS's Environmental Assessment (EA), Finding of No Significant Impact (FONSI), and the IHA may be obtained visiting the Internet at:
Documents cited in this notice may be viewed, by appointment, during regular business hours, at 1315 East West Highway, Silver Spring, MD 20910.
Shane Guan, Office of Protected Resources, NMFS, (301) 427-8401.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for 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.”
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 April 9, 2014, NMFS received an application from WETA for the taking of marine mammals incidental to the construction of a Central Bay Operations and Maintenance Facility (Project). The purpose of the Project is to serve as the central San Francisco Bay (Bay) base for WETA's ferry fleet. After NMFS provided comments on the draft IHA application, WETA submitted a revised IHA application on May 15, 2014. NMFS determined that the application was adequate and complete on July 31, 2014. No changes was made for the proposed WETA's construction Project as described in the proposed IHA except the Project duration was changed to December 1, 2015, through November 30, 2016, from the original June 15 through October 15, 2014, due to funding and other constraints. Please refer to
A notice of NMFS' proposal to issue an IHA to WETA was published in the
All comments specific to WETA's application that address the statutory and regulatory requirements or findings NMFS must make to issue an IHA are addressed in this section of the
BSDC recommends that NMFS review the potential habitat impacts associated with removal of these harbor seal haul-out locations, including suggestions for mitigation and monitoring, where appropriate, as part of the IHA application for the project.
The harbor seal haul-out site that would be affected is a small craft dock located at the project site and was abandoned by the Navy when it vacated the Naval Air Station-Alameda in 1997. The unmaintained dock has been deteriorating slowly over the last 17 years and the deterioration has appeared to be accelerating in the last five years. In 2010, the portion connecting the floating dock to land broke off and sank, leaving remnant parts of the floating dock isolated from land. Since 2010, additional remnant parts of the marina have also been lost. During this period of time harbor seals have been opportunistically using the dock for haul-out purposes. At present, seals have been observed by local residents hauling out on the portion of the dock that is furthest from shore.
It is observed that on an average, about 10 to 20 harbor seals use the floating dock as haul-out periodically. Although during the spring of 2014, one pup was observed reared at the floating dock, the site is not a known breeding area for harbor seal. Because the dock has been in a gradual state of decay since the closure of the naval base and will likely continue to fall apart, the haul-out area on the dock provided for harbor seals is expected to decrease and eventually disappear.
Finally, several nearby haul-out sites are available in the Bay that are available to resident harbor seals in the area. These areas include the tip of Breakwater Island (1 mile from the WETA project site) and the haul-out at Yerba Buena Island (4 to 5 miles from the WETA project site) which is identified as one of the five major haul-out sites for harbor seals in the San Francisco Bay (Gibble 2011).
Therefore, the removal of the remnant abandoned dock would have negligible impact to harbor seal habitat in the proposed WETA construction site.
NMFS has thoroughly reviewed WETA's IHA application, including the proposed mitigation and monitoring measures to reduce potential impacts from the construction activities. These mitigation and monitoring measures include using noise attenuation devices for impact pile driving, power down/shutdown of pile driving hammer if a marine mammal is observed approaching the exclusion zone, and monitoring the exclusion zones and zones of influence. Detailed description of these monitoring and mitigation measures and NMFS analysis is provided in the
The marine mammal species under NMFS jurisdiction most likely to occur in the proposed construction area include Pacific harbor seal (
Additional information on the marine mammal species found in California waters can be found in Caretta
The primary potential impacts to marine mammals and marine mammal habitat are associated with elevated sound levels, but the project may also result in additional effects to marine mammal prey species and short-term, local water turbidity caused by in-water construction due to pile removal and pile driving. These potential effects are discussed in detail in the
The harbor seal haul-out site that would be affected is a small craft dock located at the project site and was abandoned by the Navy when it vacated the Naval Air Station-Alameda in 1997. The unmaintained dock has been deteriorating slowly over the last 17 years and the deterioration has appeared to be accelerating in the last five years. Later in 2010, the portion connecting the floating dock to land broke off and sank, leaving remnant parts of the floating dock isolated from land. Since 2010, additional remnant parts of the marina have also been lost. During this period of time harbor seals have been opportunistically using the dock for haul-out purposes. At present, seals have been observed by local residents hauling out on the portion of the dock that is furthest from shore.
It is observed that on an average, about 10 to 20 harbor seals use the floating dock as haul-out periodically. Although during the spring of 2014, one pup was observed reared at the floating dock, the site is not a known breeding area for harbor seal. Because the dock has been in a gradual state of decay since the closure of the naval base and will likely continue to fall apart, the haul-out area on the dock provided for harbor seals is expected to decrease and eventually disappear.
Finally, several nearby haul-out sites are available in the Bay that are available to resident harbor seals in the area. These areas include the tip of Breakwater Island (1 mile from the WETA project site) and the haul-out at Yerba Buena Island (4 to 5 miles from the WETA project site) which is identified as one of the five major haul-out sites for harbor seals in the San Francisco Bay (Gibble 2011).
Therefore, the removal of the remnant abandoned dock would have negligible impact to harbor seal habitat in the proposed WETA construction site.
In order to issue an incidental take authorization (ITA) 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 (where relevant).
For WETA's proposed Central Bay Operations and Maintenance Facility Project, NMFS required the following mitigation measures to minimize the potential impacts to marine mammals in the Project vicinity. The primary purposes of these mitigation measures are to minimize sound levels from the activities, to monitor marine mammals within designated zones of influence corresponding to NMFS' current Level B harassment thresholds and, if marine mammals with the ZOI appear disturbed by the work activity, to initiate immediate shutdown or power down of the piling hammer, making it very unlikely potential injury or hearing impairment to marine mammals would occur and ensuring that Level B behavioral harassment of marine mammals would be reduced to the lowest level practicable.
Noise attenuation systems (
Work would occur only during daylight hours, when visual monitoring of marine mammals can be conducted.
In addition, all in-water construction will be limited to the period between August 1 and November 30, 2016.
Before the commencement of in-water pile driving activities, WETA shall establish Level B behavioral harassment zones of influence (ZOIs) where received underwater sound pressure levels (SPLs) are higher than 160 dB (rms) and 120 dB (rms) re 1 μPa for impulse noise sources (impact pile driving) and non-impulses noise sources (vibratory pile driving and mechanic dismantling), respectively. The ZOIs delineate where Level B harassment would occur. Because of the relatively low source levels from vibratory pile driving and from impact pile driving with air bubble curtains, there will be no area where the noise level would exceed the threshold for Level A harassment for pinnipeds, which is 190 dB (rms) re 1 μPa. The modeled maximum isopleths for ZOIs are listed in Table 2.
In addition, although Level A harassment and injury by noise are not expected to occur due to implementation of noise attenuation devices and vibratory pile driving, a minimum shutdown zone of 10 m will be established during all pile driving and removal activities, regardless of the estimated zone. These precautionary measures are intended to prevent the already unlikely possibility of physical interaction with construction equipment and to establish a precautionary minimum zone with regard to acoustic effects.
Once the underwater acoustic measurements are conducted during initial test pile driving, WETA shall adjust the sizes of the exclusion zones and ZOIs only if the measured exclusion zones and ZOIs are larger than modeled zones. These zones will be monitored as described under the Proposed Monitoring section below.
A “soft-start” technique is intended to allow marine mammals to vacate the area before the pile driver reaches full power. Whenever there has been downtime of 30 minutes or more without pile driving, the contractor will initiate the driving with ramp-up procedures described below.
For vibratory hammers, the contractor will initiate the driving for 15 seconds at reduced energy, followed by a 1-minute waiting period. This procedure shall be repeated two additional times before continuous driving is started. This procedure would also apply to vibratory pile extraction.
For impact driving, an initial set of three strikes would be made by the hammer at 40 percent energy, followed by a 1-minute waiting period, then two subsequent three-strike sets at 40 percent energy, with 1-minute waiting periods, before initiating continuous driving.
WETA shall implement shutdown measures for pile driving or pile removal activities if a marine mammal is sighted within or is about to enter the 10 m exclusion zone.
In addition, WETA shall discontinue pile driving or pile removal activities if a marine mammal within a ZOI appears disturbed by the work activity. Work may not resume until the animal is seen to leave the ZOI or 30 minutes have passed since the disturbed animal was last sighted.
Furthermore, for in-water heavy machinery work with the potential to affect marine mammals (other than pile driving), if a marine mammal comes within 10 m, operations shall cease until the animal has left the shutdown zone or 15 minutes has passed. Heavy machinery work could include setting the pile and removal of the pile from the water column/substrate via a crane (
Finally, if any marine mammal species not authorized for take are encountered during pile driving or removal and are likely to be exposed to sound pressure levels (SPLs) greater than or equal to 160 dB re 1 μPa (rms) for impact pile driving or greater than or equal to 120 dB re 1 μPa (rms) for vibratory driving or removal, then the Holder of this IHA must cease those activities prior to the animal entering the applicable Level B zone to avoid take. Activities cannot commence until the animal has left the Level B zone.
NMFS has carefully evaluated the 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. Our 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.
• The practicability of the measure for applicant implementation.
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 received levels of pile driving and pile removal 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 received levels of pile driving and pile removal, 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 received levels of pile driving, 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 or 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 our 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
In order to issue an ITA 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) indicate that requests for ITAs must 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. WETA submitted a marine mammal monitoring plan as part of the IHA application. It can be found at
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 levels of pile driving that we associate with specific adverse effects, such as behavioral harassment, TTS, or PTS;
(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 received level, 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 received level, distance from 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; and
(5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.
WETA shall employee NMFS-approved protected species observers (PSOs) to conduct marine mammal monitoring for its Central Bay Operations and Maintenance Facility Project. The PSOs will observe and collect data on marine mammals in and around the project area for 30 minutes before, during, and for 30 minutes after all pile removal and pile installation work. If a PSO observes a marine mammal within a ZOI that appears to be disturbed by the work activity, the PSO will notify the work crew to initiate shutdown measures.
Monitoring of marine mammals around the construction site shall be conducted using high-quality binoculars (
Data collection during marine mammal monitoring will consist of a count of all marine mammals by species, a description of behavior (if possible), location, direction of movement, type of construction that is occurring, time that pile replacement work begins and ends, any acoustic or visual disturbance, and time of the observation. Environmental conditions such as weather, visibility, temperature, tide level, current, and sea state would also be recorded.
WETA would be required to submit weekly monitoring reports to NMFS that summarize the monitoring results, construction activities, and environmental conditions.
A final monitoring report would be submitted to NMFS within 90 days after completion of the construction work. This report would detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. NMFS would have an opportunity to provide comments on the report, and if NMFS has comments, WETA would address the comments and submit a final report to NMFS within 30 days.
In addition, NMFS would require WETA to notify NMFS' Office of Protected Resources and NMFS' Stranding Network within 48 hours of sighting an injured or dead marine mammal in the vicinity of the construction site. WETA shall provide NMFS with the species or description of the animal(s), the condition of the animal(s) (including carcass condition, if the animal is dead), location, time of first discovery, observed behaviors (if alive), and photo or video (if available).
In the event that WETA finds an injured or dead marine mammal that is not in the vicinity of the construction area, WETA would report the same information as listed above to NMFS as soon as operationally feasible.
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].
As discussed above, in-water pile removal and pile driving (vibratory and impact) generate loud noises that could potentially harass marine mammals in the vicinity of WETA's proposed Central Bay Operations and Maintenance Facility Project.
Currently, NMFS uses 120 dB re 1 μPa and 160 dB re 1 μPa at the received levels for the onset of Level B harassment from non-impulse (vibratory pile driving and removal) and impulse sources (impact pile driving) underwater, respectively. Table 3 summarizes the current NMFS marine mammal take criteria.
As explained above, ZOIs will be established that encompass the areas where received underwater SPLs exceed the applicable thresholds for Level B harassment. There will not be a zone for Level A harassment in this case, because the bubble curtain system will keep all underwater noise below the threshold for Level A harassment.
Incidental take is estimated for each species by estimating the likelihood of a marine mammal being present within a ZOI during active pile removal or driving. Expected marine mammal presence is determined by past observations and general abundance near the project area during the construction window. Typically, potential take is estimated by multiplying the area of the ZOI by the local animal density. This provides an estimate of the number of animals that might occupy the ZOI at any given moment. However, this type of calculation is not applicable in this case, because the ZOI will be relatively small and there is no specific local animal density for harbor seals or California sea lions. Based on observational data, the maximum number of harbor seals observed along the closest breakwater near the project vicinity ranges from 10 to 20 individuals. Observational data on California sea lions are not available, but they are generally less abundant than harbor seals; therefore, the number of harbor seals will be used to estimate impacts for both species.
While it is unlikely that 10 to 20 individuals would be present inside the ZOI at any one time, given the distance from the nearest haul-out site, as a worst-case, this analysis assumes that up to 20 individuals might be present.
For the Project, the total number of pile removal hours is estimated to not exceed 18 hours over 3 days, and the total number of pile driving hours is estimated to not exceed 60 hours over 10 days. Therefore, the estimated total number of days of activities that might impact marine mammals is 13 days. For the exposure estimate, it is assumed that the highest count of harbor seals observed, and the same number of California sea lions, will be foraging within the ZOI and be exposed multiple times during the Project.
The calculation for marine mammal exposures for this Project is estimated by:
Exposure estimate = N * (10 days of pile driving activity + 3 days of pile removal activity), where:
N = # of animals potentially present = 20.
This formula results in the following exposure estimate:
Exposure estimate = 20 animals * 13 days = 260 animals.
Therefore, WETA is requesting authorization for Level B acoustical harassment of up to 260 harbor seals and up to 260 California sea lions due to pile removal and driving. A summary of the take estimates and the proportions of the stocks potentially affected is provided in Table 4.
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 (
WETA's proposed Central Bay Operations and Maintenance Facility Project would involve pile removal and pile driving activities. Elevated underwater noises are expected to be generated as a result of these activities; however, these noises are expected to result in no mortality or Level A harassment and limited, if any, Level B harassment of marine mammals. WETA would use noise attenuation devices (
In addition, WETA's proposed activities are localized and of short duration. The entire project area is limited to WETA's Central Bay Operations and Maintenance Facility near Pier 3 in the City of Alameda. The entire Project would involve the
The Project also is not expected to have significant adverse effects on affected marine mammals' habitat, as analyzed in detail in the “Anticipated Effects on Marine Mammal Habitat” section in the
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, NMFS finds that the total marine mammal take from WETA's Central Bay Operations and Maintenance Facility Project will have a negligible impact on the affected marine mammal species or stocks.
Based on analyses provided above, it is estimated that approximately 260 California sea lions and 260 Pacific harbor seals could be exposed to received noise levels that could cause Level B behavioral harassment from the proposed construction work at the WETA Central Bay Operations and Maintenance Facility in Alameda, CA. These numbers represent approximately 0.06% and 0.86% of the stocks and populations of these species that could be affected by Level B behavioral harassment, respectively (see Table 4 above), which are small percentages relative to the total populations of the affected species or stocks.
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, which are expected to reduce the number of marine mammals potentially affected by the proposed action, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.
There are no subsistence uses of marine mammals in the proposed project area, and thus no subsistence uses impacted 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 taking for subsistence purposes.
No species listed under the ESA are expected to be affected by these activities. Therefore, NMFS has determined that a section 7 consultation under the ESA is not required.
NMFS prepared an Environmental Assessment (EA) and analyzed the potential impacts to marine mammals that would result from WETA's Central Bay Operations and Maintenance Facility project in Alameda, California. Therefore, A Finding of No Significant Impact (FONSI) was issued for this action. A copy of the EA and FONSI is available upon request.
NMFS has issued an IHA to USCG for the potential harassment of small numbers of marine mammal species incidental to its waterfront repair project at Station Monterey in California, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental harassment authorization.
In accordance with the Marine Mammal Protection Act (MMPA) regulations, we hereby give notification that the National Marine Fisheries Service has issued an Incidental Harassment Authorization (IHA) to Point Blue Conservation Science (Point Blue), to take marine mammals, by Level B harassment, incidental to conducting seabird and pinniped research activities in central California, January 2015 through January 2016.
Effective January 31, 2015, through January 30, 2016.
The public may obtain an electronic copy of the Point Blue's application, supporting documentation, the authorization, and a list of the references cited in this document by visiting:
The Environmental Assessment and associated Finding of No Significant Impact, prepared pursuant to the National Environmental Policy Act of 1969, are also available at the same site.
Jeannine Cody, Office of Protected Resources, NMFS (301) 427-8401.
Section 101(a)(5)(D) of the Marine Mammal Protection Act (MMPA; 16 U.S.C. 1361
We shall grant an authorization for the incidental taking of small numbers of marine mammals if we find that the taking will have a negligible impact on the species or stock(s), and will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant). Also, the authorization must set forth the permissible methods of taking and requirements pertaining to the monitoring and reporting of such takings. We have 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, 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].
We received an application on July 30, 2014, from Point Blue requesting the taking by harassment of small numbers of marine mammals incidental to conducting seabird and pinniped research activities on Southeast Farallon Island, Año Nuevo Island, Point Reyes National Seashore, San Francisco Bay, and the Russian River in central California. We determined the application complete and adequate on December 7, 2014.
Point Blue, along with partners Oikonos Ecosystem Knowledge, Point Reyes National Seashore with the National Park Service, and the Gulf of the Farallones National Marine Sanctuary would conduct this research under cooperative agreements with the U.S. Fish and Wildlife Service in consultation with the Gulf of the Farallones National Marine Sanctuary.
The proposed research activities would occur for one year, January 31, 2015, through January 30, 2016, and would involve annual monitoring and censusing of seabird colonies; seabird nesting habitat observations; nesting burrows restoration; breeding elephant seals observations; and the periodic resupply of a field station.
These proposed activities would occur in the vicinity of pinniped haul out sites and could likely result in the incidental take of marine mammals. We anticipate take, by Level B Harassment only, of individuals of either California sea lions (
This is the organization's sixth request for an Authorization. To date, we have issued an Incidental Harassment Authorization (Authorization) to Point Blue (formerly known as PRBO Conservation Science) for the conduct of similar activities from 2007 to 2013 (72 FR 71121, December 14, 2007; 73 FR 77011, December 18, 2008; 75 FR 8677, February 19, 2010; 77 FR 73989, December 7, 2012, 78 FR 66686, November 6, 2013).
Point Blue proposes to monitor and census seabird colonies; observe seabird nesting habitat; restore nesting burrows; observe breeding elephant and harbor seals; and resupply a field station annually in central California (
The purpose of the seabird research is to continue a 30-year monitoring program of the region's seabird populations. Point Blue's long-term pinniped research program monitors pinniped colonies to understand elephant and harbor seal population dynamics and to contribute to the conservation of both species.
The Authorization would be effective from January 31, 2015 through January 30, 2016. Following is a brief summary of the dates and duration of the activities.
Point Blue will conduct their research activities within the vicinity of pinniped haul out sites in the following locations:
We outlined the purpose of Point Blue's activities in a previous notice for the proposed authorization (79 FR 76975, December 23, 2014). The proposed activities have not changed between the proposed authorization notice and this final notice announcing the issuance of the Authorization. For a more detailed description of the authorized action, we refer the reader to the notice for the proposed authorization (79 FR 76975, December 23, 2014).
We published a notice of receipt of Point Blue's application and proposed Authorization in the
The marine mammals most likely to be harassed incidental to conducting seabird and pinniped research at the proposed research areas are primarily California sea lions, northern elephant seals, Pacific harbor seals, and to a lesser extent the eastern distinct population segment (DPS) of the Steller sea lion, which NMFS has removed from the list of threatened species under the U.S. Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531
We refer the public to Carretta
California (southern) sea otters (
Acoustic and visual stimuli generated by: (1) Noise generated by motorboat approaches and departures; (2) noise generated during restoration activities and loading operations while resupplying the field station; and (3) human presence during seabird and pinniped research activities, have the potential to cause California sea lions, Pacific harbor seals, northern elephant seals, and Steller sea lions hauled out in areas within Southeast Farallon Island, West End Island, Año Nuevo Island, Point Reyes National Seashore, San Francisco Bay, and the Russian River to flush into the surrounding water or to cause a short-term behavioral disturbance for marine mammals.
We expect that acoustic and visual stimuli resulting from the proposed motorboat operations and human presence has the potential to harass marine mammals. We also expect that these disturbances would be temporary and result, at worst, in a temporary modification in behavior and/or low-level physiological effects (Level B harassment) of certain species of marine mammals.
We included a summary and discussion of the ways that the types of stressors associated with Point Blue's specified activities (
The potential effects to marine mammals described in the notice for the proposed authorization (79 FR 76975, December 23, 2014) did not take into consideration the proposed monitoring and mitigation measures described later in this document (see the “Proposed Mitigation” and “Proposed Monitoring and Reporting” sections).
We considered these impacts in detail in the notice for the proposed authorization (79 FR 76975, December 23, 2014). Briefly, we do not anticipate that the proposed research activities would result in any significant or long-term effects on the habitats used by the marine mammals in the proposed area,
In order to issue an incidental take authorization under section 101(a)(5)(D) of the Marine Mammal Protection Act, we must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and the availability of such species or stock for taking for certain subsistence uses.
Point Blue has based the mitigation measures which they will implement during the proposed research, on the following: (1) Protocols used during previous Point Blue seabird research activities as required by our previous authorizations for these activities; and (2) recommended best practices in Richardson
To reduce the potential for disturbance from acoustic and visual stimuli associated with the activities Point Blue and/or its designees has proposed to implement the following mitigation measures for marine mammals:
(1) Postpone beach landings on Año Nuevo Island until pinnipeds that may be present on the beach have slowly entered the water.
(2) Select a pathway of approach to research sites that minimizes the number of marine mammals harassed.
(3) Avoid visits to sites used by pinnipeds for pupping.
(4) Monitor for offshore predators and do not approach hauled out pinnipeds if great white sharks (
(5) Keep voices hushed and bodies low to the ground in the visual presence of pinnipeds.
(6) Conduct seabird observations at North Landing on Southeast Farallon Island in an observation blind, shielded from the view of hauled out pinnipeds.
(7) Crawl slowly to access seabird nest boxes on Año Nuevo Island if pinnipeds are within view.
(8) Coordinate research visits to intertidal areas of Southeast Farallon Island (to reduce potential take) and coordinate research goals for Año Nuevo Island to minimize the number of trips to the island.
(9) Coordinate monitoring schedules on Año Nuevo Island, so that areas near any pinnipeds would be accessed only once per visit.
(10) Have the lead biologist serve as an observer to evaluate incidental take.
NMFS has carefully evaluated the applicant's proposed mitigation measures and have considered a range of other measures in the context of ensuring that we have prescribed the means of effecting the least practicable adverse impact on the affected marine mammal species and stocks and their habitat. NMFS' 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, we expect that the successful implementation of the measure would 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) 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 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 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 activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing the severity of harassment takes only).
5. Avoidance or 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 our evaluation of Point Blue's proposed measures, we have determined that the 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 incidental take authorization for an activity, section 101(a)(5)(D) of the Marine Mammal Protection Act states that we must set forth “requirements pertaining to the monitoring and reporting of such taking.” The Act's implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for an incidental take authorization must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and our expectations of the level of taking or impacts on populations of marine mammals present in the 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 later;
2. An increase in our understanding of how many marine mammals are likely to be exposed to levels of potential stressor(s) associated with the action (
3. An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on
• Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, 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 received level, distance from 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; and
5. An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.
As part of its 2015-2016 application, Point Blue proposes to sponsor marine mammal monitoring during the present project, in order to implement the mitigation measures that require real-time monitoring, and to satisfy the monitoring requirements of the incidental harassment authorization. The Point Blue researchers will monitor the area for pinnipeds during all research activities. Monitoring activities will consist of conducting and recording observations on pinnipeds within the vicinity of the proposed research areas. The monitoring notes would provide dates, location, species, the researcher's activity, behavioral state, numbers of animals that were alert or moved greater than one meter, and numbers of pinnipeds that flushed into the water.
Point Blue has complied with the monitoring requirements under the previous authorizations for the 2007 through 2014 seasons. The results from previous Point Blue's monitoring reports support our findings that the proposed mitigation measures, which we also required under the 2007-2014 Authorizations provide the means of effecting the least practicable adverse impact on the species or stock.
Point Blue will submit a monitoring report on the January 31, 2014 through January 30, 2015 research period by April 2015. Upon receipt and review, we will post this annual report on our Web site at
Point Blue must submit a draft final report to NMFS' Office of Protected Resources within 60 days after the conclusion of the 2016 field season. The report will include a summary of the information gathered pursuant to the monitoring requirements set forth in the Authorization.
Point Blue will submit a final report to the Chief, Permits and Conservation Division, Office of Protected Resources, within 30 days after receiving comments from NMFS on the draft final report. If Point Blue does not receive any comments from NMFS on the draft report, NMFS and Point Blue will consider the draft final report to be the final report.
Except with respect to certain activities not pertinent here, the Marine Mammal Protection Act 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].
NMFS proposes to authorize take by Level B harassment only for the proposed seabird research activities on Southeast Farallon Island, Año Nuevo Island, and Point Reyes National Seashore. Acoustic (
Based on Point Blue's previous research experiences, with the same activities conducted in the proposed research area, and on marine mammal research activities in these areas, we estimate that approximately 9,871 California sea lions, 343 harbor seals, 196 northern elephant seals, and 106 Steller sea lions could be affected by Level B behavioral harassment over the course of the effective period of the proposed Authorization.
The authorized take differs from Point Blue's original request for California sea lions (10,092), northern elephant seals (261), harbor seals (526) and Steller sea lions (185). NMFS bases these new estimates on historical data from previous monitoring reports and anecdotal data for the same activities conducted in the proposed research area. In brief, for each species, we created a statistical model to derive an estimate of the average annual increase of reported take based on a best fit regression analysis (
There is no evidence that Point Blue's planned activities could result in injury, serious injury or mortality within the action area. Moreover, the required mitigation and monitoring measures will minimize further any potential risk for injury, serious injury, or mortality. Thus, we do not authorize any injury, serious injury or mortality. We expect all potential takes to fall under the category of Level B harassment only.
Point Blue will continue to coordinate monitoring of pinnipeds during the research activities occurring on Southeast Farallon Island, Año Nuevo Island, and Point Reyes National Seashore. Point Blue conducts bone fide research on marine mammals, the results of which may contribute to the basic knowledge of marine mammal biology or ecology, or are likely to identify, evaluate, or resolve conservation problems.
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.” The lack of likely adverse effects on annual rates of recruitment or survival (
In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, feeding, migration, etc.), as well as the number and nature of estimated Level A
In making a negligible impact determination, we consider:
(1) The number of anticipated injuries, serious injuries, or mortalities;
(2) The number, nature, and intensity, and duration of Level B harassment;
(3) The context in which the takes occur (
(4) The status of stock or species of marine mammals (
(5) Impacts on habitat affecting rates of recruitment/survival; and
(6) The effectiveness of monitoring and mitigation measures.
For reasons stated previously in this document and based on the following factors, NMFS does not expect Point Blue's specified activities to cause long-term behavioral disturbance, abandonment of the haulout area, injury, serious injury, or mortality:
(1) The effects of the pinniped and seabird research activities would be limited to short-term startle responses and localized behavioral changes due to the short and sporadic duration of the research activities. Minor and brief responses, such as short-duration startle or alert reactions, are not likely to constitute disruption of behavioral patterns, such as migration, nursing, breeding, feeding, or sheltering.
(2) The availability of alternate areas for pinnipeds to avoid the resultant acoustic and visual disturbances from the research operations. Results from previous monitoring reports also show that the pinnipeds returned to the various sites and did not permanently abandon haul-out sites after Point Blue conducted their pinniped and research activities.
(3) There is no potential for large-scale movements leading to injury, serious injury, or mortality because the researchers must delay ingress into the landing areas until after the pinnipeds present have slowly entered the water.
(4) The limited access of Point Blue's researchers to Southeast Farallon Island, Año Nuevo Island, and Point Reyes National Seashore during the pupping season.
We do not anticipate that any injuries, serious injuries, or mortalities would occur as a result of Point Blue's proposed activities, and we do not authorize injury, serious injury or mortality. These species may exhibit behavioral modifications, including temporarily vacating the area during the proposed seabird and pinniped research activities to avoid the resultant acoustic and visual disturbances. Further, these proposed activities would not take place in areas of significance for marine mammal feeding, resting, breeding, or calving and would not adversely impact marine mammal habitat. Due to the nature, degree, and context of the behavioral harassment anticipated, the activities are not expected to impact annual rates of recruitment or survival.
NMFS does not expect pinnipeds to permanently abandon any area that is surveyed by researchers, as is evidenced by continued presence of pinnipeds at the sites during annual monitoring counts. 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 finds that the total marine mammal take from Point Blue's seabird research activities will not adversely affect annual rates of recruitment or survival and therefore will have a negligible impact on the affected species or stocks.
As mentioned previously, NMFS estimates that four species of marine mammals could be potentially affected by Level B harassment over the course of the proposed Authorization. Because these are maximum estimates, actual take numbers are likely to be lower, as some animals may select other haulout sites the day the researchers are present. For each species, these numbers are small numbers (each, less than or equal to two percent) relative to the population size. These incidental harassment numbers represent approximately 3.33 percent of the U.S. stock of California sea lion, 1.74 percent of the California stock of Pacific harbor seal, 0.16 percent of the California breeding stock of northern elephant seal, and 0.17 percent of the eastern distinct population segment of Steller sea lion.
Section 101(a)(5)(D) of the MMPA also requires us to determine that the taking will not have an unmitigable adverse effect on the availability of marine mammal species or stocks for subsistence use. There are no relevant subsistence uses of marine mammals implicated by this action. Thus, 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 taking for subsistence purposes.
On October 23, 2013 NMFS announced the removal of the eastern distinct population segment of Steller sea lions from the list of threatened species under the ESA. No marine mammal species listed under the ESA are anticipated to occur in the action area. Therefore, NMFS has determined that a section 7 consultation under the ESA is not required.
In 2014, we prepared an Environmental Assessment (EA) analyzing the potential effects to the human environment from NMFS' issuance of a proposed Authorization to Point Blue for their seabird research activities. In January 2014, NMFS issued a Finding of No Significant Impact (FONSI) on the issuance of an Authorization for Point Blue's research activities in accordance with section 6.01 of the NOAA Administrative Order 216-6 (Environmental Review Procedures for Implementing the National Environmental Policy Act, May 20, 1999). Point Blue's proposed activities and impacts for 2015-2016 are within the scope of the 2014 EA and FONSI. NMFS has reviewed the 2014 EA and determined that there are no new direct, indirect, or cumulative impacts to the human and natural environment associated with the Authorization requiring evaluation in a supplemental EA and NMFS, therefore, reaffirms the 2014 FONSI.
As a result of these determinations, we have issued an Authorization to Point Blue for the take of marine mammals incidental to proposed seabird and pinniped research activities, provided they incorporate the previously mentioned mitigation, monitoring, and reporting requirements.
Bureau of Consumer Financial Protection.
Compliance Bulletin.
The Bureau of Consumer Financial Protection (CFPB) is issuing a compliance bulletin entitled “Treatment of Confidential of Supervisory Information” as a reminder that, with limited exceptions, persons in possession of confidential information, including confidential supervisory information (CSI), may not disclose such information to third parties.
This bulletin is effective February 25, 2015 and applicable beginning January 27, 2015.
Christopher Young, Managing Senior Counsel and Chief of Staff, (202) 435-7408, Office of Supervision Policy.
The CFPB issues this compliance bulletin as a reminder that, with limited exceptions, persons in possession of confidential information, including CSI, may not disclose such information to third parties.
1. Sets forth the definition of CSI;
2. Provides examples of CSI;
3. Highlights certain legal restrictions on the disclosure of CSI; and
4. Explains that private confidentiality and non-disclosure agreements (NDAs) neither alter the legal restrictions on the disclosure of CSI nor impact the CFPB's authority to obtain information from covered persons
The CFPB has supervisory authority over certain covered persons, including very large depository institutions, credit unions and their affiliates;
Pursuant to authority granted under the Dodd-Frank Act,
Under the CFPB's regulations, “confidential supervisory information” means:
• Reports of examination, inspection and visitation, non-public operating, condition, and compliance reports, and any information contained in, derived from, or related to such reports;
• Any documents, including reports of examination, prepared by, or on behalf of, or for the use of the CFPB or any other Federal, State, or foreign government agency in the exercise of supervisory authority over a financial institution, and any supervision information derived from such documents;
• Any communications between the CFPB and a supervised financial institution or a Federal, State, or foreign government agency related to the CFPB's supervision of the institution;
• Any information provided to the CFPB by a financial institution to enable the CFPB to monitor for risks to consumers in the offering or provision of consumer financial products or services, or to assess whether an institution should be considered a covered person, as that term is defined by 12 U.S.C. 5481, or is subject to the CFPB's supervisory authority; and/or
• Information that is exempt from disclosure pursuant to 5 U.S.C. 552(b)(8).
CSI does not include documents prepared by a financial institution for its own business purposes and that the CFPB does not possess.
Supervised financial institutions and other persons that may come into possession of CSI should understand what constitutes CSI in order to comply with the applicable rules.
• CFPB examination reports and supervisory letters;
• All information contained in, derived from, or related to those documents, including an institution's supervisory Compliance rating;
• Communications between the CFPB and the supervised financial institution related to the CFPB's examination of the institution or other supervisory activities; and
• Other information created by the CFPB in the exercise of its supervisory authority.
Thus, CSI includes any workpapers or other documentation that CFPB examiners have prepared in the course of an examination. CSI also includes supervisory information requests from the CFPB to a supervised financial institution, along with the institution's responses. In addition, any CFPB supervisory actions, such as memoranda of understanding between the CFPB and an institution, and related submissions and correspondence, are CSI.
Subject to limited exceptions, supervised financial institutions and other persons in possession of CSI of the CFPB may not disclose such information.
There are certain exceptions to the general prohibition against disclosing CSI to third parties. A supervised financial institution may disclose CSI of the CFPB lawfully in its possession to:
• Its affiliates;
• Its directors, officers, trustees, members, general partners, or employees, to the extent that the disclosure of such CSI is relevant to the performance of such individuals' assigned duties;
• The directors, officers, trustees, members, general partners, or employees of its affiliates, to the extent that the disclosure of such CSI is relevant to the performance of such individuals' assigned duties;
• Its certified public accountant, legal counsel, contractor, consultant, or service provider.
Supervised financial institutions may also in certain instances disclose CSI to others with the prior written approval of the Associate Director for Supervision, Enforcement, and Fair Lending, or his or her delegee (Associate Director).
Confidential information made available by the CFPB pursuant to 12 CFR part 1070 remains the property of the CFPB. There are other important requirements relating to the disclosure of confidential information, including disclosure pursuant to third-party legally enforceable demands, such as subpoenas or Freedom of Information Act requests. Among a number of other requirements, a recipient of a demand for confidential information must inform the CFPB's General Counsel of the demand.
The CFPB recognizes that some supervised financial institutions may have entered into third-party NDAs that, in part, purport to: (1) Restrict the supervised financial institution from sharing certain information with a supervisory agency; and/or (2) require the supervised financial institution to advise the third party when the institution shares with a supervisory agency information subject to the NDA. However, such provisions in NDAs between supervised financial institutions and third parties do not alter or limit the CFPB's supervisory authority or the supervised financial institution's obligations relating to CSI.
A supervised financial institution should not attempt to use an NDA as the basis for failing to provide information sought pursuant to supervisory authority. The CFPB has the authority to require supervised financial institutions and certain other persons to provide it with reports and other information to conduct supervisory activities, pursuant to the Dodd-Frank Act.
In addition, a supervised financial institution may risk violating the law if it relies upon provisions of an NDA to justify disclosing CSI in a manner not otherwise permitted. As noted above, any disclosure of CSI outside of the applicable exceptions would require the prior written approval of the Associate Director for Supervision, Enforcement, and Fair Lending (or his or her delegee).
Supervised financial institutions should contact appropriate CFPB supervisory personnel with any questions regarding this Bulletin.
This compliance bulletin provides nonbinding guidance on matters including limitations on disclosure of CSI under applicable law. It is therefore exempt from the notice and comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b). Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.
Defense Security Cooperation Agency, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by April 27, 2015.
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 the same electronic docket and downloaded for reviewing/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 Security Cooperation Agency (DSCA) (ATTN: David Frasher, 220 12th Street South, Suite 203, Arlington VA, 22202-5408 or call (703) 601-4459 or Defense Institute of Security Assistance Management (DISAM), ATTN: Donald McCormick, 2475 K Street, Wright-Patterson AFB, OH 45433-7803, or call Director of Academic Support, at 937-713-3340.
Disam Student Registration Form:
Disam Guest Speaker Form: (Still in development).
Respondents are contractor personnel, non-DOD U.S. Federal Government, Foreign Service nationals and industry students, guest speakers and lecturers involved in the Security Cooperation initiatives as prescribed by the President of the United States, Congress and Departments of State and Defense. Security Cooperation and Assistance programs as authorized by the Foreign Assistance Act (FAA), and the Arms Export Control Act (AECA) are required to be administered by qualified personnel receiving formal education through the Defense Institute of Security Assistance Management (DISAM) or other authorized Security Cooperation agencies. If the information collected on the student registration form is not collected, personnel looking to verify the qualifications of individuals in the Security Cooperation workforce database on the SAN, DISAM Student Database or the DISAM Personnel Database would be unable to match personnel to training and ensure compliance with DepSecDef directive and federal law requiring the reporting of training of foreign nationals (ref. AECA). The DISAM Personnel Database in conjunction with the Travel Forms maintains records of the personnel TDY travel and reimbursement as required by federal law and DoD regulations.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by March 27, 2015.
Fred Licari, 571-372-0493.
Written comments and recommendations on the proposed information collection should be sent to Ms. Jasmeet Seehra at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503.
You may also submit comments, identified by docket number and title, by the following method:
• Federal eRulemaking Portal:
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
Department of Defense.
Notice of meeting.
The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the Judicial Proceedings since Fiscal Year 2012 Amendments Panel (“the Judicial Proceedings Panel” or “the Panel”). The meeting is open to the public.
A meeting of the Judicial Proceedings Panel will be held on Friday, March 13, 2015. The Public Session will begin at 9:00 a.m. and end at 5:00 p.m.
U.S. District Court for the District of Columbia, 333 Constitution Avenue NW, Courtroom #20, 6th floor, Washington, DC 20001.
Ms. Julie Carson, Judicial Proceedings Panel, One Liberty Center, 875 N. Randolph Street, Suite 150, Arlington, VA 22203. Email:
This public meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
Department of the Army, DoD.
Notice of open subcommittee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Remember Subcommittee of the Advisory Committee on Arlington National Cemetery (ACANC). The meeting is open to the public. For more information about the Committee and the Remember Subcommittee, please visit
The Remember Subcommittee will meet from 0900 a.m.-1000 a.m. on Thursday, March 12, 2015.
Women in Service to America Memorial, Arlington National Cemetery, Arlington, VA 22211.
Ms. Renea C. Yates; Designated Federal Officer for the committee and the Remember Subcommittee, in writing at Arlington National Cemetery, Arlington VA 22211, or by email at
This subcommittee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (U.S.C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3.150).
Department of the Army, DoD.
Notice of open subcommittee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Honor Subcommittee of the Advisory Committee on Arlington National Cemetery (ACANC). The meeting is open to the public. For more information about the Committee and the Honor Subcommittee, please visit
The Honor Subcommittee will meet from 10:00 a.m.-11:30 a.m. on Thursday, March 12, 2015.
Women in Service to America Memorial, Arlington National Cemetery, Arlington, VA 22211.
Ms. Renea C. Yates; Designated Federal Officer for the committee and the Honor Subcommittee, in writing at Arlington National Cemetery, Arlington VA 22211, or by email at
This subcommittee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (U.S.C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3.150).
Office of Special Education and Rehabilitative Services (OSERS), 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 March 27, 2015.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
For specific questions related to collection activities, please contact Edward West, 202-245-6145.
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.
Office of Innovation and Improvement (OII), 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 March 27, 2015.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
For specific questions related to collection activities, please contact Patricia Kilby-Robb, 202-260-2225.
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.
Office of the Secretary/Office of the Deputy Secretary (OS), 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 March 27, 2015.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
For specific questions related to collection activities, please contact Sedika Franklin, (202) 453-5630.
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.
Office of Special Education and Rehabilitative Services (OSERS), 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 March 27, 2015.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
For specific questions related to collection activities, please contact Joan Ward, 202-245-7565.
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
Office of Elementary and Secondary Education (OESE), 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 March 27, 2015.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
For specific questions related to collection activities, please contact Daryn Hedlund, 202-401-3008.
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.
National Advisory Committee on Institutional Quality and Integrity (NACIQI), Office of Postsecondary Education, Department of Education.
U.S. Department of Education, Office of Postsecondary Education, 1990 K Street NW., Room 8072, Washington, DC 20006.
Notice of an open (virtual) meeting and the opportunity to make third party comments.
• The establishment and enforcement of the criteria for recognition of accrediting agencies or associations under Subpart 2, Part H, Title IV, of the HEA, as amended.
• The recognition of specific accrediting agencies or associations or a specific State approval agency.
• The preparation and publication of the list of nationally recognized accrediting agencies and associations.
• The eligibility and certification process for institutions of higher education under Title IV, of the HEA, together with recommendations for improvement in such process.
• The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions.
• Any other advisory function relating to accreditation and institutional eligibility that the Secretary may prescribe.
This notice sets forth the schedule for the March 23, 2015, virtual meeting of NACIQI, and provides information to members of the public on registering for the meeting, and for submitting written comments and requests to make oral comments. The notice of this virtual meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act (FACA) and Section 114(d)(2)(B) of the Higher Education Act (HEA) of 1965, as amended, 20 U.S.C. 1011c.
The NACIQI virtual meeting will be held on Monday, March 23, 2015, beginning at 1:00 p.m. and ending at 4:00 p.m., Eastern Time. The proposed agenda for this virtual meeting consists of discussion and final action on the draft NACIQI Policy Recommendations Report. The report may be accessed at:
To request to make oral comments during the meeting, email your request to
A total of 30 minutes will be allotted for public comment. Six commenters will be selected on a first-come, first-served basis. Each commenter will be allotted no more than five minutes. The Department will inform all requesters of their selection status in advance of the meeting. Individuals who need accommodations for a disability in order to attend the virtual meeting should contact Patricia Howes at
Carol Griffiths, Executive Director, NACIQI, U.S. Department of Education, 1990 K Street NW., Room 8073, Washington, DC 20006-8129, telephone: (202) 219-7035, fax: (202) 502-7874, or email
You may also access documents of the Department published in the
Section 114 (d)(2)(B) of the HEA of 1965, as amended, 20 U.S.C. 1011c.
Take notice that the Commission received the following electric corporate filings:
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:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Calciners and Dryers in Mineral Industries (40 CFR part 60, subpart UUU) (Renewal)” (EPA ICR No. 0746.09, OMB Control No. 2060-0251), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0028, to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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. The docket can be viewed online at
In general, all NSPS standards require initial notification reports, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS. Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NESHAP for Shipbuilding and Ship Repair Facilities—Surface Coating (40 CFR part 63, subpart II) (Renewal)” (EPA ICR No. 1712.09, OMB Control No. 2060-0330) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0056, to (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
Changes in the Estimates:
There is no change of hours in the total estimated respondent burden compared with the ICR currently approved by OMB.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Municipal Solid Waste Landfills (40 CFR part 60, subpart WWW) (Renewal)” (EPA ICR No. 1557.09, OMB Control No. 2060-0220) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0047, to (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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. The docket can be viewed online at
In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS. Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records.
There is also an increase in the total estimated Capital/Startup and O&M costs. This increase occurred as a result of incorporating comments received, which stated that the previous ICR did not include the purchase price and O&M costs of three additional devices that respondents are required to use.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Petroleum Refineries (40 CFR part 60, subpart J) (Renewal)” (EPA ICR No. 1054.12, OMB Control No. 2060-0022) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0033, to (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “Greenhouse
Additional comments may be submitted on or before March 27, 2015.
Submit your comments, referencing Docket ID Number No. EPA-HQ-OAR-2010-0162, to (1) EPA 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.
Fakhri Hamady, Office of Transportation and Air Quality, Mail Code 6406J, Environmental Protection Agency, 2000 Traverwood Dr., Ann Arbor, MI 48105; telephone number: 734-214-4330; fax number: 734-214-4869; 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. The docket can be viewed online at
Manufacturer test results will be used by EPA to perform confirmatory testing on a sufficient number of engines and vehicles to confirm manufacturer-reported results. EPA's emission certification programs and NHTSA's fuel efficiency programs are statutorily mandated. EPA does not have discretion to cease these functions under Section 206(a) of the CAA (42 U.S.C. 7521).
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Metal Coil Surface Coating (40 CFR part 60, subpart TT) (Renewal)” (EPA ICR No. 0660.12, OMB Control No. 2060-0107) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0026, to (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A,
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
In general, all NSPS standards require initial notification reports, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.
Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the U.S. Environmental Protection Agency (EPA) regional office.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Participation by Disadvantaged Business Enterprises in Procurement under EPA Financial Assistance Agreements (Renewal)” (EPA ICR No. 2047.05, OMB Control No. 2090-0030) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments may be submitted on or before April 27, 2015.
Submit your comments, referencing Docket ID No. EPA-HQ-OA-2006-0278 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.
Teree Henderson, Office of Small Business Programs, (mail code: 1230T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-566-2222; fax number: 202-566-0548; 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. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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,
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NESHAP for Iron and Steel Foundry Area Sources (40 CFR part 63, subpart ZZZZZ) (Renewal)” (EPA ICR No. 2267.04, OMB Control No. 2060-0605), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0096, to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NESHAP for Primary Lead Smelters (40 CFR part 63, subpart TTT) (Renewal)” (EPA ICR No. 1856.10, OMB Control No. 2060-0414) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0068, to (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “Certification of Pesticide Applicators (Renewal)” (EPA ICR No. 0155.12, OMB Control No. 2070-0029) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OPP-2014-0446, to (1) EPA 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.
Lily G. Negash, Office of Pesticide Programs, Field & External Affairs Division, 7605P, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 703-347-8515; fax number: 703-305-5884; 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. The docket can be viewed online at
Personally identifying information (PII) is collected in the process of certifying individuals to apply RUPs as private or commercial applicators. This information is collected to differentiate between individuals sharing the same names and is subject to Agency-wide security requirements governing all Privacy Act database systems at EPA.
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Environmental Protection Agency, (EPA).
Notice.
The Environmental Protection Agency (EPA) announces a teleconference of the Great Lakes Advisory Board (Board). The purpose of this teleconference is to discuss the Great Lakes Restoration Initiative covering (GLRI) FY15-19 and other relevant matters.
The teleconference will be held Thursday, March 19, 2015 from 9 a.m. to 11 a.m. Central Time, 10 a.m. to 12 p.m. Eastern Time. An opportunity will be provided to the public to comment.
The public teleconference will be held by teleconference only. The teleconference number is: (877) 744-6030; Participant code: 83810127.
Any member of the public wishing further information regarding this meeting may contact Rita Cestaric, Designated Federal Officer (DFO), by email at
The Board consists of 16 members appointed by EPA's Administrator in her capacity as IATF Chair. Members serve as representatives of state, local and tribal government, environmental groups, agriculture, business, transportation, foundations, educational institutions, and as technical experts.
Environmental Protection Agency (EPA).
Notice.
In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of request for amendments by registrants to terminate uses in certain pesticide registrations. FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any request in the
Unless a request is withdrawn by March 27, 2015 for registrations for which the registrant requested a waiver of the 180-day comment period, EPA expects to issue orders terminating these uses. The Agency will consider withdrawal requests postmarked no later than March 27, 2015. Comments must be received on or before March 27, 2015, for those registrations where the 180-day comment period has been waived.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2014-0888, by one of the following methods:
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Mark Hartman, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-5440; email address:
This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action.
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This notice announces receipt by the Agency of applications from registrants to terminate uses in certain pesticide products registered under FIFRA section 3 (7 U.S.C. 136a) or 24(c) (7 U.S.C. 136v(c)). These registrations are listed in Table 1 of this unit by registration number, product name, active ingredient, and specific uses terminated.
Unless a request is withdrawn by the registrant within 30 days of publication of this notice, EPA expects to issue orders terminating all of these uses. Users of these pesticides or anyone else desiring the retention of a use should contact the applicable registrant directly during this 30-day period.
Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number:
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Registrants who choose to withdraw a request for use termination must submit such withdrawal in writing to the person listed under
7 U.S.C. 136
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before April 27, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before March 27, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page <
In addition, this collection is necessary to allow the Commission to evaluate the extent to which the E-rate program is meeting the statutory objectives specified in section 254(h) of the 1996 Act.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
The Centers for Disease Control and Prevention (CDC) has submitted 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. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
State Health Department Access to Electronic Health Record Data from Healthcare Facilities during a Healthcare-Associated Infection Outbreak: A Retrospective Assessment—New—National Center for Emerging and Zoonotic Infections Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Two years ago, contaminated steroid injections caused the largest fungal meningitis outbreak in the United States, affecting 20 states and resulting in 751 infections and 64 deaths. The subsequent healthcare-associated infection (HAI) outbreak response required significant collaboration between healthcare providers and facilities and public health departments (HDs). Following the outbreak response, HDs reported that various challenges with access to patient health information in electronic health records (EHRs) hindered the efficient and rapid identification of potential fungal meningitis cases in healthcare facilities. The fungal meningitis outbreak experience highlights the need to better understand the landscape of granting and using access to EHRs for outbreak investigations.
The Division of Healthcare Quality Promotion (a component of NCEZID), the Office for State, Tribal, Local and Territorial Support, and the Office of Public Health Scientific Services at the Centers for Disease Control and Prevention (CDC) are partnering with Association of State and Territorial Health Officials and The Keystone Center to evaluate the challenges surrounding HDs access to EHRs in healthcare facilities' during an HAI outbreak investigation. The evaluation seeks to compile information across states from experts in the public and private sector to assess experiences, identify issues, and seek recommendations for improving HDs access to EHRs during future outbreaks.
In addition to a study report, the insights from healthcare facility staff will be used to build a toolkit to help state HDs understand the perspectives and needs of the healthcare facilities related to EHR access. The toolkit will provide perceived barriers, recommendations to overcome those barriers, best practices that support EHR access, and practical tools such as templates, memorandums of understanding (MOUs), and policies. The toolkit will be distributed to HDs, healthcare facilities, and other stakeholders to support awareness and
These activities will facilitate the quick and efficient identification of cases in future outbreaks and protect the health and safety of patients. This request corresponds with an initial ongoing data collection (Phase I), State Health Department Access to Electronic Health Record Data during an Outbreak: A Retrospective Assessment, which involves interviews with four types of Health Department staff: Healthcare-associated infection coordinator, epidemiologist, legal counsel, and informatics director (OMB Number 0920-0879, approved on 04/24/2014). Phase I data analysis is ongoing.
For Phase II of this study, we will be requesting participation from hospital and clinic staff in their official capacities across the same 15 states included in the Phase I request. The states chosen for Phase I and Phase II data collections are: Florida, Indiana, Kansas, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Tennessee, Texas, and Virginia. Data will be collected from 150 hospital and clinic staff in their official capacities using one 30-minute telephone interview per person and limiting interviews to two hospitals and two clinics per state. Hospital participants include: Infection preventionists, informatics directors, and others as referred. Clinic participants include: Clinic directors and others as referred.
The focus of this OMB request is to conduct interviews with 150 healthcare facilities' staff, hospitals and clinics, in their official capacity who has been asked by HDs to provide access to their EHRs during an HAI outbreak investigation. In hospitals, the evaluation team will be conducting interviews with staff members serving in one of three roles: Infection preventionist, informatics director, and other as referred (
The maximum estimates for burden hours are derived from interview guide pilot testing and data collection with HDs during Phase I data collection, in which interviews took 27 minutes. The total annual burden is 90 hours.
The data to be collected do not involve questions of a personal or sensitive nature and should have no impact on the individual's privacy. There are no costs to the respondents other than their time.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. 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 shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed 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 of information 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. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Written comments should be received within 60 days of this notice.
Extended Evaluation of the National Tobacco Prevention and Control Public Education Campaign—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
In 2012, Centers for Disease Control and Prevention (CDC) launched the first federally funded, national mass media campaign to educate consumers about the adverse health consequences of tobacco use (the National Tobacco Prevention and Control Public Education Campaign, or “The Campaign”). The Campaign continued in 2013 and 2014 with advertisements known as “Tips from Former Smokers.” Activities for Phase 3 of the campaign are ongoing. To assess the impact of The Campaign in Phases 1-3, CDC obtained OMB approval to conduct a series of longitudinal surveys of smokers and nonsmokers (OMB Control Number 0920-0923, exp. 3/31/2017).
New media activities for Phases 4 and 5 of The Campaign are scheduled to launch in March 2015. To support evaluation of The Campaign through Phase 5, CDC plans to field four new waves of information collection. The surveys will be fielded in English and Spanish and will occur during late 2015, 2016, and early 2017. Once enrolled in the first wave of data collection, all participants will be re-contacted for follow-up at subsequent survey waves.
The sample for the data collection will originate from two sources: (1) An online longitudinal cohort of smokers and nonsmokers, sampled randomly from postal mailing addresses in the United States (address-based sample, or ABS); and (2) the existing GfK KnowledgePanel, an established long-term online panel of U.S. adults. The ABS-sourced longitudinal cohort will consist of smokers and nonsmokers who have not previously participated in any established online panels to reduce potential panel conditioning bias from previous participation. The new cohort will be recruited by GfK, utilizing similar recruitment methods that are used in the recruitment of KnowledgePanel. The GfK KnowledgePanel will be used in combination with the new ABS-sourced cohort to support larger sample sizes that will allow for more in-depth subgroup analysis, which is a key objective for CDC. All online surveys, regardless of sample source, will be conducted via the GfK KnowledgePanel Web portal for self-administered surveys.
Information will be collected through Web surveys to be self-administered on computers in the respondents' homes or in another convenient location. Information will be collected about smokers' and nonsmokers' awareness of and exposure to specific campaign advertisements; knowledge, attitudes, beliefs related to smoking and secondhand smoke; and other marketing exposure. The surveys will also measure behaviors related to smoking cessation (among the smokers in the sample) and behaviors related to nonsmokers' encouragement of smokers to quit smoking, recommendations of cessation services, and attitudes about other tobacco and nicotine products.
It is important to evaluate The Campaign in a context that assesses the dynamic nature of tobacco product marketing and uptake of various tobacco products, particularly since these may affect successful cessation rates. Survey instruments may be updated to include new or revised items on relevant topics, including cigars, noncombustible tobacco products, and other emerging trends in tobacco use.
OMB approval is requested for two years. Participation is voluntary and there are no costs to respondents other than their time.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. 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 shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed 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 of information 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. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Written comments should be received within 60 days of this notice.
National Syndromic Surveillance Program (BioSense, OMB Control No. 0920-0824, Expiration Date 10/31/2015)—Revision—Center for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC).
The BioSense Program was created by congressional mandate as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and was launched by the Centers for Disease Control and Prevention (CDC) in 2003. The BioSense Program has since been expanded into the National Syndromic Surveillance Program (NSSP) to promote the use of high-quality syndromic surveillance data for improved nationwide all-hazard situational awareness for public health decision making and enhanced responses to hazardous events and outbreaks.
NSSP is a collaboration among individuals and organizations from the local, state, and federal levels of public health; other federal agencies, including the Department of Defense (DoD) and the Department of Veterans Affairs (VA); and associations of public health officials, including the Association of State and Territorial Health Officials. NSSP includes a community of practice, a stakeholder governance process, and a cloud-based syndromic surveillance platform (the NSSP platform) that hosts the BioSense application and other analytic tools and services.
Syndromic surveillance is a process that regularly and systematically uses health and health-related data in near real-time to make information on the health of a community available to public health officials. Patient encounter, laboratory, and pharmacy data from healthcare settings including emergency departments, urgent care, ambulatory care and inpatient settings provide critical information for syndromic surveillance and are used by public health agencies under authorities granted to them by applicable local and state laws.
CDC requests a three-year approval for a Revision for NSSP (BioSense, OMB Control No. 0920-0824, Expiration Date 10/31/2015). With this revision, CDC also requests the following collection title: National Syndromic Surveillance Program (NSSP). The NSSP will continue to receive and processes four different types of information: (1) Contact information for state and local public health officials who wish to have data from their jurisdictions submitted to NSSP (recruitment data); (2) contact information for public health officials and other new users needed to provide them with access to the NSSP Platform (registration data); (3) NSSP user information needed to determine for development of the NSSP platform and to assess the usability of the platform (user data) (since the number of respondents will not exceed nine non-federal users to assess usability, the associated burden is not applicable to this request); and (4) existing healthcare encounter, pharmacy, and laboratory data (healthcare data) without personally identifiable information (PII).
As in the past, healthcare data will continue to be submitted to NSSP by state and local health departments or hospitals in those jurisdictions, federal agencies including the VA, DoD, a national level private sector clinical laboratory, and a private sector health information exchange company.
In addition, healthcare data will be submitted from urgent care, ambulatory care and inpatient settings. The inclusion of these additional data in NNSP is consistent with the Department of Health and Human Services' criteria for the “meaningful use” by public health of electronic health records for syndromic surveillance.
There are no costs to respondents other than their time. Respondents in this data submission include state and local public health jurisdictions, federal agencies, and the private sector providers of healthcare, laboratory and pharmacy data.
Though a large number of electronic health records are transmitted to NSSP, once the automated interfaces are set up for transmission (developing the data sharing agreements), there is no burden for record transmission. The estimated annual burden is 51 hours.
The Administration for Children and Families, Office of Child Care, in collaboration with the Health Resources and Services Administration, Maternal and Child Health Bureau, has awarded grants for the Tribal Maternal, Infant, and Early Childhood Home Visiting Program (Tribal Home Visiting). The Tribal Home Visiting discretionary grants support cooperative agreements to conduct community needs assessments; plan for and implement high-quality, culturally-relevant, evidence-based home visiting programs in at-risk tribal communities; establish, measure, and report on progress toward meeting performance measures in six legislatively-mandated benchmark areas; and participate in rigorous evaluation activities to build the knowledge base on home visiting among Native populations.
Tribal Home Visiting grantees have been notified that in every year of their grant, after the first year, they must comply with the requirement for submitting an Annual Report to the Secretary that should feature activities carried out under the program during the past reporting period. In order to assist grantees with meeting the requirements of the Annual Report to the Secretary, ACF created guidance for grantees to use when writing their annual reports. The existing guidance (OMB Control No. 0970-0409, Expiration Date 9/30/15) provides sections where grantees must address the following:
• Update on Home Visiting Program Goals and Objectives
• Update on the Implementation of Home Visiting Program in Targeted Community(ies)
• Progress toward Meeting Legislatively Mandated Benchmark Requirements
• Update on Rigorous Evaluation Activities
• Home Visiting Program Continuous Quality Improvement (CQI) Efforts
• Administration of Home Visiting Program
• Technical Assistance Needs
The proposed data collection form is as follows:
ACF is requesting approval to renew and update the existing Tribal Home Visiting Guidance for Submitting an Annual Report to the Secretary (OMB Control No. 0970-0409) that will include instructions for grantees to submit either an annual or final report (in the final year of the grant) on the progress of their program to the Secretary, depending on the reporting period.
In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above.
Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Administration for Community Living, HHS.
Notice of proposed priority.
The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Employer Practices Leading to Successful Employment Outcomes for Individuals with Disabilities. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment practices and successful employment outcomes for individuals with disabilities.
We must receive your comments on or before March 27, 2015.
Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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Patricia Barrett. Telephone: (202) 245-6211 or by email:
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.
This notice of proposed priority is in concert with NIDILRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the
The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities of all ages; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.
This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at
The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at:
Although the employment of individuals with disabilities is the result of a complex interaction among many variables, employer practices comprise an important factor in the employment of individuals with disabilities. In recent years, researchers (Bruyère & Barrington, 2012; Chan et al., 2010a) have recognized the importance of considering demand-side,
A number of employer practices are associated with better employment outcomes (
However, knowledge of employer practices that are associated with better employment outcomes for individuals with disabilities does not tell us whether those practices actually caused those outcomes (Bruyère & Barrington, 2012; Fraser et al., 2011). In addition to the need for a stronger evidence base for the effectiveness of promising employer practices, there is a need for the development of measures that employers can use to track employment outcomes for individuals with disabilities (Erickson et al., 2013; Von Schrader et al., 2013). Both of these types of knowledge are critical to the development of effective workplace programs and practices to improve employment outcomes for individuals with disabilities.
(a)
(b)
(c)
(d)
(a) Identifying promising employer practices most strongly associated with desired employment outcomes for individuals with disabilities as well as the prevalence of these practices. Practices should include those related to the hiring, retention, and advancement of individuals with disabilities.
(b) Developing measures of employment outcomes that include hiring, retention, and advancement of individuals with disabilities. These measures must be developed for use by employers and other stakeholders. These measures may also include employment quality, such as, but not limited to, earnings, full- or part-time employment, or opportunities for on-the-job training. In developing these measures, the RRTC must collaborate with the NIDILRR-funded RRTC on Employment Policy and Measurement.
(c) Generating new knowledge of the effectiveness of promising employer practices by identifying or developing, and then implementing and evaluating pilot workplace program(s) based on practices identified in (a). This work should be conducted in employment settings in collaboration with employers, and should include:
(1) Implementation of practices that are particularly likely to be effective in improving employment outcomes for individuals with disabilities;
(2) Implementation of practices among different types of employers (
(3) Collection of data using, but not limited to, outcome measures from (b) above.
(d) Focusing its research on one or more specific stages of research. If the RRTC is to conduct research that can be categorized under more than one of the research stages, or research that progresses from one stage to another, those stages should be clearly justified.
(e) Serving as a national resource center related to employment for individuals with disabilities, their families, and other stakeholders by conducting knowledge translation activities that include, but are not limited to:
(1) Providing information and technical assistance to employers, employment service providers, employer groups, individuals with
(2) Providing training, including graduate, pre-service, and in-service training, to employers and employer groups, to facilitate more effective employer practices for individuals with disabilities. This training may be provided through conferences, workshops, public education programs, in-service training programs, and similar activities;
(3) Disseminating research-based information and materials related to increasing employment levels for individuals with disabilities; and
(4) Involving key stakeholder groups in the activities conducted under paragraphs (a) and (b) of this priority to promote the new knowledge generated by the RRTC.
This notice does
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement 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 the Executive Order.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, 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 a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
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.” 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.”
We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve outcomes for individuals with disabilities in the area of employment.
You may also access documents of the Department published in the
Administration for Community Living, HHS.
Notice of proposed priority.
The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Employment for Individuals with Blindness or other Visual Impairments. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment for individuals with blindness or other visual impairments.
We must receive your comments on or before March 27, 2015.
Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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•
Patricia Barrett. Telephone: (202) 245-6211 or by email:
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.
This notice of proposed priority is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the
The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities of all ages; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.
This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at
The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified
(a) Deaf blindness—Rough estimates suggest there are approximately 45 to 50 thousand individuals with deaf-blindness in the United States (Gallaudet University, 2010). Among students who received services under the Individuals with Disabilities Education Act (IDEA), 36.1 percent of students with multiple disabilities/deaf-blindness were employed after leaving high school as compared to 62.4 percent among students with visual impairments only (American Federation of the Blind, 2014). For the 2,020 persons with deaf-blindness who received services through the Federal/State Vocational Rehabilitation program from 2008 through 2013, 64.5 percent achieved employment outcomes (Rehabilitation Services Administration, 2014). Prevalence and employment data thus vary considerably and strategies for improving communication, social development, self-determination, and employment for this subpopulation have not kept pace with emerging technologies accessible to most citizens (Hartman, 2010). Development and testing of new technologies focused on improving the employment and quality of life outcomes of people with deaf-blindness is needed along with effective knowledge translation and dissemination.
(b) Blindness or low vision related to traumatic brain injury (TBI)—In 2010, approximately 2.5 million people received a traumatic brain injury (Center for Disease Control (2010). TBI is also a signature cause of disability among veterans of the wars in Iraq and Afghanistan (U.S. Department of Defense, 2012). Closed head injuries often result in focal axonal swelling and disconnection, damage to optic nerves, impaired visual processing, and eye movement difficulties due to cranial nerve disruption. Research has estimated that among individuals with TBI in the United States, 42 percent were unemployed (Doctor, Castro, Temkin, Fraser, Machamer & Dikmen, 2005). For Vocational Rehabilitation consumers with TBI, 49.4 percent or 6,040 achieved employment in 2013 (Rehabilitation Services Administration, 2014). There are little data on the employment outcomes of individuals with TBI who experience low-vision and blindness, however. Research is needed to document the employment outcomes of individuals who experience low vision and blindness due to or in addition to TBI and to develop effective neuropsychological rehabilitation, psychotherapy, vocational rehabilitation, and other interventions for improving employment outcomes for these individuals.
(c) Transition-age students—High school students with blindness or visual impairments demonstrate higher academic achievement and are more likely to continue with postsecondary education when compared to other students receiving special education services under the IDEA. However, these students are less likely to achieve employment outcomes despite demonstrated academic success (Wagner, Newman, Cameto, Levine & Garza 2006; McDonnall, 2010). Qualitative research suggests that early intervention and planning, family involvement, interagency coordination and early work-based experiences may improve employment outcomes for transition-age students with blindness or visual impairments (Crudden, 2012). Rigorous research evaluating the potential of these and other employment-focused strategies, including vocational rehabilitation, may thus yield results that inform effective policies and practice.
(a)
(b)
(c)
(d)
The RRTC must contribute to improving the employment outcomes of individuals with blindness or other visual impairments by:
(a) Conducting research on the efficacy of rehabilitation services and technology used to enhance employment outcomes of individuals with blindness or other visual impairments. Outcomes must include but are not limited to obtaining employment, retention, promotion, and quality of salary and benefits. The RRTC must focus its research on the target population of individuals with blindness or other visual impairments, including at least one of the following subpopulations of particular concern: (1) Individuals who are deaf-blind, (2) individuals with blindness or low vision related to traumatic brain injury, and (3) transition-age young people with blindness or other visual impairments;
(b) Generating new knowledge about how the outcomes of the services and technologies investigated in paragraph (a) vary with relevant variables such as service type, consumer characteristics, and provider characteristics;
(c) Focusing its research on one or more specific stages of research. If the RRTC is to conduct research that can be categorized under more than one of the research stages, or research that progresses from one stage to another, those stages should be clearly justified;
(d) Serving as a national resource center related to employment for individuals with blindness or other visual impairments, their families, and other stakeholders by conducting knowledge translation, technical assistance, and training activities;
(e) Disseminating research-based information and materials related to improving the quality of services to individuals with blindness or other visual impairments; and
(f) Involving key stakeholder groups in the activities conducted under paragraphs (a) and (b) of this priority to promote the new knowledge generated by the RRTC.
This notice does
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement 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 the Executive Order.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that
(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 a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
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.” 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.”
We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve employment outcomes for individuals with blindness or other visual impairments.
You may also access documents of the Department published in the
Administration for Community Living.
Notice of proposed priority.
The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Self-Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment for individuals with serious mental illness (SMI) and co-occurring conditions.
We must receive your comments on or before March 27, 2015.
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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•
The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at
Patricia Barrett. Telephone: (202) 245-6211 or by email:
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.
This notice of proposed priority is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the
The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and
This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at
The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at:
Mental health disorders are one of the leading causes of disability in the United States. In 2012, there were an estimated 9.6 million adults aged 18 or older in the U.S. with serious mental illness, representing 4.1 percent of all U.S. adults (U.S. Department of Health and Human Services, 2012a). Most individuals with mental illness today live in community settings—a result of the deinstitutionalization movement of the 1960s to 1980s, the Americans with Disabilities Act of 1990, and the 1999 U.S. Supreme Court
Over the last few decades, the concept of self-determination has become more widespread in the design and conceptualization of services for individuals with mental illness. In this context, self-determination refers to individuals' rights to direct their own services, to be involved in decisions that impact their wellbeing, to be meaningfully involved in the design, delivery and evaluation of services and supports, and to develop and use their own personal goals to guide their lives and actions (Cook & Jonikas, 2002). Self-determination is a central component of the Substance Abuse and Mental Health Services Administration's definition of recovery (U.S. Department of Health and Human Services, 2012b) and has become an important component of recovery-oriented mental health treatment and services. It is closely related to the guiding principle of informed choice in vocational rehabilitation and supported employment (Drake, Bond & Becker, 2012; Workforce Innovation and
At the system level, the self-determination approach in health care has informed systems in which individuals with disabilities control the services they receive. These systems are known by a variety of names, (
Other system-level approaches to improving both access to health care and the health of individuals with mental illness have incorporated principles of care coordination to integrate mental health services with general medical services (Barry & Huskamp, 2014; Croft & Parish, 2012; Druss et al., 2010; Kelly et al., 2014; Mechanic, 2014). Services provided through care coordination models can bridge the gap between mental health and general health services and improve outcomes both in mental and in general medical health (Woltmann et al., 2012). Although care coordination organizations do not necessarily incorporate self-determination features, they can do so. For example, care coordination models may include illness self management programs, which train individuals on how to manage their symptoms and improve their functioning and quality of life. In fact, the Improving Chronic Illness Care Initiative includes illness self-management as a core feature (Kelly et al., 2014; McDonald et al., 2007; Woltmann et al., 2012). Illness self-management interventions can be effective for people with mental illness dealing with general medical problems (Kelly et al., 2014) or mental illness (Roe et al., 2009). In addition, there is preliminary evidence that mental illness self-management may have positive effects on employment outcomes (Michon, 2011).
However, coordinated care systems can be complex for consumers to negotiate. Therefore, many systems provide staff who serve as navigators to help guide clients through the barriers of complex health care systems and provide support for consumers in such self-directed activities as developing plans and making choices. Early research indicates that provision of navigator services can improve health outcomes and use of medical services for individuals with mental illness (Griswold et al., 2010; Kelly et al., 2013). In addition, having peers serve either as navigators or to deliver mental or general healthcare interventions can be effective for individuals with mental illness (Brekke et al., 2013; Chinman et al., 2014; Kelly et al, 2014; Pitt et al., 2013).
Research on the use of self-directed services and supports, and self-directed care, for individuals with mental illness is in preliminary stages. There is a need for better understanding of the optimal use of self-directed strategies in the integration of general health care and mental health care, as well as the optimal involvement of peer supports for people with serious mental illness.
The research that is proposed under this priority must be focused on one or more stages of research. If the RRTC is to conduct research that can be categorized under more than one research stage, or research that progresses from one stage to another, those research stages must be clearly specified. For purposes of this priority, the stages of research are from the notice of final priorities and definitions published in the
(a)
(b)
(c)
(d)
The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by
(1) Increased knowledge that can be used to enhance the health and well-being of individuals with serious mental illness and co-occurring conditions. The RRTC must contribute to this outcome by:
(a) Conducting research to develop a better understanding of the barriers to and facilitators of implementing models that integrate general medical and mental health care for individuals with SMI. These models must incorporate self-management and self-direction strategies. This research must specifically examine models that incorporate peer-provided services and supports along with research-based service integration strategies such as health navigation and care coordination.
(b) Conducting research to identify or develop and then test interventions that use individual budgets or flexible funds to increase consumer choice. The RRTC must design this research to determine the extent to which the consumer-choice intervention improves health outcomes and promotes recovery among individuals living with SMI. In carrying out this activity, the grantee must investigate the applicability of strategies that have proven successful with the general population or other subpopulations to determine if they are effective with individuals with SMI and co-occurring conditions.
(2) Improved employment outcomes among individuals with SMI. The RRTC must contribute to this outcome by:
(a) Conducting research to develop a better understanding of the barriers to and facilitators of implementing vocational service and support models that incorporate self management and self-direction features. These features must include self-directed financing and flexible funding of services that support mental health treatment and recovery, general health, and employment. These services may include services and supports not traditionally supplied by mental health or general medical systems.
(3) Increased incorporation of research findings related to SMI, self-directed care, health management, and employment into practice or policy.
(a) Developing, evaluating, or implementing strategies to increase utilization of research findings related to SMI, co-occurring conditions, health management, and employment.
(b) Conducting training, technical assistance, and dissemination activities to increase utilization of research findings related to self-directed care of individuals living with SMI to promote and co-occurring conditions, health management, and employment.
We will announce the final priority in a notice in the
This notice does
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement 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 the Executive Order.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, 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 a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
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.” 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.”
We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve recovery, health, and wellness outcomes for individuals with serious mental illness (SMI) and co-occurring conditions.
You may also access documents of the Department published in the
Administration for Community Living, Department of Health and Human Services.
Notice of proposed priority.
The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Employment Policy and Measurement. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment outcomes for individuals with disabilities.
We must receive your comments on or before March 27, 2015.
Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
•
•
Patricia Barrett. Telephone: (202) 245-6211 or by email:
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.
This notice of proposed priority is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the
The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.
This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at
The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at:
29 U.S.C. 762(g) and 764(b)(2).
This notice contains one proposed priority.
Since the 2007 recession, Social Security Disability Insurance (SSDI) applications and awards have increased rapidly. There are nearly 9 million beneficiaries currently receiving SSDI payments, and this figure is expected to grow as workers age and increase their likelihood of experiencing disability. With this growth in program participation, actuaries estimate that the SSDI trust fund will be depleted in late 2016 unless substantial changes occur (Social Security Administration, 2014). Given this scenario, developing informed employment policy options is essential. These options require sound research to inform policymakers regarding the projected impacts of policies that encourage employment among individuals with disabilities while ensuring an adequate safety net. Research is also needed to evaluate the long-term impacts of policies and programs that aim to facilitate employment and improve the quality of life among people with disabilities.
The interactions between Social Security disability programs and public health insurance programs have long been considered a substantial barrier to employment for people with disabilities (Loprest & Maag, 2001; National Council on Disability, 2007). The 2010 enactment of the Patient Protection and Affordable Care Act (ACA) provided improved access to public and private insurance for all Americans including those with disabilities. For example, the ACA prevents health care coverage denials due to pre-existing conditions, increases coverage requirements, and provides mental health parity for persons with psychiatric disabilities. The impact of the ACA on employment outcomes for people with disabilities is an important research area.
Prior RRTC-EPM work focused on examining and improving extant methods of measuring disability status, as well as measuring employment outcomes among people with disabilities. For example, the RRTC illustrated how self-reported disability status changes over time through an analysis of longitudinal data focusing on youth (Mann and Honeycutt, 2014). These analyses indicated that the proportion of respondents with a disability doubled from 12 percent to nearly 25 percent over the course of 13 years. Multivariate analyses showed that women were more likely than men to report changes in health condition or disability status, and those with mild disabilities were relatively less likely than those without or with severe disabilities to experience changes in disability status. The RRTC also studied extant surveys and found that commonly used measures overestimated employment and underestimated receipt of disability income assistance such as SSDI (Burkhauser, Houtenville and Tenant, 2014). Other researchers have recently explored similar issues related to the reliability and stability of disability measures (Brault, 2013; Davies & Fisher, 2013; Sears & Rupp, 2003). Knowledge gained through this work has highlighted a need to develop improved methods of measuring both disability and employment in ways that generate more reliable and valid research findings. Continued innovation is thus needed to develop measures and metrics that accurately reflect the changing nature of disability across the life span as well as changes in the workforce over time. By doing so, research results may be more relevant for policy and program decisions aimed at improving employment outcomes for people with disabilities.
The research that is proposed under this priority must be focused on one or more stages of research. If the RRTC is to conduct research that can be categorized under more than one research stage, or research that progresses from one stage to another, those research stages must be clearly specified. For purposes of this priority, the stages of research are from the notice of final priorities and definitions published in the
(a)
(b)
(c)
(d)
The Administrator of the Administration for Community Living proposes a priority for an RRTC on Employment Policy and Measurement. The purpose of the proposed RRTC on Employment Policy and Measurement RRTC (RRTC-EPM) is to investigate the impact of Federal and State policies and programs on employment of individuals with disabilities, paying particular attention to the effects of program interactions. The RRTC-EPM will also examine new ways of measuring employment outcomes and facilitate the translation of research findings to guide policymaking and program administration. Applicants must identify targeted research questions in response to the problems identified below and propose rigorous research methodologies to answer these questions. Of particular interest is research that investigates the interaction between the Affordable Care Act (ACA), Social Security Disability Insurance (SSDI), and employment. The desired outcome of this investment is new knowledge about the effect of new or existing policies on employment-related decision-making of individuals with disabilities, and ultimately on rates and quality of employment by these individuals.
The RRTC must contribute to improving the employment outcomes of individuals with disabilities by:
(a) Generating new knowledge about the effects of program interactions on employment outcomes of individuals with disabilities, including but not necessarily limited to the interaction between Social Security disability benefit programs and the ACA. Specifically, the RRTC must generate new knowledge of the potential impacts of varied policy scenarios regarding the SSDI trust fund exhaustion on the employment and economic outcomes of individuals with disabilities.
(b) Developing reliable and valid methods of measuring employment outcomes for people with disabilities;
(c) Serving as a national resource center on policy issues that impact employment outcomes of individuals with disabilities, and
(d) Increasing incorporation of research findings from the RRTC into practice or policy by:
(1) Collaborating with stakeholder groups to develop, evaluate, or implement strategies to increase utilization of research findings;
(2) Conducting training and dissemination activities to facilitate the utilization of research findings by policymakers, employers, and individuals with disabilities;
(3) Providing technical assistance to facilitate use of information produced by the RRTC research; and
(4) Collaborating and sharing information with other agencies across the Federal government. In addition, the RRTC must collaborate with appropriate
We will announce the final priority in a notice in the
This notice does
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement 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 the Executive Order.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, 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 a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
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.” 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.”
We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve outcomes for individuals with disabilities in the area of employment.
You may also access documents of the Department published in the
Administration for Community Living, HHS.
Notice of proposed priority.
The Administrator of the Administration for Community Living proposes a priority for the Disability and Rehabilitation Research Projects (DRRPs) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for Promoting
We must receive your comments on or before March 27, 2015.
Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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Patricia Barrett. Telephone: (202) 245-6211 or by email:
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.
This notice of proposed priority is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the
The Plan identifies a need for research and training regarding employment, community living and participation, and health and function of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities of all ages; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.
This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at
The purpose of NIDILRR's DRRPs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to improve the effectiveness of services authorized under the Rehabilitation Act by developing methods, procedures, and rehabilitation technologies that advance a wide range of independent living and employment outcomes for individuals with disabilities, especially individuals with the most significant disabilities. DRRPs carry out one or more of the following types of activities, as specified and defined in 34 CFR 350.13 through 350.19: research, training, demonstration, development, utilization, dissemination, and technical assistance.
An applicant for assistance under this program must demonstrate in its application how it will address, in whole or in part, the needs of individuals with disabilities from minority backgrounds (34 CFR 350.40(a)). The approaches an applicant may take to meet this requirement are found in 34 CFR 350.40(b). Additional information on the DRRP program can be found at:
29 U.S.C. 762(g) and 764(a).
NIDILRR grantees have substantially contributed to the development, refinement, and application of UD principles. In particular, the NIDILRR-funded Center for Universal Design at North Carolina State University (in collaboration with other researchers and practitioners) developed the seven “Principles of Universal Design” (The Principles of Universal Design, 1997). These principles (equitable use, flexibility in use, simple and intuitive use, perceptible information, tolerance for error, low physical effort, and appropriate size and space for approach and use regardless of users' body size, posture, and mobility) have increasingly guided designers, builders, developers, and other stakeholders in the provision of accessible housing and built environments. Examples of UD found in the built environment include: curb cuts, building ramps, automatic door openers, fully accessible restrooms, moving walkways, and wayfinding systems that facilitate user access and orientation.
All NIDILRR-funded Rehabilitation Engineering Research Centers (RERCs) must incorporate UD principles in their research and development activities. Funded for the past 15 years, the RERC on Universal Design and the Built Environment is specifically charged with advancing the implementation of UD principles in the built environment. Center outcomes include a tool set for UD research and practice, prototypes for built environments, and UD standards. NIDILRR funding has contributed to the development of 35 state and local visitability ordinances and initiatives across the U.S, which require or encourage affordable and sustainable integration of basic accessibility features into all newly-built homes. NIDILRR funding also supported the inclusion of UD principles in a building manual which the New York City Department of Design and Construction adopted as the official reference for all architects working in the city (Center for Inclusive Design and Universal Access, 2003).
Despite these notable outcomes, application of UD principles to the built environment has not become a mainstream practice (Ostroff, 2011; Dong 2011). Practical demonstrations of UD applications for buildings, homes, and outdoor environments, as well as a strengthened evidence-base for UD standards and strategies are yet needed. These needs will only increase as the baby boom generation ages while seeking to live and thrive in their own homes and communities (Federal Interagency Forum on Aging-Related Statistics, 2012). Making research-based knowledge about UD accessible to designers, developers, architects, and builders will help to advance UD implementation and realize the goals of improving human performance, health and wellness, and social participation for the entire population, including individuals with disabilities. Accordingly, NIDILRR aims to sponsor a DRRP on Promoting UD in the Built Environment to conduct research, knowledge translation, technical assistance, and training activities aimed at continued implementation of UD principles in the built environment.
(a) Conducting research activities toward developing evidence-based practices for UD implementation in commercial and private facilities, outdoor environments, and housing.
(b) Creating measurable UD standards and guidelines to facilitate the implementation of UD principles in commercial and private facilities, outdoor environments, and housing.
(c) Developing and promoting curricula on UD for university-level architecture, engineering, and design students.
(d) Providing training and technical assistance to designers, architects, and builders to incorporate UD principles and features into their buildings, projects, and communities.
(e) Providing training and technical assistance to NIDILRR's engineering and assistive technology grantees to incorporate UD strategies and standards into development projects serving the needs of individuals with disabilities and the broader population.
(f) Partnering with relevant stakeholders in carrying out all DRRP activities. Stakeholders include but are not limited to: Individuals with disabilities, professional organizations that teach design principles, researchers, engineers, planners, designers, developers, architects, and builders.
This notice does
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement 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 the Executive Order.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, 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 a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
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.” 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.”
We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new DRRP would generate, disseminate, and promote the use of new information that would improve accessibility of the built environment for individuals with disabilities.
You may also access documents of the Department published in the
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by March 27, 2015.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices (CGMPs) to ensure that such drug meets the requirements of the FD&C Act as to safety, and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
The FDA has the authority under section 701(a) of the FD&C Act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the FD&C Act regarding CGMP procedures for manufacturing, processing, and holding drugs and drug products. The CGMP regulations help ensure that drug products meet the statutory requirements for safety and have their purported or represented identity, strength, quality, and purity characteristics. The information collection requirements in the CGMP regulations provide FDA with the necessary information to perform its duty to protect public health and safety. CGMP requirements establish accountability in the manufacturing and processing of drug products, provide for meaningful FDA inspections, and enable manufacturers to improve the quality of drug products over time. The CGMP recordkeeping requirements also serve preventive and remedial purposes and provide crucial information if it is necessary to recall a drug product.
The general requirements for recordkeeping under part 211 (21 CFR part 211) are set forth in § 211.180. Any production, control, or distribution record associated with a batch and required to be maintained in compliance with part 211 must be retained for at least 1 year after the expiration date of the batch and, for certain over-the-counter (OTC) drugs, 3 years after distribution of the batch (§ 211.180(a)). Records for all components, drug product containers, closures, and labeling are required to be maintained for at least 1 year after the expiration date and 3 years for certain OTC products (§ 211.180(b)).
All part 211 records must be readily available for authorized inspections during the retention period (§ 211.180(c)), and such records may be retained either as original records or as true copies (§ 211.180(d)). In addition, 21 CFR 11.2(a) provides that for records required to be maintained but not submitted to the Agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. To the extent this electronic option is used, the burden of maintaining paper records should be substantially reduced, as should any review of such records.
In order to facilitate improvements and corrective actions, records must be maintained so that data can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures (§ 211.180(e)). Written procedures for these evaluations are to be established and include provisions for a review of a representative number of batches and, where applicable, records associated with the batch; provisions for a review of complaints, recalls, returned, or salvaged drug products; and investigations conducted under § 211.192 for each drug product.
The specific recordkeeping requirements provided in table 1 are as follows:
Section 211.34—Consultants advising on the manufacture, processing, packing, or holding of drug products must have sufficient education, training, and experience to advise on the subject for which they are retained. Records must be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.
Section 211.67(c)—Records must be kept of maintenance, cleaning, sanitizing, and inspection as specified in §§ 211.180 and 211.182.
Section 211.68—Appropriate controls must be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Section 211.68(a)—Records must be maintained of calibration checks, inspections, and computer or related system programs for automatic, mechanical, and electronic equipment.
Section 211.68(b)—All appropriate controls must be exercised over all computers or related systems and control data systems to assure that changes in master production and control records or other records are instituted only by authorized persons.
Section 211.72—Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use must not release fibers into such products.
Section 211.80(d)—Each container or grouping of containers for components or drug product containers or closures must be identified with a distinctive code for each lot in each shipment received. This code must be used in recording the disposition of each lot. Each lot must be appropriately identified as to its status.
Section 211.100(b)—Written production and process control procedures must be followed in the execution of the various production and process control functions and must be documented at the time of performance. Any deviation from the written procedures must be recorded and justified.
Section 211.105(b)—Major equipment must be identified by a distinctive identification number or code that must be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code.
Section 211.122(c)—Records must be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination, or testing.
Section 211.130(e)—Inspection of packaging and labeling facilities must be made immediately before use to assure that all drug products have been removed from previous operations. Inspection must also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection must be documented in the batch production records.
Section 211.132(c)—Certain retail packages of OTC drug products must bear a statement that is prominently placed so consumers are alerted to the specific tamper-evident feature of the package. The labeling statement is required to be so placed that it will be unaffected if the tamper-resistant feature of the package is breached or missing. If the tamper-evident feature chosen is one that uses an identifying characteristic, that characteristic is required to be referred to in the labeling statement.
Section 211.132(d)—A request for an exemption from packaging and labeling requirements by a manufacturer or packer is required to be submitted in the
Section 211.137—Requirements regarding product expiration dating and compliance with 21 CFR 201.17.
Section 211.160(a)—The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, must be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. These requirements must be followed and documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms must be recorded and justified.
Section 211.165(e)—The accuracy, sensitivity, specificity, and reproducibility of test methods employed by a firm must be established and documented. Such validation and documentation may be accomplished in accordance with § 211.194(a)(2).
Section 211.166—Stability testing program for drug products.
Section 211.173—Animals used in testing components, in-process materials, or drug products for compliance with established specifications must be maintained and controlled in a manner that assures their suitability for their intended use. They must be identified, and adequate records must be maintained showing the history of their use.
Section 211.180(e)—Written records required by part 211 must be maintained so that data can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures must be established and followed for such evaluations and must include provisions for a representative number of batches, whether approved or unapproved or rejected, and a review of complaints, recalls, returned, or salvaged drug products, and investigations conducted under § 211.192 for each drug product.
Section 211.180(f)—Procedures must be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations, conducted under § 211.198, 211.204, or 211.208, any recalls, reports of inspectional observations issued, or any regulatory actions relating to good manufacturing practices brought by FDA.
Section 211.182—Specifies requirements for equipment cleaning records and the use log.
Section 211.184—Specifies requirements for component, drug product container, closure, and labeling records.
Section 211.186—Specifies master production and control records requirements.
Section 211.188—Specifies batch production and control records requirement.
Section 211.192—Specifies the information that must be maintained on the investigation of discrepancies found in the review of all drug product production and control records by the quality control staff.
Section 211.194—Explains and describes laboratory records that must be retained.
Section 211.196—Specifies the information that must be included in records on the distribution of the drug.
Section 211.198—Specifies and describes the handling of all complaint files received by the applicant.
Section 211.204—Specifies that records be maintained of returned and salvaged drug products and describes the procedures involved.
Written procedures, referred to here as standard operating procedures (SOPs), are required for many part 211 records. The current SOP requirements were initially provided in a final rule published in the
Section 211.22(d)—Responsibilities and procedures of the quality control unit;
Section 211.56(b)—Sanitation procedures;
Section 211.56(c)—Use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents;
Section 211.67(b)—Cleaning and maintenance of equipment;
Section 211.68(a)—Proper performance of automatic, mechanical, and electronic equipment;
Section 211.80(a)—Receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers or closures;
Section 211.94(d)—Standards or specifications, methods of testing, and methods of cleaning, sterilizing, and processing to remove pyrogenic properties for drug product containers and closures;
Section 211.100(a)—Production and process control;
Section 211.110(a)—Sampling and testing of in-process materials and drug products;
Section 211.113(a)—Prevention of objectionable microorganisms in drug products not required to be sterile;
Section 211.113(b)—Prevention of microbiological contamination of drug products purporting to be sterile, including validation of any sterilization process;
Section 211.115(a)—System for reprocessing batches that do not conform to standards or specifications, to insure that reprocessed batches conform with all established standards, specifications, and characteristics;
Section 211.122(a)—Receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials;
Section 211.125(f)—Control procedures for the issuance of labeling;
Section 211.130—Packaging and label operations, prevention of mixup and cross contamination, identification and handling of filed drug product containers that are set aside and held in unlabeled condition, and identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch;
Section 211.142—Warehousing;
Section 211.150—Distribution of drug products;
Section 211.160—Laboratory controls;
Section 211.165(c)—Testing and release for distribution;
Section 211.166(a)—Stability testing;
Section 211.167—Special testing requirements;
Section 211.180(f)—Notification of responsible officials of investigations, recalls, reports of inspectional observations, and any regulatory actions relating to good manufacturing practice;
Section 211.198(a)—Written and oral complaint procedures, including quality control unit review of any complaint involving specifications failures, and serious and unexpected adverse drug experiences;
Section 211.204—Holding, testing, and reprocessing of returned drug products; and
Section 211.208—Drug product salvaging.
In addition, the following regulations in parts 610 and 680 (21 CFR parts 610
Although most of the CGMP provisions covered in this document were created many years ago, there will be some existing firms expanding into new manufacturing areas and startup firms that will need to create SOPs. As provided in table 1, FDA is assuming that approximately 100 firms will have to create up to 25 SOPs for a total of 2,500 records, and the Agency estimates that it will take 20 hours per recordkeeper to create 25 new SOPs for a total of 50,000 hours.
In the
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Fax written comments on the collection of information by March 27, 2015.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE—14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350b(a)) provides that at least 75 days before the introduction or delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary ingredient, the manufacturer or distributor of the dietary supplement or of the new dietary ingredient is to submit to us (as delegate for the Secretary of Health and Human Services) information upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. FDA's implementing regulation, 21 CFR 190.6, requires this information to be submitted to the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) in the form of a notification. Under § 190.6(b), the notification must include the following: (1) The name and complete address of the manufacturer or distributor, (2) the name of the new dietary ingredient, (3) a description of the dietary supplement(s) that contain the new dietary ingredient, including the level of the new dietary ingredient in the dietary supplement and the dietary supplement's conditions of use, (4) the history of use or other evidence of safety establishing that the new dietary ingredient will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement, and (5) the signature of a responsible person designated by the manufacturer or distributor.
These premarket notification requirements are designed to enable us to monitor the introduction into the marketplace of new dietary ingredients and dietary supplements that contain new dietary ingredients, in order to protect consumers from ingredients and products whose safety is unknown. We use the information collected in new dietary ingredient notifications to evaluate the safety of new dietary ingredients in dietary supplements and to support regulatory action against ingredients and products that are potentially unsafe.
We are developing an electronic portal that interested persons will be able to use to electronically submit their notifications to ONLDS via FDA Unified Registration and Listing System (FURLS). Firms that prefer to submit a paper notification in a format of their own choosing will still have the option to do so, however. Form FDA 3880 prompts a submitter to input the elements of a new dietary ingredient notification (NDIN) in a standard format and helps the submitter organize its NDIN to focus on the information needed for our safety review. Safety information will be submitted via a supplemental form entitled “New Dietary Ingredient (NDI) Safety Information.” This form provides a standard format to describe the history of use or other evidence of safety on which the manufacturer or distributor bases its conclusion that the new dietary ingredient will be reasonably expected to be safe under the conditions of use recommended or suggested in the labeling of the dietary supplement, as well as related identity information that is necessary to demonstrate safety by showing that the new dietary ingredient and dietary supplement(s) that are the subject of the notification are the same or similar to the ingredients and products for which safety data and information have been provided. Draft screenshots of Form FDA 3880 and the supplemental safety information form are available for comment at
In the
The third comment asserted that we underestimated the reporting burden of the NDIN procedures under § 190.6 by failing to take into account the recommendations in the draft guidance entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (the 2011 draft guidance) (available at
Although we agree with the commenter that information collection recommendations in guidance are subject to the PRA, we intend to meet our PRA obligations in that regard separately at a later time. The 2011 draft guidance was published solely for the purpose of seeking comment, and it has not been made final. Moreover, FDA intends to publish a revised draft guidance for comment later this year, and the revised draft guidance will supersede the 2011 draft guidance. Although we expect the revised draft guidance to be followed by a final guidance, there will be an interim period where no guidance on NDINs is in effect. The purpose of the current PRA proceeding is to seek comment on and obtain OMB approval for the NDIN collections of information in effect during this interim period, which are those found in the FDA's NDIN regulations at § 190.6 and in the electronic NDIN submission forms that we have made available for comment. After publishing a revised draft guidance on NDINs and related issues, we intend to publish a 60-day notice inviting comment on the proposed collections of information associated with that document. At that time, we will carefully evaluate all comments we receive.
We estimate the burden of this collection of information as follows:
We believe that the burden of the premarket notification requirement on industry is limited and reasonable because we are requesting only safety and identity information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in compliance with the FD&C Act. In the past, commenters have argued that our burden estimate is too low. We carefully considered the issue and believe that burden estimates of greater than 20 hours per notification likely include the burden associated with researching and generating safety data for a new dietary ingredient. Under section 413(a)(2) of the FD&C Act, a dietary supplement that contains a new dietary ingredient is deemed to be adulterated unless there is a history of use or other evidence of safety establishing that the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling of the dietary supplement. This requirement is separate from and additional to the requirement to submit a premarket notification for the new dietary ingredient. FDA's regulation on NDINs, § 190.6(a), requires the manufacturer or distributor of the dietary supplement, or of the new dietary ingredient, to submit to FDA the information that forms the basis for its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. Thus, § 190.6 only requires the manufacturer or distributor to extract and summarize information that should have already been developed to meet the safety requirement in section 413(a)(2) of the FD&C Act. We estimate that extracting and summarizing the relevant information from what exists in the company's files and presenting it in a format that meets the requirements of § 190.6 will take approximately 20 hours of work per notification. However, we seek comments on this estimate. We encourage comments offering alternative burden estimates to include documentation to support the alternative estimate.
We further estimate that 55 respondents will submit 1 premarket notification each. We base our estimate of the number of respondents on notifications received over the past 3 years, which averaged about 55 notifications per year.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.” This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should be provided for regulatory evaluation of a digital whole slide imaging (WSI) system. This draft guidance is not final nor is it in effect at this time.
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 of 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 May 26, 2015.
An electronic copy of the guidance document is available for
Submit electronic comments on the draft guidance to
Nicholas Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002, 301-796-4310; or Aldo Badano, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 3116, Silver Spring, MD 20993-0002, 301-796-2534.
Recent technological advances in digital microscopy, in particular the development of whole slide scanning systems, have accelerated the adoption of digital imaging in pathology, similar to the digital transformation that radiology departments have experienced over the last decade. FDA regulates WSI systems manufacturers to ensure that the images produced for clinical intended uses are safe and effective for such purposes. Essential to the regulation of these systems is the understanding of the technical performance of the components in the imaging chain, from image acquisition to image display and their effect on pathologist's diagnostic performance and workflow.
This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should be included for regulatory evaluation of a WSI. This document does not cover the clinical submission data that may be necessary to support approval or clearance. The guidance provides our suggestions on how to best characterize the technical aspects that are relevant to WSI performance for their intended use and determine any possible limitations that might affect their safety and effectiveness.
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 Agency's current thinking on technical performance assessment of digital pathology WSI devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
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 of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120, the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231, and the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485.
Interested persons may submit either electronic comments regarding this document to
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its 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 Walter Ellenberg at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA) is announcing the public workshop entitled “Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities.” FDA is holding this public workshop to obtain information on the current challenges and opportunities related to robotically-assisted surgical medical devices, which are classified as Class II medical devices. The purpose of this workshop is to obtain public feedback on scientific, clinical, and regulatory considerations associated with RAS devices. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for RAS technologies.
If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321, Silver Spring, MD 20993-0002, 301-796-5661, email:
To register for the public workshop, please visit FDA's Medical Devices News & Events—Workshops & Conferences calendar at
Regardless of attendance at the public workshop, interested persons may submit either electronic comments to
RAS devices, also known as computer-assisted surgical devices, are used by trained physicians in an operating room environment for laparoscopic surgical procedures in general surgery, cardiac, colorectal, gynecologic, head and neck, thoracic, and urologic surgical procedures. These medical devices enable the surgeon to use computer, software, and robotic technologies to control and move surgical instruments through the mouth or through one or more small incisions in the patient's body for a variety of surgical procedures. Some common procedures that may involve RAS devices include gallbladder, uterus, or prostate removal.
As discussed further in section II, there are several clinical and scientific challenges associated with regulation of RAS devices, such as appropriate nonclinical and clinical evaluation of RAS devices, use of third-party surgical instruments with legally marketed RAS devices, and clinical training programs. This workshop seeks to involve industry and academia in addressing these challenges in the development of RAS devices to ensure that there is a reasonable assurance of safety and effectiveness for RAS devices while promoting innovation in a rapidly-developing field. By bringing together relevant stakeholders including scientists, patient advocates, clinicians, researchers, industry representatives, and regulators, we hope to facilitate the improvement of this evolving product area.
Topics to be discussed at the public workshop include, but are not limited to, the following:
1. The current landscape of RAS devices and the respective Offices, Divisions, and Branches within FDA involved in the review of pre- and postmarket data associated with these devices.
2. Challenges, needs, and benefit/risk profiles for indications in various surgical areas;
3. Unique benefits of RAS devices versus traditional surgical procedures.
4. Scientific and technical considerations for third-party manufacturers seeking to claim that their surgical instruments can be used with legally marketed RAS devices.
5. Design, administration, and certification of training programs and FDA's role in this process.
6. The future landscape of RAS and robotic surgery devices.
7. Considerations regarding appropriate selection of preclinical (bench and animal) test methods and patient-centered outcome metrics in clinical use for different stages of device development.
These topics will be presented by experts in the associated area, followed by more in-depth discussions and Q&A from all participants.
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA) is announcing the availability of the report and Web site location where the Agency has posted the report entitled “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,” developed by the National Medical Device Postmarket Surveillance System Planning Board. In addition, FDA has established a docket where stakeholders may provide comments.
Submit either electronic or written comments by April 27, 2015.
Submit electronic comments on this document to
Thomas P. Gross, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2316, Silver Spring, MD 20993-0002, 301-796-5700, email:
FDA's Center for Devices and Radiological Health is responsible for protecting the public health by assuring the safety and effectiveness of medical devices. A key part of this mission is to monitor medical devices for continued safety and effectiveness after they are in use and to help the public get the accurate, science-based information they need to improve their health.
In September 2012, the FDA published a report, “Strengthening Our National System for Medical Device Postmarket Surveillance,” that proposed a strategy for improving the current system for monitoring medical device safety and effectiveness. In April 2013, the FDA issued an update to the September 2012 report that incorporated public input received and described the next steps towards fulfilling the vision for building a national postmarket surveillance system. These reports can be found at FDA's Web site
One of these next steps consisted of establishing a multistakeholder planning board to identify the governance structure, practices, policies, procedures, methodological approaches, and business model(s) necessary to facilitate the creation of a sustainable, integrated medical device postmarket surveillance system that leverages and complements existing and ongoing efforts. Under a cooperative agreement with the FDA, the Engelberg Center for Health Care Reform at the Brookings Institution convened the National Medical Device Postmarket Surveillance Planning Board (the Planning Board) in 2014. The Planning Board membership included representatives from a broad array of stakeholder groups and areas of expertise including patients, provider organizations, hospitals, health plans, industry, and government agencies, as well as methodologists and academic researchers.
The Planning Board was tasked with developing a set of long-term principles and priorities for a National Postmarket Surveillance System. The task included identifying potential governance and business models that address legal and privacy considerations, system financing and stability, mechanisms to support the appropriate use of data, and policies to ensure system transparency. The Planning Board was also asked to provide recommendations about how to leverage the system to meet the needs of other medical device stakeholders and groups seeking to develop better evidence (
This notice announces the availability and Web site location of the Planning Board's report entitled “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System.” FDA invites interested persons to submit comments on this report. We have established a docket where comments may be submitted (see
Interested persons may submit either electronic comments regarding this document to
Food and Drug Administration, HHS.
Notice; request for information.
The Food and Drug Administration (FDA or the Agency) is opening a docket to obtain information and comments on specific areas of public health concern for racial/ethnic demographic subgroup populations, focusing on certain disease areas where significant outcome differences may be anticipated. The Agency is seeking public input on identifying areas that can be addressed through regulatory science research.
Submit either electronic or written comments or information by April 27, 2015.
You may submit comments by any of the following methods:
• Federal eRulemaking Portal:
• Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Christine Merenda, Food and Drug
FDA's Office of Minority Health (OMH) was established in 2010, as mandated by the Patient Protection and Affordable Care Act (Pub. L. 111-148). OMH serves as the principal advisor to the Commissioner on minority health and health disparities. OMH provides leadership and direction in identifying Agency actions that can help reduce health disparities, including the coordination of efforts across the Agency.
OMH advances FDA's regulatory mission in addressing the reduction of racial and ethnic health disparities and in achieving the highest standard of health for all. To achieve this mission, OMH has committed to identifying gaps in existing knowledge to shape further research projects intended to lead to better understanding of medical product clinical outcomes in racial/ethnic demographic subgroups. A guiding principle for FDA in meeting the health needs of patients across the demographic spectrum is the importance of encouraging diversity in clinical trials. Thus, FDA is also interested in gaining input for improving clinical trials in therapeutic areas impacted by low rates of inclusion of racial/ethnic demographic subgroup populations, ranging from issues surrounding recruitment and participation in clinical trials to clinical outcome analysis of demographic subgroup populations. Of particular note in this regard is FDA's “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data” at
Research in regulatory science is distinctive for developing new tools, standards, and approaches for assessing the safety, efficacy, quality, and performance of all FDA-regulated products. The results can help to transform the way medical products are developed, evaluated, and manufactured. Health disparities research with a regulatory focus seeks to expand and strengthen knowledge of, and the availability of data on, medical product clinical outcomes in racial/ethnic demographic subgroups, to inform healthcare decisions by providers and patients.
OMH seeks comments and information to identify specific areas of public health concern involving racial/ethnic demographic subgroups that can be addressed through regulatory science research, including new or emerging areas of concern. We encourage comments to include supporting information regarding the topic addressed, such as previously published peer-reviewed literature or new research findings. These comments and information will support OMH in its development of a research agenda that will inform funding decisions for the next fiscal year. (This notice is not a request for specific research or grant proposals from outside entities.) In addition to input on improving clinical trial inclusion and outcome analysis, requested comments and information identifying disease areas with outcome differences for further study may include, but are not limited to, the following:
• An area of study that could lead to a diagnostic or screening test based on the development and evaluation of biomarkers for a disease or condition that disproportionately impacts racial/ethnic demographic subgroups.
• An area of study that could lead to changes in labeled indications, or dosages, for a single or class of drug(s) or biologic(s) used to treat a disease or condition that disproportionately impacts racial/ethnic demographic subgroups.
• An area of study that could lead to changes in the design or use of a device to treat a disease or condition that disproportionately impacts racial/ethnic demographic subgroups.
• Research to identify effective ways to communicate with patients and consumers from racial/ethnic subgroups, including those with low health literacy and limited English proficiency, so they are informed about FDA actions (new approvals, warnings, recalls, etc.) that impact their health.
• Research evaluating methods to accommodate cultural and language differences that can improve health communications to racial/ethnic subgroups, and assess the cost of these methods to the Government.
• Research evaluating the impact of different formats and amounts of numerical information in FDA communications for patients, health care providers, health educators, and informal caregivers.
Interested persons may submit either electronic comments regarding this document to
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Jackie Lavigne, Office of Education, Division of Cancer Epidemiology and Genetics, 9609 Medical Center Drive, MSC 9776, Bethesda, MD 20892-9776 or call non-toll-free number 240-376-7237 or Email your request, including your address to:
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 175.
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
To obtain a copy of the data collection plans and instruments or request more information on the proposed project, contact: Annette Galassi, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., Rm. 3W250, Rockville, MD 20850 or call non-toll-free number 240-276-6632 or Email your request, including your address to:
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 51.
National Institutes of Health, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
Technology descriptions follow.
Description of Technology: Sickle cell disease and thalassemia are hereditary disorders marked by the disruption in the pathways responsible for carrying oxygen to red blood cells. Symptoms associated with these disorders include anemia, jaundice, and severe pain. It has been shown that mutations during the development of fetal to adult hemoglobin can contribute to a delay in red blood cell maturity underlying sickle cell disease. As a result, there has been an increased focus on treatments that promote the induction of fetal hemoglobin (HbF) to improve clinical symptoms and ameliorate the severity of the diseases. Researchers at the National Institute of Diabetes and Digestive and Kidney Diseases have identified methods of increasing fetal hemoglobin by increasing the expression of Lin28 or decreased expression of let-7 micro-RNAs. The lead inventor and colleagues have developed novel lentiviral expression vectors containing hemoglobin regulators under the control of erythroid-specific promoters that can be used to increase Hbf expression without affecting the maturity of red blood cells. In addition, they have found, through the use of tough decoy inhibition of Let-7 micro-RNAs, a selection of Let-7 genes with greater involvement in HbF expression. This technology could lead to development of novel HbF induction therapies that reactivate and reduce the aberrant pathologies associated with human sickle-cell anemia and beta thalassemia.
Potential Commercial Applications:
• Ex vivo and in vivo therapeutics for treatment of sickle-cell anemia and beta thalassemias.
• Potential use in combination with other transduction methods for unique therapeutic strategies.
Competitive Advantages:
• Reduced production of symptom-associated adult hemoglobin.
• Lin28 overexpression at defined stage of hematopoietic cell development.
• Therapeutic increases in patient HbF expression at lower viral titers than current direct transduction methods.
• Improved safety and reduced toxicity as a result of erythroid-specific expression.
Development Stage:
• Early-stage
• In vitro data available
• In vivo data available (animal)
Inventors: Jeffery L. Miller, Yuanwei T. Lee, Jaira F. de Vasconcellos, Colleen K. Byrnes (all of NIDDK)
Intellectual Property: HHS Reference No. E-249-2014/0—US Provisional Application No. 62/046,247 filed September 5, 2014
Related Technology: HHS Reference No. E-456-2013/2—PCT Application No. PCT/US2013/067811 filed October 31, 2013, which published as WO 2014/200557 on December 18, 2014
Licensing Contact: Vince Contreras, Ph.D.; 301-435-4711;
Collaborative Research Opportunity: The National Institute of Diabetes and Digestive and Kidney Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Marguerite J. Miller at
Description of Technology: Available for licensing are methods to generate T cells responsive to multiple polyomaviruses. The resulting T cell populations could be useful in treating immunosuppressed individuals with polyomavirus infections or polyomavirus-associated pathologies such as Merkel cell carcinoma (MCC), polyomavirus-associated nephropathy (PVAN), hemorrhagic cystitis,
Potential Commercial Applications: Immunotherapy for immunosuppressed individuals with polyomavirus-associated pathologies.
Competitive Advantages: Methods allow development of polyomavirus antigen-specific T cells.
Development Stage:
• Early-stage
• In vitro data available
Inventors: John A. Barrett (NHLBI), Dhanalakshmi Chinnasamy (NHLBI), Pawel J. Muranski (NHLBI), Christopher B. Buck (NCI)
Intellectual Property: HHS Reference No. E-166-2014/0—US Application No. 62/075,726 filed November 5, 2014
Related Technologies:
• HHS Reference No. E-168-2011
• HHS Reference No. E-549-2013
Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560;
Collaborative Research Opportunity: The National Heart, Lung, and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize methods to generate T cells responsive to multiple polyomaviruses. For collaboration opportunities, please contact Dr. Vincent Kolesnitchenko at
Description of Technology: This technology relates to a Zirconium-89 (
Potential Commercial Applications: Cell therapies and diagnostics.
Competitive Advantages: Simple preparation, broadly applicable cell label, high resolution imaging and monitoring over period of a week, low toxicity, easily combined with labeling technologies and cell therapies.
Development Stage: In vivo data available (animal).
Inventors: Noriko Sato (NCI), Haitao Wu (NHLBI), Gary L. Griffiths (NCI), Peter L. Choyke (NCI)
Publications:
1. Sato N, et al. Generation and use of long-lasting cell labeling agent for positron emission tomography (PET) imaging. J Nucl Med. May 2014; 55 (Supplement 1):273.
2. Sato N, et al.
Intellectual Property: HHS Reference No. E-080-2014/0—US Patent Application No. 61/973,706 filed April 1, 2014
Licensing Contact: Edward (Tedd) Fenn; 424-297-0336;
Collaborative Research Opportunity: The National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize cell labeling, cell tracking, cell trafficking, cell-based therapy, PET imaging. For collaboration opportunities, please contact John D. Hewes, Ph.D. 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 would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, DHS.
Notice of availability.
On February 7, 2014, the Coast Guard announced the availability, in the docket, of two draft policy letters for which it sought public comment. This notice announces the availability of the finalized Coast Guard policy letters, including explanations of changes made to the policy letters and enclosures based on the public comments received. The first policy letter provides voluntary guidance for liquefied natural gas (LNG) fuel transfer operations on vessels using natural gas as fuel in U.S. waters, and training of personnel on those vessels. It recommends transfer and personnel training measures that we believe will achieve a level of safety that is at least equivalent to that provided for traditional fueled vessels. It applies to vessels equipped to receive LNG for use as fuel, but not to vessels regulated as LNG carriers that utilize boil-off gas as fuel. The second policy letter discusses voluntary guidance and existing regulations applicable to vessels and waterfront facilities conducting LNG marine fuel transfer (bunkering) operations. The second policy letter provides voluntary guidance on safety, security, and risk assessment measures we believe will enhance safe LNG bunkering operations. Both policy letters are available on the public docket. They have been updated to reflect publication numbers of the current year. Accordingly, as discussed in this notice, Policy Letter 01-14 became Policy Letter 01-15 and Policy Letter 02-14 became Policy Letter 02-15.
If you have questions on this notice, call or email Ken Smith, Vessel and Facility Operating Standards Division (CG-OES-2), U.S. Coast Guard; telephone 202-372-1413, email
The shipping industry is exploring conversion from oil-based fuel to cleaner burning natural gas, because the use of natural gas as fuel would substantially reduce carbon emissions, sulfur emissions, and nitrogen oxide emissions. This natural gas fuel would be stored on and transferred to vessels in the form of liquefied natural gas (LNG). Existing regulations cover design, equipment, operations, and training of personnel on vessels that carry LNG as cargo and at waterfront facilities that handle LNG in bulk. They also cover conventional oil fuel transfer operations, but do not address LNG transferred as fuel.
On February 7, 2014, the Coast Guard published two draft policy letters (CG-OES 01-14 and CG-OES 02-14), requesting comments, that recommended the transfer procedures and other operating guidelines for vessels and waterfront facilities providing LNG to vessels for use as fuel and for vessels operating in U.S. waters that will be fueled with natural gas that will be stored onboard as LNG. The Coast Guard has revised these policy letters based on comments received and now makes the final policy letters available to the public.
The policy letters and voluntary guidance do not apply to vessels regulated as LNG carriers that utilize their boil-off gas as fuel. They also do not provide guidance on vessel design criteria for natural gas fuel systems or design of vessels providing LNG for use as fuel. If you have questions about the design of these systems, please contact the Coast Guard's Office of Design and Engineering Standards (CG-ENG, formerly CG-521). See
The Coast Guard received 27 letters from the public containing a combined total of 185 individual comments which are discussed below. We discuss more fully the changes we made to the policy letters in response to comments.
All letters received were generally supportive of the Coast Guard's effort to provide guidance on the use and transfer of LNG as a marine fuel and the Coast Guard appreciates this important feedback.
We also received various comments recommending changes that cannot be made in a policy document because the Coast Guard would need to undergo rulemaking to make these recommended changes enforceable. For example, one submitter suggested that we provide specific details concerning the information that risk assessments should contain. Another submitter suggested that we provide common checklists for industry to follow when conducting bunkering operations. The Coast Guard will consider these comments and determine whether any further action is necessary. Additionally, the Coast Guard received comments on matters unrelated to the two policy letters discussed in this notice. Those comments have been reviewed but did not effect any changes to these policy letters. Examples of some of the comments we received pertaining to design were related to venting arrangements, LNG tank design, and gas detection.
Vessel design issues relating to the technical aspects and problems inherent in vessel design are not discussed in Policy Letters 01-15 and 02-15. We do not intend to include vessel design recommendations or equivalencies in either policy letter and thus comments requesting design related revisions cannot be incorporated. Information concerning design criteria for natural gas fuel systems can be found in CG-521 Policy Letter 01-12, “Equivalency Determination—Design Criteria For Natural Gas Fuel Systems,” which can be viewed at the following location:
The Coast Guard also identified certain non-substantive recommendations in comments. Many of these are useful and have been incorporated where appropriate.
Six comments were submitted recommending that Compressed Natural Gas (CNG) and other alternative fuels be addressed in our policy letters. The Coast Guard believes it is better at this time to evaluate other alternative fuels on a case-by-case basis and will continue to gather information on how these alternative fuels are used to determine whether guidance is necessary and appropriate. One submitter suggested that it would be useful if we added language indicating how LNG differs from other “conventional” liquid hydrocarbon fuels. The Coast Guard agrees and added additional information in Policy Letter 01-15, Enclosure (1).
Five comments were submitted on the topic of hot work. Based on the comments received, the Coast Guard revised its discussion on hot work in Policy Letter 01-15, Enclosure (1) to further clarify that hot work must be conducted in accordance with the existing regulations to which vessels are inspected. Where no regulations are specified, we recommend that the regulations in 46 CFR 91.50-1 be followed.
Six comments were received on the Coast Guard's use of the term “in bulk.” Three comments asked whether LNG packaged in ISO tanktainers, and loaded on a vessel, is not “in bulk” and therefore not subject to 33 CFR Part 127. The Coast Guard confirms that LNG in packaged form such as LNG in ISO tanktainers is not considered an “in bulk” shipment and the facility where those packages are loaded does not need to comply with 33 CFR Part 127. The Coast Guard further clarifies that LNG in ISO tanktainers is a hazardous material in packaged form and as such must be loaded from a facility that complies with 33 CFR Part 126. Three additional comments requested clarification on the Coast Guard's definition of the term “bulk.” In response to these requests, the Coast Guard clarifies in Policy Letter 01-15, Enclosure (1) that “bulk” has the meaning defined in the Marine Safety Manual as a material that is transported on board a vessel without mark or count and which is directly loaded into a hold or tank on a vessel without containers or wrappers.
Six comments were received on LNG tank truck operations. Three spoke to matters involving the driving and transfer of LNG from tank trucks directly on a vessel, and one wanted to know why the Coast Guard doesn't discuss the activity. The Coast Guard does not discuss this type of operation because the operation is not considered as safe as other forms of transfer operations available. Driving LNG tank trucks aboard a vessel and conducting LNG transfer operations while aboard is considered to be a transfer involving a greater risk than other forms of LNG transfers because vessels and LNG tank trucks cannot remove themselves from the area in the event of an emergency. The Coast Guard does not wish to promote the operation in general, but remains open to evaluating requests on a case-by-case basis. One submitter requested to know if all of 33 CFR Part 127 would apply to LNG tank truck and rail car transfers. As discussed in Enclosure 1 of Policy Letter 02-15, existing regulatory standards may not be appropriate for small scale (
Five comments were received concerning ISO type tanks. One submitter noted that ISO tanks need to be properly approved and designed and are not as robust as type “C” tanks. The Coast Guard notes that LNG in portable tanks must meet specifications outlined by the Department of Transportation for transport and carriage of hazardous materials in accordance with the Hazardous Material Regulations contained in Title 49 of the U.S. Code of Federal Regulations. The Coast Guard Office of Design and Engineering (CG-ENG) and/or the Marine Safety Center will evaluate as part of their plan review and approval process the design and construction of tanks used to store LNG as fuel on board U.S. vessels.
Four comments were received concerning guidance to the COTP for considering alternatives to the requirements in 33 CFR Part 127. Of those comments received, two comments also recommended Coast Guard Headquarters oversight so as to ensure greater consistency from port to port. The Coast Guard recognizes the need and desire for consistency from port to port and throughout the Coast Guard. To help COTPs understand alternatives which may be considered for the requirements in 33 CFR Part 127, we have added a new enclosure. Enclosure (4) to Policy letter 02-15 has been added to provide COTPs with guidance as to alternatives which may be considered in lieu of the requirements of 33 CFR Part 127 for LNG fuel facilities. Through publication of these policy letters and continued work within the Coast Guard, we hope to provide consistent application of regulations and policies for LNG operations throughout the country.
Ten comments were received on the topic of conducting Risk Assessments. One of the submitters recommended we add more wording concerning identification of hazards (HAZID's), operational hazards (HAZOP's) and quantitaive risk assessments (QRA's). The Coast Guard agrees and added additional guidance and information concerning the need to conduct risk assessments. We have revised Enclosure 1 of Policy Letter 01-15 and Enclosures 1 and 2 of Policy Letter 02-15 to include more information on recommendations for risk assessments established by recognized industry organizations. Finally, one submitter stated that there is no clearly defined or broadly accepted standard for evaluating risk assessments and noted that NFPA standard 551 has some guidance which should be considered. For the purpose of harmonizing with the international community, we recommend and reference in the policy letters the publications of the classification society Det Norske Veritas—Germanischer Lloyd (DNV-GL) and the International Organization for Standardization (ISO) as guides which should be used to conduct risk assessments.
The Coast Guard received twelve comments on training and drills. One submitter indicated that the Coast Guard should establish and specify definite training intervals in order to avoid differing interpretations. The Coast Guard agrees that guidance on appropriate intervals would be helpful and suggests as an example that the drills be conducted quarterly. One submitter indicated that they strongly support having defined training requirements and believe this will significantly contribute to a safer industry. The Coast Guard agrees. The amendments to this policy include recommended training provisions. This guidance identifies a two-tier system—basic and advanced training that
One submitter presumed that the Coast Guard will not require a special endorsement on a license or Merchant Mariner Document (MMD) for mariners serving aboard an LNG powered vessel other than the PIC, who must hold a proper endorsement in order to conduct the transfer operation. The submitter also stated that the policy letter was silent as to the level of competency that each company must provide for other shipboard personnel involved in LNG bunkering operations. In response, the Coast Guard has expanded the training section of the policy letter to include recommended training for members of the vessel's crew who have safety responsibilities in regard to the gases or low flashpoint fuels being used and that documentary evidence such as course completion certificates, company letters, etc., should be issued indicating that the holder has successfully completed the basic or advanced training, as appropriate—See Enclosure 3 of Policy Letter 01-15. One submitter indicated that care should be taken to assure that training for personnel on board vessels using gas fuels are differentiated from a full tankerman (LG endorsement) as appropriate and that referencing the parts of 46 CFR that are for Tankerman should be eliminated. The Coast Guard agrees that vessel personnel on vessels using gases and low flashpoint fuels should be differentiated from full tankerman. As a result, recommendations specific to their training have been provided in Enclosure (3) accordingly.
The Coast Guard received three comments concerning PICs. One submitter indicated that the Coast Guard needs to clarify the meaning of the word “enough” where it is stated that, “. . . there must be enough Tankerman-PICs on duty . . .” noting that the word “enough” is too vague. The Coast Guard notes the submitters concern, and understands that the term may be ambiguous. However, the term is carried forth from the existing regulations for cargo handling operations in 46 CFR 35.35-1 allowing flexibilty to owners, managing operators, masters, and PICs in determining the number of qualified personnel needed to safely transfer liquid cargo based on the details of a specific transfer operation. Enclosure 2 of Policy Letter 02-15, pertaining to tank vessels transfering LNG, remains unchanged in this regard and points to the regulations in 46 CFR 35.35-1 and 154.1831 outlining the qualifications for personnel involved in liquid cargo transfer. However, aboard the receiving vessel that uses gases or low flashpoint fuels, the Coast Guard recommends in Enclosure (1) of Policy Letter 01-15, that the Master of a vessel using LNG as fuel should ensure that all personnel involved with LNG fuel use, transfer, or emergency response meet the standards of competence or advanced standards of competence outlined in Enclosure (3) of Policy Letter 01-15 for the duties to which they are assigned. One submitter noted that both the receiving vessel and supplier of LNG have PICs but our policy letters did not discuss an overall PIC, and requested to know who the overall PIC is. The Coast Guard does not discuss designatation of an overall PIC, because the Coast Guard does not believe an overall PIC is necessary. Similar to conventional fuel transfer operations, no one individual is designated as having overall control and responsibility for the transfer. Each PIC is responsible for their part of the transfer operation (supplier and receiver) and each side of the transfer should have a means to stop the transfer in the event of an emergency (See 33 CFR 127.205 and 155.780). Both supplier and receiver must have a means for dedicated voice communication with each other in order to maintain oversight and control of LNG tanks and transfer lines (See 33 CFR 127.111 and 155.785). Given that personnel on either side of the transfer
Two comments were submitted on portable gas detectors. Both expressed a belief that it was unnecessary for all personnel involved in an LNG transfer to have a portable gas detector and suggested that the policy letter align with existing regulations (See 33 CFR 127.203 and 46 CFR 154.1345) which require at least 2 portable gas detectors in the marine transfer area. The Coast Guard agrees and has modified the policy letters to align with existing regulations.
Eight comments were received concerning simultaneous operations. All but one supported the need to conduct simultaneous operations. The one comment submitted against simultaneous operations stated that simultaneous operations create a significant risk factor, dramatically increasing the likelihood of a casualty while fueling. The Coast Guard agrees that simultaneous operations may introduce increased risk, but believes that performance of a risk analysis and incorporation of risk mitigation measures can be useful toward decreasing the likelihood of a casualty occurring while fueling. One comment stated that simultaneous operations should not be treated any differently than current fueling operations. One comment indicated that simultaneous operations should only be allowed after a detailed risk analysis and dispersion analysis are completed. Two comments indicated the need to have a definitive statement that the Coast Guard recognizes the need to allow simultaneous operations. The Coast Guard agrees with the majority of commenters and has modified the discussion of simultaneous operations in Policy Letter 01-15, Enclosure (1) to include a more definitive statement concerning the need for considering simultaneous operations and identifies recommended industry standards which may be used by facility owners to conduct risk assessments. The Coast Guard does not wish to specify what operations may or may not be conducted simultaneously while LNG transfer operations are in progress and the COTP will evaluate each proposal on a case-by-case basis based on the specific hazards involved.
Three comments were submitted on emergency shutdown devices (ESD). One submitter said all ESD components are to be tested no more than 24 hours before commencement of the actual bunkering operation and that the tests should be documented in accordance with the bunkering procedure. The Coast Guard agrees. In accordance with 33 CFR 127.315(i), and 156.120(r), the ESD system is currently required to be tested by the PIC prior to transfer which should be well within the 24 hour period suggested. One submitter suggested that there could be an exemption for testing bunker tanker ESD equipment, provided evidence of regular testing is available or alternative requirements are deemed as an acceptable equivalence. The Coast Guard disagrees. As noted previously, testing of the ESD system must be conducted by the PIC prior to the transfer as required by existing regulations 33 CFR 127.315(i), and 156.120(r). One submitter suggested that automatic activation of the ESD system due to a gas detection alarm should be reconsidered noting that gas detection systems have been prone to false alarms, particularly if located in humid areas, and repeated shutdowns due to erroneous alarms could create an unanticipated hazard. The Coast Guard is unaware of this being a widespread problem attributed to the performance of all gas detection systems available on the market. However, we have amended Policy Letter 01-15, Enclosure (1) such that gas detection is one of eight items that can be considered as a means to activate the ESD system.
Two comments were received on checklists. One commenter indicated that compatibility between the LNG supplier and the vessel receiving LNG must be ensured in terms of LNG transfer system design, operational manuals, emergency response procedures and a common checklist for the LNG transfer operation. Another comment requested that we consider adopting a professional industry organization's bunker checklists into our policy letters. The Coast Guard agrees that the use of checklists is valuable. We have provided a hyperlink in our policy letters recommending that owners and operators involved in LNG transfer operations consider using checklists in order to help globally standardize LNG transfer operations.
Five comments were submitted concerning hazard zones, safety distances, and transfer areas. One submitter questioned whether or not the transfer area is considered to be a hazardous area and asserted that no ignition sources should exist in the transfer area. The Coast Guard agrees and confirms that the transfer area is considered to be a hazardous area. Details concerning removal of ignition sources associated with LNG supply are addressed in Policy Letter 02-15 which focuses on vessels and facilities providing LNG as fuel. One submitter noted that we refer to transfer area and hazardous area, but believed that consideration on ‘Determination of safety and security zones’ should be given. They also pointed out a key aspect with regard to the responsibility of the PIC is to establish the exchange of sufficient information to allow completion of a Declaration of Security (if required), agreement on how and between whom, communications regarding security that are to be made and actions to be taken in the event of a breach of security. Another submitter commented that there should be a discussion about hazardous areas and safety and security areas around the LNG transfer area. The Coast Guard agrees and has added a new paragraph discussing the items in Enclosure (1) of Policy Letter 01-15. One additional submitter stated that advice needs to be given regarding safety distances at different transfer rates, due to increasing “largest credible spills” and that dispersion analysis needs to be included. The Coast Guard agrees with the need to provide additional information concerning safety and security areas and has added information in Policy Letter 01-15, Enclosure (1) indicating they should be established in accordance with industry standards established by the International Organization for Standardization (ISO) which is a recognized organization that has published information related to determining the size of safety and security areas around LNG transfer points. The Coast Guard doesn't agree with the need to require a declaration of security at this time, and notes that existing regulations concerning the declaration of inspection (33 CFR 127.317, and 33 CFR 156.150) require PICs to conduct a series of checks before
Four comments were submitted concerning pipelines. One comment suggested that we delete references to bonding of pipelines in Policy Letter 01-14, Enclosure (1) in the section discussing detailed diagrams of the transfer area. The submitter indicated it was not clear how this would be shown on a diagram. The Coast Guard agrees and has removed the item as suggested. One submitter addressed the discussion on, “Conduct before a LNG Fuel Transfer” under Regulations and Recommendations for Vessels Bunkering LNG, of Enclosure (2) to CG-OES Policy Letter No. 02-14. The submitter noted the policy letter states that before transferring LNG to a vessel for use of gas as fuel, the PIC for transferring LNG should inspect the accessible portions of the transfer piping system and equipment to be used during the transfer and ensure that any worn or inoperable parts are replaced and any leaks are identified. The Coast Guard agrees and has added an item recommending that the transfer piping be tested for leaks prior to the transfer of LNG. Finally, one comment was received concerning Policy Letter 02-14, Enclosure (2) section discussing, “Conduct after a LNG Fuel Transfer.” The submitter requested adding a requirement to ensure that transfer hoses, manifolds, and associated piping are purged so that natural gas levels are below the lower flammability level. The Coast Guard has amended the section to recommend these types of safety measures.
We received one comment on loading flanges. The submitter indicated the existing regulations contain seemingly contradictory provisions which could complicate the siting, permitting and operation of such facilities. The submitter noted that Part 127 and Part 193 contain differing requirements in terms of the location of LNG loading flanges in relation to nearby bridges. The Coast Guard understands the concerns, but notes that any correction to these regulations would need to go through the Department of Transporation or USCG rulemaking process. Therefore, the noted discrepancies cannot be rectified through these policy letters.
We received one comment concerning transfer hoses. The submitter referenced an early draft version of our policy letter suggesting that the transfer hose should include provisions to prevent electrical flow during connection or disconnection of the transfer hose string through the hose string or loading arm. The insertion of one short length of non-conducting hose without internal bonding in each hose string, or installation of an insulating flange, should be addressed. In addition, the submitter suggested that each transfer hose string should contain only one electrically discontinuous length of hose or insulating flange, to prevent electrostatic build-up in the hose string. The Coast Guard agrees and has amended Policy Letter 02-15, Enclosure (2) to include these recommendations.
One comment was received on lighting whereby the submitter suggested that the intensity levels should not be specified. The Coast Guard disagrees as the lighting intensity levels specified in the policy letters simply mirror existing federal regulations already imposed for transfer operations. See 33 CFR 127.109 and 155.790.
One comment was submitted concerning operations manuals whereby the submitter said there should be a provision to demonstrate that all relevant personnel are familiar with the operations manual. The Coast Guard agrees and has modified the opening paragraph discussing operation, emergency, and maintenance manuals in policy letter 01-15, Enclosure (1) indicating that the master of a vessel using LNG as fuel should ensure that all personnel involved with LNG fuel use, transfer, or emergency response are familiar with the contents of the LNG fuel transfer system operations manual.
We received three comments concerning emergency procedures. One commenter stated that simultaneous operations imposes the need for more requirements, especially where passengers, public or non-qualified/briefed personnel are in proximity of the bunkering operation. At a minimum, the submitter stated a need to consider emergency procedures for handling of passengers in the event of an incident during bunkering. The Coast Guard agrees and has modified Policy Letter 01-15, Enclosure (1) to include a provision in the emergency manual for removing or relocating passengers in the event of an LNG incident during bunkering. One commenter suggested that the LNG bunkering and emergency response procedures take into account the LNG bunkering system in place and that the results of the risk assessment studies are adequately managed. The Coast Guard agrees and has included reference to recognized standards for conducting risk assessments which are identified in Enclosure 1 of Policy Letter 01-15 and Enclosures 1 and 2 of Policy Letter 02-15. The risk assessment we recommend should be based on specific details of the operation intended and identify associated risks and hazards and the means to mitigate those risks. The risk assessment is expected to be used as a guide to assist owners and operators in developing their bunkering and emergency response procedures. One commenter asked for guidance on what security requirements, if any, will be required for the vessel arriving at the facility to receive LNG for fuel. If applicable, the security requirements for vessels may be based on the requirements of 33 CFR part 104—Maritime Security: Vessels. Additionally, a safety or security zone may be established around a vessel by the COTP if it is determined necessary based on the results of a risk assessment.
Six comments were received concerning the topic of LNG bunkering. One commenter suggested that LNG bunkering procedures should ensure that unauthorized and non-essential personnel cannot enter the bunkering area. The Coast Guard agrees and has amended Policy Letter 01-15, Enclosure (1) to include a recommendation that procedures be established for setting, securing, and clearing safety and security areas around the LNG transfer point. Two commenters recommended that the operator define the operational envelope under which transfer can take place noting that this should be indicated as a “permissible range of motion where transfer operations can proceed (to be defined for the operation as well as the transfer equipment)”, and be included in the Operations manual. The Coast Guard agrees and has amended Policy Letter 01-15, Enclosure (1) recommending that the operations manual define the operating envelope for which safe transfer operations can
Eight comments were submitted concerning referenced standards. The Coast Guard received one comment pointing out that the reference to SIGTTO's LNG Ship to Ship Transfer Guidelines, 1st Edition, 2011, was outdated and should be replaced with SIGTTO's “Ship to Ship Transfer Guide—Petroleum, Chemicals, & Liquefied Gases,” 1st Edition, 2013, whenever referenced. The Coast Guard agrees and has modified the policy letters as suggested to reflect the updated industry standard. One comment requested referencing NFPA 59A, the “Standard for the Production, Storage, and Handling of Liquefied Natural Gas” and SIGTTO's “Liquid Gas Fire Hazard Management” in our discussion of firefighting equipment in Policy Letter 02-14, Enclosure (2). The Coast Guard agrees in part and has added a reference to the SIGTTO publication, but does not reference NFPA 59A because the standard refers to shore based LNG storage and production facilities and Enclosure (2) of Policy Letter 02-15 is focused on vessels providing LNG as fuel. We received a comment suggesting that we add a reference to SIGTTO 2009 publication, “ESD Arrangements & Linked Ship/Shore Systems for Liquefied Gas Carriers” in the discussion of emergency shutdown devices in Enclosure (1) of Policy Letter 01-14. The Coast Guard agrees and has modified the section as requested. Two comments suggested full incorporation of International Maritime Organization (IMO) standards and guidelines. Policy letter 01-15 outlines these operational items in great detail but we have added a recommendation to better align with IMO guidance noting that procedures for confined space entry should be included in the operations manual. One submitter provided a list of industry standards and guides which the Coast Guard should consider recognizing. The Coast Guard has provided a hyperlink to a free publication provided by the LNG Ship Fuel Advisory Group, titled, “Standards and Guidelines for Natural Gas Fuelled Ship Projects” which identifies many of these standards and recommends that owners and operators become familiar with its contents. This change can be found in Policy Letter 01-15, Enclosure (1), and Policy Letter 02-15, Enclosures (1) and (2) under the section labeled Job Aides.
One submitter suggested Policy Letter 01-14, Enclosure (1) not recommend installation of firefighting equipment on unmanned barges because potential operating scenarios of a barge may include operations away from the LNG facility and firefighting capabilities of a towing vessel during vessel-to-vessel operations could be difficult to ensure. The Coast Guard disagrees and believes operators should consider all firefighting equipment available in the vicinity of an LNG transfer operation whether the transfer is off port or at shore. When conducting a safety assessment for a particular operation, all available firefighting equipment and emergency response equipment should be considered.
One comment suggested that due to the cryogenic properties of LNG, personal protective equipment should be listed with more specificity, including such items as leather working boots (no canvas sneakers should be worn during fueling or transfer operations), loose fitting fire resistant gloves, full face shields, and fit-for purpose multi-layer clothing. The Coast Guard agrees and has modified the sections in Policy Letter 01-15, Enclosure (1) and Policy Letter 02-15, Enclosure (2) discussing recommended personal protective equipment.
The Coast Guard received comments about how the policy letters will be enforced. One commenter raised concerns regarding the notice and comment process of the Administrative Procedure Act (APA), 5 U.S.C. 551,
We received one comment asking for guidance on the topic of roll over. As a result of this comment, the Coast Guard added roll over to the list of items in Policy Letter 01-15, Enclosure (1) for which emergency actions and response measures should be described in the emergency manual.
One comment suggested that the word, “if used” be deleted in enclosure (1) to CG-OES Policy Letter No. 01-14, on page 2, under the heading, “Operations, Emergency, and Maintenance Manuals,” noting that inert gas must be used to prevent potentially explosive conditions. The Coast Guard agrees and has amended the policy letter as suggested.
Finally, one comment was submitted requesting that the Coast Guard
The Coast Guard's intent in issuing these policy letters is to assist the industry, public, Coast Guard, and other Federal and State regulators in applying existing statutory and regulatory requirements. Following the policy and guidance recommended in these policy letters is voluntary. The policy letters are not a substitute for applicable legal requirements nor are they regulations themselves. The policy letters, however, do contain references to existing requlations which may require certain action where applicable. The Coast Guard notes those instances where it discusses requirements under existing regulations instead of policy or guidance. Nothing in the policy letters and guidance they contain are meant to override or subvert the discretion of the COTP when addressing the unique safety and security concerns of an LNG operation.
This notice is issued under authority of 5 U.S.C. 552(a).
Coast Guard, DHS.
Notice of public meeting.
The Coast Guard announces three public meetings to receive comments on a port access route study (PARS) published in the
The first meeting will be held in Juneau, Alaska on March 9, 2015 from 2 p.m. to 7 p.m. The second meeting will be held in Anchorage, Alaska on March 30, 2015 from 12 p.m. to 6 p.m. The third and final meeting will be held in Nome, Alaska on April 2, 2015 from 3 p.m. to 6 p.m.
(1)
(2)
(3)
(4)
To avoid duplication, please use only one of these four methods.
If you have questions on this notice of study or any of the meetings, call or email LT Kody Stitz, Seventeenth Coast Guard District (dpw); telephone (907) 463-2270; email
We encourage you to participate in this study by submitting comments and related materials as well as attending a public meeting. All comments received will be posted without change to
Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the
Under the Ports and Waterways Safety Act (PWSA) (33 U.S.C. 1223(c)), the Commandant of the Coast Guard may designate necessary fairways and traffic separation schemes (TSSs) to provide safe access routes for vessels proceeding to and from U.S. ports.
For information on facilities or services for individuals with disabilities or to request special assistance at the public meeting, contact LT Kody Stitz at the telephone number or email address provided under the
All meetings are open to the public. The purpose of the meetings is to increase awareness of the PARS and to receive feedback and comments from the public regarding the PARS. Each meeting will begin with the Coast Guard meeting facilitator presenting an explanation of and the purpose for the PARS along with an overview of the Coast Guard's proposed two-way route through the region. Public participants will then be able to provide comments and feedback to the meeting facilitator. Public participants are not required to stay for the entire meeting duration as the process of the meeting facilitator presenting the PARS information followed by a public comment period will be repeated hourly throughout the allotted meeting time.
Copies of the PARS announced in the
Federal Emergency Management Agency, DHS.
Notice.
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (
Comments must be submitted on or before March 27, 2015.
Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to
Requests for additional information or copies of the information collection should be made to Director, Records Management Division, 500 C Street SW., Room 7NE, Washington, DC 20472, facsimile number (202) 212-4701, or email address
On October 10, 2014, FEMA published in the
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
The effective date of March 2, 2015 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
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 March 16, 2015 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
I. Watershed-based studies:
II. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
This notice is to announce four public meetings to solicit public input on the proposed “Revised Guidelines for Implementing Executive Order 11988, Floodplain Management.”
The first public meeting will be held in Ames, IA on March 3, 2015, from 3:00 p.m. to 5:30 p.m. Central Standard Time (CST). The second public meeting will be held in Biloxi, MS on March 5, 2015, from 9:00 a.m. to 12:00 p.m. Central Standard Time (CST). The third public meeting will be held in Sacramento, CA on March 11, 2015, from 2:00 p.m. to 5:00 p.m. Pacific Standard Time (PST). The fourth public meeting will be held in Hampton Roads, VA on March 11, 2015, from 9:00 a.m. to 12:00 p.m. Eastern Standard Time (EST).
The first public meeting will be held in Ames, IA, at the Iowa Water Conference Venue, Iowa State University, Scheman Building, 1810 Lincoln Way, Ames, IA 50011. The second public meeting will be held in Biloxi, MS at the Mississippi Recovery Office, 220 Popps Ferry Road, Biloxi, MS 39591. The third public meeting will be held in Sacramento, CA at the CA Office of Emergency Services, 3650 Schriever Ave, Mather, CA 95655. The fourth public meeting will be held in Hampton Roads, VA at Old Dominion University, 4320 Hampton Blvd., Norfolk, VA 23529.
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, please contact the person listed in the
Due to space constraints of the facilities, seating will be limited to 300 participants for the Ames, IA meeting, 100 participants for the Biloxi, MS meeting, 200 participants for the Sacramento, CA meeting, and 225 participants for the Hampton Roads meeting. To reserve a seat in advance, please provide a request via email or mail with the contact information of the participant (including name, mailing address, and email address), the meeting(s) to be attended, and include the subject/attention line (or on the envelope if by mail): Reservation Request for FFRMS Meeting. Advance reservations must be received 3 business days prior to each meeting to ensure processing. Unregistered participants will be accepted after all participants with reservations have been accommodated and will be admitted on a first-come, first-serve basis, provided the person capacity is not exceeded. To submit reservations, please email:
To facilitate public participation, members of the public are invited to provide written comments on the issues to be considered at the public meetings. Comments may be submitted by one of the following methods:
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Bradley Garner, 202-646-3901 or
On January 30, 2015, the President signed Executive Order 13690, directing FEMA, on behalf of the Mitigation Framework Leadership Group, to publish for public comment draft revised Floodplain Management Guidelines to provide guidance to agencies on the implementation of Executive Order 11988, as amended, consistent with a new Federal Flood Risk Management Standard. These draft revised Guidelines were developed by the Mitigation Framework Leadership Group in consultation with the Federal Interagency Floodplain Management Task Force. FEMA is publishing this Notice on behalf of the Mitigation Framework Leadership Group, which is chaired by FEMA, to solicit and consider public input on the draft revised Guidelines at four public meetings.
Background information about these topics is available on the FFRMS Web site at
These meetings are exempt from the Federal Advisory Committee Act (FACA), as the Mitigation Framework Leadership Group is an intergovernmental committee and falls under the intergovernmental committee exception to FACA, 41 CFR 102-3.40(g).
Executive Order 11988, as amended; Executive Order 13690.
Transportation Security Administration, DHS.
Notice of availability.
The Transportation Security Administration (TSA) is providing notice that it has issued an annual summary of all enforcement actions taken by TSA under the authority granted in the Implementing Recommendations of the 9/11 Commission Act of 2007.
Emily Su, Assistant Chief Counsel, Civil Enforcement, Office of the Chief Counsel, TSA-2, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6002; telephone (571) 227-2305; facsimile (571) 227-1378; email
On August 3, 2007, section 1302(a) of the Implementing Recommendations of the 9/11 Commission Act of 2007 (the 9/11 Act), Public Law 110-53, 121 Stat. 392, gave TSA new authority to assess civil penalties for violations of any surface transportation requirements under title 49 of the U.S. Code (U.S.C.) and for any violations of chapter 701 of title 46 of the U.S. Code, which governs transportation worker identification credentials (TWICs).
Section 1302(a) of the 9/11 Act, codified at 49 U.S.C. 114(v), authorizes the Secretary of the Department of Homeland Security (DHS) to impose civil penalties of up to $10,000 per violation of any surface transportation requirement under 49 U.S.C. or any requirement related to TWICs under 46 U.S.C. chapter 701. TSA exercises this function under delegated authority from the Secretary.
Under 49 U.S.C. 114(v)(7)(A), TSA is required to provide the public with an annual summary of all enforcement actions taken by TSA under this subsection; and include in each such summary the identifying information of each enforcement action, the type of alleged violation, the penalty or penalties proposed, and the final assessment amount of each penalty. This summary is for calendar year 2014. TSA will publish a summary of all enforcement actions taken under the statute in January to cover the previous calendar year.
You can get an electronic copy of both this notice and the enforcement actions summary on the Internet by searching the electronic Federal Docket Management System (FDMS) Web page at
You can get an electronic copy of only this notice on the Internet by—
(1) Accessing the Government Publishing Office's Web page at
(2) Visiting TSA's Security Regulations Web page at
In addition, copies are available by writing or calling the individual in the
Pursuant to 49 U.S.C. 114(v)(7)(A), TSA provides the following summary of enforcement actions taken by TSA in calendar year 2014 under section 114(v).
Section 114(v) of title 49 of the U.S. Code gave the Transportation Security Administration (TSA) new authority to assess civil penalties for violations of any surface transportation requirements under 49 U.S.C. and for any violations of chapter 701 of title 46 of the U.S. Code, which governs transportation worker identification credentials (TWICs). Specifically, section 114(v) authorizes the Secretary of the Department of Homeland Security (DHS) to impose civil penalties of up to $10,000 per violation of any surface transportation requirement under title 49 U.S.C. or any requirement related to TWICs under 46 U.S.C. chapter 701.
Office of the Assistant Secretary for Public and Indian Housing, and Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
The RAD statute gives HUD authority to establish waivers and alternative requirements. Pursuant to this authority, HUD has waived, to date, the statutory 20 percent cap on project-basing of a PHA's tenant-based voucher funding for RAD-converted units. This notice advises that HUD is waiving for the San Francisco Housing Authority (SFHA), to a limited extent and subject to certain conditions, the 20 percent cap on project-basing and certain other provisions governing project-based assistance with respect to an identified portfolio that includes RAD funding. These waivers are in response to plans submitted by SFHA to address capital needs of the portfolio and preserve available affordable housing for the SFHA's jurisdiction. Without this waiver, SFHA states that its plan for improving its affordable housing portfolio with RAD would not be workable, and the conversion of units under RAD would not be effective for its purpose.
Janet Golrick, Acting Director of the Office of Recapitalization, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410-7000; telephone number 202-708-0001 (this is not a toll-free number). Hearing- and speech-impaired persons may access these numbers through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
The RAD statute (Pub. L. 112-55, approved November 18, 2011) gives HUD authority to waive or specify alternative requirements for, among other things, section 8(o)(13) of the United States Housing Act of 1937 (the 1937 Act). In order to utilize this authority, the RAD statute requires HUD to publish by notice in the
On July 2, 2013, notice 2012-32 Rev-1(as corrected by the technical correction issued February 6, 2014) (“the revised notice”) superseded PIH Notice 2012-32. The revised notice is found at the following URL:
The revised notice at section 1.9, paragraph F, entitled “Portfolio Awards,” also sets forth a new option of a “portfolio award,” which allows PHAs to apply for RAD conversions affecting a group of projects. This type of award is meant to enable PHAs to create a comprehensive revitalization plan for multiple buildings they oversee. SFHA has submitted an application for a portfolio award under RAD.
The revised notice contains a waiver of 8(o)(13)(B) and other sections of the 1937 Act. Section 1.6, “Special Provisions Affecting Conversions to PBVs,” at paragraph A.1, allows a project that converts from one form of rental assistance to another under RAD to exceed the 20 percent project-basing cap. Section 1.6.A.2 allows sets alternate requirements for the percent limitation on the number of units in a project that may receive PBV assistance. Section 1.6.C. sets forth alternative requirements for resident rights and participation. (Collectively, the waivers and alternative requirements set forth in Sections 1.6.A.1, 1.6.A.2 and 1.6.C are referred to herein as the “Applicable Alternative Tenanting Requirements.”)
As part of its application for a portfolio award, SFHA's comprehensive revitalization planning contemplates not only the conversion of assistance pursuant to RAD, but also to supplement such converted projects by project-basing additional voucher assistance. SFHA has submitted a waiver request that seeks permission to apply the Applicable Alternative Tenanting Requirements to all units in those projects with assistance converted under RAD. HUD has granted that request, subject to certain conditions which SFHA has agreed to carry out.
Bureau of Indian Affairs, Interior.
Notice.
These updated guidelines provide guidance to State courts and child welfare agencies implementing the Indian Child Welfare Act's (ICWA) provisions in light of written and oral comments received during a review of the Bureau of Indian Affairs (BIA)
These guidelines are effective on February 25, 2015.
Hankie Ortiz, Deputy Director—Indian Services, Bureau of Indian Affairs, U.S. Department of the Interior, 1849 C Street, NW., Washington, DC 20240, (202) 208-2874;
These updated BIA guidelines provide standard procedures and best practices to be used in Indian child welfare proceedings in State courts. The updated guidelines are issued in response to comments received during several listening sessions, written comments submitted throughout 2014, and recommendations of the Attorney General's Advisory Committee on American Indian/Alaska Native Children Exposed to Violence.
Congress enacted ICWA in 1978 to address the Federal, State, and private agency policies and practices that resulted in the “wholesale separation of Indian children from their families.” H. Rep. 95-1386 (July 24, 1978), at 9. Congress found “that an alarmingly high percentage of Indian families are broken up by the removal, often unwarranted, of their children from them by nontribal public and private agencies and that an alarmingly high percentage of such children are placed in non-Indian foster and adoptive homes and institutions . . . . ” 25 U.S.C. 1901(4). Congress determined that cultural ignorance and biases within the child welfare system were significant causes of this problem and that state administrative and judicial bodies “have often failed to recognize the essential tribal relations of Indian people and the cultural and social standards prevailing in Indian communities and families.” 25 U.S.C. 1901(5); H. Rep. 95-1386, at 10. Congress enacted ICWA to “protect the best interests of Indian children and to promote the stability and security of Indian tribes and families by establishing minimum Federal standards for the removal of Indian children from their families and the placement of such children in foster or adoptive homes or institutions which will reflect the unique values of Indian culture.” H. Rep. 95-1386, at 8. ICWA thus articulates a strong “federal policy that, where possible, an Indian child should remain in the Indian community.”
Following ICWA's enactment, in July 1979, the Department of the Interior (Department) issued regulations addressing notice procedures for involuntary child custody proceedings involving Indian children, as well as governing the provision of funding for and administration of Indian child and family service programs as authorized by ICWA.
In 2014, the Department invited comments to determine whether to update its guidelines and what changes should be made. The Department held several listening sessions, including sessions with representatives of federally recognized Indian tribes, State court representatives (
The Department is issuing these updated guidelines under ICWA, 25 U.S.C. 1901
The 1979 guidelines included “commentary” for each section, which was intended to explain the requirements of each section. The updated guidelines are clearer, making the commentary unnecessary. Recognizing the important role that child welfare agencies play in ICWA compliance, these updated guidelines broaden the audience of the guidelines to include both State courts and any agency or other party seeking placement of an Indian child. The guidelines identify procedures to address circumstances in which a parent desires anonymity in a voluntary proceeding. Those procedures clarify that a parent's desire for anonymity does not override the responsibility to comply with ICWA. The guidelines also establish that agencies and courts should document their efforts to comply with ICWA. The following paragraphs include section-by-section highlights of the substantive updates that these guidelines make to the 1979 version.
The updated guidelines add several provisions to section A, to provide better context for the guidelines and clear direction on implementing the guidelines. For example, this section includes definitions of key terms used throughout the guidelines, such as “active efforts” and “child custody proceeding.” The phrase “active efforts” has been inconsistently interpreted. The guidelines' definition is intended to provide clarity—particularly in establishing that “active efforts” require a level of effort beyond “reasonable efforts.”
Section A also includes an applicability section, which incorporates many of the provisions of the 1979 guidelines' section B.3. In addition, section A:
• Clarifies that agencies and State courts must ask, in every child custody proceeding, whether ICWA applies;
• Clarifies that courts should follow ICWA procedures even when the Indian child is not removed from the home, in order to allow tribes to intervene as early as possible to assist in preventing a breakup of the family; and
• Provides that, where agencies and State courts have reason to know that a child is an Indian child, they must treat that child as an Indian child unless and until it is determined that the child is not an Indian child.
These clarifications are necessary to ensure that the threshold question for determining whether ICWA applies (is
The updated guidelines also add a section regarding how to contact a tribe, in case the agency or State court is unfamiliar with whom to contact.
Section A is intended to make clear that there is no existing Indian family (EIF) exception to application of ICWA. The EIF doctrine is a judicially-created exception to the application of ICWA. Since first recognition of the EIF in 1982, the majority of State appellate courts that have considered the EIF have rejected it as contrary to the plain language of ICWA. Some State legislatures have also explicitly rejected the EIF within their State ICWA statutes. The Department agrees with the States that have concluded that there is no existing Indian family exception to application of ICWA.
Section A also clarifies that ICWA and the guidelines apply in certain voluntary placements.
The updated guidelines, and section B in particular, promote the early identification of ICWA applicability. Such identifications will promote proper implementation of ICWA at an early stage, to prevent—as much as possible—delayed discoveries that ICWA applies. Often, those circumstances resulting from delayed discoveries have caused heartbreaking separations and have sometimes led to noncompliance with ICWA's requirements. By requiring agencies and courts to consider, as early as possible, whether ICWA applies, the updated guidelines will ensure that proper notice is given to parents/Indian custodians and tribes, that tribes have the opportunity to intervene or take jurisdiction over proceedings, as appropriate, and that ICWA's placement preferences are respected.
With regard to early discovery, section B requires agencies and courts to consider whether the child is an Indian child, and sets out the steps for verifying the tribe(s) and providing notice to the parents/Indian custodians and tribe(s). Section B also adds guidance regarding the evidence a court may require an agency to provide of the agency's investigations into whether the child is an Indian child.
With regard to application of ICWA, the updated section B clarifies when the Act's requirement to conduct “active efforts” begins. ICWA requires “active efforts to provide remedial services and rehabilitative programs designed to prevent the breakup of the Indian family.”
Section B adds a new paragraph clarifying that the tribe alone retains the responsibility to determine tribal membership. This section makes clear that there is no requirement for the child to have a certain degree of contact with the tribe or for a certain blood degree, and notes that a tribe may lack written rolls. The updated guidelines delete the provision allowing BIA, in lieu of the tribe, to verify the child's status. This provision has been deleted because it has become increasingly rare for the BIA to be involved in tribal membership determinations, as tribes determine their own membership.
The updated section B also expands upon procedures for determining a child's tribe in the event that more than one tribe is identified as the child's tribe. Specifically, it changes the criteria for determining with which tribe the child has “significant contacts,” adding that the parents' preference for membership will be considered, and deleting factors that are subjective or inapplicable to infants.
With regard to providing notice to Indian tribes and the child's parents/Indian custodians, the updated section B:
• Clarifies that notice is required for each proceeding (not just for the first or last proceeding);
• States that notice must be sent, at a minimum, by registered mail, return receipt requested, and that personal service or other types of service may be in addition to, but not in lieu of, such mail; and
• Clarifies that the tribe has the right to intervene at any time.
The updated guidelines expand upon the emergency procedure provisions in light of evidence that some States routinely rely upon emergency removals and placements in a manner that bypasses implementation of ICWA.
The updated section C deletes the requirement that requests to transfer to
The updated section C also updates the “good cause” factors for denying transfer to tribal court. The updated criteria are more general; in summary, good cause may be found if either parent objects, the tribal court declines, or the State court otherwise determines that good cause exists. The updated guidelines specifically omit some of the factors that were the basis for finding that “good cause” exists under the 1979 guidelines. One such factor that should no longer be considered is whether the proceeding was at an advanced stage. As mentioned above, there may be valid reasons for waiting to transfer a proceeding until it reaches an advanced stage. Another factor that should no longer be considered is the level of contacts the child has had with the tribe—this factor unnecessarily introduces an outsider's evaluation of the child's relationship with the tribe and cannot sensibly be applied to infants.
The updated guidelines also specify that it is inappropriate to conduct an independent analysis, inconsistent with ICWA's placement preferences, of the “best interest” of an Indian child. The provisions of ICWA create a presumption that ICWA's placement preferences are in the best interests of Indian children; therefore, an independent analysis of “best interest” would undermine Congress's findings. Finally, the updated guidelines provide that the tribal court's prospective placement of an Indian child should not be considered, because it invites speculation regarding the tribal court's findings and conclusions and, therefore, undermines the independence of tribal court decision making.
The updated section D establishes that parties have the right to examine records and reports in a timely manner; this ensures that parents/Indian custodians and tribes have the opportunity to examine information necessary to protect their rights under ICWA. This updated section also expands significantly on how to comply with the Act's “active efforts” requirement. Specifically, the updated guidelines:
• Require demonstration that “active efforts” were made, not only “prior to” the commencement of the proceeding, but also “until” the commencement of the proceeding;
• Require documentation of what “active efforts” were made; and
Require a showing that active efforts have been unsuccessful. The updated section D also provides guidance regarding how to identify an appropriate “qualified expert witness.” Commenters indicated that some States rely on witnesses' qualifications as child care specialists, or on other areas of expertise, but do not require any expert knowledge related to the tribal community. The updated guidelines establish a preferential order for witnesses who are experts in the culture and customs of the Indian child's tribe. This will ensure that the expert witness with the most knowledge of the Indian child's tribe is given priority.
ICWA applies to voluntary proceedings that operate to prohibit an Indian child's parent or Indian custodian from regaining custody of the child upon demand; nevertheless, evidence suggests that ICWA is sometimes ignored or intentionally bypassed in voluntary proceedings. The updated section E clarifies that, even in voluntary proceedings, it is necessary to determine whether ICWA applies, and to comply with ICWA's provisions. To ensure that parents and Indian custodians understand the significance of their consent, the updated section E requires the consent document to identify any conditions to the consent and requires the court to explain the consequences of the consent before its execution. It also addresses steps for withdrawal of consent. The updated section E further restates the statutory restriction that a consent given prior to or within 10 days after birth of an Indian child is not valid.
The updated guidelines provide more information regarding when and how to apply ICWA's placement preferences for foster and adoptive placements. In some cases, agencies fail to conduct any investigation of whether placements that conform to ICWA's placement preferences are available. The updated section F requires that:
• The agency bears the burden of proof if it departs from any of the placement preferences and must demonstrate that it conducted a diligent search to identify placement options that satisfy the placement preferences, including notification to the child's parents or Indian custodians, extended family, tribe, and others; and
• The court determines whether “good cause” to deviate from the placement preferences exists before departing from the placement preferences.
Evidence suggests that “good cause” has been liberally relied upon to deviate from the placement preferences in the past. Commenters noted that, in some cases, a State court departed from the placement preferences because an Indian child has spent significant time in a family's care, despite the fact that the placement was made in violation of ICWA. The guidelines attempt to prevent such circumstances from arising by encouraging early compliance with ICWA (see sections A and B, in particular). The guidelines also specify in section F that “good cause” does not include normal bonding or attachment that may have resulted from a placement that failed to comply with the Act. As in other parts of the guidelines, this section clarifies that an independent consideration of the child's “best interest” is inappropriate for this determination because Congress has already addressed the child's best interest in ICWA. Because ICWA does not allow for consideration of socio-economic status in the placement preferences, this section also now clarifies that the court may not depart from the preferences based on the socio-economic status of one placement relative to another, except in extreme circumstances.
ICWA is intended to protect the rights, not only of Indian children, parents and Indian custodians, but also of Indian tribes. The updated guidelines establish that an Indian child, parent or Indian custodian, or tribe may petition to invalidate an action if the Act or guidelines have been violated, regardless of which party's rights were violated. This approach promotes compliance with ICWA and reflects that ICWA is intended to protect the rights of each of these parties.
Adults who had been adopted by non-Indian families and seek to reconnect with their tribes often face significant hurdles in obtaining needed information. The updated guidelines attempt to protect those adults' rights to obtain information about their tribal relationship by specifying that, even in States where adoptions remain closed, the relevant agency should facilitate communication directly with the tribe's enrollment office.
The guidelines also recommend that courts work with tribes to identify tribal designees who can assist adult adoptees to connect with their tribes.
Finally, the updated guidelines clarify that the requirement to maintain records on foster care, preadoptive placement and adoptive placements applies not only in involuntary proceedings, but also in voluntary proceedings.
These guidelines supersede and replace the guidelines published at 44 FR 67584 (November 28, 1979).
These guidelines clarify the minimum Federal standards, and best practices, governing implementation of the Indian Child Welfare Act (ICWA) to ensure that ICWA is applied in all States consistent with the Act's express language, Congress' intent in enacting the statute, and the canon of construction that statutes enacted for the benefit of Indians are to be liberally construed to their benefit. In order to fully implement ICWA, these guidelines should be applied in all proceedings and stages of a proceeding in which the Act is or becomes applicable.
(1) Engaging the Indian child, the Indian child's parents, the Indian child's extended family members, and the Indian child's custodian(s);
(2) Taking steps necessary to keep siblings together;
(3) Identifying appropriate services and helping the parents to overcome barriers, including actively assisting the parents in obtaining such services;
(4) Identifying, notifying, and inviting representatives of the Indian child's tribe to participate;
(5) Conducting or causing to be conducted a diligent search for the Indian child's extended family members for assistance and possible placement;
(6) Taking into account the Indian child's tribe's prevailing social and cultural conditions and way of life, and requesting the assistance of representatives designated by the Indian child's tribe with substantial knowledge of the prevailing social and cultural standards;
(7) Offering and employing all available and culturally appropriate family preservation strategies;
(8) Completing a comprehensive assessment of the circumstances of the Indian child's family, with a focus on safe reunification as the most desirable goal;
(9) Notifying and consulting with extended family members of the Indian child to provide family structure and support for the Indian child, to assure cultural connections, and to serve as placement resources for the Indian child;
(10) Making arrangements to provide family interaction in the most natural setting that can ensure the Indian child's safety during any necessary removal;
(11) Identifying community resources including housing, financial, transportation, mental health, substance abuse, and peer support services and actively assisting the Indian child's parents or extended family in utilizing and accessing those resources;
(12) Monitoring progress and participation in services;
(13) Providing consideration of alternative ways of addressing the needs of the Indian child's parents and extended family, if services do not exist or if existing services are not available;
(14) Supporting regular visits and trial home visits of the Indian child during any period of removal, consistent with the need to ensure the safety of the child; and
(15) Providing post-reunification services and monitoring.
“Active efforts” are separate and distinct from requirements of the Adoption and Safe Families Act
(1)
(2)
(3)
(4)
(1) For a parent or any person over the age of eighteen, physical presence in a place and intent to remain there;
(2) For an Indian child, the domicile of the Indian child's parents. In the case of an Indian child whose parents are not married to each other, the domicile of the Indian child's mother. Under the principle for determining the domicile of an Indian child, it is entirely logical that “[o]n occasion, a child's domicile of origin will be in a place where the child has never been.”
(a) ICWA applies whenever an Indian child is the subject of a State child custody proceeding as defined by the Act. ICWA also applies to proceedings involving status offenses or juvenile delinquency proceedings if any part of those proceedings results in the need for placement of the child in a foster care, preadoptive or adoptive placement, or termination of parental rights.
(b) There is no exception to application of ICWA based on the so-called “existing Indian family doctrine.” Thus, the following non-exhaustive list of factors should not be considered in determining whether ICWA is applicable: the extent to which the parent or Indian child participates in or observes tribal customs, votes in tribal elections or otherwise participates in tribal community affairs, contributes to tribal or Indian charities, subscribes to tribal newsletters or other periodicals of special interest in Indians, participates in Indian religious, social, cultural, or political events, or maintains social contacts with other members of the tribe; the relationship between the Indian child and his/her Indian parents;
(c) Agencies and State courts, in every child custody proceeding, must ask whether the child is or could be an Indian child and conduct an investigation into whether the child is an Indian child. Even in those cases in which the child is not removed from the home, such as when an agency opens an investigation or the court orders the family to engage in services to keep the child in the home as part of a diversion, differential, alternative response or other program, agencies and courts should follow the verification and notice provisions of these guidelines. Providing notice allows tribes to intervene as early as possible in a child custody proceeding and provides an opportunity for the tribe to bring resources to bear to assist the family in preventing a breakup of the family.
(d) If there is any reason to believe the child is an Indian child, the agency and State court must treat the child as an Indian child, unless and until it is determined that the child is not a member or is not eligible for membership in an Indian tribe.
(e) ICWA and these guidelines or any associated Federal guidelines do not apply to:
(1) Tribal court proceedings;
(2) Placements based upon an act by the Indian child which, if committed by an adult, would be deemed a criminal offense; or
(3) An award, in a divorce proceeding, of custody of the Indian child to one of the parents.
(f) Voluntary placements that do not operate to prohibit the child's parent or Indian custodian from regaining custody of the child upon demand are not covered by the Act.
(1) Such placements should be made pursuant to a written agreement, and the agreement should state explicitly the right of the parent or Indian custodian to regain custody of the child upon demand.
(2) Nevertheless, it is a best practice to follow the procedures in these guidelines to determine whether a child is an Indian child and to notify the tribe.
(g) Voluntary placements in which a parent consents to a foster care placement or seeks to permanently terminate his or her rights or to place the child in a preadoptive or adoptive placement are covered by the Act.
To contact a tribe to provide notice or obtain information or verification under these Guidelines, you should direct the notice or inquiry as follows:
(1) Many tribes designate an agent for receipt of ICWA notices. The Bureau of Indian Affairs publishes a list of tribes' designated tribal agents for service of ICWA notice in the
(2) For tribes without a designated tribal agent for service of ICWA notice, contact the tribe(s) to be directed to the appropriate individual or office.
(3) If you do not have accurate contact information for the tribe(s) or the tribe(s) contacted fail(s) to respond to written inquiries, you may seek assistance in contacting the Indian tribe(s) from the Bureau of Indian Affairs' Regional Office and/or Central Office in Washington DC (see
(a) These guidelines provide minimum Federal standards and best practices to ensure compliance with ICWA and should be applied in all child custody proceedings in which the Act applies.
(b) In any child custody proceeding where applicable State or other Federal law provides a higher standard of protection to the rights of the parent or Indian custodian than the protection accorded under the Act, ICWA requires that the State court must apply the higher standard.
(a) The requirement to engage in “active efforts” begins from the moment the possibility arises that an agency case or investigation may result in the need for the Indian child to be placed outside the custody of either parent or Indian custodian in order to prevent removal.
(b) Active efforts to prevent removal of the child must be conducted while investigating whether the child is a member of the tribe, is eligible for membership in the tribe, or whether a biological parent of the child is or is not a member of a tribe.
(a) Agencies must ask whether there is reason to believe a child that is subject to a child custody proceeding is an Indian child. If there is reason to believe that the child is an Indian child, the agency must obtain verification, in writing, from all tribes in which it is believed that the child is a member or eligible for membership, as to whether the child is an Indian child.
(b) State courts must ask, as a threshold question at the start of any State court child custody proceeding, whether there is reason to believe the child who is the subject of the proceeding is an Indian child by asking each party to the case, including the guardian ad litem and the agency representative, to certify on the record whether they have discovered or know of any information that suggests or indicates the child is an Indian child.
(1) In requiring this certification, the court may require the agency to provide:
(i) Genograms or ancestry charts for both parents, including all names known (maiden, married and former names or aliases); current and former addresses of the child's parents, maternal and paternal grandparents and great grandparents or Indian custodians; birthdates; places of birth and death; tribal affiliation including all known Indian ancestry for individuals listed on the charts, and/or other identifying information; and/or
(ii) The addresses for the domicile and residence of the child, his or her parents, or the Indian custodian and whether either parent or Indian custodian is domiciled on or a resident of an Indian reservation or in a predominantly Indian community.
(2) If there is reason to believe the child is an Indian child, the court must confirm that the agency used active efforts to work with all tribes of which the child may be a member to verify whether the child is in fact a member or eligible for membership in any tribe, under paragraph (a).
(c) An agency or court has reason to believe that a child involved in a child custody proceeding is an Indian child if:
(1) Any party to the proceeding, Indian tribe, Indian organization or public or private agency informs the agency or court that the child is an Indian child;
(2) Any agency involved in child protection services or family support has discovered information suggesting that the child is an Indian child;
(3) The child who is the subject of the proceeding gives the agency or court reason to believe he or she is an Indian child;
(4) The domicile or residence of the child, parents, or the Indian custodian is known by the agency or court to be, or is shown to be, on an Indian
(5) An employee of the agency or officer of the court involved in the proceeding has knowledge that the child may be an Indian child.
(d) In seeking verification of the child's status, in a voluntary placement proceeding where a consenting parent evidences a desire for anonymity, the agency or court must keep relevant documents confidential and under seal. A request for anonymity does not relieve the obligation to obtain verification from the tribe(s) or to provide notice.
(a) Only the Indian tribe(s) of which it is believed a biological parent or the child is a member or eligible for membership may make the determination whether the child is a member of the tribe(s), is eligible for membership in the tribe(s), or whether a biological parent of the child is a member of the tribe(s).
(b) The determination by a tribe of whether a child is a member, is eligible for membership, or whether a biological parent is or is not a member of that tribe, is solely within the jurisdiction and authority of the tribe.
(c) No other entity or person may authoritatively make the determination of whether a child is a member of the tribe or is eligible for membership in the tribe.
(1) There is no requirement that the child maintain a certain degree of contacts with the tribe or for a certain blood quantum or degree of Indian blood.
(2) A tribe need not formally enroll its members for a child to be a member or eligible for membership. In some tribes, formal enrollment is not required for tribal membership. Some tribes do not have written rolls and others have rolls that list only persons that were members as of a certain date.
(d) The State court may not substitute its own determination regarding a child's membership or eligibility for membership in a tribe or tribes.
(a) Agencies are required to notify all tribes, of which the child may be a member or eligible for membership, that the child is involved in a child custody proceeding. The notice should specify the other tribe or tribes of which the child may be a member or eligible for membership.
(b) If the Indian child is a member or eligible for membership in only one tribe, that tribe should be designated as the Indian child's tribe.
(c) If an Indian child is a member or eligible for membership in more than one tribe, ICWA requires that the Indian tribe with which the Indian child has the more significant contacts be designated as the Indian child's tribe.
(1) In determining significant contacts, the following may be considered:
(i) Preference of the parents for membership of the child;
(ii) Length of past domicile or residence on or near the reservation of each tribe;
(iii) Tribal membership of custodial parent or Indian custodian; and
(iv) Interest asserted by each tribe in response to the notice that the child is involved in a child custody proceeding;
(d) When an Indian child is already a member of a tribe, but is also eligible for membership in another tribe, deference should be given to the tribe in which the Indian child is a member, unless otherwise agreed to by the tribes. However, if the Indian child is not a member of any tribe, an opportunity should be provided to allow the tribes to determine which of them should be designated as the Indian child's tribe.
(i) If the tribes are able to reach an agreement, the agreed upon tribe should be designated as the Indian child's tribe.
(ii) If the tribes do not agree, the following factors should be considered in designating the Indian child's tribe:
(A) The preference of the parents or extended family members who are likely to become foster care or adoptive placements; and/or
(B) Tribal membership of custodial parent or Indian custodian; and/or
(C) If applicable, length of past domicile or residence on or near the reservation of each tribe; and/or
(D) Whether there has been a previous adjudication with respect to the child by a court of one of the tribes; and/or
(E) Self-identification by the child; and/or
(F) Availability of placements.
(iii) In the event the child is eligible for membership in a tribe but is not yet a member of any tribe, the agency should take the steps necessary to obtain membership for the child in the tribe that is designated as the Indian child's tribe.
(3) Once an Indian tribe is designated as the child's Indian tribe, all tribes which received notice of the child custody proceeding must be notified in writing of the determination and a copy of that document must be filed with the court and sent to each party to the proceeding and to each person or governmental agency that received notice of the proceeding.
(4) A determination of the Indian child's tribe for purposes of ICWA and these guidelines does not constitute a determination for any other purpose or situation.
(d) The tribe designated as the Indian child's tribe may authorize another tribe to act as a representative for the tribe in a child custody case, including, for example, having the representative tribe perform home studies or expert witness services for the Indian child's tribe.
Subject to B.8 (emergency procedures), the following limitations on a State court's jurisdiction apply:
(a) The court must dismiss any child custody proceeding as soon as the court determines that it lacks jurisdiction.
(b) The court must make a determination of the residence and domicile of the Indian child. If either the residence or domicile is on a reservation where the tribe exercises exclusive jurisdiction over child custody proceedings, the State court must dismiss the State court proceedings, the agency must notify the tribe of the dismissal based on the tribe's exclusive jurisdiction, and the agency must transmit all available information regarding the Indian child custody proceeding to the tribal court.
(c) If the Indian child has been domiciled or previously resided on an Indian reservation, the State court must contact the tribal court to determine whether the child is a ward of the tribal court. If the child is a ward of a tribal court, the State court must dismiss the State court proceedings, the agency must notify the tribe of the dismissal, and the agency must transmit all available information regarding the Indian child custody proceeding to the tribal court.
(a) When an agency or court knows or has reason to know that the subject of an involuntary child custody proceeding is an Indian child, the agency or court must send notice of each such proceeding (including but not limited to a temporary custody hearing, any removal or foster care placement, any adoptive placement, or any termination of parental or custodial
(1) Each tribe where the child may be a member or eligible for membership;
(2) The child's parents; and
(3) If applicable, the Indian custodian.
(b) Notice may be sent via personal service or electronically in addition to the methods required by the Act, but such alternative methods do not replace the requirement for notice to be sent by registered mail with return receipt requested.
(c) Notice must be in clear and understandable language and include the following:
(1) Name of the child, the child's birthdate and birthplace;
(2) Name of each Indian tribe(s) in which the child is a member or may be eligible for membership;
(3) A copy of the petition, complaint or other document by which the proceeding was initiated;
(4) Statements setting out:
(i) The name of the petitioner and name and address of petitioner's attorney;
(ii) The right of the parent or Indian custodian to intervene in the proceedings.
(iii) The Indian tribe's right to intervene at any time in a State court proceeding for the foster care placement of or termination of a parental right.
(iv) If the Indian parent(s) or, if applicable, Indian custodian(s) is unable to afford counsel based on a determination of indigency by the court, counsel will be appointed to represent the parent or Indian custodian where authorized by State law.
(v) The right to be granted, upon request, a specific amount of additional time (up to 20 additional days) to prepare for the proceedings due to circumstances of the particular case.
(vi) The right to petition the court for transfer of the proceeding to tribal court under 25 U.S.C. 1911, absent objection by either parent:
(vii) The mailing addresses and telephone numbers of the court and information related to all parties to the proceeding and individuals notified under this section.
(viii) The potential legal consequences of the proceedings on the future custodial and parental rights of the Indian parents or Indian custodians.
(d) In order to assist the Indian tribe(s) in making a determination regarding whether the child is a member or eligible for membership, the agency or court should include additional information in the notice, such as:
(1) Genograms or ancestry charts for both parents, including all names known (maiden, married and former names or aliases); current and former addresses of the child's parents, maternal and paternal grandparents and great grandparents or Indian custodians; birthdates; places of birth and death; tribal affiliation including all known Indian ancestry for individuals listed on the charts, and/or other identifying information; and/or
(2) The addresses for the domicile and residence of the child, his or her parents, or the Indian custodian and whether either parent or Indian custodian is domiciled on or a resident of an Indian reservation or in a predominantly Indian community.
(3) In the event that a parent has requested anonymity, the agency and court must take steps to keep information related to the parent confidential and sealed from disclosure.
(e) If the identity or location of the Indian parents, Indian custodians or tribes in which the Indian child is a member or eligible for membership cannot be ascertained, but there is reason to believe the child is an Indian child, notice of the child custody proceeding must be sent to the appropriate Bureau of Indian Affairs Regional Director (see
(f) Because child custody proceedings are usually conducted on a confidential basis, information contained in the notice should be kept confidential to the extent possible.
(g) The original or a copy of each notice sent under this section should be filed with the court together with any return receipts or other proof of service.
(h) If a parent or Indian custodian appears in court without an attorney, the court must inform him or her of the right to appointed counsel, the right to request that the proceeding be transferred to tribal court, the right to object to such transfer, the right to request additional time to prepare for the proceeding and the right (if the parent or Indian custodian is not already a party) to intervene in the proceedings.
(i) If the court or an agency has reason to believe that a parent or Indian custodian possesses limited English proficiency and is therefore not likely to understand the contents of the notice, the court or agency must, at no cost, provide a translated version of the notice or have the notice read and explained in a language that the parent or Indian custodian understands. To secure such translation or interpretation support, a court or agency should contact the Indian child's tribe or the local BIA agency for assistance in locating and obtaining the name of a qualified translator or interpreter.
(j) In voluntary proceedings, notice should also be sent in accordance with this section because the Indian tribe might have exclusive jurisdiction and/or the right to intervene. Further, notice to and involvement of the Indian tribe in the early stages of the proceedings aids the agency and court in satisfying their obligations to determine whether the child is an Indian child and in complying with 25 U.S.C. 1915.
(k) If the child is transferred interstate, regardless of whether the Interstate Compact on the Placement of Children (ICPC) applies, both the originating State court and receiving State court must provide notice to the tribe(s) and seek to verify whether the child is an Indian child.
(l) The notice requirement includes providing responses to requests for additional information, where available, in the event that a tribe indicates that such information is necessary to determine whether a child is an Indian child.
(a) No hearings regarding decisions for the foster care or termination of parental rights may begin until the waiting periods to which the parents or Indian custodians and to which the Indian child's tribe are entitled have passed. Additional extensions of time may also be granted beyond the minimum required by the Act.
(b) A tribe, parent or Indian custodian entitled to notice of the pendency of a child custody proceeding has a right, upon request, to be granted an additional 20 days from the date upon which notice was received in accordance with 25 U.S.C. 1912(a) to prepare for participation in the proceeding.
(c) The proceeding may not begin until all of the following dates have passed:
(1) 10 days after each parent or Indian custodian (or Secretary where the parent or Indian custodian is unknown to the petitioner) has received notice in accordance with 25 U.S.C. 1912(a);
(2) 10 days after the Indian child's tribe (or the Secretary if the Indian child's tribe is unknown to the party
(3) 30 days after the parent or Indian custodian has received notice in accordance with 25 U.S.C. 1912(a), if the parent or Indian custodian has requested an additional 20 days to prepare for the proceeding; and
(4) 30 days after the Indian child's tribe has received notice in accordance with 25 U.S.C. 1912(a), if the Indian child's tribe has requested an additional 20 days to prepare for the proceeding.
(d) The court should allow, if it possesses the capability, alternative methods of participation in State court proceedings by family members and tribes, such as participation by telephone, videoconferencing, or other methods.
(a) The emergency removal and emergency placement of an Indian child in a foster home or institution under applicable State law is allowed only as necessary to prevent imminent physical damage or harm to the child. This requirement applies to all Indian children regardless of whether they are domiciled or reside on a reservation. This does not, however, authorize a State to remove a child from a reservation where a tribe exercises exclusive jurisdiction.
(b) Any emergency removal or emergency placement of any Indian child under State law must be as short as possible. Each involved agency or court must:
(1) Diligently investigate and document whether the removal or placement is proper and continues to be necessary to prevent imminent physical damage or harm to the child;
(2) Promptly hold a hearing to hear evidence and evaluate whether the removal or placement continues to be necessary whenever new information is received or assertions are made that the emergency situation has ended; and
(3) Immediately terminate the emergency removal or placement once the court possesses sufficient evidence to determine that the emergency has ended.
(c) If the agency that conducts an emergency removal of a child whom the agency knows or has reason to know is an Indian child, the agency must:
(1) Treat the child as an Indian child until the court determines that the child is not an Indian child;
(2) Conduct active efforts to prevent the breakup of the Indian family as early as possible, including, if possible, before removal of the child;
(3) Immediately take and document all practical steps to confirm whether the child is an Indian child and to verify the Indian child's tribe;
(4) Immediately notify the child's parents or Indian custodians and Indian tribe of the removal of the child;
(5) Take all practical steps to notify the child's parents or Indian custodians and Indian tribe about any hearings regarding the emergency removal or emergency placement of the child; and
(6) Maintain records that detail the steps taken to provide any required notifications under section B.6 of these guidelines.
(d) A petition for a court order authorizing emergency removal or continued emergency physical custody must be accompanied by an affidavit containing the following information:
(1) The name, age and last known address of the Indian child;
(2) The name and address of the child's parents and Indian custodians, if any;
(3) If such persons are unknown, a detailed explanation of what efforts have been made to locate them, including notice to the appropriate Bureau of Indian Affairs Regional Director (see
(4) Facts necessary to determine the residence and the domicile of the Indian child;
(5) If either the residence or domicile is believed to be on an Indian reservation, the name of the reservation;
(6) The tribal affiliation of the child and of the parents and/or Indian custodians;
(7) A specific and detailed account of the circumstances that led the agency responsible for the emergency removal of the child to take that action;
(8) If the child is believed to reside or be domiciled on a reservation where the tribe exercises exclusive jurisdiction over child custody matters, a statement of efforts that have been made and are being made to transfer the child to the tribe's jurisdiction;
(9) A statement of the specific active efforts that have been taken to assist the parents or Indian custodians so the child may safely be returned to their custody; and
(10) A statement of the imminent physical damage or harm expected and any evidence that the removal or emergency custody continues to be necessary to prevent such imminent physical damage or harm to the child.
(e) At any court hearing regarding the emergency removal or emergency placement of an Indian child, the court must determine whether the removal or placement is no longer necessary to prevent imminent physical damage or harm to the child. The court should accept and evaluate all information relevant to the agency's determination provided by the child, the child's parents, the child's Indian custodians, the child's tribe or any participants in the hearing.
(f) Temporary emergency custody should not be continued for more than 30 days. Temporary emergency custody may be continued for more than 30 days only if:
(1) A hearing, noticed in accordance with these guidelines, is held and results in a determination by the court, supported by clear and convincing evidence and the testimony of at least one qualified expert witness, that custody of the child by the parent or Indian custodian is likely to result in imminent physical damage or harm to the child; or
(2) Extraordinary circumstances exist.
(g) The emergency removal or placement must terminate as soon as the imminent physical damage or harm to the child which resulted in the emergency removal or placement no longer exists, or, if applicable, as soon as the tribe exercises jurisdiction over the case, whichever is earlier.
(h) Once an agency or court has terminated the emergency removal or placement, it must expeditiously:
(1) Return the child to the parent or Indian custodian within one business day; or
(2) Transfer the child to the jurisdiction of the appropriate Indian tribe if the child is a ward of a tribal court or a resident of or domiciled on a reservation; or
(3) Initiate a child custody proceeding subject to the provisions of the Act and these guidelines.
(i) The court should allow, if it possesses the capability, alternative methods of participation in State court proceedings by family members and tribes, such as participation by telephone, videoconferencing, or other methods.
(a) If, in the course of any Indian child custody proceeding, any party asserts or the court has reason to believe that the Indian child may have been improperly removed from the custody of his or her parent or Indian custodian, or that the Indian child has been improperly retained, such as after a visit or other temporary relinquishment of custody, the court must immediately stay the proceeding until a determination can be made on the question of improper removal or retention, and such
(b) If the court finds that the Indian child was improperly removed or retained, the court must terminate the proceeding and the child must be returned immediately to his or her parents or Indian custodian, unless returning the child to his parent or custodian would subject the child to imminent physical damage or harm.
(a) Either parent, the Indian custodian, or the Indian child's tribe may request, orally on the record or in writing, that the State court transfer each distinct Indian child custody proceeding to the tribal court of the child's tribe.
(b) The right to request a transfer occurs with each proceeding. For example, a parent may request a transfer to tribal court during the first proceeding for foster placement and/or at a proceeding to determine whether to continue foster placement, and/or at a later proceeding, for example at a hearing for termination of parental rights.
(c) The right to request a transfer is available at any stage of an Indian child custody proceeding, including during any period of emergency removal.
(d) The court should allow, if possible, alternative methods of participation in State court proceedings by family members and tribes, such as participation by telephone, videoconferencing, or other methods.
(a) Upon receipt of a petition to transfer by a parent, Indian custodian or the Indian child's tribe, the State court must transfer the case unless any of the following criteria are met:
(1) Either parent objects to such transfer;
(2) The tribal court declines the transfer; or
(3) The court determines that good cause exists for denying the transfer.
(b) To minimize delay, the court should expeditiously provide all records related to the proceeding to the tribal court.
(a) If the State court believes, or any party asserts, that good cause not to transfer exists, the reasons for such belief or assertion must be stated on the record or in writing and made available to the parties who are petitioning for transfer.
(b) Any party to the proceeding must have the opportunity to provide the court with views regarding whether good cause to deny transfer exists.
(c) In determining whether good cause exists, the court may not consider whether the case is at an advanced stage or whether transfer would result in a change in the placement of the child because the Act created concurrent, but presumptively, tribal jurisdiction over proceedings involving children not residing or domiciled on the reservation, and seeks to protect, not only the rights of the Indian child as an Indian, but the rights of Indian communities and tribes in retaining Indian children. Thus, whenever a parent or tribe seeks to transfer the case it is presumptively in the best interest of the Indian child, consistent with the Act, to transfer the case to the jurisdiction of the Indian tribe.
(d) In addition, in determining whether there is good cause to deny the transfer, the court may not consider:
(1) The Indian child's contacts with the tribe or reservation;
(2) Socio-economic conditions or any perceived inadequacy of tribal or Bureau of Indian Affairs social services or judicial systems; or
(3) The tribal court's prospective placement for the Indian child.
(e) The burden of establishing good cause not to transfer is on the party opposing the transfer.
(a) Upon receipt of a transfer petition the State court must promptly notify the tribal court in writing of the transfer petition and request a response regarding whether the tribal court wishes to decline the transfer. The notice should specify how much time the tribal court has to make its decision; provided that the tribal court has at least 20 days from the receipt of notice of a transfer petition to decide whether to accept or decline the transfer.
(b) The tribal court should inform the State court of its decision to accept or decline jurisdiction within the time required or may request additional time; provided that the reasons for additional time are explained.
(c) If the tribal court accepts the transfer, the State court should promptly provide the tribal court with all court records.
(a) The court must inform each party to a foster care placement or termination of parental rights proceeding under State law involving an Indian child of his or her right to timely examination of all reports or other documents filed with the court and all files upon which any decision with respect to such action may be based.
(b) Decisions of the court may be based only upon reports, documents or testimony presented on the record.
(a) Any party petitioning a State court for foster care placement or termination of parental rights to an Indian child must demonstrate to the court that prior to, and until the commencement of, the proceeding, active efforts have been made to avoid the need to remove the Indian child from his or her parents or Indian custodians and show that those efforts have been unsuccessful.
(b) Active efforts must be documented in detail and, to the extent possible, should involve and use the available resources of the extended family, the child's Indian tribe, Indian social service agencies and individual Indian care givers.
(a) The court may not issue an order effecting a foster care placement of an Indian child unless clear and convincing evidence is presented, including the testimony of one or more qualified expert witnesses, demonstrating that the child's continued custody with the child's parents or Indian custodian is likely to result in serious harm to the child.
(b) The court may not order a termination of parental rights unless the court's order is supported by evidence beyond a reasonable doubt, supported by the testimony of one or more qualified expert witnesses, that continued custody of the child by the parent or Indian custodian is likely to result in serious harm to the child.
(c) Clear and convincing evidence must show a causal relationship between the existence of particular conditions in the home that are likely to result in serious emotional or physical damage to the particular child who is the subject of the proceeding. Evidence that shows only the existence of
(a) A qualified expert witness should have specific knowledge of the Indian tribe's culture and customs.
(b) Persons with the following characteristics, in descending order, are presumed to meet the requirements for a qualified expert witness:
(1) A member of the Indian child's tribe who is recognized by the tribal community as knowledgeable in tribal customs as they pertain to family organization and childrearing practices.
(2) A member of another tribe who is recognized to be a qualified expert witness by the Indian child's tribe based on their knowledge of the delivery of child and family services to Indians and the Indian child's tribe.
(3) A layperson who is recognized by the Indian child's tribe as having substantial experience in the delivery of child and family services to Indians, and knowledge of prevailing social and cultural standards and childrearing practices within the Indian child's tribe.
(4) A professional person having substantial education and experience in the area of his or her specialty who can demonstrate knowledge of the prevailing social and cultural standards and childrearing practices within the Indian child's tribe.
(c) The court or any party may request the assistance of the Indian child's tribe or the Bureau of Indian Affairs agency serving the Indian child's tribe in locating persons qualified to serve as expert witnesses.
(a) Agencies and State courts must ask whether a child is an Indian child in any voluntary proceeding under sections B.2. to B.4. of these guidelines.
(b) Agencies and State courts should provide the Indian tribe with notice of the voluntary child custody proceedings, including applicable pleadings or executed consents, and their right to intervene under section B.6. of these guidelines.
(a) A voluntary termination of parental rights, foster care placement or adoption must be executed in writing and recorded before a court of competent jurisdiction.
(b) Prior to accepting the consent, the court must explain the consequences of the consent in detail, such as any conditions or timing limitations for withdrawal of consent and, if applicable, the point at which such consent is irrevocable.
(c) A certificate of the court must accompany a written consent and must certify that the terms and consequences of the consent were explained in detail in the language of the parent or Indian custodian, if English is not the primary language, and were fully understood by the parent or Indian custodian.
(d) Execution of consent need not be made in open court where confidentiality is requested or indicated.
(e) A consent given prior to or within 10 days after birth of the Indian child is not valid.
(a) The consent document must contain the name and birthdate of the Indian child, the name of the Indian child's tribe, identifying tribal enrollment number, if any, or other indication of the child's membership in the tribe, and the name and address of the consenting parent or Indian custodian. If there are any conditions to the consent, the consent document must clearly set out the conditions.
(b) A consent to foster care placement should contain, in addition to the information specified in subsection (a), the name and address of the person or entity by or through whom the placement was arranged, if any, or the name and address of the prospective foster parents, if known at the time.
(a) Withdrawal of consent must be filed in the same court where the consent document was executed.
(b) When a parent or Indian custodian withdraws consent to foster care placement, the child must be returned to that parent or Indian custodian immediately.
(a) A consent to termination of parental rights or adoption may be withdrawn by the parent at any time prior to entry of a final decree of voluntary termination or adoption, whichever occurs later. To withdraw consent, the parent must file, in the court where the consent is filed, an instrument executed under oath asserting his or her intention to withdraw such consent.
(b) The clerk of the court in which the withdrawal of consent is filed must promptly notify the party by or through whom any preadoptive or adoptive placement has been arranged of such filing and the child must be returned to the parent or Indian custodian as soon as practicable.
(a) In any preadoptive, adoptive or foster care placement of an Indian child, the Act's placement preferences apply; except that, if the Indian child's tribe has established by resolution a different order of preference than that specified in the Act, the agency or court effecting the placement must follow the tribe's placement preferences.
(b) The agency seeking a preadoptive, adoptive or foster care placement of an Indian child must always follow the placement preferences. If the agency determines that any of the preferences cannot be met, the agency must demonstrate through clear and convincing evidence that a diligent search has been conducted to seek out and identify placement options that would satisfy the placement preferences specified in sections F.2. or F.3. of these guidelines, and explain why the preferences could not be met. A search should include notification about the placement hearing and an explanation of the actions that must be taken to propose an alternative placement to:
(1) The Indian child's parents or Indian custodians;
(2) All of the known, or reasonably identifiable, members of the Indian child's extended family members;
(3) The Indian child's tribe;
(4) In the case of a foster care or preadoptive placement:
(i) All foster homes licensed, approved, or specified by the Indian child's tribe; and
(ii) All Indian foster homes located in the Indian child's State of domicile that are licensed or approved by any authorized non-Indian licensing authority.
(c) Where there is a request for anonymity, the court should consider whether additional confidentiality protections are warranted, but a request for anonymity does not relieve the
(d) Departure from the placement preferences may occur only after the court has made a determination that good cause exists to place the Indian child with someone who is not listed in the placement preferences.
(e) Documentation of each preadoptive, adoptive or foster care placement of an Indian child under State law must be provided to the State for maintenance at the agency. Such documentation must include, at a minimum: the petition or complaint; all substantive orders entered in the proceeding; the complete record of, and basis for, the placement determination; and, if the placement deviates from the placement preferences, a detailed explanation of all efforts to comply with the placement preferences and the court order authorizing departure from the placement preferences.
(a) In any adoptive placement of an Indian child under State law, preference must be given in descending order, as listed below, to placement of the child with:
(1) A member of the child's extended family;
(2) Other members of the Indian child's tribe; or
(3) Other Indian families, including families of unwed individuals.
(b) The court should, where appropriate, also consider the preference of the Indian child or parent.
In any foster care or preadoptive placement of an Indian child:
(a) The child must be placed in the least restrictive setting that:
(1) Most approximates a family;
(2) Allows his or her special needs to be met; and
(3) Is in reasonable proximity to his or her home, extended family, and/or siblings.
(b) Preference must be given, in descending order as listed below, to placement of the child with:
(1) A member of the Indian child's extended family;
(2) A foster home, licensed, approved or specified by the Indian child's tribe, whether on or off the reservation;
(3) An Indian foster home licensed or approved by an authorized non-Indian licensing authority; or
(4) An institution for children approved by an Indian tribe or operated by an Indian organization which has a program suitable to meet the child's needs.
(a) If any party asserts that good cause not to follow the placement preferences exists, the reasons for such belief or assertion must be stated on the record or in writing and made available to the parties to the proceeding and the Indian child's tribe.
(b) The party seeking departure from the preferences bears the burden of proving by clear and convincing evidence the existence of “good cause” to deviate from the placement preferences.
(c) A determination of good cause to depart from the placement preferences must be based on one or more of the following considerations:
(1) The request of the parents, if both parents attest that they have reviewed the placement options that comply with the order of preference.
(2) The request of the child, if the child is able to understand and comprehend the decision that is being made.
(3) The extraordinary physical or emotional needs of the child, such as specialized treatment services that may be unavailable in the community where families who meet the criteria live, as established by testimony of a qualified expert witness; provided that extraordinary physical or emotional needs of the child does not include ordinary bonding or attachment that may have occurred as a result of a placement or the fact that the child has, for an extended amount of time, been in another placement that does not comply with the Act. The good cause determination does not include an independent consideration of the best interest of the Indian child because the preferences reflect the best interests of an Indian child in light of the purposes of the Act.
(4) The unavailability of a placement after a showing by the applicable agency in accordance with section F.1., and a determination by the court that active efforts have been made to find placements meeting the preference criteria, but none have been located. For purposes of this analysis, a placement may not be considered unavailable if the placement conforms to the prevailing social and cultural standards of the Indian community in which the Indian child's parent or extended family resides or with which the Indian child's parent or extended family members maintain social and cultural ties.
(d) The court should consider only whether a placement in accordance with the preferences meets the physical, mental and emotional needs of the child; and may not depart from the preferences based on the socio-economic status of any placement relative to another placement.
(a) Within two years after a final decree of adoption of any Indian child by a State court, or within any longer period of time permitted by the law of the State, a parent who executed a consent to termination of paternal rights or adoption of that child may petition the court in which the final adoption decree was entered to vacate the decree and revoke the consent on the grounds that consent was obtained by fraud or duress, or that the proceeding failed to comply with ICWA.
(b) Upon the filing of such petition, the court must give notice to all parties to the adoption proceedings and the Indian child's tribe.
(c) The court must hold a hearing on the petition.
(d) Where the court finds that the parent's consent was obtained through fraud or duress, the court must vacate the decree of adoption, order the consent revoked and order that the child be returned to the parent.
(a) Any of the following may petition any court of competent jurisdiction to invalidate an action for foster care placement or termination of parental rights where it is alleged that the Act has been violated:
(1) An Indian child who is the subject of any action for foster care placement or termination of parental rights;
(2) A parent or Indian custodian from whose custody such child was removed; and
(3) The Indian child's tribe.
(b) Upon a showing that an action for foster care placement or termination of parental rights violated any provision of 25 U.S.C. 1911, 1912, or 1913, the court must determine whether it is appropriate to invalidate the action.
(c) There is no requirement that the particular party's rights under the Act be violated to petition for invalidation; rather, any party may challenge the action based on violations in implementing the Act during the course of the child custody proceeding. For example, it is acceptable for the tribe to petition to invalidate an action because
(d) The court should allow, if it possesses the capability, alternative methods of participation in State court proceedings by family members and tribes, such as participation by telephone, videoconferencing, or other methods.
(a) Upon application by an Indian individual who has reached age 18 who was the subject of an adoptive placement, the court that entered the final decree must inform such individual of the tribal affiliations, if any, of the individual's biological parents and provide such other information necessary to protect any rights, which may include tribal membership, resulting from the individual's tribal relationship.
(b) This section should be applied regardless of whether the original adoption was subject to the provisions of the Act.
(c) Where State law prohibits revelation of the identity of the biological parent, assistance of the Bureau of Indian Affairs should be sought to help an adoptee who is eligible for membership in a tribe to become a tribal member without breaching the Privacy Act or confidentiality of the record.
(d) In States where adoptions remain closed, the relevant agency should, at a minimum, communicate directly with the tribe's enrollment office and provide the information necessary to facilitate the establishment of the adoptee's tribal membership.
(e) Agencies should work with the tribe to identify at least one tribal designee familiar with 25 U.S.C. 1917 to assist adult adoptees statewide with the process of reconnecting with their tribes and to provide information to State judges about this provision on an annual basis.
(a) Notice by the court, or an agency authorized by the court, must be given to the child's biological parents or prior Indian custodians and the Indian child's tribe whenever:
(1) A final decree of adoption of an Indian child has been vacated or set aside; or
(2) The adoptive parent has voluntarily consented to the termination of his or her parental rights to the child; or
(3) Whenever an Indian child is removed from a foster care home or institution to another foster care placement, preadoptive placement, or adoptive placement.
(b) The notice must inform the recipient of the right to petition for return of custody of the child.
(c) A parent or Indian custodian may waive his or her right to such notice by executing a written waiver of notice filed with the court. The waiver may be revoked at any time by filing with the court a written notice of revocation. A revocation of the right to receive notice does not affect any proceeding which occurred before the filing of the notice of revocation.
(a) Any state entering a final adoption decree or order must furnish a copy of the decree or order to the Bureau of Indian Affairs, Chief, Division of Human Services, 1849 C Street NW., Mail Stop 4513 MIB, Washington, DC 20240, along with the following information:
(1) Birth name of the child, tribal affiliation and name of the child after adoption;
(2) Names and addresses of the biological parents;
(3) Names and addresses of the adoptive parents;
(4) Name and contact information for any agency having files or information relating to the adoption;
(5) Any affidavit signed by the biological parent or parents asking that their identity remain confidential; and
(6) Any information relating to the enrollment or eligibility for enrollment of the adopted child.
(b) Confidentiality of such information must be maintained and is not subject to the Freedom of Information Act, 5 U.S.C. 552, as amended.
(a) The State must establish a single location where all records of every voluntary or involuntary foster care, preadoptive placement and adoptive placement of Indian children by courts of that State will be available within seven days of a request by an Indian child's tribe or the Secretary.
(b) The records must contain, at a minimum, the petition or complaint, all substantive orders entered in the proceeding, and the complete record of the placement determination.
National Park Service, Interior.
Notice of availability.
The National Park Service (NPS) has prepared a Draft Environmental Impact Statement (DEIS) for the Alcatraz Ferry Embarkation project. The project would establish a new, long-term ferry embarkation site for passenger service between the northern San Francisco waterfront and Alcatraz Island. It would also establish occasional special ferry service between the selected Alcatraz ferry embarkation site and the existing Fort Baker pier, as well as between Fort Mason and other destinations in San Francisco Bay.
All comments must be postmarked or transmitted not later than 90 days from the date of publication in the
Please contact the Golden Gate National Recreation Area Planning Division at (415) 561-4930 or
The purpose and need for the project is driven by the following factors: (1) Alcatraz Island ferry service has been subject to location changes every 10 years, which has led to visitor confusion, community concerns, and inconsistency in visitor support services. The site and associated connections should be a consistent feature for visitors to Golden Gate National Recreation Area (GGNRA). (2)
Key project objectives include: (1) Establish a long-term (50 years or more) primary location that is economically feasible and sustainable, and enables substantial reinvestment in Alcatraz Island and other park facilities and visitor programs; (2) provide visitor access to Alcatraz Island that is compatible with nearby land uses, including neighborhoods, businesses, and transportation services; (3) accommodate the critical facilities and programs needed for the safety and comfort of visitors and staff, and provide for efficient ferry operations; (4) locate within a reasonable crossing time from Alcatraz Island and meet specific basic program element requirements for logistics; (5) provide an identifiable area for a quality welcome, orientation, and interpretation of the natural, cultural, scenic, and recreational resources of Alcatraz Island, other GGNRA system parklands, and the larger national park system; and (6) provide facilities for expanded ferry service to accommodate existing and future visitor demand for travel to Alcatraz Island and other GGNRA sites and NPS units.
All action alternatives analyzed in the DEIS would also provide the aforementioned occasional, special ferry service operated to/from Fort Baker and to/from Fort Mason. At this time, the “Preferred Alternative” has not been identified. Determination of which alternative is preferred will be informed by public comment on the DEIS and the outcome of ongoing discussions with the Port which may affect cost and logistics at the potential Port sites—Piers 31
In preparing the DEIS, the NPS consulted with elected officials in San Francisco and Sausalito, representatives of the Port of San Francisco, the Fort Mason Center, the State Office of Historic Preservation, and numerous other stakeholders, among them neighborhood associations, ferry boat operators and Native American tribes. The NPS completed over a dozen working papers and reports for this DEIS, including a feasibility analysis, visitor flow survey report, wind-wave analysis, value analysis report, and transportation and circulation study.
During the public review and comment period, visits to alternative sites will be offered and a public meeting will be conducted in San Francisco. The date, time, and location of the meeting and site visits will be publicized through local and regional news media, via the project Web site (
Copies of the DEIS (printed and electronic) will be distributed to congressional delegations, state and local elected officials, federal and state agencies, tribes, organizations, local businesses, public libraries, and the news media. Printed copies (in limited quantity) and CDs will be supplied in response to email, phone or mail requests. Printed copies will be available at public libraries in San Francisco and Sausalito.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at USITC
The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of BASF Corporation and UChicago Argonne LLC on February 20, 2015. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain lithium metal oxide cathode materials, lithium-ion batteries containing same, and products with lithium-ion batteries containing same. The complaint name as respondents Umicore N.V. of Belgium; Umicore USA Inc. of Raleigh, NC; Makita Corporation of Japan; Makita Corporation of America of Buford, GA and Makita U.S.A Inc. of La Mirada, CA. The complainant requests that the Commission issue a permanent exclusion order, permanent cease and desist order, and a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. § 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3058”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of an expedited review pursuant to section 751(c)(3) of the Tariff Act of 1930 (19 U.S.C. 1675(c)(3)) (the Act) to determine whether revocation of the antidumping duty order on tetrahydrofurfuryl alcohol from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. For further information concerning the conduct of this review and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Joanna Lo (202) 205-1888, Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
March 6, 2015 at 2:00 p.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 701-TA-528-529 and 731-TA-1264-1268 (Preliminary)(Certain Uncoated Paper from Australia, Brazil, China, Indonesia, and Portugal). The Commission is currently scheduled to complete and file its determinations on March 9, 2015; views of the Commission are currently scheduled to be completed and filed on March 16, 2015.
5. Outstanding action jackets: none.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Notice.
The Department of Labor (DOL) is submitting the Wage and Hour Division (WHD) sponsored information collection request (ICR) revision titled, “Family and Medical Leave Act of 1993, As Amended,” (FMLA) 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 March 27, 2015.
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-WHD, 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:
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 FMLA information collection approval resulting from a Final Rule the Department is publishing elsewhere in today's issuance of the
Elsewhere is today's issuance of the
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 regarding the ICR 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,
Mine Safety and Health Administration, Labor.
Notice.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations, 30 CFR part 44, govern the
All comments on the petitions must be received by the Office of Standards, Regulations, and Variances on or before March 27, 2015.
You may submit your comments, identified by “docket number” on the subject line, by any of the following methods:
1.
2.
3.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.
Barbara Barron, Office of Standards, Regulations, and Variances at 202-693-9447 (Voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
(1) These petitions will apply only to trailing cables supplying three-phase, 480-volt power for permissible pumps.
(2) The maximum length of the trailing cables for a 480-volt permissible pump will be 4000 feet.
(3) The permissible pump will be no greater than 6.2 horsepower.
(4) The 480-volt power for permissible pump trailing cables exceeding 500 feet will not be smaller than No. 6 AWG.
(5) All circuit breakers used to protect No. 6 AWG trailing cables exceeding 500 feet in length will have an instantaneous trip unit calibrated to trip at 60 amperes. These circuit breakers will be in the cable coupler and the cable coupler will have permanent, legible labels. Each label will identify the cable coupler as being suitable for protecting No. 6 AWG cables. This label will be maintained legible.
(6) Replacement circuit breakers used to protect No. 6 AWG trailing cables exceeding 500 feet in length will be calibrated to trip at 60 amperes.
(7) All circuit breakers used to protect the No. 2 AWG trailing cables exceeding 500 feet in length will have instantaneous trip units calibrated to trip at 150 amperes. These circuit breakers will be in the cable coupler and the cable coupler will have permanent, legible labels. Each label will identify the cable coupler as being suitable for protecting No. 2 AWG cables. The labels will be maintained legible.
(8) Replacement circuit breakers used to protect No. 2 AWG trailing cables exceeding 500 feet in length will be calibrated to trip at 150 amperes.
(9) The petitioner's alternative method will not be implemented until all miners who have been designated to examine and verify the short-circuit settings and proper procedures for examining trailing cables for defects and damage have received training.
(10) Within 60 days after these petitions are granted, the petitioner will submit proposed revisions for their approved 30 CFR part 48 training plans to the District Manager for the area in which the mine is located. The training will include the following:
(a) Mining methods and operating procedures for protecting the trailing cables against damage.
(b) Proper procedures for examining the trailing cables to ensure safe operating condition.
(c) The hazards of setting the instantaneous circuit breakers too high to adequately protect the trailing cables.
(d) How to verify that the circuit interrupting device(s) protecting the trailing cable(s) are properly set and maintained.
The petitioner further states that procedures specified in 30 CFR 48.3 for proposed revisions to approved training plans will apply.
The petitioner asserts that the alternative method will guarantee no less than the same measure of protection for all miners than that of the existing standard.
In accordance with the Federal Advisory Committee Act (Pub., L. 92-463, as amended), the National Science Foundation announces the following meeting:
Pursuant to delegation by the Commission,
This proceeding involves an application by Entergy Nuclear Vermont Yankee, LLC and Entergy Nuclear Operations, Inc. for a license amendment for the Vermont Yankee Nuclear Power Station, which is located in Vernon, Vermont. In response to a notice filed in the
The Board is comprised of the following administrative judges:
All correspondence, documents, and other materials shall be filed in accordance with the NRC E-Filing rule.
Pursuant to 10 CFR 2.313(c) and 2.321(b), the Atomic Safety and Licensing Board in the above-captioned
All correspondence, documents, and other materials shall continue to be filed in accordance with the NRC E-Filing rule.
Nuclear Regulatory Commission.
Branch technical position; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 of the Branch Technical Position on Concentration Averaging and Encapsulation (CA BTP). This guidance provides acceptable methods that can be used to perform concentration averaging of low-level radioactive waste (LLW) for the purpose of determining its waste class for disposal.
The Branch Technical Position referenced in this document is available on February 25, 2015.
Please refer to Docket ID NRC-2011-0022 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this document using any of the following methods:
•
•
•
Maurice Heath, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3137; email:
The NRC is issuing Revision 1 of the CA BTP. This revision provides updated guidance on the interpretation of § 61.55(a)(8) of Title 10 of the
The previous version of the CA BTP, published in 1995 (ADAMS Accession No. ML033630732), was issued before the NRC adopted its risk-informed and performance-based regulatory policy. The revised CA BTP has been informed by that policy. The revised CA BTP also contains new guidance related to blending of LLW, as directed by the Commission in its Staff Requirements Memorandum for SECY-10-0043, “Blending of Low-Level Radioactive Waste,” (ADAMS Accession No. ML102861764).
To provide protection for individuals who inadvertently intrude into a waste disposal facility, radioactive waste proposed for near-surface disposal must be classified based on its hazard to the intruder. The NRC's regulation, “Licensing Requirements for Land Disposal of Radioactive Waste,” 10 CFR part 61, establishes a waste classification system based on the concentration of specific radionuclides contained in the waste. This system is one of the key components in ensuring protection of an inadvertent intruder. In determining these concentrations, the regulation states, in 10 CFR 61.55(a)(8), that radionuclide concentrations can be averaged over the volume of the waste or its weight if the units are expressed as nanocuries per gram.
Although 10 CFR part 61 acknowledges that concentration averaging for the purposes of classifying waste for disposal is acceptable, it does not specify limitations on the implementation of concentration averaging. The staff published a technical position on radioactive waste classification, initially developed in May 1983 (ADAMS Accession No. ML033630755), that provided guidance on concentration averaging. This 1983 technical position describes overall procedures acceptable to NRC staff which could be used by licensees to determine the presence and concentrations of the radionuclides listed in 10 CFR 61.55, and thereby classify waste for near-surface disposal. Section C.3 of the 1983 technical position provided guidance on averaging of radionuclide concentrations for the purpose of classifying the waste.
In 1995, the NRC staff updated a portion of the 1983 technical position, publishing as a separate document the “Branch Technical Position on Concentration Averaging and Encapsulation,” (60 FR 4451, January 23, 1995). The 1995 CA BTP significantly expanded and further defined Section C.3 of the 1983 technical position dealing with concentration averaging, specifying a number of constraints on concentration averaging.
The current update to the CA BTP is necessary due to the significant number of changes in the LLW program since the CA BTP was published in 1995. First, the Commission reviewed the 1995 CA BTP's position on blending of LLW in 2010 and directed the staff to revise it to be more risk-informed and performance-based. The 1995 version constrained the concentration of certain waste types put into a mixture (
Revision 1 of the CA BTP has been developed after consideration of public comments on three drafts. The first draft (ADAMS Accession No. ML103430088) was noticed in the
Fifteen organizations representing a variety of interests submitted comments on the drafts. They included Federal and State agencies and organizations, a nuclear power plant research organization, disposal and waste processing facility licensees, industry professional organizations, an advocacy group, and a waste services company. These comments have been considered by the NRC staff in developing this revision to the CA BTP. An overview of the changes to the 1995 CA BTP is presented below. Detailed responses to each of the public comments are available in Vol. 2 of the revised CA BTP and in the drafts referenced above.
The major changes to the 1995 CA BTP are summarized below. Appendix B of Volume 1 of the revised CA BTP has a more complete list of changes. The staff responses to individual public comments are contained in Section 3 of Volume 2 of the CA BTP. Finally, a summary of the changes to the May 2012 version published for public comment is available in ADAMS Accession No. ML14157A227.
In developing the revised CA BTP, the staff identified one issue that may need further clarification. One of the categories of discrete wastes that are subject to special concentration averaging constraints is “contaminated materials.” The 1995 CA BTP defines contaminated materials as components or metals on which radioactivity resides on or near the surface in a fixed or removable condition. To demonstrate compliance with these averaging constraints, the radiological characteristics and volumes of individual items are typically determined. However, items with surface contamination may also be categorized as radioactive trash which is not subject to any special averaging constraints. Items in radioactive trash do not need to be individually characterized. Instead, a container of radioactive trash can be surveyed to determine its overall radioactivity and its classification determined by dividing the overall activity by the waste volume. Neither the 1995 CA BTP nor draft revisions published for public comment provided guidance for categorizing items as either contaminated materials or radioactive trash. In addition, the staff received no comments from stakeholders on this issue. The staff will consider whether additional guidance, such as a Regulatory Issue Summary (RIS), is warranted for distinguishing contaminated materials from radioactive trash. The staff may also formally clarify or supplement other positions in the CA BTP at a later time, as necessary.
This CA BTP is a rule as defined in the Congressional Review Act (5 U.S.C. 801-9808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
The revised CA BTP describes and makes available to NRC and Agreement State licensees, Agreement States, and the public, methods that the NRC believes are acceptable for implementing specific parts of the Commission's regulations. The positions in this document are not intended as a
In addition to the guidance in the revised CA BTP, licensees that ship waste for disposal in a 10 CFR part 61 or Agreement State equivalent facility should ensure that the waste meets the concentration averaging provisions in the land disposal facility license. Where there are conflicts with this guidance, the land disposal facility license conditions issued by the regulatory authority (
The revised CA BTP revision describes a voluntary method that the NRC staff considers acceptable for complying with the regulation in 10 CFR 61.55(a)(8), regarding averaging of radionuclide concentrations for the purpose of determining waste classification. Compliance with the revised CA BTP is not an NRC requirement, and licensees and applicants may choose this or another method to achieve compliance with this provision in the 10 CFR part 61. In particular, current licensees may continue to use the averaging positions in the 1995 CA BTP. The revised CA BTP does not require a backfit analysis, as described in 10 CFR 50.109(c), because (1) it does not impose a new or amended provision in the NRC's rules, (2) does not present a regulatory staff position that interprets the NRC's rules in a manner that is either new or different from a previous staff position; and (3) does not require the modification of, or addition to, the systems, structures, components, or design of a facility, or the procedures or organizations required to design, construct, or operate a facility.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an addition of Priority Mail Contract 112 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
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.
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. MC2015-32 and CP2015-42 to consider the Request pertaining to the proposed Priority Mail Contract 112 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 February 26, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-32 and CP2015-42 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller 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 February 26, 2015.
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 an addition of Priority Mail Contract 113 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
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.
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. MC2015-33 and CP2015-43 to consider the Request pertaining to the proposed Priority Mail Contract 113 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 February 26, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints James F. Callow to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-33 and CP2015-43 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, James F. Callow 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 February 26, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on February 18, 2015, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on February 18, 2015, it filed with the Postal Regulatory Commission a
On December 24, 2014, Financial Industry Regulatory Authority, Inc. (“FINRA”), on behalf of the following parties to the National Market System Plan: BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., NASDAQ OMX
The Eighth Amendment includes two proposed changes to the Plan. First, the Participants propose to amend the Plan to establish a requirement for the Participants to submit a Supplemental Joint Assessment to the Commission by May 29, 2015. Second, the Participants propose to extend the end date of the pilot period of the Plan from February 20, 2015 to October 23, 2015.
The Plan, approved by the Commission in March 2012,
After careful review, the Commission finds that the Eighth Amendment is consistent with the requirements of the Act and the rules and regulations thereunder.
The Supplemental Joint Assessment will evaluate the impact of the Plan using the measures set forth in Appendix B of the Plan
These areas are intended to capture the key measures necessary to assess the impact of the Plan and, if and where appropriate, to support recommendations relating to the calibration of the Percentage Parameters to help ensure that the stated objectives of the Plan are achieved.
The Participants further believe that extending the end date of the pilot period will: (i) Provide the Participants with time to use the information collected during the operation of the Plan to perform further analysis and recommend further amendments to the Plan, as necessary; (ii) provide a reasonable period of time for the public to comment on the Supplemental Joint Assessment and recommendations; and (iii) allow the Commission and the public adequate time to review the Supplemental Joint Assessment and any recommendations provided by the Participants, and to determine if any modifications to the Plan are appropriate.
The Commission believes that the Supplemental Joint Assessment and any resulting recommendations for modifications to the Plan from the Participants, along with any public comment in response thereto, will assist the Commission in assessing the operation of the Plan and in considering any future determinations regarding the Plan.
For the reasons noted above, the Commission finds that the Eighth Amendment to the Plan is consistent with Section 11A of the Act
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a Closed Meeting on Thursday, February 26, 2015 at 2:00 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or her designee, has certified that, in her opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matter at the Closed Meeting.
Commissioner Stein, as duty officer, voted to consider the items listed for the Closed Meeting in closed session, and determined that no earlier notice thereof was possible.
The subject matter of the Closed Meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551-5400.
On December 19, 2014, the Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change File No. SR-OCC-2014-23 pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
OCC is modifying its By-Laws to add an interpretation and policy to Section 7 of Article XII of its By-Laws to clarify that OCC will not treat a futures transaction that is an exchange-for-physical (“EFP”)
According to OCC, under OCC's By-Laws, the novation of confirmed trades (
When OCC began clearing EFPs and Block Trades, it established that the commencement time for such transactions is expressly conditioned upon the receipt by OCC of variation payments due from purchasing and selling clearing members because EFPs and Block Trades could be executed away from the market and be executed at other than market prices. These factors were viewed as creating heightened exposure to OCC if a clearing member defaults on a trade executed at an off-market price and, as a result, Article XII, Section 7 of OCC's By-Laws establishes that the commencement time for an EFP or Block Trade is the time of the first variation payment after the trade is reported to OCC (typically 9:00 a.m. Central Time the following business day).
According to OCC, in the time since OCC adopted Article XII, Section 7 of its By-Laws, the Commodity Futures Trading Commission (“CFTC”) has adopted Regulation 1.73, which requires clearing futures commission merchants (“FCMs”) to establish certain risk controls, including risk based limits for bilaterally executed transactions and for Block Trades.
OCC has determined that EFPs and Block Trades that are subject to price reasonability checks do not present the same settlement risks discussed above in relation to non-competitively executed EFPs and Block Trades. Specifically, should a clearing member that executed a reasonably priced EFP or Block Trades fail to pay its first variation payment to OCC on the trade, OCC anticipates it will liquidate the futures positions at the prevailing market price and obtain sufficient funds, or OCC will already have sufficient funds in its clearing fund, to pay or reimburse itself for the first variation settlement to the counterparty to the trade. This is the same risk management methodology OCC currently uses for other competitively executed trades in cleared contracts that OCC accepts for clearance and settlement on a daily basis.
Accordingly, OCC is amending Article XII, Section 7, of its By-Laws by adding an interpretation and policy to exclude EFPs and Block Trades from the delayed novation and to provide for the treatment of these trades as competitively executed trades, provided that the s EFPs and Block Trades are reported by an exchange that represents to OCC that it performs a price reasonableness check on the trade, and that such price is validated by the exchange.
Before permitting an exchange to submit EFPs and Block Trades that will not be subject to delayed novation, OCC will require an exchange to provide OCC with a certification that the exchange has rules, policies or procedures as they relate to verifying the reasonableness of the price of the EFP and Block Trade. Specifically, OCC will require an exchange to certify that its rules, policies or procedures provide that the price at which a EFP or Block Trade is executed must be fair and reasonable in light of: (i) The size of the EFP or Block Trade; (ii) the prices and sizes of other transactions in the same contract at the relevant time; and (iii) the prices and sizes of transactions in other relevant markets, including, without limitation, the underlying cash market or related futures markets, at the relevant time.
In addition to exchanges implementing rules, policies or procedures regarding the price reasonableness checks for EFPs and Block Trades, exchanges may continue to use their existing authority to notify OCC pursuant to Article VI, Section 7(c) of OCC's By-Laws, to disregard any EFP or Block Trade submitted to OCC that was executed at an unreasonable price. The notification will be delivered to OCC along with other trades “busted” by an exchange, in accordance with an operational process that currently occurs every day before daily position reports are distributed. Such trades could not be properly cleared under amended Article XII, Section 7, but instead would fall within the non-competitively executed category and therefore be subject to delayed novation. Taken together, OCC believes that these measures appropriately protect OCC in the event OCC receives a EFP or Block Trade at an unreasonable price. Moreover, OCC and the exchanges will continue to maintain an ongoing dialogue about operational matters, which OCC will use to confirm the continued application of price reasonableness controls.
Section 19(b)(2)(C) of the Act
The Commission finds that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act
OCC has determined that EFPs and Block Trades that are subject to price reasonability checks do not present the same settlement risks as those executed on exchanges without price reasonability checks, and as such has determined that OCC's requirement that exchanges certify price reasonableness policies and procedures are sufficiently appropriate to mitigate the risks associated with non-competitively executed trades. In addition, in the event a clearing member fails to its first variation payment to OCC on an EFP or Block Trade that was executed on an exchange with price reasonability checks, OCC will employ the same risk management methodology used for all other competitively executed trades accept for clearing at OCC, which should in turn reduce settlement risks that could expose OCC to loss if it is required to close out a defaulting purchaser's EFP or Block Trade position. Combining OCC's price reasonableness requirements for exchanges and OCC's ability to liquidate futures positions or use its clearing fund to management risks associated with non-payment of premiums for those trades accepted for clearance and settlement, OCC should have sufficient risk management controls in place in to assure the safeguarding of securities and funds which are in the custody of control of OCC or for which it is responsible.
On the basis of the foregoing, the Commission finds that the proposal is consistent with the requirements of the Act and in particular with the requirements of Section 17A of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend Exchange Rule 404.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The Exchange proposes to amend Exchange Rule 404, Interpretations and Policies .02, to extend current $0.50 strike price intervals in non-index options to short term options with strike prices less than $100. This is a competitive filing that is based on proposals recently submitted by the International Securities Exchange, LLC (“ISE”) and BOX Options Exchange LLC (“BOX”).
The Exchange proposes to amend its rules governing the Short Term Option Series Program to introduce finer strike price intervals for certain Short Term Option Series. In particular, the Exchange proposes to amend Rule 404, Interpretations and Policies .02(e), to extend $0.50 strike price intervals in non-index options to Short Term Options Series with strike prices less than $100 instead of the current $75. This proposed change is intended to eliminate gapped strikes between $75 and $100 that result from conflicting strike price parameters under the Short Term Option Series and $2.50 Strike Price Programs as described in more detail below.
Under the Exchange's rules, the Exchange may list Short Term Option Series in up to fifty option classes in addition to option classes that are selected by other securities exchanges that employ a similar program under their respective rules.
The Exchange also operates a $2.50 Strike Price Program that permits the Exchange to select up to sixty options classes on individual stocks to trade in $2.50 strike price intervals, in addition to option classes selected by other securities exchanges that employ a similar program under their respective rules.
MIAX believes that its proposed rule change is consistent with Section 6(b) of the Act
During the month prior to expiration, the Exchange is permitted to list related monthly option contracts in the narrower strike price intervals available for Short Term Options Series.
The Short Term Option Series Program has been well-received by market participants and the Exchange believes that introducing finer strike price intervals for Short Term Options Series with strike prices between $75 and $100, and thereby eliminating the gapped strikes described above, will benefit these market participants by giving them more flexibility to closely tailor their investment and hedging decisions.
With regard to the impact of this proposal on system capacity, the Exchange has analyzed its capacity and represents that it and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle any potential additional traffic associated with this proposed rule change. The Exchange believes that its members will not have a capacity issue as a result of this proposal. The Exchange also represents that it does not believe this expansion will cause fragmentation of liquidity.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. In this regard and as indicated above, the Exchange notes that the rule change is being proposed as a competitive response to filings submitted by ISE and BOX.
Written comments were neither solicited nor 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, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Exchange stated that waiver of this requirement will allow the Exchange to compete with other exchanges with similar provisions without putting the Exchange at a competitive disadvantage. For this reason, the Commission believes that the proposed rule change presents no novel issues and that waiver of the 30-day operative delay is consistent with the protection of investors and the public interest; and will allow the Exchange to remain competitive with other exchanges. Therefore, the Commission designates the proposed rule change to be operative upon filing.
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 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 (the “Act”),
ISE Gemini proposes to extend a pilot program under Rule 703A(d) that suspends Rule 720 regarding obvious errors during Limit and Straddle States in securities that underlie options traded on the Exchange. The text of the proposed rule change is available on the Exchange's Internet Web site at
In its filing with the Commission, the Exchange 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 these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
Rule 703A(d), which was adopted as part of the Exchange's Form 1 application for registration as a national securities exchange,
The Exchange believes the benefits to market participants from this provision should continue on a pilot basis. The Exchange continues to believe that adding certainty to the execution of orders in Limit or Straddle States will encourage market participants to continue to provide liquidity to the Exchange, and, thus, promote a fair and orderly market during these periods. Barring this provision, the obvious error provisions of Rule 720 would likely apply in many instances during Limit and Straddle States. The Exchange believes that continuing the pilot will protect against any unanticipated consequences in the options markets during a Limit or Straddle State. Thus, the Exchange believes that the protections of current rule should continue while the industry gains further experience operating the Plan.
In connection with this proposed extension, each month the Exchange shall provide to the Commission, and the public, a dataset containing the data for each Straddle and Limit State in optionable stocks that had at least one trade on the Exchange. For each trade on the Exchange, the Exchange will provide (a) the stock symbol, option symbol, time at the start of the Straddle or Limit State, an indicator for whether it is a Straddle or Limit State, and (b) for the trades on the Exchange, the executed volume, time-weighted quoted bid-ask spread, time-weighted average quoted depth at the bid, time-weighted average quoted depth at the offer, high execution price, low execution price, number of trades for which a request for review for error was received during Straddle and Limit States, an indicator variable for whether those options outlined above have a price change exceeding 30% during the underlying stock's Limit or Straddle State compared to the last available option price as reported by OPRA before the start of the Limit or Straddle State (1 if observe 30% and 0 otherwise), and another indicator variable for whether the option price within five minutes of the underlying stock leaving the Limit or Straddle State (or halt if applicable) is 30% away from the price before the start of the Limit or Straddle State.
In addition, the Exchange will provide to the Commission, and the public, no later than May 29, 2015, assessments relating to the impact of the operation of the obvious error rules during Limit and Straddle States including: (1) An evaluation of the statistical and economic impact of Limit and Straddle States on liquidity and market quality in the options markets, and (2) an assessment of whether the lack of obvious error rules in effect during the Straddle and Limit States are problematic.
The Exchange believes that its proposal is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
In particular, the Exchange further believes that it is necessary and appropriate in the interest of promoting fair and orderly markets to exclude transactions executed during a Limit or Straddle State from certain aspects of Rule 720. The Exchange believes the application of the current rule will be impracticable given the lack of a reliable national best bid or offer in the options market during Limit and Straddle States, and that the resulting actions (
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Specifically, the Exchange believes that, by extending the expiration of the pilot, the proposed rule change will allow for further analysis of the pilot and a determination of how the pilot shall be structured in the future. In doing so, the proposed rule change will also serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace and facilitating investor protection.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The
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 if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, as it will allow the obvious error pilot program to continue uninterrupted while the industry gains further experience operating under the Plan, and avoid any investor confusion that could result from a temporary interruption in the pilot program. For this reason, the Commission designates the proposed rule change to be operative upon filing.
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 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 Brent J. Fields, 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 (the “Act”),
The Exchange proposes to amend Interpretive Material 1 to Rule 7080 to extend, through October 23, 2015, the pilot program that suspends certain obvious error provisions during limit up-limit down states in securities that underlie options traded on the Exchange. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's Internet 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 these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to extend through October 23, 2015 the pilot that permits the Exchange to suspend certain provisions in BOX Rule 7170 (Obvious and Catastrophic Errors) during limit up-limit down states in securities that underlie options traded on the Exchange (“Pilot”). The Pilot is currently scheduled to expire on February 20, 2015.
The Pilot allows the Exchange to exclude transactions executed during a Limit State or Straddle State from provisions in BOX Rule 7170. This does not include Rule 7170(e) and (f), which specify when a trade resulting from an erroneous print or quote in the underlying security may be adjusted or busted.
The remaining provisions in BOX Rule 7170 provide a process by which a transaction may be busted or adjusted when the execution price of a transaction deviates from the option's theoretical price by a certain amount. Under these provisions, the theoretical price is the national best bid price for the option with respect to a sell order and the national best offer for the option with respect to a buy order. During a Limit State or Straddle State, options prices may deviate substantially from those available prior to or following the limit state. Consequently, the Exchange believed that these provisions would be impracticable given the lack of a reliable national best bid or offer in the options market during Limit States and Straddle States, and could produce undesirable effects.
The Exchange proposes to extend the operation of this Pilot to analyze the impact of the Limit and Straddle States. The Exchange will also continue to evaluate whether adopting a provision for reviewing trades on its own motion during Limit and Straddle States is necessary and appropriate.
Additionally, the Exchange represents that it will conduct its own analysis concerning the elimination of the obvious error rule during Limit and Straddle States and agrees to provide the Commission with relevant data to assess the impact of the Pilot. As part of its analysis, the Exchange will evaluate (1) the options market quality during Limit and Straddle States, (2) assess the character of incoming order flow and transactions during Limit and Straddle States, and (3) review any complaints from members and their customers concerning executions during Limit and Straddle States. The Exchange also agrees to provide to the Commission data requested to evaluate the impact of the elimination of the obvious error rule, including data relevant to assessing the various analyses noted above.
Specifically, the Exchange agrees to provide the following data to the Commission and the public to help evaluate the impact of the Pilot. By May 29, 2015 the Exchange shall provide an assessment relating to the impact of the Plan and calibration of the Percentage Parameters. On a monthly basis, the Exchange shall provide both the Commission and public a dataset containing the data for each Straddle and Limit State in optionable stocks.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,
Because the proposed rule change does not impose any new or additional burden on BOX Options Participants, and only extends the current Pilot, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has neither solicited nor received comments on 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 if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, as it
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 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 Brent J. Fields, 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”),
The Exchange proposes to modify and reorganize Chapter VI (Trading Systems), Section 8 (BX Opening and Halt Cross) of the Exchange's Options rules. The proposal would update or add Section 1 and Section 8 definitions in respect of the BX Opening and Halt Cross. The proposal would also make changes regarding: The criteria for opening of trading or resumption of trading after a halt; BX posting on its Web site any changes to the dissemination interval or prior Order Imbalance Indicator; the procedure if more than one price exists; the procedure if there are unexecuted contracts; and the ability of firms to elect that orders be returned in symbols that were not opened on BX before the conclusion of the Opening Order Cancel Timer.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The purpose of the proposed rule change is to modify BX Chapter VI, Section 1 and Section 8 to update or add definitions, which include Current Reference Price, BX Opening Cross, Eligible Interest, Valid Width National Best Bid or Offer (“Valid Width NBBO”), Away Best Bid or Offer (“ABBO”), and On the Open Order (“OPG”). The purpose is to also make changes regarding: The criteria for opening of trading or resumption of trading after a halt; BX posting on its Web site any changes to the dissemination interval or prior Order Imbalance Indicator; the procedure if more than one price exists; the procedure if there are unexecuted contracts; and the ability of firms to elect that orders be returned in symbols
Section 8 of Chapter VI describes the BX opening and halt cross and opening imbalance process (“Opening Cross”). Section 8(a) currently contains definitions that are applicable to Section 8. Section 8(b) currently states that for the opening of trading of System Securities,
First, the Exchange proposes to update or add new Section 8 definitions.
The Exchange proposes a change to the definition of “Current Reference Price”. Current Section 8(a)(2)(A) defines the “Current Reference Price” to mean: (i) The single price at which the maximum number of contracts of Eligible Interest can be paired at or within the NBBO; (ii) If more than one price exists under subparagraph (i), the Current reference Price shall mean the entered price at which contracts will remain unexecuted in the cross; (iii) If more than one price exists under subparagraph (ii), the Current Reference Price shall mean the price that is closest to the midpoint of the (1) National Best Bid or the last offer on BX against which contracts will be traded whichever is higher, and (2) National Best Offer or the last bid on BX against which contracts will be traded whichever is lower. Proposed Section 8(a)(2)(A) seeks to simplify the definition of the “Current Reference Price” to state that “Current Reference Price” shall mean an indication of what the Opening Cross price would be at a particular point in time. The “Current Reference Price” determination will be substantively similar to what is currently described in Section 8(a)(2)(A), with the criteria for the Opening Cross price, as discussed below, set forth elsewhere in Section 8,
The Exchange proposes a change to the definition of “BX Opening Cross”. Specifically, in proposed Section 8(a)(3) the Exchange introduces a clarifying change that references opening or resuming trading, and states that “BX Opening Cross” shall mean the process for opening or resuming trading pursuant to this rule and shall include the process for determining the price at which Eligible Interest, as discussed below, shall be executed at the open of trading for the day, or the open of trading for a halted option, and the process for executing that Eligible Interest.
The Exchange proposes to define a new order type in Section 1(e)(11), “On the Open Order”, which is an order with a designated time-in-force of OPG.
The Exchange proposes a change to the definition of “Eligible Interest” contained in current Section 8(a)(4). Specifically, in Section 8(a)(4) the Exchange proposes a change to reflect the addition of a new order type, On the Open Order, with a time-in force of OPG, so that “Eligible Interest” shall mean any quotation or any order that may be entered into the system and designated with a time-in-force of IOC (immediate-or-cancel), DAY (day order), GTC (good-till-cancelled), and OPG. The Exchange also proposes new language to indicate how certain time-in-force orders will be handled, to state that orders received via FIX protocol prior to the BX Opening Cross designated with a time-in-force of IOC will be rejected and shall not be considered Eligible Interest. Orders received via SQF prior to the BX Opening Cross designated with a time-in-force of IOC will remain in-force through the opening and shall be cancelled immediately after the opening. The Exchange notes that FIX protocol users generally prefer a cancel if an order is not executed immediately in order that these users have an a opportunity to access other markets. SQF users are liquidity providers who
The Exchange proposes to add the concept of a Valid Width NBBO and ABBO with respect to away and on-Exchange interest. Specifically, in proposed Section 8(a)(6) the Exchange defines “Valid Width NBBO” as the combination of all away market quotes and any combination of BX Options-registered Market Maker (“Market Maker”) orders and quotes received over the SQF Protocol within a specified bid/ask differential as established and published by the Exchange. The Valid Width NBBO will be configurable by underlying, and a table with valid width differentials will be posted by BX on its Web site. Away markets that are crossed (
The Exchange is making these proposals to ensure that all away market quotes and any combination of Market Maker orders and quotes,
Following are examples to illustrate, among other things, the calculation of the Valid Width NBBO as proposed in Section 8(a)(6) and the definition of the ABBO as proposed in Section 8(a)(7).
Second, in current Section 8(b) the Exchange proposes to remove language that “there is no Imbalance” and language regarding “on a class-by-class basis”, and proposes to add additional clarifying language pertaining to an Opening Cross after a trading halt. The Imbalance language is being removed from the introductory sentence of current Section 8(b) to make the language of the Processing of the Opening Cross apply more generally. The details surrounding the Opening Cross as it relates specifically to an Imbalance is currently provided for in Section 8(b)(5) and is being added in new proposed Section 8(b)(4)(C). The Exchange proposes to remove the “on a class-by-class basis” language because the Exchange will use a regular market hours quote or trade (as determined by the Exchange) for all classes on the Exchange for the Opening Cross, without distinguishing among different classes. Additionally, the Exchange proposes to add language to current Section 8(b) to make it clear that an Opening Cross shall occur after a trading halt when trading resumes pursuant to Chapter V, Section 4.
Third, the Exchange proposes to add certain criteria to current Section 8(b), in order to describe how the opening process will differ depending on whether a trade is possible or not on BX Options. Provided that the ABBO is not crossed these criteria necessitate, per
Fourth, the Exchange proposes changes to provide additional information during the opening process. Current Section 8(b)(1) indicates that BX shall disseminate an Order Imbalance Indicator every 5 seconds and does not allow for a shorter dissemination interval. New proposed Section 8(b)(3) indicates that BX shall disseminate by electronic means an Order Imbalance Indicator
Fifth, the Exchange proposes to add language regarding how the Opening Cross will occur in relation to the Valid Width NBBO, and further what would happen if more than one price exists under certain circumstances. With this proposal, current Section 8(b)(2)(B) will be deleted and the determination of the Opening Cross price will be more fully described under proposed new Section 8(b)(4)(A)-(C). The new language added to current subparagraph (A) stipulates that the Opening Cross shall occur at the price that maximizes the number of contracts of Eligible Interest in BX Options to be executed at or within the ABBO and within a defined range, as established and published by the Exchange, of the Valid Width NBBO. Current subparagraph (A) simply states the Opening Cross shall occur at the price that maximizes the number of contracts of Eligible Interest in BX Options to be executed at or within the NBBO. The new proposed language being added to (A) will require that the Opening Cross price not only be at a price at or within the ABBO but also be within a defined range of the Valid Width NBBO. This addition will ensure that the Exchange does not open at a price too far away from the best interest available in the marketplace as a whole.
The new proposed Section 8(b)(4)(B) and (C) describe in detail at what price the Opening Cross will occur if there exists more than one price under Section 8(b)(4)(A) at which the maximum number of contracts could be executed at or within the ABBO and equal to or within a defined range of the Valid Width NBBO. Current Section 8(b)(2)(C) (renumbered as proposed to (b)(4)(B)) states that if more than one price exists under subparagraph (B),
The following examples illustrate, among other things, the determination of the Opening Cross price.
Because new proposed subsections (b)(1) and (b)(2) are added, current subsections (b)(1) through (b)(5) are re-numbered to (b)(3) through (b)(7), and the reference to (b)(2) in current (b)(7) is re-numbered to (b)(4).
Sixth, the Exchange is proposing new language to indicate the price at which remaining unexecuted contracts will be posted. Specifically, in proposed Section 8(b)(4)(C), formerly covered in (b)(2), the Exchange proposes to state that if more than one price exists under subparagraph (A), and contracts would remain unexecuted in the cross, then the opening price will be the price at which the maximum number of contracts can trade that are equal to or within the defined range of the Valid Width NBBO on the contra side of the imbalance that would not trade through the ABBO. New proposed subsections (i)-(iv) to Section 8(b)(4)(C) indicate the price at which unexecuted contracts will be posted on the book following the Opening Cross and the subsequent handling of the residual unexecuted contracts, as follows: (i) If unexecuted contracts remain with a limit price that is equal to the opening price, then the remaining unexecuted contracts will be
Following are examples illustrating the proposed rule text regarding the handling of unexecuted contracts.
Seventh, the Exchange is proposing new language to indicate the use of execution algorithms assigned to the underlying options. Specifically, in proposed Section 8(b)(5) (formerly (b)(3)), the Exchange proposes to delete price/time priority and add the use of execution algorithms by stating that if the BX Opening Cross price is selected and fewer than all contracts of Eligible Interest that are available in BX Options would be executed, all Eligible Interest shall be executed at the BX Opening Cross price in accordance with the execution algorithm assigned to the associated underlying option. By substituting language indicating use of execution algorithms rather than price/time priority, the Exchange recognizes that there are now multiple execution allocation models,
Lastly, the Exchange proposes to add a provision regarding the return of orders in un-opened symbols in the absence of an Opening Cross. Proposed new Section 8(c) is substituted for current Section 8(c) and provides the procedure if an Opening Cross in a symbol is not initiated before the conclusion of the Opening Order Cancel Timer. Specifically, proposed new Section 8(c) states that if an Opening Cross is not initiated under such circumstances, a firm may elect to have orders returned by providing written notification to the Exchange. These orders include all non GTC orders received over the FIX protocol. The Opening Order Cancel Timer represents a period of time since the underlying market has opened, and shall be established and disseminated by BX on its Web site. Proposed Section 8(c) will provide participants the ability to have their orders returned to them if BX Options is unable to initiate an Opening Cross within a reasonable time of the opening of the underlying market. In addition, proposed Section 8(c) deletes language which is present in current Section 8(c) regarding how the Opening Cross operates in relation to the presence or absence of a regular market hour quote or trade by the Market for the Underlying and the process of the Opening Cross in relation to opening quotes or orders which lock or cross each other. The deleted provisions are now being more thoroughly described in proposed Section 8(b).
The Exchange believes that the proposed changes significantly improve the quality of execution of BX Options' opening. The proposed changes give participants more choice about where, and when, they can send orders for the opening that would afford them the best experience. The Exchange believes that this should attract new order flow. The proposed changes should prove to be very helpful to market participants, particularly those that are involved in adding liquidity during the Opening Cross. Absent these proposed enhancements, BX Options' opening quality will remain less robust than on other exchanges.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The proposal is consistent with the goals of the Act because it will enhance and clarify the Opening Cross process, minimize or negate unnecessary complexity, and encourage liquidity at the crucial time of market open. The proposed change will also enhance the price discovery mechanism in the opening process to include not only Market Maker orders and quotes but also away market interest as represented by quotes. The Exchange believes this change will make the transition from the Opening Cross period to regular market trading more efficient and thus promote just and equitable principles of trade and serve to protect investors and the public interest.
The proposal is designed to promote just and equitable principles of trade by updating and clarifying the rules regarding the BX Opening and Halt Cross. In particular, the proposal would update or add Chapter VI, Section 8 definitions regarding BX Opening Cross, Eligible Interest, NBBO, and ABBO in respect of the Opening Cross and resuming options trading after a halt. The Exchange would add to Chapter VI, Section 1 the definition of “On the Opening Order” (OPG) as used in Section 8 in respect of the Opening Cross. The proposal would also, as discussed, make changes in Section 8 regarding: The criteria for opening of trading or resumption of trading after a halt; BX posting on its Web site any changes to the dissemination interval or prior Order Imbalance Indicator; the procedure if more than one price exists; the procedure if there are unexecuted contracts; and the ability of firms to elect that orders be returned in symbols that were not opened on BX Options before the conclusion of the Opening Order Cancel Timer.
The proposal is designed to remove impediments to and perfect the mechanism of a free and open market and a national market system. In particular, the Exchange proposes in Chapter VI, Section 8(b) to remove the class-by-class quote or trade characteristic because for the Opening Cross the Exchange will use a regular market hours quote or trade (as determined by the Exchange) for all underylings [sic] on the Exchange, without distinguishing among underlying symbols, or, in the case of a trading halt the Opening Cross shall occur when trading resumes pursuant to Chapter V, Section 4. The Exchange proposes to set forth in Section 8(b) clear language describing under what circumstances an Opening Cross will occur, and how the Opening Cross will occur if more than one price exists under certain circumstances. Thus, for example, proposed Section 8(b)(4) specifies that if more than one price exists under subparagraph (A), and contracts would remain unexecuted in the cross, then the opening price will be the highest/lowest price, in the case of a buy/sell imbalance, at which the maximum number of contracts can trade which is equal to or within a defined range, as established and published by the Exchange, of the Valid Width NBBO on the contra side of the imbalance that would not trade through the ABBO. The Exchange proposes, in Section 8(b)(4)(C), three alternatives for how remaining unexecuted contracts will be handled. These include: If unexecuted contracts remain with a limit price that is equal to the opening price, if unexecuted contracts remain with a limit price that is through the opening price and there is a contra side ABBO at the opening price, and if unexecuted contracts remain with a limit price that is through the opening price and there is no contra side ABBO at the opening price. The Exchange also proposes to clarify what happens if an Opening Cross in a symbol is not initiated before the conclusion of the Opening Order Cancel Timer. In that case, proposed
The proposal is designed in general to protect investors and the public interest. The Exchange proposes to add certain criteria to current Section 8(b), in order to describe how the opening process will differ depending on whether a trade is possible or not on BX Options. Assuming that ABBO is not crossed, proposed new Chapter VI, Section 8(b)(1) states that if there is a possible trade on BX, a Valid Width NBBO must be present. Assuming that ABBO is not crossed, proposed Section 8(b)(2) states that if no trade is possible on BX, then BX will open dependent upon one of the following: A Valid Width NBBO is present; a certain number of other options exchanges (as determined by the Exchange) have disseminated a firm quote on OPRA; or a certain period of time (as determined by the Exchange) has elapsed. The Exchange proposes to further enhance price discovery and disclosure regarding the Opening Cross process, by proposing in current Section (b)(1) (renumbered to be (b)(3)) that BX may choose to establish a dissemination interval that is shorter than every 5 seconds; and that the Exchange will indicate the interval on its Web site in conjunction to other information regarding the Opening Process. Moreover, the Exchange proposes to add language in current Section 8(c)(2) regarding the return of orders in un-opened symbols in the absence of an Opening Cross. Thus, if an Opening Cross in a symbol is not initiated before the conclusion of the Opening Order Cancel Timer, a firm may elect to have orders returned by providing written notification to the Exchange. These orders include all non GTC orders received over the FIX protocol. The Opening Order Cancel Timer represents a period of time since the underlying market has opened, and shall be established and disseminated by BX on its Web site.
For the above reasons, BX believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act. The Exchange believes that the proposed changes significantly improve the quality of execution of BX Options' opening. The proposed changes give participants more choice about where, and when, they can send orders for the opening that would afford them the best experience. The Exchange believes that this should attract new order flow. The proposed changes should prove to be more robust and helpful to market participants, particularly those that are involved in adding liquidity during the Opening Cross.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. While the Exchange does not believe that the proposal should have any direct impact on competition, it believes the proposal should help to further clarify the Opening Cross process and make it more efficient, reduce order entry complexity, enhance market liquidity, and be beneficial to market participants. Moreover, the Exchange believes that the proposed changes significantly improve the quality of execution of the BX Options opening. The proposed changes give participants more choice about where, and when, they can send orders for the opening that would afford them the best experience. The Exchange believes that this should attract new order flow. Absent these proposed enhancements, BX Options' opening quality will remain less robust than on other exchanges, and the Exchange will remain at a competitive disadvantage.
No written comments were either solicited or received.
Because the foregoing 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
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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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 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 Brent J. Fields, 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 (the “Act”),
The Exchange proposes to extend the pilot period applicable to Rule 6.65A(c), which addresses how the Exchange treats Obvious and Catastrophic Errors during periods of extreme market volatility, until October 23, 2015. The pilot period is currently set to expire on February 20, 2015. The text of 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.
The Exchange proposes to extend the pilot period applicable to Rule 6.65A(c), which addresses how the Exchange treats Obvious and Catastrophic Errors during periods of extreme market volatility, until October 23, 2015. The pilot period is currently set to expire on February 20, 2015.
In April 2013, in connection with the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS (the “Plan”),
The Plan has been amended several times since inception and was not implemented until February 24, 2014. The Participants to the Plan recently filed to extend the Plan's pilot period until October 23, 2015 (the “Eighth Amendment”).
In order to align the pilot period for Rule 6.65A(c) with the proposed pilot period for the Plan, the Exchange similarly proposes to extend the pilot period until October 23, 2015. The Exchange believes the benefits afforded to market participants under Rule 6.65A(c) should continue on a pilot basis during the same period as the Plan pilot. The Exchange continues to believe that adding certainty to the execution of orders in Limit or Straddle States would encourage market participants to continue to provide liquidity to the Exchange, and thus, promote a fair and orderly market during those periods. Thus, the Exchange believes that the protections of current Rule 6.65A(c) should continue while the industry gains further experience operating the Plan. In addition, the Exchange believes that extending the pilot period for Rule 6.65A(c) would allow the Exchange to continue to collect and evaluate data, as well as to conduct further data analyses, related to this provision.
Specifically, in connection with the adoption of Rule 6.65A(c), the Exchange committed to review the operation of this provision and to analyze the impact of Limit and Straddle States accordingly.
• Stock symbol, option symbol, time at the start of the Straddle or Limit
• For activity on the Exchange:
• executed volume, time-weighted quoted bid-ask spread, time-weighted average quoted depth at the bid, time-weighted average quoted depth at the offer;
• high execution price, low execution price;
• number of trades for which a request for review for error was received during Straddle and Limit States;
• an indicator variable for whether those options outlined above have a price change exceeding 30% during the underlying stock's Limit or Straddle state compared to the last available option price as reported by OPRA before the start of the Limit or Straddle State (1 if observe 30% and 0 otherwise). Another indicator variable for whether the option price within five minutes of the underlying stock leaving the Limit or Straddle state (or halt if applicable) is 30% away from the price before the start of the Limit or Straddle state.
In addition, the Exchange has committed to provide to the Commission by May 29, 2015 assessments relating to the impact of the operation of the Obvious Error rules during Limit and Straddle States as follows: (1) Evaluate the statistical and economic impact of Limit and Straddle States on liquidity and market quality in the options markets; and (2) Assess whether the lack of Obvious Error rules in effect during the Straddle and Limit States are problematic. The Exchange notes that, to date, there have not been any requests for review of Obvious Error of options trades that occur during a Limit or Straddle State in the underlying security.
The Exchange believes that the extension of the pilot period of Rule 6.65A(c) would allow the Exchange to continue to observe the operation of the pilot and conduct its assessments relating to the impact of the operation of the Rule during Limit and Straddle States, which information will continue to be shared with the Commission and the public as set forth above.
The Exchange believes the proposed rule change is consistent with Section 6(b) of the Act
Specifically, the proposal to extend the pilot program of Rule 6.65A(c) until October 23, 2015 would align that pilot program with the Pilot Period for the Plan, as proposed in the Eighth Amendment to the Plan. The Exchange believes that aligning the pilot periods would ensure that trading in options that overlay NMS Stocks continues to be appropriately modified to reflect market conditions that occur during a Limit State or a Straddle State in a manner that promotes just and equitable principles of trade and removes impediments to, and perfects the mechanism of, a free and open market and a national market system. The Exchange believes that the extension of Rule 6.65A(c) would help encourage market participants to continue to provide liquidity during extraordinary market volatility.
Moreover, the Exchange believes that extending the pilot period for Rule 6.65A(c) would remove impediments to, and perfect the mechanisms of, a free and open market because it would enable the Exchange to continue to continue to conduct its assessments relating to the impact of the operation of the Obvious Error rules during Limit and Straddle States as set forth above, which, in turn, provides the Exchange with more information from which to assess the impact of Rule 6.65A(c).
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes will not impose any burden on competition and will instead provide certainty regarding the treatment and execution of options orders, specifically the treatment of Obvious and Catastrophic Errors during periods of extraordinary volatility in the underlying NMS Stock, and will facilitate appropriate liquidity during a Limit State or Straddle State.
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 if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, as it will allow the obvious error pilot program to continue uninterrupted while the industry gains further experience operating under the Plan, and avoid any investor confusion that could result from a temporary interruption in the pilot program. For this reason, the Commission designates the proposed rule change to be operative upon filing.
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 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 Brent J. Fields, 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.
On December 19, 2014, The NASDAQ Stock Market LLC (“Nasdaq” or “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 Fund under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares on the Exchange. The Shares will be offered by ETFis Series Trust I (“Trust”), which is registered with the Commission as an investment company.
Etfis Capital LLC will be the investment adviser (“Adviser”), and Tuttle Tactical Management, LLC will be the investment sub-adviser (“Sub-Adviser”), to the Fund. ETF Distributors LLC will be the principal underwriter and distributor of the Fund's Shares, and Bank of New York Mellon will act as the administrator, accounting agent, custodian, and transfer agent to the Fund.
The Exchange represents that the Adviser and Sub-Adviser are not registered as broker-dealers, and the Sub-Adviser it not affiliated with a broker-dealer; however, the Exchange represents that the Adviser is affiliated with a broker-dealer. The Exchange states that the Adviser has implemented a fire wall with respect to its broker dealer affiliate regarding access to information concerning the composition of or changes to the portfolio.
The Exchange has made the following representations and statements in describing the Fund and its investment strategy, including, among other things, portfolio holdings and investment restrictions.
According to the Exchange, the Fund's investment objective will be to provide long-term capital appreciation, while maintaining a secondary emphasis on capital preservation, primarily through investments in the U.S. equity market. The Sub-Adviser will employ four tactical models in seeking to achieve the Fund's investment objective: “S&P 500 Absolute Momentum,” “Relative Strength Equity,” “Beta Opportunities,” and “Short-Term S&P 500 Counter Trend.” While the Sub-Adviser will generally seek to maintain an equal weighting among these four tactical models, market movements may result in the Fund being overweight or underweight one or more of the tactical models. The Fund will be an actively managed exchange-traded fund (“ETF”) that seeks to achieve its investment objective by utilizing a long-only, multi-strategy, tactically-managed exposure to the U.S. equity market. To obtain such exposure, the Sub-Adviser will invest, under normal circumstances, not less
In order to seek its investment objective, the Fund will not employ other strategies outside of the above-described “Principal Investments.” However, the Fund may, from time to time, take temporary defensive positions that are inconsistent with the Fund's principal investment strategies in an attempt to respond to adverse market, economic, political, or other conditions. In such circumstances, the Fund may also hold up to 100% of its portfolio in cash or other short-term, highly liquid investments, such as money market instruments, U.S. government obligations, commercial paper, repurchase agreements, or other cash equivalents. When the Fund takes a temporary defensive position, the Fund may not be able to achieve its investment objective.
As stated above, the Fund will invest not less than 80% of its total assets in shares of ETPs, individually selected U.S. exchange-traded common stocks (when the Sub-Adviser determines that it is more efficient or otherwise advantageous to do so), money market funds, U.S. treasuries, or money market instruments. The Fund will not purchase securities of open-end or closed-end investment companies except in compliance with the 1940 Act. In addition, the Fund will not use derivative instruments, including options, swaps, forwards, and futures contracts, either listed or over-the-counter. Under normal circumstances, the Fund will not invest more than 25% of its total assets in leveraged ETPs. The Fund does not presently intend to engage in any form of borrowing for investment purposes, and will not be operated as a “leveraged ETF,”
The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid securities and other illiquid assets (calculated at the time of investment). The Fund will monitor its portfolio liquidity on an ongoing basis to determine whether, in light of current circumstances, an adequate level of liquidity is being maintained, and will consider taking appropriate steps in order to maintain adequate liquidity if, through a change in values, net assets, or other circumstances, more than 15% of the Fund's net assets are held in illiquid securities or other illiquid assets. Illiquid securities and other illiquid assets include securities subject to contractual or other restrictions on resale and other instruments that lack readily available markets, as determined in accordance with Commission staff guidance.
Additional information regarding the Trust, Fund, and Shares, including investment strategies and restrictions, risks, creation and redemption procedures, fees, portfolio holdings disclosure policies, distributions and taxes, calculation of net asset value per share (“NAV”), availability of information, trading rules and halts, and surveillance procedures, among other things, can be found in the Notice, Registration Statement, and Exemptive Order, as applicable.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of Section 6 of the Act
The Commission 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,
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 Commission notes that the Exchange will obtain a representation from the issuer of the Shares that the NAV will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time.
The Exchange represents that it deems the Shares to be equity securities, thus rendering trading in the Shares subject
(1) The Shares will be subject to Rule 5735, which sets forth the initial and continued listing criteria applicable to Managed Fund Shares.
(2) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(3) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (a) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (b) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in the Shares to customers; (c) how information regarding the Intraday Indicative Value and Disclosed Portfolio is disseminated; (d) the risks involved in trading the Shares during the Pre-Market and Post-Market Sessions when an updated Intraday Indicative Value will not be calculated or publicly disseminated; (e) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (f) trading information.
(4) Trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and FINRA,
(5) For initial and continued listing, the Fund must be in compliance with Rule 10A-3 under the Act.
(6) A minimum of 100,000 Shares will be outstanding at the commencement of trading on the Exchange.
(7) The Fund will invest at least 80% of its assets under normal market conditions in shares of ETPs, individually selected U.S. exchange-traded common stocks (when the Sub-Adviser determines that it is more efficient or otherwise advantageous to do so), money market funds, U.S. treasuries, or money market instruments. In order to seek its investment objective, the Fund will not employ other strategies outside of the above-described “Principal Investments.”
(8) The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment) and will monitor its portfolio liquidity on an ongoing basis to determine whether, in light of current circumstances, an adequate level of liquidity is being maintained. The Fund will consider taking appropriate steps in order to maintain adequate liquidity if, through a change in values, net assets, or other circumstances, more than 15% of the Fund's net assets are held in illiquid assets.
(9) While the Fund may invest in leveraged ETFs (
(10) The Fund will not use derivative instruments, including options, swaps, forwards, and futures contracts.
(11) The Fund's investments will be consistent with the Fund's investment objective.
The Commission notes that the Fund and the Shares must comply with the requirements of Nasdaq Rule 5735 to be initially and continuously listed and traded on the Exchange. This approval order is based on all of the Exchange's representations and description of the Fund, including those set forth above and in the Notice.
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 (the “Act”),
The Exchange proposes to extend a pilot program related to Rule 6.25 (Nullification and Adjustment of Options Transactions). The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The purpose of this filing is to extend the effectiveness of the Exchange's current rule applicable to obvious errors. Interpretation and Policy .06 to Rule 6.25, explained in further detail below, is currently operating on a pilot program set to expire on February 20, 2015. The Exchange proposes to extend the pilot program to October 23, 2015.
On April 5, 2013, the Commission approved, on a pilot basis, amendments to Exchange Rule 6.25 that stated that options executions will not be adjusted or nullified if the execution occurs while the underlying security is in a limit or straddle state as defined by the Plan. Under the terms of this current pilot program, though options executions will generally not be adjusted or nullified while the underlying security is in a limit or straddle state, such executions may be reviewed by the Exchange should the Exchange decide to do so under its own motion.
Pursuant to a comment letter filed in connection with the order approving the establishment of the pilot, the Exchange committed to submit monthly data regarding the program. In addition, the Exchange agreed to submit an overall analysis of the pilot in conjunction with the data submitted under the Plan and any other data as requested by the Commission. Pursuant to a rule filing, approved on April 3, 2014, each month, the Exchange committed to provide the Commission, and the public, a dataset containing the data for each straddle and limit state in optionable stocks that had at least one trade on the Exchange. The Exchange will continue to provide the Commission with this data on a monthly basis from February 2015 through the end of the pilot. For each trade on the Exchange, the Exchange will provide (a) the stock symbol, option symbol, time at the start of the straddle or limit state, an indicator for whether it is a straddle or limit state, and (b) for the trades on the Exchange, the executed volume, time-weighted quoted bid-ask spread, time-weighted average quoted depth at the bid, time-weighted average quoted depth at the offer, high execution price, low execution price, number of trades for which a request for review for error was received during straddle and limit states, an indicator variable for whether those options outlined above have a price change exceeding 30% during the underlying stock's limit or straddle state compared to the last available option price as reported by OPRA before the start of the limit or straddle state (1 if observe 30% and 0 otherwise), and another indicator variable for whether the option price within five minutes of the underlying stock leaving the limit or straddle state (or halt if applicable) is 30% away from the price before the start of the limit or straddle state.
In addition, the Exchange will provide to the Commission and the public, no later than May 29, 2015, assessments relating to the impact of the operation of the obvious error rules during limit and straddle states including: (1) An evaluation of the statistical and economic impact of limit and straddle states on liquidity and market quality in the options markets, and (2) an assessment of whether the lack of obvious error rules in effect during the straddle and limit states are problematic.
The Exchange is now proposing to extend the pilot period until October 23, 2015. The Exchange believes the benefits to market participants from this provision should continue on a pilot basis. The Exchange continues to believe that adding certainty to the execution of orders in limit or straddle states will encourage market participants to continue to provide liquidity to the Exchange, and, thus, promote a fair and orderly market during these periods. Barring this provision, the provisions of Rule 6.25 would likely apply in many instances during limit and straddle states. The Exchange believes that continuing the pilot will protect against any unanticipated consequences in the options markets during a limit or straddle state. Thus, the Exchange believes that the protections of current Rule should continue while the industry gains further experience operating the Plan.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange further believes that it is necessary and appropriate in the interest of promoting fair and orderly markets to exclude transactions executed during a limit or straddle state from certain aspects of the Exchange Rule 6.25. The Exchange believes the application of the current rule will be impracticable given the lack of a reliable NBBO in the options market during limit and straddle states, and that the resulting actions (
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Specifically, the Exchange believes that, by extending the expiration of the pilot, the proposed rule change will allow for further analysis of the pilot and a determination of how the pilot shall be structured in the future. In doing so, the proposed rule change will also serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace and facilitating investor protection.
The Exchange neither solicited nor received comments on 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 if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, as it will allow the obvious error pilot program to continue uninterrupted while the industry gains further experience operating under the Plan to Address Extraordinary Market Volatility, and avoid any investor confusion that could result from a temporary interruption in the pilot program. For this reason, the Commission designates the proposed rule change to be operative upon filing.
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 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.
On June 17, 2014, Miami International Securities Exchange LLC (“MIAX” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”)
In addition, on July 28, 2014, the Exchange filed with the Commission a proposed rule change to list and trade options on shares of the Market Vectors
The Exchange proposes to list for trading on the Exchange options on shares of the iShares and Market Vectors ETFs. According to the Exchange, the iShares ETFs are registered pursuant to the Investment Company Act of 1940 as management investment companies designed to hold a portfolio of securities that track the MSCI Brazil 25/50 Index (“Brazil Index”), which consists of stocks traded primarily on BM&FBOVESPA; MSCI Chile Investable Market Index (IMI) 25/50 (“Chile Index”), which consists of stocks traded primarily on the Santiago Stock Exchange; MSCI All Peru Capped Index (“Peru Index”), which consists of stocks traded primarily on Bolsa de Valores de Lima; and MSCI Spain 25/50 Index (“Spain Index”), which consists of stocks traded primarily on Bolsa de Madrid.
Similarly, according to the Exchange, the Market Vectors ETFs are registered pursuant to the Investment Company Act of 1940 as management investment companies designed to hold a portfolio of securities that track the Market Vectors Brazil Small-Cap Index (“Brazil Small-Cap Index”), which consists of stocks traded primarily on BM&FBOVESPA; the Market Vectors Indonesia Index (“Indonesia Index”), which consists of stocks traded primarily on the Indonesia Stock Exchange; the Market Vectors Poland Index (“Poland Index”), which consists of stocks traded primarily on the Warsaw Stock Exchange; and the Market Vectors Russia Index (“Russia Index”), which consists of stocks traded primarily on the Moscow Exchange.
MIAX Rule 402 establishes the Exchange's initial listing standards for equity options (the “Listing Standards”) pursuant to which the Exchange can list and trade options on the shares of open-end investment companies, such as the iShares ETFs and Market Vectors ETFs.
According to the Exchange, it has attempted, but not entered into, CSSAs with the applicable foreign markets. In its proposals, the Exchange requested that the Commission allow it to rely on agreements between the Commission and the applicable foreign regulators, in place of the requirement to have a CSSA, with respect to the listing and trading of options on shares of the iShares ETFs and Market Vectors ETFs. Specifically, the Exchange cited to the agreements between the Commission and the Comissao de Valores Mobiliarios (“CVM”),
In its letter, MIAX stated its belief that the proposals were consistent with the requirements of the Act and that the Commission should approve the filings. In addition, MIAX believes that its proposals are consistent with the approach previously allowed by the Commission. Specifically, MIAX noted that the Commission has, in the past, allowed exchanges to rely on agreements between the Commission and foreign regulators in lieu of a CSSA between an exchange and the applicable foreign market.
Under section 19(b)(2)(C) of the Act, the Commission shall approve a proposed rule change of a self-regulatory organization (“SRO”) if it finds that such proposed rule change is consistent with the requirements of the Act, and the rules and regulations thereunder that are applicable to such organization.
After careful consideration, the Commission does not find that the proposed rule changes are consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
As noted by MIAX, the Commission has permitted an SRO to rely on an agreement between the Commission and the applicable foreign regulator in the absence of a CSSA
The Commission notes that Rule 700(b)(3) of its Rules of Practice reiterates that “[t]he burden to demonstrate that a proposed rule change is consistent with the Exchange Act . . . is on the self-regulatory organization that proposed the rule change.”
For the foregoing reasons, the Commission does not find that the proposed rule changes are consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange, and, in particular, with Section 6(b)(5) of the Act.
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 (the “Act”),
The Exchange is filing a proposal to amend Exchange Rule 530 to extend the pilot period for the treatment of erroneous transactions during a Limit or Straddle State.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange 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 these 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 aspects of such statements.
The Exchange proposes to amend Rule 530 (Limit Up-Limit Down) in order to extend the pilot period for the treatment of erroneous transactions that occur in a Limit or Straddle State until October 23, 2015.
Exchange Rule 530(j) provides for the treatment of erroneous transactions occurring during Limit and Straddle States. Specifically, once an NMS Stock has entered a Limit or Straddle State, the Exchange will nullify a transaction in an option overlying such an NMS Stock as provided in the Rule 530(j). This provision was adopted for a one year pilot period beginning on the date of the implementation of the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS, April 8, 2013.
To assist the Commission in its analysis, the Exchange will provide the Commission and the public with data and analysis during the duration of the pilot in order to evaluate the impact of Limit and Straddle States on liquidity and market quality in the options markets. Specifically, by May 29, 2015, the Exchange represents that it shall provide the Commission and the public assessments relating to the impact of the obvious error Rules during Limit and Straddle States that (i) evaluate the statistical and economic impact of Limit and Straddle States on liquidity and market quality in the options markets; and (ii) assess whether the lack of obvious error rules in effect during the Straddle and Limit States are problematic. Additionally, each month during the pilot period the Exchange shall provide to the Commission and the public a dataset containing the data for each Straddle and Limit State in optionable stocks. For each stock that reaches a Straddle or Limit State, the number of options included in the dataset can be reduced by selecting options in which at least one (1) trade occurred on the Exchange during the Straddle or Limit State. For each of those options affected, each data record should contain the following information: (i) Stock symbol, option symbol, time at the start of the straddle or limit state, an indicator for whether it is a straddle or limit state; and (ii) for activity on the exchange—(A) executed volume, time-weighted quoted bid-ask spread, time-weighted average quoted depth at the bid, time-weighted average quoted depth at the offer, (B) high execution price, low execution price, (C) number of trades for which a request for review for error was received during Straddle and Limit States, (D) an indicator variable for whether those options outlined above have a price change exceeding 30% during the underlying stock's Limit or Straddle state compared to the last available option price as reported by OPRA before the start of the Limit or Straddle state (1 if observe 30% and 0 otherwise) and another indicator variable for whether the option price within five minutes of the underlying stock leaving the Limit or Straddle state (or halt if applicable) is 30% away from the price before the start of the Limit or Straddle state.
MIAX believes that its proposed rule change is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes are being made to extend the pilot program that provides for how the Exchange shall treat orders and quotes in options overlying NMS stocks when the Limit Up-Limit Down Plan is in effect and will not impose any burden on competition while providing certainty of treatment and execution of options orders during periods of extraordinary volatility in the underlying NMS stock, and facilitating appropriate liquidity during a Limit State or Straddle State.
Written comments were neither solicited nor 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 if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, as it will allow the obvious error pilot program to continue uninterrupted while the industry gains further experience operating under the Plan to Address Extraordinary Market Volatility, and avoid any investor confusion that could result from a temporary interruption in the pilot program. For this reason, the Commission designates the proposed rule change to be operative upon filing.
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 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 Brent J. Fields, 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 (the “Act”),
The Exchange proposes to extend the pilot period applicable to Rule 953.1NY(c), which addresses how the Exchange treats Obvious and Catastrophic Errors during periods of extreme market volatility, until October 23, 2015. The pilot period is currently set to expire on February 20, 2015. The text of 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
The Exchange proposes to extend the pilot period applicable to Rule 953.1NY(c), which addresses how the Exchange treats Obvious and Catastrophic Errors during periods of extreme market volatility, until October 23, 2015. The pilot period is currently set to expire on February 20, 2015.
In April 2013, in connection with the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS (the “Plan”),
The Plan has been amended several times since inception and was not implemented until February 24, 2014. The Participants to the Plan recently filed to extend the Plan's pilot period until October 23, 2015 (the “Eighth Amendment”).
In order to align the pilot period for Rule 953.1NY(c) with the proposed pilot period for the Plan, the Exchange similarly proposes to extend the pilot period until October 23, 2015. The Exchange believes the benefits afforded to market participants under Rule 953.1NY(c) should continue on a pilot basis during the same period as the Plan pilot. The Exchange continues to believe that adding certainty to the execution of orders in Limit or Straddle States would encourage market participants to continue to provide liquidity to the Exchange, and thus, promote a fair and orderly market during those periods. Thus, the Exchange believes that the protections of current Rule 953.1NY(c) should continue while the industry gains further experience operating the Plan. In addition, the Exchange believes that extending the pilot period for Rule 953.1NY(c) would allow the Exchange to continue to collect and evaluate data, as well as to conduct further data analyses, related to this provision.
Specifically, in connection with the adoption of Rule 953.1NY(c), the Exchange committed to review the operation of this provision and to analyze the impact of Limit and Straddle States accordingly.
• Stock symbol, option symbol, time at the start of the Straddle or Limit State, an indicator for whether it is a Straddle or Limit State.
• For activity on the Exchange:
• executed volume, time-weighted quoted bid-ask spread, time-weighted average quoted depth at the bid, time-weighted average quoted depth at the offer;
• high execution price, low execution price;
• number of trades for which a request for review for error was received during Straddle and Limit States;
• an indicator variable for whether those options outlined above have a price change exceeding 30% during the underlying stock's Limit or Straddle state compared to the last available option price as reported by OPRA before the start of the Limit or Straddle State (1 if observe 30% and 0 otherwise). Another indicator variable for whether the option price within five minutes of the underlying stock leaving the Limit or Straddle state (or halt if applicable) is 30% away from the price before the start of the Limit or Straddle state.
In addition, the Exchange has committed to provide to the Commission by May 29, 2015 assessments relating to the impact of the operation of the Obvious Error rules during Limit and Straddle States as follows: (1) Evaluate the statistical and economic impact of Limit and Straddle States on liquidity and market quality in the options markets; and (2) Assess whether the lack of Obvious Error rules in effect during the Straddle and Limit States are problematic. The Exchange notes that, to date, there have not been any requests for review of Obvious Error of options trades that occur during a Limit or Straddle State in the underlying security.
The Exchange believes that the extension of the pilot period of Rule 953.1NY(c) would allow the Exchange to continue to observe the operation of the pilot and conduct its assessments relating to the impact of the operation of the Rule during Limit and Straddle States, which information will continue to be shared with the Commission and the public as set forth above.
The Exchange believes the proposed rule change is consistent with Section 6(b) of the Act
Specifically, the proposal to extend the pilot program of Rule 953.1NY(c) until October 23, 2015 would align that pilot program with the Pilot Period for the Plan, as proposed in the Eighth Amendment to the Plan. The Exchange
Moreover, the Exchange believes that extending the pilot period for Rule 953.1NY(c) would remove impediments to, and perfect the mechanisms of, a free and open market because it would enable the Exchange to continue to continue to conduct its assessments relating to the impact of the operation of the Obvious Error rules during Limit and Straddle States as set forth above, which, in turn, provides the Exchange with more information from which to assess the impact of Rule 953.1NY(c).
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes will not impose any burden on competition and will instead provide certainty regarding the treatment and execution of options orders, specifically the treatment of Obvious and Catastrophic Errors during periods of extraordinary volatility in the underlying NMS Stock, and will facilitate appropriate liquidity during a Limit State or Straddle State.
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 if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, as it will allow the obvious error pilot program to continue uninterrupted while the industry gains further experience operating under the Plan, and avoid any investor confusion that could result from a temporary interruption in the pilot program. For this reason, the Commission designates the proposed rule change to be operative upon filing.
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 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 Brent J. Fields, 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.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Calypte
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of EC Development, Inc. because it has not filed any periodic reports since the period ended September 30, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Information Architects Corporation (n/k/a Dakota Creative Group Corporation) because it has not filed any periodic reports since the period ended September 30, 2012.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EST on February 20, 2015, through 11:59 p.m. EST on March 5, 2015.
By the Commission.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Akesis Pharmaceuticals, Inc. because it has not filed any periodic reports since the period ended September 30, 2008.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Stellar Resources, Ltd. because it has not filed any periodic reports since the period ended January 31, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Thwapr, Inc. because it has not filed any periodic reports since the period ended June 30, 2012.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies.
Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EST on February 20, 2015, through 11:59 p.m. EST on March 5, 2015.
By the Commission.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Innovative Software Technologies, Inc. because it has not filed any periodic reports since the period ended March 31, 2010.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of National Health Partners, Inc. because it has not filed any periodic reports since the period ended September 30, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of The Laguna Group, Inc. (a/k/a Eco Energy Pumps, Inc.) because it has not filed any periodic reports since the period ended April 30, 2011.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of TYIN Group Holdings Limited because it has not filed any periodic reports since the period ended December 31, 2012.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EST on February 20, 2015, through 11:59 p.m. EST on March 5, 2015.
By the Commission.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Revonergy Inc. because it has not filed any periodic reports since the period ended September 30, 2011.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Siberian Energy Group Inc. because it has not filed any periodic reports since the period ended June 30, 2012.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Tao Minerals Ltd. (n/k/a Canam Gold Corp.) because it has not filed any periodic reports since the period ended October 31, 2011.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Todays Alternative Energy Corp. because it has not filed any periodic reports since the period ended July 31, 2012.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies.
Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EST on February 20, 2015, through 11:59 p.m. EST on March 5, 2015.
By the Commission.
Small Business Administration.
30-Day Notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before March 27, 2015.
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
Applicants for SBA-guaranteed commitment must complete these forms as part of the application process. SBA uses the information to make informed and proper credit decisions and to establish the SBIC's eligibility for leverage and need for funds.
Comments may be submitted on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. chapter 35 requires federal agencies to publish a notice in the
Submit comments on or before April 27, 2015.
Send all comments to Louis Cupp, New Markets Policy Analyst, Office of Investment, Small Business Administration, 409 3rd Street, 7th Floor, Washington, DC 20416.
Louis Cupp, New Markets Policy Analyst, Office of Investment, 202-619-0511, or Curtis B. Rich, Management Analyst, 202-205-7030,
Small Business Administration (SBA) Forms 856 and 856A are used by SBA examiners as part of their examination of licensed small business investment companies (SBICs). This information collection obtains representations from an SBIC's management regarding certain obligations, transactions and relationships of the SBIC and helps SBA to evaluate the SBIC's financial condition and compliance with applicable laws and regulations.
SBA is requesting comments on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. chapter 35 requires federal agencies to publish a notice in the
Submit comments on or before April 27, 2015.
Send all comments to Gina Beyer, Program Analyst, Office of Disaster Assistance, Small Business Administration, 409 3rd Street, 6th Floor, Washington, DC 20416.
Gina Beyer, Program Analyst, Disaster Assistance,
Small Business Administration Form 700 provides a record of interviews conducted by SBA personnel with small business owners, homeowners and
SBA is requesting comments on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. Ch. 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before March 27, 2015.
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
This information collection is provided by SBA lenders and borrowers to provide basic loan information and certifications regarding the disbursement of loan proceeds. SBA relies on this information during the guaranty purchase review process as a component in determining whether to honor a loan guaranty.
Comments may be submitted on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
U.S. Small Business Administration, SBA.
Notice of open Hearing of Region VIII Small Business Owners in Salida, CO.
The SBA, Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Salida, CO Regulatory Fairness Hearing. This hearing is open to the public.
The hearing will be held on Wednesday, March 18, 2015, from 2:30 p.m. to 4:30 p.m. (MDT).
The hearing will be at the Administrative Offices for Chaffee County Colorado, 104 Crestone Avenue, 2nd Floor, Salida, CO 81201.
Pursuant to the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121), Sec. 222, SBA announces the hearing for Small Business Owners, Business Organizations, Trade Associations, Chambers of Commerce and related organizations serving small business concerns to report experiences regarding unfair or excessive Federal regulatory enforcement issues affecting their members.
The hearing is open to the public; however, advance notice of attendance is requested. Anyone wishing to attend and/or make a presentation at the Salida, CO hearing must contact Dr. Alison Brown by March 11, 2015 in writing, by phone, or email in order to be placed on the agenda. For further information, please contact Dr. Alison Brown at NAVSYS Corporation, 14960 Woodcarver Road, Colorado Springs, CO 80921, by phone at (719) 481-4877, ext. 124, or email at
For more information on the Office of the National Ombudsman, see our Web site at
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The
Written comments should be submitted by March 27, 2015.
Send comments to the FAA at the following address: Ms. Kathy DePaepe, Room 126B, Federal Aviation Administration, ASP-110, 6500 S. MacArthur Blvd., Oklahoma City, OK 73169.
Kathy DePaepe at (405) 954-9362, or by email at:
In accordance with Part 235 of Title 49 Code of Federal Regulations (CFR) and 49 U.S.C. 20502(a), this document provides the public notice that by a document dated December 30, 2014, CSX Transportation (CSX) has petitioned the Federal Railroad Administration (FRA) seeking approval for the discontinuance or modification of a signal system. FRA assigned the petition Docket Number FRA-2015-0006.
CSX seeks approval of the proposed discontinuance of a traffic control system (TCS) between Control Point (CP) SW Cabin, Milepost (MP) CLS 67.1, and CP Man, MP CLS 78.6, on the Logan Subdivision, Huntington East Division, at Man, WV.
The reason given for the proposed discontinuance is that TCS is no longer needed due to traffic level reductions. The TCS will be discontinued and replaced with track warrant control D-505 rules.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
• Web site:
• Fax: 202-493-2251.
• Mail: Docket Operations Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC 20590.
• Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays.
Communications received by April 13, 2015 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with Part 235 of Title 49 Code of Federal Regulations (CFR) and 49 U.S.C. 20502(a), this document
UP seeks approval of the discontinuance of the automatic cab signal (ACS) system between Milepost (MP) 81.7 and MP 84.1 on the Portland Subdivision, near The Dalles, OR. The purpose of the discontinuance is to establish a consistent limit for the ACS system. The affected trackage will be converted to traffic control system operation.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
• Web site:
• Fax: 202-493-2251.
• Mail: Docket Operations Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC 20590.
• Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays.
Communications received by April 13, 2015 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with Part 235 of Title 49 Code of Federal Regulations (CFR) and 49 U.S.C. 20502(a), this document provides the public notice that by a document dated December 30, 2014, CSX Transportation (CSX) has petitioned the Federal Railroad Administration (FRA) seeking approval for the discontinuance or modification of a signal system. FRA assigned the petition Docket Number FRA-2015-0004.
CSX seeks approval of the proposed discontinuance of an automatic block signal (ABS) system between Control Point (CP) Mitchell, Milepost (MP) OOQ 256.0 and CP NE Vernia, MP OOQ 314.6, on the Hoosier Subdivision, Louisville Division, at Mitchell, IN.
The reason given for the proposed discontinuance is that ABS is no longer needed due to traffic level reductions. The subdivision is being used for storage only. The ABS will be discontinued and replaced with track warrant control D-505 rules.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received by April 13, 2015 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated June 18, 2014, the Alaska Railroad (ARR) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 236, Rules, Standards, and Instructions Governing the Installation, Inspection, Maintenance, and Repair of Signal and Train Control Systems, Devices, and Appliances. FRA assigned the petition Docket Number FRA-2015-0012.
This request is for relief from the requirements of 49 CFR 236.51,
The location of the proposed track circuit replacement is from Whittier, Milepost (MP) F2.5 to Bear Valley, MP F5.2, on the Kenai Subdivision, Whittier Division, at Whittier, AK. The Whittier Division is a single track line with a traffic control system (TCS) with a dedicated TCS block used to protect Whittier Tunnel.
The tunnel is 2.6 miles long and is a mixed use facility allocating exclusive train and automobile occupancy at any given time.
The track circuit installed within the tunnel experiences false occupancy failures that contribute to a backup of train and auto travel through the tunnel. The embedded track and the consistently wet road combined with fouling soil and a failing pump system create an extremely low ballast resistance which inhibits the safe, reliable operation of the track circuit.
Axle counters function by detecting the presence and traveling direction of wheels at entrance and exit points of defined blocks of track. The wheels are counted into and out of the block. If the same amount of axles are detected departing the block as were detected entering it, the block is considered vacant. Axle counters provide no broken rail detection, as required in 49 CFR 236.51.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
• Web site:
• Fax: 202-493-2251.
• Mail: Docket Operations Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC 20590.
• Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays.
Communications received by April 13, 2015 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this provides the public notice that by a document dated January 29, 2015, the Northeast Illinois Regional Commuter Railroad (METRA) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from several provisions of the Federal railroad safety regulations. Specifically, METRA requests relief from certain provisions of 49 CFR part 240, Qualification and Certification of Locomotive Engineers, and Part 242, Qualification and Certification of Conductors. The request was assigned Docket Number FRA-2015-0011. The relief is contingent on METRA's implementation of and participation in the Confidential Close Call Reporting System (C
METRA seeks to shield reporting employees and the railroad from mandatory punitive sanctions that would otherwise arise as provided in 49 240.117(e)(1)-(4); 240.305(a)(l)-(4) and (a)(6); 240.307; and 242.403(b), (c), (e)(l)-(4), (e)(6)-(11), (f)(l)-(2). The C
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
• Web site:
• Fax: 202-493-2251.
• Mail: Docket Operations Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC 20590.
• Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays.
Communications received within April 13, 2015 of the date of this notice will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this provides the public notice that by a document dated December 14, 2014, Michigan Southern Railroad Company (MSO) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 223, Safety Glazing Standards—Locomotives, Passenger Cars and Cabooses. FRA assigned the petition Docket Number FRA-2014-0129.
MSO, located in Peoria, IL, has petitioned FRA for a waiver of compliance for one caboose, specifically Caboose MSO 500006. MSO is a shortline railroad that operates trains at 10 mph or less. MSO 500006 would be used as a shoving platform during reverse moves that extend up to 5 miles in distance within the area of Sturgis, SD. Sturgis is an urban community that had a population of 10,884 in 2012. The shove move originates in the southern portion of the town that is an industrial/rural area and ends at the wye in Sturgis. The shove move spans approximately 12 grade crossings, and the train lengths range from 2 to 5 cars, including the locomotive and caboose. The waiver is sought because the caboose is not used as historically or traditionally intended, and the cost to upgrade the equipment is significant for a shortline railroad. In addition, using the caboose would enhance employee safety.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
• Web site:
• Fax: 202-493-2251.
• Mail: Docket Operations Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC 20590.
• Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
Communications received by April 13, 2015 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated December 17, 2014, Keolis Commuter Services (KRSM), a contracted commuter railroad operator for the Massachusetts Bay Transportation Authority, has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from several provisions of the Federal railroad safety regulations. Specifically, KRSM requests relief from certain provisions of 49 CFR part 240, Qualification and Certification of Locomotive Engineers, and Part 242, Qualification and Certification of
KRSM seeks to shield reporting employees and the railroad from mandatory punitive sanctions that would otherwise arise as provided in 49 CFR 240.117(e)(1)-(4); 240.305(a)(1)-(4) and (a)(6); 240.307; and 242.403(b), (c), (e)(1)-(4), (e)(6)-(11), (f)(1)-(2). The C
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received within April 13, 2015 of the date of this notice will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated November 18, 2014, the National Railroad Passenger Corporation (Amtrak) petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained in 49 CFR, governing the operation of passenger trains on the Northeast Corridor (NEC). Relief was also requested from speed limitations imposed by the Order of Particular Applicability for the Advanced Civil Speed Enforcement System (ACSES) Order. [FRA Docket No. 87-2, Notice No. 7; 63 FR 39343; July 28, 1998]. FRA assigned the petition Docket Number FRA-2014-0124.
Amtrak's petition incorporated by reference a prior request for relief in Docket Number FRA-2013-0128 (
The Amtrak petitions address two distinct requests. First, both petitions request permission to operate existing Acela trainsets, built in compliance with the specific requirements for Tier II equipment under 49 CFR part 238 subpart E, at speeds up to 160 miles per hour (mph) in three speed zones where track conditions can support higher speeds than currently operated. As discussed above, Amtrak's earlier petition in Docket Number FRA-2013-0128 proposed the same speed increase for a segment of track in Rhode Island, milepost (MP) AB 154.3 to MP AB 171.7.
The new petition in Docket Number FRA-2014-0124 adds a request for a 160 mph speed zone in Massachusetts (MP AB 194 to MP AB 204) and—subject to completion of certain infrastructure improvements—a 160 mph speed zone in New Jersey (MP AN 33 to MP AB 55.5).
In summary, Amtrak seeks a waiver of provisions in the ACSES Order and the 150 mph limitation for Tier II equipment in the Passenger Equipment Safety Standards to permit operation up to 160 mph in each of these discrete zones. Amtrak does not seek to use the existing Acela trainsets at speeds higher than presently authorized elsewhere on the NEC. Amtrak notes that increasing speeds in the subject zones would be subject to special approvals qualifying the existing Acela Tier II trainsets at the higher speed under 49 CFR part 213, Track Safety Standards, and regulations governing Positive Train Control, such as 49 CFR part 236, Rules, Standards, and Instructions Governing the Installation, Inspection, Maintenance, and Repair of Signal and Train Control Systems, Devices, and Appliances. With FRA oversight, Amtrak has been conducting tests that, although not yet concluded, are intended by Amtrak to support qualification of the existing trainsets and train control system for 160 mph operation. Successful completion of these processes would be necessary for Amtrak to use any relief related to the Acela service that might be granted in this proceeding.
Secondly, in Docket Number FRA-2014-0124, Amtrak requests approval to operate, on the “spine” of the NEC between Washington, DC and Boston, new trainsets that would be built to “Tier III” standards proposed by the second Engineering Task Force (ETF) of the Passenger Safety Working Group of the Railroad Safety Advisory Committee (RSAC). Those standards were accepted by the full RSAC on June 14, 2013, (
Amtrak proposes to use Tier III equipment on the NEC at speeds up to 160 mph (rather than the 220 mph maximum contemplated for Tier III equipment operating on dedicated right-of-way). In support of this request, Amtrak has submitted a review of NEC operating experience that Amtrak represents as demonstrating a high level of safety, supported by compliance with FRA safety regulations and existing risk mitigations undertaken as voluntary measures. Amtrak notes that Tier III trainsets would be operated at greater than Tier I speeds (
In further support of its Tier III request, Amtrak has submitted the report of a semi-quantitative risk assessment and a description of specific safety mitigations designed to compensate for the differences in crashworthiness between equipment built to Tier II and Tier III standards. Amtrak asserts that, with the existing and proposed mitigations, Tier III equipment can be operated at a level of safety equivalent to, or better than, operations with Tier II equipment. Amtrak's petition and exhibits are available for reference in Docket Number FRA-2014-0124.
Amtrak asserts that all of the relief requested is consistent with safety and in the public interest.
Copies of the petitions, as well as any written communications concerning the petitions, are available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. If any interested party desires an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
Web site:
Fax: 202-493-2251.
Mail: Docket Operations Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC 20590.
Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays.
Communications received by April 13, 2015 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Departmental Offices, Treasury.
Notice.
The Treasury Department (“Treasury”) seeks nominations for appointments by the Secretary of the Treasury (“Secretary”) to the Treasury Tribal Advisory Committee (TTAC), established pursuant to the Tribal General Welfare Exclusion Act of 2014 (Pub. L. 113-168, or TGWEA). The TTAC will advise the Secretary on matters related to the taxation of Indians, training and education for Internal Revenue Service (“Service”) field agents who administer and enforce internal revenue laws with respect to Indian tribes; and training and technical assistance for tribal financial officers. Nominations should describe the candidate's qualifications for TTAC membership. Submittal of an application and resume is required.
This request for nominations, particularly from tribal leaders, is in furtherance of the objectives of Executive Order 13175 under which Treasury consults with tribal officials in the development of federal policies that have tribal implications, to reinforce the United States government-to-government relationships with Indian tribes and to reduce the imposition of unfunded mandates upon Indian tribes.
Please submit the names and qualifications of individuals you would recommend for appointment to the TTAC by the Secretary, applications for appointment by the Secretary to the TTAC or comments on this matter, before April 28, 2015.
Please send recommendations and applications to
Elaine Buckberg, Deputy Assistant Secretary for Policy Coordination and Point of Contact for Tribal Consultation, Department of the Treasury, at
The TGWEA, signed into law by President Obama on September 26, 2014, requires that Treasury establish the TTAC. Committee members will advise the Secretary on matters related to the taxation of Indians, the training of Service field agents who administer and enforce internal revenue laws with respect to Indian tribes, and the provision of training and technical assistance to Native American financial officers. The Secretary will appoint three Committee members; the Chairs and Ranking Members of the Senate Finance Committee and House of Representative Ways and Means Committee will each appoint one member. The TTAC Charter has been filed; a copy of the Charter is posted at
Recommendations for the four Congressional appointments to the TTAC should be directed to the offices of the four Members of Congress
The TWGEA builds on prior guidance that Treasury and the Service issued in direct response to requests from a number of tribal leaders, including representatives of the National Congress of American Indians (NCAI), Native American Finance Officers' Association (NAFOA) and United Southern and Eastern Tribes (USET). Beginning in 2011, Treasury and the Service met extensively with tribal leaders, developed draft legal guidance, and requested comments. In IRS Notice 2012-75, draft guidance was issued “with reliance” to provide immediate certainty on conditions under which tribal government benefits are not subject to the Federal personal income tax. Final IRS guidance, issued last June as Rev. Proc. 2014-35, clarified these matters further. Building on this guidance, we anticipate that members of the TTAC will advise the Secretary on related tax issues, and on the training and education of Service field agents and tribal financial officers, as indicated in the TGWEA.
Treasury seeks applications from individuals with experience and qualifications in the subject areas identified by the TWGEA: Indian taxation, Service field agent training, and Native American financial officer training and technical assistance. Initial TTAC members appointed by the Secretary will serve as volunteers for terms of two years. TTAC member travel expenses will be reimbursed within government guidelines. No person who is a federally-registered lobbyist may serve on the TTAC. All potential candidates must pass a Service (IRS) tax compliance check and a Federal Bureau of Investigation (FBI) background investigation.
To apply, an applicant must submit an appropriately detailed resume and a cover letter that includes a description of the applicant's reason for applying. An applicant must state in the application materials that he or she agrees to submit to a pre-appointment tax and criminal background investigation in accordance with Treasury Directive 21-03.
Notification of Citizens Coinage Advisory Committee March 5, 2015, Public Meeting.
Pursuant to United States Code, Title 31, section 5135(b)(8)(C), the United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for March 5, 2015. A public forum will occur the following day on March 6, 2015.
In accordance with 31 U.S.C. 5135, the CCAC:
Advises the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals.
Advises the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made.
Makes recommendations with respect to the mintage level for any commemorative coin recommended.
William Norton, United States Mint Liaison to the CCAC; 801 9th Street NW., Washington, DC 20220; or call 202-354-7200.
Any member of the public interested in submitting matters for the CCAC's consideration or addressing the CCAC at the Public Forum is invited to submit them by fax to the following number: 202-756-6525.
31 U.S.C. 5135(b)(8)(C).
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of proposed rulemaking.
The U.S. Department of Energy (DOE) proposes to establish test procedures for portable air conditioners (ACs) in accordance with the guidance and requirements set forth by the Energy Policy and Conservation Act to establish technologically feasible, economically justified energy conservation standards for products identified by specific criteria to provide national energy savings through improved energy efficiency. The proposed test procedures are based upon industry methods to determine energy consumption in active modes, off-cycle mode, standby modes, and off mode, with certain modifications to ensure the test procedures are repeatable and representative. The proposed test procedure would create a new appendix CC, which would be used to determine capacities and energy efficiency metrics that could be the basis for any future energy conservation standards for portable ACs. DOE also proposes adding a sampling plan and rounding requirements for portable ACs, necessary when certifying capacity and efficiency of a basic model.
DOE will accept comments, data, and information regarding this notice of proposed rulemaking (NOPR) before and after the public meeting, but no later than May 11, 2015. See section V, “Public Participation,” for details.
DOE will hold a public meeting on Wednesday, March 18, 2015, from 9 a.m. to 12 p.m., in Washington, DC. The meeting will also be broadcast as a webinar. See section V, “Public Participation,” for webinar registration information, participant instructions, and information about the capabilities available to webinar participants.
The public meeting will be held at the U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585. To attend, please notify Ms. Brenda Edwards at (202) 586-2945. See section V Public Participation for additional meeting information.
Any comments submitted must identify the NOPR for Test Procedures for Portable Air Conditioners, and provide docket number EERE-2014-BT-TP-0014 and/or regulatory information number (RIN) number 1904-AD22. Comments may be submitted using any of the following methods:
1.
2.
3.
4.
For detailed instructions on submitting comments and additional information on the rulemaking process, see section V of this document (Public Participation).
A link to the docket Web page can be found at:
For further information on how to submit a comment, review other public comments and the docket, or participate in the public meeting, contact Ms. Brenda Edwards at (202) 586-2945 or by email:
Mr. Bryan Berringer, U.S. Department of Energy, Office of Building Technology Programs, Appliance Standards Division, 950 L'Enfant Plaza SW. Room 603, Washington, DC 20585-0121. Telephone: 202-586-0371. Email:
Ms. Sarah Butler, U.S. Department of Energy, Office of the General Counsel, Mailstop GC-33, 1000 Independence Ave. SW., Washington, DC 20585-0121. Telephone: 202-586-1777; Email:
DOE intends to incorporate by reference the following industry standards into 10 CFR part 430: Portable Air Conditioners AHAM PAC-1-2014, 2014.
Copies of AHAM PAC-1-2014 can be obtained from the Association of Home Appliance Manufacturers, 1111 19th Street NW., Suite 402, Washington, DC 20036, 202-872-5955, or by going to
Title III of the Energy Policy and Conservation Act (EPCA), as amended (42 U.S.C. 6291,
(1) Classifying the product as a covered product is necessary for the purposes of EPCA; and
(2) The average annual per-household energy use by products of each type is likely to exceed 100 kilowatt-hours (kWh) per year. (42 U.S.C. 6292(b)(1))
To prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p) for covered products added pursuant to 42 U.S.C. 6292(b)(1), the Secretary must also determine that:
(1) The average household energy use of the products has exceeded 150 kWh per household for a 12-month period;
(2) The aggregate 12-month energy use of the products has exceeded 4.2 terawatt-hours (TWh);
(3) Substantial improvement in energy efficiency is technologically feasible; and
(4) Application of a labeling rule under 42 U.S.C. 6294 is unlikely to be sufficient to induce manufacturers to produce, and consumers and other persons to purchase, covered products of such type (or class) that achieve the maximum energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6295(l)(1))
Under EPCA, the energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products must use as the basis for: (1) Certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA, and (2) making representations about the efficiency of those products. Similarly, DOE must use these test procedures to determine whether the products comply with any relevant standards promulgated under EPCA.
Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA provides in relevant part that any test procedures prescribed or amended under this section shall be reasonably designed to produce test results that measure energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))
In addition, if DOE determines that a test procedure should be prescribed or amended, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2))
There are currently no DOE test procedures or energy conservation standards for portable ACs. On July 5, 2013, DOE issued a notice of proposed determination (NOPD) of coverage (hereinafter referred to as the “July 2013 NOPD”), in which DOE announced that it tentatively determined that portable ACs meet the criteria under 42 U.S.C. 6292(b)(1) to be classified as a covered product. 78 FR 40403. DOE estimated that 973.7 thousand portable AC units were shipped in North America in 2012, with a projected growth to 1743.7 thousand units by 2018, representing nearly 80-percent growth in 6 years.
In response to the July 2013 NOPD, DOE received comments from interested parties on several topics regarding appropriate test procedures for portable ACs that DOE should consider if it issues a final determination classifying portable ACs as a covered product.
On May 9, 2014, DOE published in the
As discussed above, DOE also recently initiated a separate rulemaking to consider establishing energy conservation standards for portable ACs. Any new standards would be based on the same efficiency metrics derived from the test procedure that DOE would adopt in a final rule in this rulemaking.
In this NOPR, DOE proposes to establish in Title 10 of the Code of Federal Regulations (CFR), section 430.2, the definition of portable AC that was initially proposed in the July 2013 NOPD, modified to distinguish from room ACs and dehumidifiers.
DOE also proposes to establish in 10 CFR part 430, subpart B, a test procedure for single-duct and dual-duct portable ACs that would provide an accurate representation of performance in active modes, standby modes, and off mode. Because spot cooler portable ACs do not provide net cooling to a conditioned space, DOE is not proposing test procedures for these products in this NOPR. The proposed active mode testing methodology would utilize the Association of Home
For those single-duct and dual-duct portable ACs that incorporate a heating function, DOE proposes additional testing methodology for measuring energy use in heating mode similar to the methodology proposed for the measurement of cooling capacity and EER
The proposed single-duct and dual-duct portable AC test procedure also includes a measure of energy use in off-cycle mode, which occurs when the ambient dry-bulb temperature reaches the setpoint. This may include operation of the fan either continuously or cyclically without activating the refrigeration (or heating) system, or periods in standby mode when the fan is not operating.
In this NOPR, DOE identifies and discusses all relevant low-power modes, including bucket-full mode, delay-start mode, inactive mode, and off mode. DOE also proposes definitions for inactive mode and off mode, and proposes test procedures to determine energy consumption representative of each of these low-power modes based on the procedures outlined in the standard published by the International Electrotechnical Commission (IEC), titled “Household electrical appliances—Measurement of standby power,” Publication 62301, Edition 2.0 (2011-01) (hereinafter referred to as “IEC Standard 62301”).
In addition, DOE proposes a combined energy efficiency ratio (CEER) metric to be used in reporting the overall energy efficiency of a single-duct and dual-duct portable AC. The CEER metric would represent energy use in all available operating modes. DOE also proposes to define a separate CEER metric for cooling mode that would also apply to units that include heating mode and would be a common metric used for comparison among portable ACs. DOE also proposes an EER metric to represent performance in cooling and heating modes that could be used to compare cooling and heating performance with other similar products.
Finally, DOE proposes adding a sampling plan and rounding requirements for portable ACs to a new section 10 CFR 429.62. These instructions are necessary when certifying capacity and efficiency of a basic model.
A portable AC is a self-contained, refrigeration-based product that, similar to a room AC, removes latent and sensible heat from the ambient air in a single space such as a room. Similar to room ACs, portable ACs are standalone appliances designed to operate independently of any other air treatment devices, though they may also be used in conjunction with other pre-existing air treatment devices. However, unlike room ACs, portable ACs are not designed as a unit to be mounted in a window or through the wall. Portable ACs are placed in the conditioned space and may have flexible ducting, typically connected to a window to remove condenser outlet air from the conditioned space.
DOE is generally aware of 3 categories of portable ACs including single-duct models, dual-duct models, and spot coolers. Single-duct portable ACs utilize a single condenser exhaust duct to vent heated air to the unconditioned space. Other configurations include dual-duct, which intakes some or all condenser air from and exhausts to unconditioned space, and spot coolers, which have no ducting on the condenser side and may utilize small directional ducts on the evaporator exhaust. Spot coolers are often used in applications that require cooling in one localized zone and can tolerate exhaust heat outside of this zone.
In the July 2013 NOPD, DOE proposed to define “portable air conditioner” as:
A consumer product, other than a “packaged terminal air conditioner” which is powered by a single-phase electric current and which is an encased assembly designed as a portable unit that may rest on the floor or other elevated surface for the purpose of providing delivery of conditioned air to an enclosed space. It includes a prime source of refrigeration and may include means for ventilating and heating. 78 FR 40403, 40404 (July 5, 2013).
DOE maintained this proposed definition in the May 2014 NODA. In the July 2013 NOPD, DOE also stated that portable ACs are moveable units typically designed to provide 8,000 to 14,000 British thermal units per hour (Btu/h) of cooling capacity for a single room.
In response to the proposed definition, Pacific Gas and Electric Company, Southern California Gas Company, San Diego Gas and Electric, and Southern California Edison (hereinafter referred to as the “California Investor-Owned Utilities (IOUs)”) and Edison Electric Institute (EEI) stated that the requirement in the definition to be powered by a single-phase electric current may exclude some equipment designed for commercial applications. The California IOUs encouraged DOE to consider a large range of portable ACs, both residential and commercial, to ensure that all potential savings are examined and analyzed. In particular, the California IOUs recommended that DOE consider covering portable ACs with capacities above 14,000 Btu/h because there are units currently on the market with cooling capacities up to and above 65,000 Btu/h. (California IOUs, NOPD No. 5 at pp. 1-2;
Oceanaire Inc. (Oceanaire) commented that according to the EPCA definition, commercial spot coolers (portable ACs that do not have ducting attached to the condenser) are not covered products. According to Oceanaire, commercial spot coolers are mainly used in the rental market where emergencies create a need for immediate and focused cooling systems, with example applications including food and cosmetics processing plants,
Portable ACs, most commonly in single-duct or dual-duct configuration, typically range in cooling capacity from 5,000 to 14,000 Btu/h when measured according to existing industry test methods. According to sizing charts provided by vendors, these portable ACs are intended to cool rooms of up to approximately 525 square feet in area,
DOE recognizes that certain portable ACs also include options for operating as a dehumidifier and/or heater, with heating means provided by either an electric resistance heater or by modifying internal refrigerant flow to operate the unit as a heat pump. The dehumidification function may be achieved in some units by decreasing fan speeds, removing the condenser duct(s), and for some units, disabling the self-evaporative feature by draining the condensate before it reaches the condenser coils or deactivating the condensate slinger fan when the controls are set to dehumidification mode. In all of these cases, the air flow pattern and psychrometrics differ fundamentally from those of a dehumidifier, resulting in different energy efficiencies during dehumidification operation, even though both products may use a refrigeration system to remove moisture from the air.
DOE also recognizes that although room ACs and portable ACs share many of the same components that operate similarly to provide cooled air to a conditioned space, a portable AC, unlike a room AC, may be entirely located within the conditioned space so that some or all of the condenser air may be drawn from that space, and some heat from the refrigeration system and ducting is transferred to the conditioned space as well. These differences would lead to differing cooling mode energy efficiencies between room ACs and portable ACs, even if the products were to incorporate the same components. In addition, operation of the portable AC without activation of the refrigeration system may be more accurately characterized as “air circulation” rather than “ventilation” because the portable AC may be operated without drawing air from outside the conditioned space. Thus, DOE proposes to clarify in the definition of “portable air conditioner” that the primary function of the product is to provide cooled, conditioned air to the space in addition to other functions such as air circulation or heating, and that it is a product other than a room AC or dehumidifier. DOE also proposes to restructure the portable AC definition to align with both the room AC and dehumidifier definitions. In sum, DOE proposes to add to 10 CFR 430.2 the following definition for “portable air conditioner.”
An encased assembly, other than a “packaged terminal air conditioner,” “room air conditioner,” or “dehumidifier,” designed as a portable unit for delivering cooled, conditioned air to an enclosed space, that is powered by single-phase electric current, which may rest on the floor or other elevated surface. It includes a source of refrigeration and may include additional means for air circulation and heating.
Although this proposed definition differs from the definition presented in the July 2013 NOPD, DOE maintains its tentative determination that portable ACs qualify as a covered product under Part A of Title III of EPCA, as amended. A product may be added as a covered product, pursuant to 42 U.S.C. 6292(b)(1), if (1) classifying products of such type as covered products is necessary and appropriate to carry out the purposes of EPCA; and (2) the average per-household energy use by products of such type is likely to exceed 100 kWh (or its Btu equivalent) per year. As discussed in the July 2013 NOPD, DOE determined that portable ACs meet the first requirement because: Shipments are projected to increase 80 percent over a 6-year period from 2012 to 2017, coverage of portable ACs would allow for conservation of energy through labeling programs and the regulation of portable AC energy efficiency, and there is significant variation in the annual energy consumption of different portable AC models currently available on the market. 78 FR 40403, 40404 (July 5, 2013). For the second requirement, DOE determined that a typical portable AC uses approximately 650 kWh/year, well above the 100 kWh/year threshold. 78 FR 40403, 40404-40405 (July 5, 2013). The updated portable AC definition proposed in this NOPR only includes additional clarification to differentiate portable ACs from dehumidifiers and room ACs, it does not alter the intended scope of the definition. Accordingly, the determinations from the July 2013 NOPD remain valid for the revised proposed portable AC definition.
DOE also proposes to include in the new test procedure at appendix CC the following definitions for different portable AC configurations to clarify the testing provisions to be used to obtain representative results for cooling capacity, heating capacity (where applicable), and CEER:
“Single-duct portable air conditioner” means a portable air conditioner that
“Dual-duct portable air conditioner” means a portable air conditioner that draws some or all of the condenser inlet air from outside the conditioned space through a duct, and may draw additional condenser inlet air from the conditioned space. The condenser outlet air is discharged outside the conditioned space by means of a separate duct.
DOE is also proposing a definition for “spot cooler” as a portable air conditioner that draws condenser inlet air from and discharges condenser outlet air to the conditioned space, and draws evaporator inlet air from and discharges evaporator outlet air to a localized zone within the conditioned space. DOE is proposing such a definition in this NOPR to clarify that testing these products would not be required at this time, as discussed previously in this section.
DOE requests comment on these proposed definitions for portable ACs and their specific configurations, including the proposal that spot coolers not be addressed in this rulemaking.
Portable ACs are typically purchased by consumers to provide cooled air to a conditioned space, although certain models provide additional functions such as heating, dehumidification, and air circulation. Because room ACs and dehumidifiers share many of the same internal components and incorporate some of the same operating modes as portable ACs, DOE considered the mode definitions for these products to develop applicable mode definitions for portable ACs.
Appendix F of title 10, part 430, subpart B of the CFR defines “active mode” for room ACs as a mode in which the room AC is connected to a mains power source, has been activated and is performing the main function of cooling or heating the conditioned space, or circulating air through activation of its fan or blower, with or without energizing active air-cleaning components or devices such as ultraviolet (UV) radiation, electrostatic filters, ozone generators, or other air-cleaning devices. Appendix X within that same subpart of the CFR defines “active mode” for dehumidifiers as a mode in which a dehumidifier is connected to a mains power source, has been activated, and is performing the main functions of removing moisture from air by drawing moist air over a refrigerated coil using a fan, or circulating air through activation of the fan without activation of the refrigeration system.
Portable ACs provide the same main functions as room ACs: (1) Cooling with activation of the refrigeration system and blower or fan; (2) for certain models, heating by means of activation of a blower or fan and either the refrigeration system and a reverse-cycle solenoid valve or a resistance heater; or (3) air circulation by activating only the blower or fan. As with dehumidifiers, a portable AC evaporator may also experience frosting and may need to perform a defrost operation. DOE, therefore, proposes the following definition for portable AC active mode:
“Active mode” means a mode in which the portable air conditioner is connected to a mains power source, has been activated, and is performing the main functions of cooling or heating the conditioned space, circulating air through activation of its fan or blower without activation of the refrigeration system, or defrosting the refrigerant coil.
DOE proposes to designate active mode functions performed when the temperature setpoint is not yet reached as either “cooling mode” or “heating mode,” depending upon the user-selected function.
Portable ACs may also operate in “off-cycle mode,” during which the fan or blower may operate without activation of the refrigeration system after the temperature setpoint has been reached. Under these conditions, the fan may be operated to ensure that air is drawn over the thermostat to monitor ambient conditions, or for air circulation in the conditioned space. It is also possible that immediately following a period of cooling or heating, fan operation may be initiated to remove any remaining frost or moisture from the evaporator. Although the periods of fan operation would classify those periods of off-cycle mode as an active mode, DOE notes that the portable AC may also enter one or more periods of a standby mode during off-cycle mode, in which the fan or blower does not operate. Therefore, DOE proposes to define off-cycle mode to include all periods of fan operation and standby mode that occur when the temperature set point has been reached, and further proposes to measure the energy consumption during off-cycle mode according to methodology discussed in section III.B.2 of this NOPR.
Portable ACs may also operate in a consumer-selected mode during which the blower is operated with all other cooling or heating components disabled. The blower may operate cyclically or continuously to circulate air in the conditioned space. DOE refers to this consumer-selected, active mode as “air-circulation mode.” DOE does not currently have information on the usage of this consumer-initiated air circulation feature and, therefore is not proposing to measure energy usage during “air-circulation mode.” However, DOE seeks information on annual hours associated with this mode.
Some portable ACs also include a dehumidification or “dry” function. DOE learned through manufacturer interviews that portable AC operation in this mode is adjusted to maximize latent rather than sensible heat removal, typically by decreasing the evaporator fan or blower speed. Though not always specified in the user manual, when operating in dry mode, the installation may be modified to direct condenser exhaust into the conditioned space. In this case, a drain setup is necessary to remove condensate before it passes over the condenser to be re-evaporated into the condenser exhaust. Though the evaporator and condenser outlet air streams are not fully mixed, the net effect is minimal heating or cooling within the conditioned space and a reduction in relative humidity. DOE considered addressing dehumidification performance as part of this test procedure proposal, and determined that it is not technically feasible to combine dehumidification performance, in units of liters per kWh, with a cooling or heating performance, in units of Btu/Wh. Because dehumidification is not the primary mode of operation for portable ACs, DOE does not believe that the annual operating hours in dehumidification mode would be significant and would therefore not substantially impact a metric that considers the combined annual energy consumption of each operating mode. DOE's tentative conclusion is supported by a recent field study conducted by Burke,
In summary, DOE proposes to include the following definitions in new appendix CC to clarify the types of portable AC operation within active mode:
“Cooling mode” means an active mode in which a portable air conditioner has activated the main cooling function according to the thermostat or temperature sensor signal, including activating the refrigeration system, or the fan or blower without activation of the refrigeration system.
“Heating mode” means an active mode in which a portable air conditioner has activated the main heating function according to the thermostat or temperature sensor signal, including activating a resistance heater, the refrigeration system with a reverse refrigerant flow valve, or the fan or blower without activation of the resistance heater or refrigeration system.
Further discussion of off-cycle mode, including a proposed definition, is included in section III.2 of this NOPR.
As discussed in the May 2014 NODA, DOE identified three industry test procedures that measure portable AC performance in cooling mode and that are applicable to products sold in North America:
(1) AHAM PAC-1-2009 “Portable Air Conditioners” (AHAM PAC-1-2009) specifies cooling mode testing conducted in accordance with American National Standards Institute (ANSI)/American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) Standard 37-2005 “Methods of Testing for Rating Electrically Driven Unitary Air-Conditioning and Heat Pump Equipment” (ANSI/ASHRAE Standard 37-2005).
(2) Canadian Standards Association (CSA) C370-2013 “Cooling Performance of Portable Air Conditioners” (CSA C370-2013) is harmonized with AHAM PAC-1-2009, and thus also incorporates testing provisions from ANSI/ASHRAE Standard 37-2009.
(3) ANSI/ASHRAE Standard 128-2011 “Method of Rating Unitary Spot Air Conditioners” (ANSI/ASHRAE Standard 128-2011) is adapted from the previous 2009 version of CSA C370. It too references ANSI/ASHRAE Standard 37-2009. The previous version of ANSI/ASHRAE Standard 128, published in 2001, is required by California regulations to be used to certify spot cooler performance for such products sold in that State. A key difference between ANSI/ASHRAE Standard 128-2011 and ANSI/ASHRAE Standard 128-2001 is that the older version specifies a higher indoor ambient testing temperature, which increases measured cooling capacity and EER. 79 FR 26639, 26640-26641 (May 9, 2014).
DOE found no significant differences that would produce varying results among the three test procedures. The aforementioned versions of the AHAM, CSA, and ASHRAE test procedures each measure cooling capacity and EER based on an air enthalpy approach that measures the airflow rate, dry-bulb temperature, and water vapor content of air at the inlet and outlet of the indoor (evaporator) side. In addition, for air-cooled portable ACs with cooling capacity less than 135,000 Btu/h, which include the products that are the subject of this NOPR, the indoor air enthalpy results must be validated by measuring cooling capacity by either an outdoor air enthalpy method or a compressor calibration method. As explained in the May 2014 NODA, DOE selected the outdoor air enthalpy method for its investigative testing to minimize test burden because it only requires additional metering components, similar to those used for the indoor air enthalpy method. DOE conducted initial testing according to AHAM PAC-1-2009 to establish baseline capacities and efficiencies of a preliminary sample of test units according to the existing industry test procedures. 79 FR 26639, 26641 (May 9, 2014).
To investigate the contribution of operational factors on the apparent reduction in cooling capacity observed for units in the field, DOE compared the results of AHAM PAC-1-2009 testing with the results of additional testing with a test room calorimeter approach based on ANSI/ASHRAE Standard 16-1983 (RA 99), “Method of Testing for Rating Room Air Conditioners and Packaged Terminal Air Conditioners” (ANSI/ASHRAE Standard 16-1983), with certain modifications to allow testing of portable ACs. The room calorimeter approach allowed DOE to determine the cooling capacity of a portable AC that accounts for any air infiltration effects and heat transfer to the conditioned space through gaps in the product case and seams in the duct connections, along with an associated EER. Values of these performance metrics measured accordingly may more accurately reflect real-world portable AC operation. In that test series, DOE also investigated cooling capacity and EER as a function of the infiltration air temperature for single-duct and dual-duct units, and the effect of condenser exhaust air entrainment at the intake for dual-duct portable ACs. DOE presented the results of this preliminary testing in the May 2014 NODA. 79 FR 26639, 26643-26648 (May 9, 2014).
Although AHAM PAC-1-2009, CSA C370-2013, and ANSI/ASHRAE Standard 128-2011, all reference the test setup and methodology from ANSI/ASHRAE Standard 37, AHAM PAC-1-2009 did not specify the particular sections in ANSI/ASHRAE Standard 37 that are to be used. However, AHAM recently published an updated version of its portable AC test procedure, AHAM PAC-1-2014, that references specific sections in ANSI/ASHRAE Standard 37 for equipment setup, cooling capacity determination, power input determination, data recording, and results reporting, consistent with the approach in CSA C370-2013 and ANSI/ASHRAE Standard 128-2011. These clarifications will likely improve testing reproducibility by eliminating different possible interpretations of the provisions to reference from ANSI/ASHRAE Standard 37. AHAM also slightly revised the evaporator inlet and condenser inlet temperatures for its standard rating conditions in AHAM PAC-1-2014, in order to harmonize with the temperatures specified in CSA C370-2013 and ANSI/ASHRAE Standard 128-2011. Conditions that had been specified as 80 degrees Fahrenheit (°F) dry-bulb temperature and 67 °F wet-bulb temperature were adjusted to 80.6 °F/66.2 °F, and conditions that had been specified as 95 °F/75 °F were adjusted to 95 °F/75.2 °F. DOE did not identify other substantive changes between the 2009 and 2014 versions of AHAM PAC-1 that would affect testing results.
For the May 2014 NODA, DOE conducted an initial round of performance testing on a preliminary sample of test units representative of products available at that time on the U.S. market. The test sample included a total of eight portable ACs (four single-duct, two dual-duct, and two spot coolers), covering a range of rated cooling capacities (8,000-13,500 Btu/h) and EERs (7.0-11.2 Btu per watt-hour (Btu/Wh)). Following publication of the May 2014 NODA, DOE performed additional testing on a larger set of test units. This second test sample included a total of eighteen portable ACs; thirteen
Because DOE does not currently regulate portable ACs, manufacturers may advertise or market their products using any available test procedure. For those models that are included in the California Energy Commission (CEC) product database and that are sold in California, however, manufacturers must report cooling capacity and EER according to ANSI/ASHRAE Standard 128-2001. DOE notes that the cooling capacities and EERs obtained from using ANSI/ASHRAE Standard 128-2001 are higher than those obtained using the current ANSI/ASHRAE Standard 128-2011, primarily due to higher temperature evaporator inlet air in the 2001 version of the test procedure.
Due to the consistent method of reporting performance required by the CEC, DOE selected units for its test sample largely from cooling capacities and EERs listed in the CEC product database. However, due to the difference in testing temperature, DOE expected that these values would differ from the cooling capacities and EERs that would be obtained using any of the three current industry test methods. For additional products not listed in the CEC product database, DOE utilized information from manufacturer literature to inform its selection.
The 24 test units
DOE first performed testing in accordance with AHAM PAC-1-2009
AHAM PAC-1-2009 requires two-chamber air enthalpy testing for single-duct and dual-duct units, and a single-chamber setup for spot coolers. For each ducted configuration, the portable AC and any associated ducting is located entirely within a chamber held at “indoor” standard rating conditions at the evaporator inlet of 80 °F dry-bulb temperature and 67 °F wet-bulb temperature, which correspond to 51-
Section 6.1 of AHAM PAC-1-2009, “Method of Test,” instructs that the details of testing are as specified in ANSI/ASHRAE Standard 37-2005, but does not identify particular provisions to be used other than noting that references in Section 8.5.1 of ANSI/ASHRAE Standard 37-2005 refer to the indoor side (the cooling, or evaporator side) and the outdoor side (the heat rejection, or condenser, side) of the portable AC under test. DOE determined that additional relevant sections to incorporate would include those referring to test setup, test conduct, cooling capacity and power input determination, data recording, and test result reporting. The following paragraphs describe the equivalent clauses from ANSI/ASHRAE Standard 37-2009 that DOE decided were appropriate for conducting its baseline tests for both the May 2014 NODA and this proposal.
The test apparatus (
These collected data were then used to calculate total, sensible, and latent indoor cooling capacity based on the equations in Section 7.3.3, “Cooling Calculations,” of ANSI/ASHRAE Standard 37-2009. This section provides calculations to determine indoor cooling capacity based on both the indoor and outdoor air enthalpy methods. As described in Section 7.3.3.3 of ANSI/ASHRAE Standard 37-2009, the indoor air enthalpy cooling capacity calculation was adjusted for heat transferred from the surface of the duct(s) to the conditioned space. DOE estimated a convective heat transfer coefficient of 4 Btu/h per square foot per °F, based on a midpoint of values for forced convection and free convection as recommended by the test laboratory for this specific test and setup. Four thermocouples were placed in a grid on the surface of the condenser duct(s). The heat transfer was determined by multiplying the estimated heat transfer coefficient by the surface area of each component and by the average temperature difference between the duct surface and test chamber air.
Although AHAM PAC-1-2009 specifies in Section 5.1 that the evaporator circulating fan heat shall be included in the total cooling capacity by means of fan power measurement, DOE selected an alternate calculation that it concluded would provide a more accurate measure of overall heat transfer to the conditioned space. DOE estimated this heat transferred to the conditioned space by monitoring the temperature differential between the case surfaces and the indoor room, with measurements and calculations similar to those used for the ducts. This estimate was made by placing four thermocouples on each surface of the case and measuring the surface area to determine the total heat transfer through the case. This approach directly estimates the heating contribution of all internal components within the case to the cooling capacity, while making no assumption regarding whether the heat from individual components is transferred to the cooling or heat rejection side.
Based on the provisions discussed above, DOE used the following equation when calculating the cooling capacity and EER for portable ACs according to AHAM PAC-1-2009:
From the calculated evaporator air enthalpy cooling capacity, DOE determined the associated EER consistent with the definitions in Sections 3.8 and 3.9 and ratings requirements in Sections 5.3 and 5.4 of AHAM PAC-1-2009. Table III.2 shows the results of the baseline testing for all test units according to AHAM PAC-1-2009, including results from testing for the May 2014 NODA and this proposal.
For the May 2014 NODA and this proposal, DOE further investigated heat transfer effects not currently captured in available portable AC test procedures, through additional testing according to the room calorimeter approach described in the May 2014 NODA. 79 FR 26639, 26644 (May 9, 2014). This approach, adapted from ANSI/ASHRAE Standard 16-1983, used two test chambers, one maintained at the indoor conditions and the other adjusted to maintain the outdoor conditions as specified below. The portable AC under test was located within the indoor test room with the condenser duct(s) interfacing with the outdoor test room by means of the manufacturer-supplied or manufacturer-recommended mounting fixture, unless otherwise noted. Infiltration air from the outdoor chamber at 95 °F dry-bulb and 75 °F wet-bulb (40-percent relative humidity) was introduced by means of a pressure-equalizing device to the indoor chamber, which was maintained at 80 °F dry-bulb and 67 °F wet-bulb (51-percent relative humidity). The pressure-equalizing device maintained a static pressure differential of less than 0.005 inches of water between the chambers, as specified in Section 4.2.3 of ANSI/ASHRAE Standard 16-1983.
DOE measured all energy consumed by the indoor chamber components to maintain the required ambient conditions while the portable AC under test operated continuously at its maximum fan speed during a 1-hour stable period following a period of no less than 1 hour with stabilized conditions. All heating and cooling contributions to the indoor chamber were summed, including: Chamber cooling, heat transferred through the chamber wall, air-circulation fans, dehumidifiers, humidifiers, and scales. The net indoor chamber cooling was recorded as the portable AC's cooling capacity. This approach encompasses all cooling and heating effects generated by the portable AC, including air infiltration effects that are not captured or estimated by the air enthalpy approach.
The test units were installed with the manufacturer-provided ducting, duct attachment collar, and mounting fixture. This test approach included the impacts of heat transfer from the ducts and air leaks in the duct connections and mounting fixture, in addition to heat leakage through the case and infiltration air. Table III.3 shows the measured net cooling capacities and EER values for all units tested according to the calorimeter approach when the infiltration air dry-bulb temperature was 95 °F. Also included are the results for the rated and baseline values. Figure III.1 also presents the comparison of baseline and calorimeter testing results.
Figure III.1 demonstrates that there is little correlation between EER and cooling capacity for the baseline results when the effects of air infiltration and heat losses are not accounted for. When such effects are included, the values of both EER and cooling capacity are reduced for a given test unit, but the data evidence a clear relationship between EER and cooling capacity. Figure III.1 also demonstrates that the net cooling of portable ACs may be significantly lower than an air enthalpy measurement would suggest, due to the effects of infiltration air. Thus, DOE determined that the existing representations of capacity and EER, which are based on air enthalpy methods, are likely to be inconsistent and may not represent true portable AC performance. Further, the varying differences between the calorimeter and baseline results indicate that varying infiltration air flow rates and heat losses would preclude a fixed translation factor that could be applied to the results of an air enthalpy measurement to account for the impact of these effects. For these reasons, DOE determined that a DOE test procedure for portable ACs that includes a measure of infiltration air effects and heat losses would provide consistency and clarity for representation of capacity and energy use for these products. Specific proposals for such a test procedure are discussed in the following sections.
As discussed in the previous section, the results from baseline testing according to AHAM PAC-1-2009 and investigative testing according to the calorimeter approach suggest that the calorimeter approach most accurately represents portable AC performance by accounting for the effects of air infiltration and heat losses.
DOE considered comments received in response to the initial baseline and calorimeter approach results presented in the May 2014 NODA. Appliance Standards Awareness Project, Alliance to Save Energy, American Council for an Energy-Efficient Economy, Consumers Union, Natural Resources Defense Council, and Northwest Energy Efficiency Alliance (hereinafter referred to as the “Joint Commenters”) and the California IOUs observed that the current industry test procedures do not capture the effects of infiltration air and duct heat loss and leakage, which would lead to an overestimation of portable AC
AHAM supports the incorporation by reference of AHAM PAC-1-2014, which is harmonized with CSA C370-2013, in a DOE test procedure for portable ACs. AHAM indicated that AHAM PAC-1-2014 best measures representative performance for each portable AC configuration, in comparison to other approaches. AHAM commented that, unlike other air conditioning products, portable ACs are intended to be easily relocated from one room to another and therefore the compressor and condenser are both inside the conditioned room, as opposed to a room AC, where the compressor and condenser are outside the room. Because a portable AC does not operate in between the conditioned and unconditioned space as room ACs do, and instead is located solely in the conditioned space, AHAM believes that the calorimeter approach, intended for room ACs, may not be as representative as the enthalpy approach for portable ACs. AHAM also commented that ANSI/ASHRAE 128-2011 instructs that it is not to be used for portable ACs with cooling capacities less than 65,000 Btu/h, and ANSI/AHAM 128-2001 does not address all portable AC configurations. AHAM noted that Canada may promulgate portable AC standards using CSA C370-2013, and stated that North American harmonization will provide consistency and clarity for regulated parties and consumers in both countries. (AHAM, No. 4 at p. 2) AHAM acknowledged the differences between rated values and baseline test results obtained using AHAM PAC-1-2009, and stated that a conversion factor between rated values and results obtained using its recommended test procedure, AHAM PAC-1-2014, is not feasible due to the wide range of differences between these values. (AHAM, No. 4 at p. 3)
De' Longhi Appliances s.r.l. (De' Longhi) indicated that the air enthalpy method and a calorimeter method with no air infiltration would ensure levels of reproducibility and repeatability required for regulated products. Further, De' Longhi stated that AHAM PAC-1-2009 and CSA C370-2013 are more suitable for representing performance of all the categories of portable ACs. (De' Longhi, No. 3 at p. 5)
AHAM and De' Longhi also stated that the calorimeter approach is much more burdensome than the air enthalpy approach, requiring more expensive test equipment and longer test times. AHAM believes that adoption of the calorimeter method for testing portable ACs would also require many laboratories to build new test facilities because portable ACs are not currently tested using a calorimeter approach, representing a significant burden. AHAM is also concerned that there are few third-party test laboratories that have the capability to test using a calorimeter approach, which would impact choice and availability for testing. Therefore, AHAM urged DOE to adopt the test approach of AHAM PAC-1-2014 to produce representative test results that are not unduly burdensome to conduct. (AHAM, No. 4 at p. 4) De' Longhi stated that the test burden associated with a test method should be proportionate to the amount of energy consumed by a certain product category. According to De' Longhi, because portable ACs are a small fraction of the air conditioning market with a unique usage pattern, being operated generally for short period of time, the test burden should be minimized. De' Longhi commented that the calorimeter method would result in an unreasonably large burden for this product category, and therefore, the air enthalpy method is preferable due to the higher availability of testing apparatus and lower cost of testing. (De' Longhi, No. 3 at p. 3)
The results presented in Table III.3 and displayed in Figure III.1 demonstrate that the calorimeter method provides a measure of net portable AC cooling capacity and EER across different product configurations and varying air infiltration rates that is comparable to the performance trends obtained according to AHAM PAC-1-2009. However, DOE found in its testing that, although equipment setup is simpler for the calorimeter approach as based on ANSI/ASHRAE Standard 16 requirements, maintaining the conditions in a calorimeter chamber can be difficult, particularly at higher test unit cooling capacities. In those cases, additional climate control components may be necessary, all of which must be monitored to measure the heat transfer to and from the indoor side test room. These additional components may include air circulating fans to ensure conditions are uniform throughout the test room, humidifiers and dehumidifiers to maintain the necessary relative humidity, and scales to measure the evaporated or condensed moisture during testing. Incorporating the heating and cooling effects from each of these components proved to be complex, with potential uncertainties in the net cooling capacity accumulating with each additional component. After considering the burdens and complexity of the calorimeter approach, DOE determined the air enthalpy approach provided in AHAM PAC-1-2009 and AHAM PAC-1-2014 to be a less burdensome approach. Although AHAM PAC-1-2014 requires comprehensive instrumentation to monitor air stream enthalpies and specific measures to ensure that this instrumentation has no impact on performance, it also provides a straight-forward calculation for determining indoor-side cooling based on a well-defined set of variables. Many of the instruments required for the air enthalpy approach, as specified in ANSI/ASHRAE Standard 37, are used in testing central ACs and heat pumps, and ANSI/ASHRAE Standard 37 is also referenced in the DOE test procedure to determine energy consumption of furnace fans. Thus, DOE believes that many commercial laboratories have the capability to perform the air enthalpy test, while few laboratories in the United States have the test chamber and instrumentation required to test according to the calorimeter approach. In addition, the air enthalpy approach, as specified in ANSI/ASHRAE Standard 37 with additional guidance in AHAM PAC-1-2014, is specifically applicable for testing portable ACs, while the calorimeter approach requires modifications from the room AC test procedure specified in ANSI/ASHRAE 16 to accommodate portable ACs.
Therefore, if DOE determines that portable ACs are covered products and establishes a test procedure for them, DOE proposes that AHAM PAC-1-2014 be the basis of the DOE test procedure to ensure that multiple labs are capable of performing the test, to minimize added test burden, and to align with current industry practices. However, as described in the remaining subsections of section III.1.a, DOE believes that additional provisions and clarifications
Infiltration from outside the conditioned space in which the portable AC is located occurs due to the negative pressure induced as condenser air is exhausted to the outdoor space. Although this effect is most pronounced for single-duct units, which draw all of their condenser air from within the conditioned space, dual-duct units also draw a portion of their condenser air from the conditioned space. In its testing, DOE estimated the infiltration air flow rate as equal to the condenser exhaust flow rate to the outdoor chamber minus any condenser intake flow rate from the outdoor chamber because it had determined that air leakage from the outdoor chamber to locations other than the indoor chamber was negligible.
For a single-duct unit, the air balance equation results in the infiltration air flow rate being equal to the condenser exhaust air flow rate. For dual-duct units, the condenser exhaust duct flow rate may be higher than the inlet duct flow rate. This is due to some intake air being drawn from the indoor chamber via louvers or leakage through the case, duct connections, or between the evaporator and condenser sections. Table III.4 presents the estimated infiltration air flow rates for the full test sample.
As discussed in the May 2014 NODA, DOE investigated various infiltration air temperatures. In its initial calorimeter tests, DOE maintained the outdoor test chamber conditions at 95 °F dry-bulb temperature and 75 °F wet-bulb temperature, which would be representative of outdoor air being drawn directly into the conditioned space to replace any condenser inlet air from that same conditioned space. However, it is possible that some or all of the replacement air is drawn from a location other than the outdoors directly, such as a basement, attic, garage, or a space that is conditioned by other equipment. Because varying infiltration air temperature would have a significant impact on cooling capacity and EER, DOE performed additional testing over a range of dry-bulb temperatures for the infiltration air that spanned 78 °F to 95 °F, all at the 40-percent relative humidity specified at the 95 °F condition. 79 FR 26639, 26646 (May 9, 2014).
In response to the May 2014 NODA, the Joint Commenters and California IOUs stated that the current industry standard outdoor air conditions (95 °F dry-bulb temperature and 75 °F wet-bulb temperature) are appropriate for infiltration air. (Joint Commenters, No. 6 at p. 3; California IOUs, No. 5 at p. 3) The Joint Commenters added that although some or all of the infiltration air may be drawn from a location other than the outdoors directly, such as a basement, attic, garage, or a space that is conditioned by other equipment, all infiltration air is ultimately coming from the outdoors and adding heat to the home where the portable AC is installed. (Joint Commenters, No. 6 at p. 3)
AHAM stated that in the field, there is a mixture of indoor and outdoor air, and infiltration air will be at different temperature and humidity levels in every home, due to varying home designs. Therefore, AHAM does not
DOE agrees that, as for all covered products, real-world installations experience varying ambient conditions. The test procedure must thus consider the most representative operation in selecting appropriate specifications for those conditions. Recognizing that in some cases the infiltration air enters the conditioned space directly from outdoors, and that any air infiltrating from other conditioned spaces likely also originated from outdoors before being conditioned by other cooling equipment, DOE concludes that 95 °F dry-bulb temperature and 75 °F wet-bulb temperature is most representative for infiltration air conditions, in accordance with the outdoor conditions specified in AHAM PAC-1-2014, and proposes to specify these conditions in the portable AC test procedure. Such conditions would also produce comparable results for single-duct and dual-duct configurations.
DOE also developed methodology for the May 2014 NODA that would adjust the results obtained from an air enthalpy method to account for the total heat added to the room by the infiltration air. The infiltration air mass flow rate of dry air would be calculated as:
The sensible heat contribution of the infiltration air would be calculated as follows:
DOE used the following equation for the latent heat contribution of the infiltration air:
The total heat contribution of the infiltration air is the sum of the sensible and latent heat.
Table III.5 displays the cooling capacity as determined by the baseline air enthalpy testing approach of AHAM PAC-1-2009, and the modified air enthalpy approach that subtracts the estimated infiltration air heat input from the cooling capacity measurement.
The data above show the significant reduction in cooling capacity and EER
In response to this approach, which was presented in the May 2014 NODA, the Joint Commenters stated that this modified air enthalpy testing approach is not a suitable alternative to the proposed calorimeter approach. According to the Joint Commenters, the alternate testing approach would provide a significant improvement over the current industry test procedures by addressing the impact of infiltration air with a numerical adjustment, but the alternate testing approach fails to capture additional impacts on portable AC performance such as leakage through gaps in the ducts and duct connections and heat transfer through the ducts. The Joint Commenters expressed concern that DOE found no consistent difference between the calorimeter approach and the alternate test approach, and therefore believe the alternate test approach would not necessarily provide a good indication of real-world portable AC performance. Although the alternate testing approach may represent a lower testing burden compared to the calorimeter approach, the Joint Commenters reminded DOE that the current room AC test procedure is based on a calorimeter approach, and stated that the calorimeter approach is also appropriate for portable ACs. (Joint Commenters, No. 6 at p. 3)
DOE recognizes that the modified air enthalpy approach and calorimeter approach both greatly reduce the cooling capacity and EER
Based on the significant heat input from infiltration air seen from testing, DOE determined that applying such a numerical adjustment for infiltration air to the results of testing with AHAM PAC-1-2014 would accurately reflect portable AC performance. Therefore, DOE proposes the adjusted cooling capacity be determined as follows:
AHAM PAC-1-2014 requires two-chamber air enthalpy testing in which the “indoor” standard rating conditions are maintained at the evaporator inlet of 80.6 °F dry-bulb temperature and 66.2
Table III.6 below, based on those test conditions specified in Table 3, “Standard Rating Conditions,” of AHAM PAC-1-2014. The test configurations in
Table III.6 refer to the test configurations referenced in Table 2 of AHAM PAC-1-2014, with Test Configuration 3 applicable to dual-duct portable ACs and Test Configuration 5 applicable to single-duct portable ACs.
For single-duct units, AHAM PAC-1-2014 specifies identical evaporator and condenser inlet conditions, with the same allowable tolerances on the dry-bulb and wet-bulb temperatures. Depending upon the airflow and unit configuration, the evaporator and condenser inlet may be directly adjacent to one another or on opposite faces of the test unit case. Thus, although both evaporator and condenser inlets intake air from the same conditioned space, it is possible that the two inlet air conditions may not simultaneously meet the requirements in AHAM PAC-1-2014 due to slight non-homogeneity in the test chamber, even if one or the other inlet is within tolerance.
Table 2b in Section 8.7 of ANSI/ASHRAE Standard 37-2009, referenced by AHAM PAC-1-2014, specifies that both condenser inlet and evaporator inlet dry-bulb temperatures must be maintained within a range of 2.0 °F and an average within 0.5 °F of the nominal values. However, test chambers may experience varying levels of homogeneity in test conditions and test laboratories may differently prioritize maintaining conditions at either the condenser inlet or evaporator inlet. Therefore, to ensure repeatability and reproducibility, DOE proposes in this NOPR to specify a more stringent tolerance for the evaporator inlet dry-bulb that is consistent with the evaporator inlet wet-bulb temperature tolerance, within a range of 1.0 °F with an average difference of 0.3 °F. The condenser inlet dry-bulb temperature would be maintained within the test tolerance as specified in Table 2b of ANSI/ASHRAE Standard 37-2009. This tolerance modification will ensure that all test laboratories employ the same approach in testing, to first maintain the evaporator inlet test conditions and then ensure that condenser inlet conditions satisfy the tolerance requirements.
As discussed in the May 2014 NODA, portable AC manufacturers typically provide a single mounting fixture for dual-duct units that houses both the condenser inlet and exhaust ducts to minimize installation time and optimize the use of window space. However, this approach typically positions the condenser inlet and exhaust directly adjacent to one another. During operation when installed in the field, short-circuiting may occur between some of the condenser exhaust air and the outdoor ambient air. DOE investigated the effects of potential condenser inlet and exhaust mixing and results indicated that there was minimal mixing between the condenser exhaust and inlet air flows. 79 FR 26639, 26648 (May 9, 2014).
In response to the May 2014 NODA, De' Longhi commented that the condenser inlet and exhaust mixing only has a minimal influence as reported by DOE results. (De' Longhi, No. 3 at p. 4) AHAM agreed with DOE's conclusion that condenser exhaust air and inlet air mixing in dual-duct units need not be addressed or measured in a portable AC test procedure. (AHAM, No. 4 at p. 5)
In response to the May 2014 NODA, the California IOUs commented that it is unclear if there is a standard test set-up in regards to length of ducting and distance from the portable AC to the outdoor chamber. They suggested that DOE should address alignment of the portable AC and the associated ducting, in relation to the outdoor chamber, including distance, duct length, duct insulation, and duct configuration (
DOE also received comments from AHAM and De' Longhi expressing concern about including in a portable AC test procedure the effects of heat loss through minimally insulated ducts. They commented that there is no standardized method to account for such heat loss and that incorporating duct heat loss and leakage would impact test reproducibility and repeatability. AHAM stated that the approach DOE used in its investigative testing for estimating duct heat transfer is overly complicated and unnecessary. Accordingly, AHAM and De' Longhi suggested that the DOE test procedure should not address these factors. (AHAM, No. 4 at pp. 3-4; De' Longhi, No. 3 at p. 3)
As discussed in the May 2014 NODA, DOE investigated cooling performance impacts of uninsulated ducts and any air leakage at the duct connections or mounting fixtures. To quantify the heat transfer to the conditioned space through the minimally insulated condenser duct(s) and from any leaks at the duct connections or mounting fixture, DOE repeated the calorimeter testing with insulation surrounding the condenser ducts to benchmark results without this heat transfer for the initial
Section 7.3.3.3 of ANSI/ASHRAE Standard 37, as referenced by AHAM PAC-1-2014, specifies that the indoor cooling capacity shall be adjusted for heat transferred from the surface of ducts to the conditioned space. DOE recognizes that additional guidance may be necessary to determine such an adjustment, and for this reason proposes to account for heat transferred from the duct surface to the conditioned space in a portable AC test procedure methodology.
DOE proposes that four equally spaced thermocouples be adhered to the side of the entire length of the condenser exhaust duct for single-duct units and to each of the condenser inlet and exhaust ducts for dual-duct units. To ensure accurate heat transfer estimates, DOE proposes that temperature measurements would be required to have an accuracy to within ±0.5 °F. DOE proposes to average the four surface temperatures measurements to obtain T
Heat transferred from the surface of the duct(s) to the indoor conditioned space while operating in cooling mode shall be calculated as follows:
As discussed previously in section III.B.1.a, DOE baseline testing incorporated a case heat transfer calculation, similar to that required to determine the heat transfer from the duct to the conditioned space in ANSI/AHAM Standard 37-2009, in lieu of the evaporator circulating fan heat measurement specified in AHAM PAC-1-2014. To determine case heat transfer, DOE placed four thermocouples on each face of the case to calculate average surface temperatures throughout the cooling mode test period. Table III.7 shows the average surface temperatures during the baseline testing for all single-duct and dual-duct test units.
As shown in Table III.7, surface temperature varies significantly among different case surfaces of a given test unit during cooling mode, and that variation is a function of the particular test unit. For example, temperatures on test unit SD1 ranged from a top surface temperature of 79.4 °F to a bottom side temperature of 84.2 °F, a range of 4.8 °F, while test unit SD10 had a top surface temperature of 76.8 °F and a bottom side temperature of 97.4 °F, a range of 20.7 °F. Because each surface on a given test unit has a unique surface area and average surface temperature, DOE proposes that the heat transfer from the case to the ambient indoor space be calculated individually for each surface.
In response to the same methodology proposed in the May 2014 NODA, AHAM commented that this approach for estimating case heat transfer is overly complicated and unnecessary. AHAM believes that the approach in AHAM PAC-1-2014, which directly measures the evaporator circulating fan heat, is easier and simpler. AHAM also stated that DOE's method would introduce unnecessary variation in test results. (AHAM, No. 4 at p. 3)
DOE acknowledges that the proposed case heat transfer approach would require additional instrumentation. However, DOE believes that the testing burden imposed by the use of multiple thermocouples to measure surface temperatures is likely outweighed by the benefit of addressing the heat transfer effects of all internal heating components. In contrast, AHAM PAC-1-2014 only considers the evaporator fan heat, which is just one of the components that generates heat internally. Further, the proposed surface temperature approach would provide a direct measure of the overall heat transfer of heat-contributing components within the case to the room, without assuming the proportion of heat transferred to either the cooling or heat rejection side.
Therefore, DOE proposes in this NOPR that cooling mode testing include case surface heat transfer measured by means of four evenly spaced thermocouples placed on each case surface. The thermocouples would be positioned such that the case surface, when divided into quadrants, contains at least one thermocouple in each quadrant. If even spacing would result in a thermocouple being placed on an air inlet or exhaust grille, the thermocouple would be placed adjacent to the inlet or exhaust grille, maintaining the even spacing as closely as possible. To ensure accurate heat transfer estimates, DOE proposes to specify that temperature measurements be accurate to within ±0.5 °F. DOE further proposes to average the four surface temperatures measurements on each side to obtain T
The surface area of each case side, A
Heat transferred from all case sides to the indoor conditioned space would be calculated according to the following:
Many portable ACs include a feature to re-evaporate the condensate and remove it from the indoor space through the condenser exhaust air stream. This feature is performed by slinging or directing condensate that collects and drips off of the evaporator on to one or multiple condenser coil surfaces. All units in DOE's test sample included this feature. In the event that the condensate collection rate exceeds the removal rate of the auto-evaporation feature and the internal condensate collection bucket fills, all of the units provide a drain option to remove the collected condensate. Portable ACs typically ship with this drain sealed with a temporary plug, although a consumer-supplied drain line may also be installed. Manufacturer setup instructions typically do not specify that a drain line be installed during normal operation, relying primarily instead on the auto-evaporative condensate removal feature.
In response to the May 2014 NODA, the California IOUs confirmed DOE's research and indicated that there are different methods of handling condensate. Units may include an internal reservoir with a fill sensor to interrupt operation until the reservoir is emptied, a heater to re-evaporate the water into the exhaust air stream, or slingers that pass the condensate over the condenser to re-evaporate condensate and improve heat transfer. The California IOUs recommended that DOE address the different means of condensate handling. (California IOUs, No. 5 at p. 4) DOE agrees that a portable AC test procedure should recognize various methods of condensate removal to ensure comparable results among units with different condensate removal approaches.
DOE's investigative testing was conducted with a drain line attached to simplify condensate draining if necessary, but the line was elevated to simulate testing with the drain plug in place. Nonetheless, DOE observed that the auto-evaporation feature was effective for all test units under testing conditions so that no unit cycled off due to a full condensate bucket. Therefore, DOE proposes that the portable AC under test be set up in accordance with manufacturer instructions. If an auto-evaporative feature is provided along with a condensate drain, and the drain setup is unspecified, the drain plug would remain in place as shipped and no means of condensate removal would be installed for the duration of cooling mode testing. If the internal bucket fills during testing, the test would be invalid and halted, the drain plug would be removed, means would be provided to drain the condensate from the unit, and the test would be started from the beginning.
Section 7.1.2 of AHAM PAC-1-2014 contains provisions for portable ACs that incorporate condensate pumps that cycle to dispose condensate collected by the unit. DOE found through market
Section 6.3.3 of AHAM PAC-1-2014 states that “. . . equipment recommended as part of the air conditioner shall be in place.” Therefore, DOE proposes that portable AC cooling mode testing would be performed in accordance with manufacturer installation and setup instructions, unless otherwise specified in the DOE test procedure. In addition, where available and as instructed by the manufacturer, DOE proposes that the auto-evaporation feature would be utilized for condensate removal during cooling mode testing. If no auto-evaporative feature is available, the gravity drain would be used. If no auto-evaporative feature or gravity drain is available, or if the manufacturer specifies the use of an included condensate pump during cooling mode operation, then DOE proposes that the portable AC would be tested with the condensate pump enabled. For these units, DOE also proposes to require the use of Section 7.1.2 of AHAM PAC-1-2014 if the pump cycles on and off.
Portable ACs typically incorporate electronic controls that allow selection of the fan speed during cooling or heating mode. The highest fan speed will produce the most rapid rate of cooling or heating, while the lower fan speeds may be provided to reduce noise. Section 7.3.1 of AHAM PAC-1-2014 states that all adjustable settings, including fan speed, shall be set to achieve maximum capacity. Although the fan speed setting is clearly specified, it is not clear what setting should be selected for the cooling or heating setpoint. Many portable ACs have controls that allow consumers to select a target temperature, for example by setting the desired temperature or by adjusting a dial to a more or less cool setting. When the cooling setpoint temperature is lower than the ambient temperature, or higher than the ambient temperature in heating mode, the portable AC will operate continuously. AHAM PAC-1-2014 requires that the test chamber be maintained at 80.6 °F throughout the cooling mode test period, during which the unit must operate continuously, but does not specify a particular cooling setpoint temperature. To ensure that the test unit does not enter off-cycle mode, the test operator must select a control setting that corresponds to a temperature lower than 80.6 °F, particularly because no portable ACs in DOE's test sample included a “continuous on” setting. Because DOE acknowledges the potential for a unit to operate differently when cooling controls are set to different target temperatures below 80.6 °F, DOE proposes during cooling mode testing that the fan be set at the maximum speed if the fan speed is user adjustable and the temperature controls be set to the lowest available value. Similarly, as discussed in section III.B.1.b.i, DOE proposes during heating mode testing that the fan be set at the maximum speed if the fan speed is user adjustable and the temperature controls be set to the highest available value. These settings would likely best represent the settings that a consumer would select to achieve the primary function of the portable AC, which is to cool or heat the desired space as quickly as possible and then to maintain these conditions.
A number of test units in DOE's test sample included the option to oscillate the evaporator exhaust louvers to help circulate air throughout the conditioned space. Although AHAM PAC-1-2014 does not directly address louver oscillation, Section 7.3.1 of AHAM PAC-1-2014 states that all adjustable setting such as louvers, fan speed, and special functions must be set for maximum capacity. Accordingly, if there is a setting that automatically opens and closes the louvers, this feature would be disabled for the entirety of the rating test period, and the louvers would be opened to allow maximum capacity. If there is a manual setting to control louver direction and opening size, in accordance with section 7.3.1 of AHAM PAC-1-2014, the louvers shall be fully open to provide maximum airflow and capacity, and be positioned parallel to the air flow. However, this provision does not address an oscillating louver function that maintains constant and maximum louver exhaust area while redirecting the evaporator exhaust air flow. DOE does note, though, that AHAM PAC-1-2014 requires a constant external static pressure that is consistent with typical operation. The static pressure is initially affected by the test instrumentation that is placed over the evaporator exhaust grille to capture and measure the air flow rate, temperature, and humidity, such that a variable speed fan is required to adjust the external static pressure to ensure it is representative of normal operation. If the louvers were oscillating during the test period, the external static pressure measured at the evaporator exhaust would vary cyclically and thus the test would no longer be compliant with the required conditions. Also, oscillating louvers may interfere with the temperature and humidity instrumentation and possibly dislodge them, which could impact the measured performance and the integrity of the test procedure. In addition, DOE lacks information on the percentage of time that this feature is selected among those units equipped with oscillating louvers. Therefore, to provide comparable testing results in cooling mode for products with and without a louver oscillation feature, DOE proposes that portable AC cooling mode testing be conducted with any louver oscillation feature disabled. If the feature is included but there is no option to disable it, testing shall proceed with the louver oscillation enabled, without altering the unit construction or programming. DOE requests feedback on the proposal to disable louver oscillation where available and to maximize louver opening, either manually or by disabling an automatic feature.
Section 8.1.3 of ANSI/ASHRAE Standard 37 states that the outdoor condition test room must be of sufficient volume and circulate air in a manner that does not change the normal air-circulation patterns of the unit under test. Specifically, the dimensions of the room must be sufficient to ensure that the distance from any room surface to any equipment surface where air is discharged is not less than 6 feet and the distance to all other equipment surfaces must be no less than 3 feet. However, no comparable requirements are specified for the indoor test room. When tested according to AHAM PAC-1-2014 and ANSI/ASHRAE Standard 37, a portable AC is set up entirely within the indoor condition test room with the evaporator exhaust connected to instrumentation and ducted away from the test unit, and the condenser exhaust ducted with instrumentation to the outdoor test room. In that case, the requirements in Section 8.1.3 of ASNI/ASHRAE Standard 37 are not applicable, as no part of the case is within the outdoor condition test room. Instead, the portable AC is placed in the indoor condition test room, where walls and other obstructions may impede air flow
Section 7.3.2 of AHAM PAC-1-2014 does not require a specific test voltage, but rather states that the nameplate voltage shall be used. DOE notes that its dehumidifier test procedure requires a test voltage of either 115 or 230 volts (V), and these voltages would be comparable to those required for portable ACs, which are similar consumer products. To maintain repeatability and reproducibility for portable AC testing, DOE proposes that for active mode testing, the input standard voltage would be maintained at 115 V ±1 percent. DOE also proposes that the electrical supply be set to the nameplate listed rated frequency, maintained within ±1 percent.
In response to the May 2014 NODA, DOE received a comment from the California IOUs suggesting that any future DOE test procedure for portable ACs include a measure of heating mode energy consumption. They stated that about 25 percent of models for sale at a major home improvement retailer include a heating function, and all of these models were marketed as a portable AC. The California IOUs suggested that DOE should ensure that the scope of a proposed test procedure that covers any products marketed as a portable AC also include testing the product's heating performance. (California IOUs, No. 5 at pp. 3-4)
DOE is aware that certain portable ACs, including some of the units in DOE's test sample, incorporate a heating function in addition to cooling and air-circulation modes. During teardowns, DOE found that there are two primary approaches to implement a heating function for portable ACs. The first, and most common, is a reverse-cycle heat pump, which requires a four-way reversing solenoid valve in the refrigerant loop that reroutes the refrigerant flow and converts the cooling air conditioning system to a heat pump. The second type of heating that DOE observed during teardowns was a resistance heater installed adjacent to the evaporator and in line with the evaporator exhaust air stream.
In consideration of the comment received and DOE's market and teardown observations, DOE conducted additional research to determine whether it could incorporate appropriate test methodology to measure heating mode energy consumption in a DOE portable AC test procedure.
ANSI/ASHRAE Standard 37, the basis for DOE's proposed air enthalpy cooling mode test procedure, is intended for heat pump equipment in addition to air conditioning equipment. Section 1.1 of ANSI/ASHRAE Standard 37 states that the purpose of the standard is, in addition to determining cooling capacity of air conditioning equipment, providing methods to determine cooling and heating capacities of heat pump equipment. DOE reviewed ANSI/ASHRAE Standard 37 and determined that the same test chamber and instrumentation requirements and capacity calculations would apply to portable AC heating mode testing as for the proposed cooling mode testing. Further, as with the cooling mode test, the unit configurations included in AHAM PAC-1-2014 would be applicable to a heating mode test. Therefore, DOE proposes that the test unit be set up for a heating mode energy consumption test in accordance with the unit and duct setup requirements of AHAM PAC-1-2014, including those in Table 2 and Figure 1 of that standard. DOE also proposes to specify the same test requirements as for cooling mode, including infiltration air, duct heat transfer, case heat transfer, control settings, and test unit placement, discussed in the subsections of section III.B.1.a of this NOPR. However, DOE proposes that the temperature setpoint for heating mode be at the highest available temperature setting to ensure continuous operation.
ANSI/ASHRAE Standard 37 specifies the test setup, instrumentation, and test conduct, but does not specify the ambient test conditions for testing. For cooling mode, AHAM PAC-1-2014 provides the ambient test conditions for testing. To determine appropriate test conditions for a heating mode test, DOE reviewed ANSI/Air-Conditioning, Heating, and Refrigeration Institute (AHRI) 210/240—2008, “Performance Rating of Unitary Air-Conditioning and Air-Source Heat Pump Equipment” (ANSI/AHRI 210/240), which provides test conditions for determining performance of ACs and heat pumps. Table 4 of Section 6.1.4.2 of ANSI/AHRI 210/240 provides three test conditions in heating mode for a heat pump with a single-speed compressor and a fixed-speed indoor fan. The indoor air temperatures are the same for all three tests, 70 °F dry-bulb and 60 °F wet-bulb. For the outdoor air inlet temperatures, the high-temperature test, “H1,” requires 47 °F dry-bulb and 43 °F wet-bulb, while the frost accumulation test, “H2,” requires 35 °F dry-bulb and 33 °F wet-bulb, and the low-temperature test, “H3,” specifies 17 °F dry-bulb and 15 °F wet bulb.
DOE believes that the test conditions for H1 are the most representative of typical heating mode use for portable ACs, which are likely used as supplemental or low-capacity heaters when a central heating system is not necessary or operating. Therefore, DOE proposes the following ambient air test conditions as shown in Table III.8 below, with the test configurations referring to the test configurations referenced in Table 2 of AHAM PAC-1-2014. Test Configuration 3 is applicable to dual-duct portable ACs, and Test Configuration 5 is applicable to single-duct portable ACs. DOE notes that the terms “Evaporator” and “Condenser” refer to the heat exchanger configuration in cooling mode, not the reverse-cycle heating mode. This terminology maintains consistency with the cooling mode test conditions specification and would still be applicable for portable ACs that incorporate a resistance heater.
Under the proposed heating mode testing conditions, DOE expects that the calculations provided by AHAM PAC-1-2014 would result in negative cooling (
Certain portable ACs maintain blower operation without activation of the compressor after the temperature setpoint has been reached, rather than entering standby mode or off mode, or may operate with a combination of periods of blower operation and standby mode after reaching the setpoint. The fan-only operation may be intended to draw air over the internal thermostat to monitor ambient conditions, or may occur immediately following a period of cooling mode to defrost and dry the evaporator coil (or the condenser coil when operating in reverse-cycle heating mode). The blower may operate continuously, or may cycle on and off intermittently. In addition, some units allow the consumer to select operation of the blower continuously for air circulation purposes, without activation of the refrigeration system.
The existing industry portable AC test procedures do not presently contain provisions to measure energy use during this fan-only operation. However, DOE recently proposed a method for determining fan-only mode energy use in DOE's test procedure for dehumidifiers based on existing methodologies for measuring power consumption in standby mode and off mode (hereinafter referred to as the “dehumidifier test procedure NOPR”). 79 FR 29272 (May 21, 2014). In the dehumidifier test procedure NOPR, DOE proposed measuring fan-only mode average power by adjusting the setpoint to a relative humidity that is higher than the ambient relative humidity to ensure that the refrigeration system does not cycle on. To minimize testing burden, DOE proposed that the testing may be conducted immediately after the conclusion of dehumidification mode testing while maintaining the same ambient conditions, or may be conducted separately under the test conditions specified for standby mode and off mode testing.
In the dehumidifier test procedure NOPR, DOE observed that the period of cyclic fan operation was approximately 10 minutes for dehumidifiers with cyclical fan-operation in fan-only mode. In addition, DOE's research indicated that some units may cycle on for a period of a few minutes per hour. In order to obtain a representative average measure of fan-only mode power consumption, DOE proposed that the fan power be measured and averaged over a period of 1 hour for fan-only mode in which the fan operates continuously. For fan-only mode in which the fan operates cyclically, the average fan-only mode power would be measured over a period of 3 or more full cycles for no less than 1 hour. DOE also clarified that units with adjustable fan speed settings would be set to the maximum fan speed during fan-only mode testing, because the maximum speed is typically recommended to consumers as the setting that produces the maximum moisture removal rate.
DOE subsequently published a supplemental notice of proposed rulemaking (SNOPR) on February 4, 2015, that modified the proposal in the dehumidifier test procedure NOPR based on feedback from interested parties and further research (hereinafter referred to as the “dehumidifier test procedure SNOPR”). 80 FR 5994. DOE withdrew the fan-only mode definition proposed in the dehumidifier test procedure NOPR and instead modified the proposed “off-cycle mode” definition to encompass all operation when dehumidification mode has cycled off after the humidity setpoint has been reached. DOE proposed to define off-cycle mode as a mode in which the dehumidifier:
(1) Has cycled off its main moisture removal function by humidistat, humidity sensor, or control setting;
(2) May or may not operate its fan or blower; and
(3) May reactivate the main moisture removal function according to the humidistat or humidity sensor signal.
(
During investigative testing for this rulemaking, DOE found that all portable ACs in its test sample operate the fan in off-cycle mode, similar to dehumidifiers, once cooling mode operation reduces the ambient temperature below the set point. DOE investigated the approach for measuring this fan operation as a part of off-cycle mode, as was proposed in the dehumidifier test procedure SNOPR, and found that it was applicable to portable ACs. Table III.9 shows the results from this portable AC off-cycle mode investigative testing.
Due to the similarity between dehumidifiers and portable ACs, and to maintain harmonization among similar test procedures, DOE proposes in this NOPR that off-cycle mode for portable ACs be defined as proposed in the dehumidifier test procedure SNOPR, modified for portable AC operation in either cooling or heating mode. Specifically, DOE proposes to define off-cycle mode as a mode in which the portable air conditioner:
(1) Has cycled off its main heating or cooling function by thermostat or temperature sensor;
(2) May or may not operate its fan or blower; and
(3) Will reactivate the main cooling or heating function according to the thermostat or temperature sensor signal.
In the dehumidifier test procedure SNOPR, DOE proposed that off-cycle mode measurement begin immediately following compressor operation for the dehumidification mode test to ensure sufficient condensation on the evaporator to initiate fan operation for those units that dry the evaporator coil. DOE asserted that conducting the off-cycle mode test subsequent to the dehumidification mode test would capture all energy use of the dehumidifier under conditions that meet the newly proposed off-cycle mode definition, including fan operation intended to dry the evaporator coil, sample the air, or circulate the air. 80 FR 5994.
In this NOPR, DOE proposes that portable AC off-cycle mode energy use be measured five minutes after the termination of compressor operation in cooling mode. Because the evaporator is still cool at the end of compressor operation in cooling mode, additional room cooling is possible through continued fan operation at relatively low energy consumption. Therefore, DOE proposes the 5-minute delay before the start of off-cycle mode testing to prevent penalizing manufacturers for utilizing the cooling potential of the evaporator following the compressor cycle. Continued fan operation once that cooling potential is no longer available would be included as off-cycle mode energy consumption and factored into the CEER measurement.
In the dehumidifier test procedure SNOPR, DOE determined, based on data from its testing, that 2 hours is a typical off-cycle duration and would therefore be a representative test duration for off-cycle mode. 80 FR 5994. In lieu of field data for portable AC operation in off-cycle mode, and due to the similarity between typical portable dehumidifiers and portable ACs, DOE believes that the analysis conducted for dehumidifiers is representative for portable ACs. Therefore, DOE proposes that the off-cycle mode test begin 5 minutes after the completion of the cooling mode test and end after a period of 2 hours. DOE further proposes that the electrical supply be the same as specified for cooling mode, as discussion section III.B.1.a.ix, and that this measurement be made using the same power meter specified for standby mode and off mode, as discussed in section III.3.
DOE further proposes to require that, for units with adjustable fan speed settings, the fan be set at the maximum speed during fan-only mode testing, because the maximum speed is typically recommended to consumers as the setting that produces the maximum rate of cooling or heating.
DOE estimates that off-cycle mode energy consumption is similar for periods following both heating mode and cooling mode because the fan speed setting is selected by the same controls and all other significantly energy consumptive components are disabled. Therefore, to minimize testing burden, DOE proposes that off-cycle mode testing be conducted only after cooling mode. Annual hours for off-cycle mode would be allocated for the total hours in this mode following either cooling mode or heating mode.
Section 310 of the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, amended EPCA to require DOE to amend the test procedures for covered products to address standby mode and off mode energy consumption. Specifically, the amendments require DOE to integrate standby mode and off mode energy consumption into the overall energy efficiency, energy consumption, or other energy descriptor for each covered product unless the current test procedures already fully account for such consumption or integration of such test procedure is technically infeasible. If integration is technically infeasible, DOE must prescribe a separate standby mode and off mode energy use test procedure, if technically feasible. (42 U.S.C. 6295(gg)(2)(A)) Any such amendment must consider the most current versions of IEC Standard 62301, “Household electrical appliances—Measurement of standby power,” and IEC Standard 62087, “Methods of measurement for the power consumption of audio, video, and related equipment.”
In addition, these amendments direct DOE to incorporate standby mode and
Should DOE determine to classify portable ACs as a covered product, DOE would be required to promulgate energy conservation standards that incorporate energy use in active mode, standby mode, and off mode into a single metric, if feasible, in accordance with EISA 2007. (42 U.S.C. 6295 (gg)(3)) In addition, a DOE test procedure for portable ACs would be required to measure and, if feasible, integrate standby mode and off mode energy consumption into the overall energy descriptor. (42 U.S.C. 6295 (gg)(2)) Therefore, DOE is proposing the following definitions and methods to measure standby mode and off mode energy consumption for portable ACs. Based on the similar components and primary function to room ACs and dehumidifiers, DOE proposes standby mode and off mode definitions for portable ACs that are similar to those included in the room AC and dehumidifier test procedures found in appendix F and appendix X, respectively, codified at 10 CFR part 430, subpart B.
“Standby mode” would mean any mode where a portable air conditioner is connected to a mains power source and offers one or more of the following user-oriented or protective functions which may persist for an indefinite time:
(a) To facilitate the activation of other modes (including activation or deactivation of active mode) by remote switch (including remote control), internal sensor, or timer; or
(b) Continuous functions, including information or status displays (including clocks) or sensor-based functions. A timer is a continuous clock function (which may or may not be associated with a display) that provides regular scheduled tasks (
DOE is aware of two relevant modes that would meet the proposed definition of standby mode for portable ACs: (1) Inactive mode and (2) bucket-full mode.
Portable ACs often include a digital control board with switches or a remote control device to modify settings and initiate or disable cooling, heating, or air circulation. When the unit is plugged in and awaiting a signal to initiate one of the active modes, it would be considered to be in “inactive mode.” That is, inactive mode would be defined as a standby mode that facilitates the activation of active mode by remote switch (including remote control), internal sensor, or timer, or that provides continuous status display.
Unlike room ACs, portable ACs are installed and operated entirely within the conditioned space, and thus do not have a means to discharge any liquid condensate directly outdoors. Although many portable ACs incorporate a feature to re-evaporate the condensate and exhaust it in the condenser outlet air stream, under certain ambient conditions this moisture removal rate may not be high enough to exhaust all of the condensate. Thus, portable ACs may enter a “bucket-full mode” when the condensate level in the internal collection container reaches a manufacturer-specified threshold or the collection container is removed; any cooling, heating, or air-circulation functions are disabled; and an indication is provided to the consumer that the container is full. The portable AC will reactivate the main cooling, heating, or air-circulation function once the collection container is drained or emptied and is in place in the unit.
DOE is also aware of an additional low-power mode for portable ACs with power consumption levels comparable to inactive mode and bucket-full modes. “Delay-start mode” facilitates activation of an active mode by a timer. Due the similarity in power consumption levels between delay-start mode and inactive mode, DOE proposes to consider the power consumption in inactive mode as representative of delay-start mode and to include the operating hours for delay-start mode in the estimate for inactive mode operating hours for the purposes of calculating a combined metric. In other words, DOE is not proposing to measure delay-start mode. DOE believes that this approach will minimize test burden and simplify testing and determination of overall performance.
Although all units in DOE's test sample had electronic controls and therefore default to inactive mode when connected to a power source, DOE recognizes that some portable ACs may instead utilize electromechanical controls, and therefore may employ an “off mode,” in which a portable AC is connected to a mains power source and is not providing any active mode or standby mode function, and where the mode may persist for an indefinite time. An indicator that only shows the user that the product is in the off position is included within the classification of an off mode.
In accordance with the requirements of EISA 2007, DOE is proposing to specify testing equipment and conditions for measuring standby mode and off mode power consumption in the portable AC test procedure based on the provisions from IEC Standard 62301. (42 U.S.C. 6295 (gg)(1)(B)) The measured wattages would then be used in calculations to determine standby mode and off mode energy consumption. DOE has reviewed IEC Standard 62301, and tentatively concluded that it is generally applicable to portable ACs, with certain clarifications, and notes that a similar determination has already been made for the DOE test procedures for closely-related covered products, such as dehumidifiers and room air conditioners. AHAM PAC-1-2014 also references IEC Standard 62301 for portable AC standby power measurements.
In examining portable AC operation, DOE recognizes that there is a certain commonality between inactive mode and bucket-full mode, in that there are no major energy-consuming components energized and there is typically only a display to the consumer that provides information as to product status. Therefore, DOE expects that the power consumption these two modes is comparable.
In the interest of reducing testing burden, DOE proposes not to require the power consumption in both of these modes be measured individually. Rather, DOE proposes that the power consumption in just inactive mode would be measured, and the annual hours assigned to that power measurement would be the sum of annual hours for inactive mode and bucket-full mode. DOE requests comment on this proposed simplification of testing, including whether the resulting calculation would adequately represent product energy use and whether it would instead be appropriate to measure each mode separately.
DOE proposes that the test room ambient air temperatures for standby mode and off mode testing would be specified in accordance with Section 4, Paragraph 4.2 of IEC Standard 62301. The IEC standard specifies a temperature range of 73.4 ± 9 °F, while the proposed DOE test procedure for portable ACs would specify an indoor-side test room ambient temperature of 80.6 ± 0.5 °F dry-bulb temperature for the cooling mode test and 70.0 ± 0.5 °F
For the duration of standby-mode and off-mode testing, DOE proposes that the electrical supply voltage shall be maintained at 115 V ±1 percent and supply frequency would be maintained at the rated frequency within ±1 percent. DOE notes that these requirements are consistent with those proposed for cooling mode, and the tolerances are in accordance with Section 4, Paragraph 4.3.1 of IEC Standard 62301. The supply voltage waveform and wattmeter would comply with the requirements in Section 4, Paragraphs 4.3.2 and 4.4 of IEC Standard 62301, respectively.
DOE is aware that some portable ACs may reduce power consumption after a period of user inactivity after entering standby mode or off mode. For products whose power consumption in standby mode or off mode varies in this manner during testing, DOE proposes that the test for inactive mode and off mode be conducted after the power level has dropped to its lowest level, as discussed in Note 1 in Section 5.1 of IEC Standard 62301. DOE further proposes that the test procedure in Section 5, Paragraph 5.3.2 of IEC Standard 62301 then be followed for inactive mode, off-cycle mode, and off mode, as available on the test unit.
In accordance with the requirements of EISA 2007, DOE is required for covered products to establish a single energy conservation standard metric that incorporates standby mode and off mode energy use, if feasible, for standards adopted after July 1, 2010. (42 U.S.C. 6295(gg)(3)(A)) For certain products, including dehumidifiers and room ACs, DOE has combined the energy use for active modes, off-cycle mode, standby modes, and off mode into a single efficiency metric using a weighted average based on annual operating hours in each mode. DOE proposes a similar approach for portable ACs based on operating hours per mode which may be available on the unit, including cooling mode, heating mode, off-cycle mode (with and without fan operation), inactive mode (including bucket-full mode), and off mode. As discussed previously in section III.B.1 of this NOPR, DOE is not addressing dehumidification mode for portable ACs in this proposal because the annual operating hours are likely small and it is not technically feasible to integrate the efficiency descriptor with an EER metric.
DOE proposes the following approach to combine energy use in each of the considered modes into a single integrated efficiency metric, CEER. Average power in each mode would be measured according to the proposals in section III.B.1.a through section III.B.1.2 and section III.B.3 of this NOPR, and then individually multiplied by the annual operating hours for each respective mode, discussed in section III.4.b of this NOPR.
Total annual energy consumption in all modes except cooling and heating would be calculated as follows.
In this NOPR, DOE proposes in 10 CFR 430.23 that the annual energy consumption in cooling mode, AEC
For units with only cooling mode, a combined cooling mode EER (CEER
For portable ACs without a heating function, the overall energy efficiency metric, or CEER, would be equal to the CEER
DOE developed several estimates of portable AC annual operating mode hours for cooling, heating, off-cycle, and inactive or off modes. DOE proposes the CEER calculations and proposes one of the estimates of annual mode hours that would be used to obtain an integrated measure of energy use in all operating modes. DOE requests comment on the proposed CEER calculation and estimates.
Because the primary function of portable ACs and room ACs is similar, DOE considered the room AC annual operating hours presented in the room AC test procedure NOPR (hereinafter referred to as “the room AC test procedure NOPR”)
However, DOE notes that these calculations consider use of portable ACs only during the cooling season. As discussed above in section III.1.b, certain portable ACs may provide a heating function and therefore may be operated during the heating season. Although DOE believes that the room AC cooling season length is relevant and representative of the portable AC cooling season due to the similar function provided to the consumer, DOE does not believe that the 2,160 hours estimated for cooling season would be representative of the heating season length. Therefore, DOE researched portable AC heating season length. As a starting point, DOE looked to the furnace test procedure located at appendix N of 10 CFR part 430, which identifies the heating season length as 4,160 hours.
To refine this estimate for portable ACs, DOE performed a climate analysis using 2012 hourly ambient temperature data from the National Climatic Data Center (NCDC) of the National Oceanic and Atmospheric Administration (NOAA), collected at weather stations in 44 representative states. DOE first calculated the number of annual hours per state associated with each temperature (in 1 °F intervals) from the NCDC data. DOE then reviewed data from the 2009
Based on the
DOE further estimated the hours associated with each operating mode within the cooling and heating seasons. Because the primary cooling function is similar between portable ACs and room ACs, DOE believes that the mode hours in cooling season would be apportioned similarly for both products. In its room AC analysis, DOE determined that, for units capable of all operating modes, 750 operating hours would be in cooling mode, 440 hours would be in off-cycle mode, 440 hours would be in fan-only mode, 90 hours would be in delay-start mode, and 440 hours would be in inactive mode and/or off mode during the cooling season. 73 FR 74639, 74648-74649 (December 9, 2008). In the room AC analysis, fan-only mode was defined as “an active mode in which the compressor shuts down when operating in constant-fan mode or user selection of fan-only operation.” As discussed above, fan operation when the compressor has cycled off is considered as off-cycle mode for the purposes of this NOPR. Also, because DOE is not proposing to measure or allocate hours to air circulation mode, any hours associated with that mode would be attributed to off-cycle mode. For portable ACs, DOE also proposes to allocate any bucket-full and other low-power mode hours to inactive/off mode hours. For portable ACs with a heating function, DOE estimated that the same ratio of mode hours to season length for the cooling season would be applicable for the available modes during heating season. The operating hours in off mode and inactive mode include operation during heating and cooling season as well as the plugged-in hours during the remainder of the year. Applying all of these apportionments, DOE developed estimates for the hourly operation in each mode, shown in Table III.11, based on the three approaches described above for estimating heating season length.
DOE proposes that the annual operating mode hours in the “Cooling Only” scenario presented in Table III.11 be used when calculating CEER
DOE requests feedback on these proposed annual operating mode hours to be used in the CEER
To provide further insight on these annual operating mode hours and explore possible alternate scenarios for operating mode allocations during the cooling season, DOE considered the analysis presented in the Burke Portable AC Study. In that study, metered data for 19 portable ACs were analyzed to develop models that estimate the percent of time spent in cooling, fan-only, and standby modes as a function of the outdoor temperature. DOE notes that these modes as defined in the Burke Portable AC Study are not entirely consistent with the mode definitions proposed in this NOPR; however, DOE expects that they would align reasonably well with cooling mode, off-cycle mode, and inactive or off mode, respectively. The models in the Burke Portable AC Study were developed for two applications for portable ACs: (1) Residential use, which DOE expects to represent daily consumer interaction with the portable AC (
Because these two models present mode operation in cooling season as a function of outdoor temperature, DOE conducted further analysis based on consumer and climate data to determine the most representative average cooling season outdoor temperature for portable AC usage. To do so, DOE used the same analytical approach as it used to determine heating season length, based on the 2009
DOE combined the individual states' average outdoor temperatures from June through September using a weighted-average approach based on the
DOE used this outdoor temperature with the models developed in the Burke Portable AC Study to calculate the estimated percent of time spent in cooling, off-cycle, and off or inactive modes during the cooling season. The operating mode time as a percentage of cooling season hours for both residential applications (low-use Scenario 1) and commercial applications (high-use Scenario 2) are shown in Table III.12. DOE also presents a third scenario that is an average of the low-use and high-use scenarios to estimate overall typical portable AC usage patterns.
For comparison with DOE's proposed cooling mode annual hour estimate of 750 hours, DOE applied these percentages to the estimated cooling season length of 2,160 hours. This results in cooling mode operating hours of 126, 887, and 507, for the usage patterns modeled in Scenario 1, Scenario 2, and Scenario 3, respectively. Note that if DOE were to use one of these model scenarios as the basis for all operating mode hours in cooling season, the proposed total annual off-cycle mode and total off/inactive mode hours would also be adjusted to account for the cooling season percentages in Table III.12. DOE notes that the cooling season mode operating hour percentages in these scenarios differ from the proposed approach that utilizes the room AC cooling season mode operating hour estimates.
DOE requests feedback on the alternative scenarios presented in this NOPR or other data that may inform the allocation of annual operating hours in each mode.
DOE is proposing the following sampling plan and rounding requirements for portable ACs to enable manufacturers to make representations of energy consumption or efficiency metrics. The sampling requirements would be included in the proposed 10 CFR 429.62. Specifically, DOE is proposing that the general sampling requirements of 10 CFR 429.11 for selecting units to be tested be applicable to portable ACs. In addition, DOE is proposing that for each portable AC basic model, a sufficient sample size must be randomly selected to ensure that a representative value of energy consumption for a basic model is greater than or equal to the higher of the mean of the sample or upper 95 percent confidence limit (UCL) of the true mean divided by 1.10. For EER
This proposed sampling plan for portable ACs is consistent with sampling plans already established for dehumidifiers and other similar products. DOE notes that certification requirements for portable ACs, which would also be located at 10 CFR part 429, would be proposed in the concurrent energy conservation standards rulemaking.
DOE also proposes that all calculations be performed with the unrounded measured values, and that the reported cooling or heating capacity
EPCA requires that any test procedures prescribed or amended shall be reasonably designed to produce test results which measure energy efficiency, energy use, or estimated annual operating cost of a covered product during a representative average use cycle or period of use, and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3)) For the reasons that follow, DOE has tentatively concluded that establishing a DOE test procedure to measure the energy consumption of portable ACs in active mode, standby mode, and off mode would produce the required test results and would not result in any undue burdens.
As discussed in section IV.B of this NOPR, the proposed test procedure would require testing equipment and facilities that are not substantially different than those that manufacturers are currently using for testing in order to report portable AC ratings to the CEC and likely already using for certifying to DOE the performance of packaged terminal ACs (PTACs), which many of the portable AC manufacturers also produce. Thus, these manufacturers are likely already equipped to test portable ACs, or are testing their products in third-party laboratories that are similarly equipped. Therefore, the proposed test procedure would not require these manufacturers to make a significant investment in test facilities and new equipment.
In addition, DOE carefully considered testing burden in proposing a modified air enthalpy method for measuring energy use in cooling mode and heating mode that is significantly less burdensome than the calorimeter method. DOE is also proposing an approach for measuring low-power mode energy use that would preclude testing of each possible mode individually and instead would require only testing modes in which the portable AC may consume significant amounts of energy, thereby reducing burden further.
Therefore, DOE determined that the proposed portable AC test procedure would produce test results that measure energy consumption during representative use, and that the test procedure would not be unduly burdensome to conduct.
Under 42 U.S.C. 6295(gg)(2)(A), EPCA directs DOE to consider IEC Standard 62087 when amending test procedures for covered products to include standby mode and off mode power measurements. DOE reviewed IEC Standard 62087, “Methods of measurement for the power consumption of audio, video, and related equipment” (Edition 3.0 2011-04), and has tentatively determined that it would not be applicable to measuring power consumption of electrical appliances such as portable ACs. Therefore, DOE determined that referencing IEC Standards 62087 is not necessary for the proposed test procedure that is the subject of this rulemaking.
The Office of Management and Budget (OMB) has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the OMB.
The Regulatory Flexibility Act (5 U.S.C. 601
DOE reviewed this proposed rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. The proposed rule prescribes the test procedure to measure the energy consumption of portable ACs in active modes, standby modes, and off mode. DOE tentatively concludes that this proposed rule would not have a significant impact on a substantial number of small entities. The factual basis for this certification is as follows:
The Small Business Administration (SBA) considers a business entity to be small business, if, together with its affiliates, it employs less than a threshold number of workers specified in 13 CFR part 121. These size standards and codes are established by the North American Industry Classification System (NAICS). The threshold number for NAICS classification code 333415, “Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing,” which includes manufacturers of portable ACs, is 750 employees.
DOE surveyed the AHAM member directory to identify manufacturers of residential portable ACs. DOE then consulted publicly available data, purchased company reports from vendors such as Dun and Bradstreet, and contacted manufacturers, where needed, to determine if the number of manufacturers with manufacturing facilities located within the United States that meet the SBA's definition of a “small business manufacturing facility.” Based on this analysis, DOE estimates that there is one small business that manufactures portable ACs.
This proposed rule would establish a DOE test procedure for portable ACs, which would require testing units according to an industry standard, AHAM PAC-1-2014, with additional calculations. Although there are no current DOE energy conservation standards for portable ACs, many manufacturers have reported cooling capacity and EER of these products to the CEC, which requires testing
The small business mentioned above does not list any portable AC models in the CEC product database, so DOE is uncertain whether it is currently testing portable ACs according to ANSI/ASHRAE Standard 128-2001. However, DOE notes that the small business also manufactures and markets PTACs that must be certified to DOE according to ANSI/AHRI Standard 310/380-2004, “Standard for Packaged Terminal Air-Conditioners and Heat Pumps” (ANSI/AHRI 310/380-2004). (10 CFR 430.96) Section 4.2.1 of ANSI/AHRI 310/380-2004 specifies that standard cooling ratings shall be verified by tests conducted in accordance with either ANSI/ASHRAE Standard 16-1999 or ANSI/ASHRAE Standard 37-1998. Due to the complexity of testing facilities required to implement the calorimeter method specified in ANSI/ASHRAE 16-1999, DOE believes that it is likely that the small business currently conducts compliance testing using the air enthalpy methods in ANSI/ASHRAE Standard 37-1998, which require comparable testing facilities and equipment as the methods proposed in this NOPR. In addition, the small business provides performance data in the literature for its portable AC model which indicates that testing was conducted at 80 °F and 50-percent relative humidity. This testing would likely have required air enthalpy measurements equivalent to those specified in AHAM PAC-1-2014 at 80 °F and 49-percent relative humidity, and the same air enthalpy measurements would be made when testing at 70 °F and 57-percent relative humidity according to the proposed method for portable AC heating mode. Therefore, DOE believes that no small businesses would require purchasing new equipment or modifying existing equipment in order to conduct the proposed test methods for measuring energy use in portable AC cooling mode and heating mode.
The proposed rule would also require the measurement of power input during standby mode, off mode, and off-cycle mode. These tests could be conducted either in the same facilities used for the cooling mode and heating mode testing of these products, or in facilities that meet the requirements for testing conditions specified in IEC Standard 62301, which could consist of any space with temperature control typically found in an office or living space. Therefore, DOE does not expect that the small business would incur additional facilities costs required by the proposed rule. In addition, in the event that the manufacturer would be required to purchase a wattmeter for measuring power input in standby mode, off mode, and off-cycle mode, the investment required would likely be relatively modest. An Internet search of equipment that specifically meets the proposed requirements reveals a cost of approximately $2,000.
The costs described above are small compared to the overall financial investment needed to undertake the business enterprise of developing and testing consumer products, which involves facilities, qualified staff, and specialized equipment. Based on its review of industry data,
For these reasons, DOE concludes and certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE will transmit the certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the SBA for review under 5 U.S.C. 605(b).
All collections of information from the public by a Federal agency must receive prior approval from OMB. DOE has established regulations for the certification and recordkeeping requirements for covered consumer products and industrial equipment. 10 CFR part 429, subpart B. DOE published a notice of proposed determination regarding portable air conditioners on July 5, 2013. 78 FR 40403. In an application to renew the OMB information collection approval for DOE's certification and recordkeeping requirements, DOE included an estimated burden for manufacturers of portable air conditioners in case DOE ultimately issues a coverage determination and sets energy conservation standards for these products. OMB has approved the revised information collection for DOE's certification and recordkeeping requirements. 80 FR 5099 (January 30, 2015). DOE estimated that it will take each respondent approximately 30 hours total per company per year to comply with the certification and recordkeeping requirements based on 20 hours of technician/technical work and 10 hours clerical work to actually submit the Compliance and Certification Management System (CCMS) templates. This rulemaking would include recordkeeping requirements on manufacturers that are associated with executing and maintaining the test data for these products. DOE notes that the certification requirements would be established in a final rule establishing energy conservation standards for portable ACs. DOE recognizes that recordkeeping burden may vary substantially based on company preferences and practices. DOE requests comment on this burden estimate.
In this proposed rule, DOE proposes test procedure amendments that it expects will be used to develop and implement future energy conservation standards for portable ACs. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that
Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this proposed rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available at
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This proposed rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988) that this proposed rule would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
This regulatory action to establish the test procedure for measuring the energy efficiency of portable ACs is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.
Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101), DOE must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; FEAA) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (FTC) concerning the impact of the commercial or industry standards on competition.
As discussed in this NOPR, the proposed rule incorporates testing methods contained in the following commercial standards: AHAM PAC-1-2014, Portable Air Conditions; and IEC 62301, Household Electrical Appliances—Measurement of Standby Power. DOE has evaluated these standards and is unable to conclude whether they fully comply with the requirements of section 32(b) of the FEAA, (
In this NOPR, DOE proposes to incorporate by reference the test standard published by AHAM, titled “Portable Air Conditioners,” AHAM PAC-1-2014. AHAM PAC-1-2014 is an industry accepted test procedure that measures portable AC performance in cooling mode and is applicable to products sold in North America. AHAM PAC-1-2014 specifies testing conducted in accordance with other industry accepted test procedures (already incorporated by reference) and determines energy efficiency metrics for various portable AC configurations. The test procedure proposed in this NOPR references various sections of AHAM PAC-1-2014 that address test setup, instrumentation, test conduct, calculations, and rounding. AHAM PAC-1-2014 is readily available on AHAM's Web site at
The time, date and location of the public meeting are listed in the
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In addition, you can attend the public meeting via webinar. Webinar registration information, participant instructions, and information about the capabilities available to webinar participants will be published on DOE's Web site
Any person who has plans to present a prepared general statement may request that copies of his or her statement be made available at the public meeting. Such persons may submit requests, along with an advance electronic copy of their statement in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format, to the appropriate address shown in the
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The public meeting will be conducted in an informal, conference style. DOE will present summaries of comments received before the public meeting, allow time for prepared general statements by participants, and encourage all interested parties to share their views on issues affecting this rulemaking. Each participant will be allowed to make a general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will permit, as time permits, other participants to comment briefly on any general statements.
At the end of all prepared statements on a topic, DOE will permit participants to clarify their statements briefly and
A transcript of the public meeting will be included in the docket, which can be viewed as described in the
DOE will accept comments, data, and information regarding this proposed rule before or after the public meeting, but no later than the date provided in the
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It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:
1.The description and definition for residential and commercial portable ACs, different configurations, and the clarification that commercial portable ACs are not considered a covered product. (See section III.A.)
2.The definitions for active mode, cooling mode, and heating mode. DOE also seeks information on annual hours associated with the consumer initiated air-circulation mode. (See section III.B.1.)
3.The proposal that AHAM PAC-1-2014 be used as the basis for the test procedure proposed in this NOPR (See section III.B.1.a.i.)
4.The proposal to modify the cooling capacity equation as included in AHAM PAC-1-2014 to address the effects of infiltration air. In addition, DOE welcomes input on the proposed infiltration air conditions of 95 °F dry-bulb temperature and
5.The proposal to specify a more stringent evaporator inlet air stream dry-bulb temperature tolerance for single-duct units and to not consider the effects of condenser exhaust air and inlet air mixing for dual-duct units. (See sectionIII.B.1.a.iii.)
6.The proposal to use the manufacturer-supplied ducting components during performance testing and the approach to characterize and determine the condenser duct(s) heat transfer to the conditioned space. (See section III.B.1.a.iv.)
7.The proposal and approach to include case heat transfer effects instead of the evaporator fan heat, based on the average case surface temperature and temperature. (See section III.B.1.a.v.)
8. The test setup for portable ACs with and without means for auto-evaporation to remove the collected condensate, including the use of any internal pump only if it is specified by the manufacturer for use during typical cooling operation. (See section III.B.1.a.vi.)
9. The proposed control settings for cooling mode and heating mode testing, which would require selecting the highest fan speed, for units with user-adjustable fan speed, and the lowest and highest available temperature settings for cooling mode and heating mode, respectively. Also, the proposed clarification that all portable AC performance testing be conducted with the maximum louver opening and, where applicable, with the louver oscillation feature disabled throughout testing. (See section III.B.1.a.vii.)
10. The proposed minimum clearance between the test unit and chamber wall surfaces. (See section III.B.1.a.viii.)
11. The proposed test setup, standard rating conditions, and conduct for determining heating mode performance for portable ACs. (See section III.B.1.b.)
12. The provisions for measuring energy consumption in off-cycle mode, including the use of the maximum speed setting for those units with adjustable fan speed settings, the measurement period specifications. DOE seeks comment on whether off-cycle mode energy consumption is independent of ambient conditions. (See section III.B.2.)
13. The proposed definitions and provisions for measuring energy consumption in various standby modes and off mode. (See section III.B.3.)
14. The proposed equation for calculating individual cooling combined energy efficiency ratio (CEER
15. The proposed reporting requirements including the sampling plan and rounding instructions. (See section III.C.)
16. The testing burden, including DOE's determination that the test would not be unduly burdensome to conduct. (See section III.D.1.)
The Secretary of Energy has approved publication of this proposed rule.
Administrative practice and procedure, Buildings and facilities, Business and industry, Energy conservation, Grant programs-energy, Housing, Reporting and recordkeeping requirements, Technical assistance.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Incorporation by reference, Intergovernmental relations, Small businesses.
For the reasons stated in the preamble, DOE proposes to amend parts 429 and 430 of Chapter II of Title 10, Code of Federal Regulations as set forth below:
42 U.S.C. 6291-6317.
(a)
(2) For each basic model of portable air conditioner, a sample of sufficient size shall be randomly selected and tested to ensure that—
(i) Any represented value of energy consumption or other measure of energy consumption of a basic model for which consumers would favor lower values shall be greater than or equal to the higher of:
(A) The mean of the sample:
Or,
(B) The upper 95 percent confidence limit (UCL) of the true mean divided by 1.10:
And,
(ii) Any represented value of the cooling or heating energy efficiency ratio, combined energy efficiency ratio, or other measure of energy consumption of a basic model for which consumers would favor higher values shall be less than or equal to the lower of:
(A) The mean of the sample:
Or,
(B) The lower 95 percent confidence limit (LCL) of the true mean divided by 0.90:
And,
(3) The value of cooling or heating mode capacity of a basic model shall be the mean of the capacities for each tested unit of the basic model. Round the mean capacity value to the nearest 50, 100, 200, or 500 Btu/h, depending on the value being rounded, in accordance with Table 1 of PAC-1-2014, “Multiples for reporting Dual Duct Cooling Capacity, Single Duct Cooling Capacity, Spot Cooling Capacity, Water Cooled Condenser Capacity and Power Input Ratings.”
(4) The value of energy efficiency ratio or combined energy efficiency ratio of a basic model shall be the mean of the efficiency metric for each tested unit of
(b) [Reserved]
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
(h) * * *
(8) AHAM PAC-1-2014, Portable Air Conditioners, 2014, IBR approved for appendix CC to subpart B.
(o) * * *
(4) IEC 62301 (“IEC 62301”), Household electrical appliances—Measurement of standby power, (Edition 2.0, 2011-01), IBR approved for appendices C1, D1, D2, G, H, I, J2, N, O, P, X, and CC to subpart B.
(dd)
(2) The estimated annual operating cost for portable air conditioners in cooling mode, expressed in dollars per year, shall be determined by multiplying the following two factors:
(i) The sum of the AEC
(ii) A representative average unit cost of electrical energy in dollars per kilowatt-hour as provided by the Secretary, the resulting product then being rounded off to the nearest dollar per year.
This appendix covers the test requirements used to measure the energy performance of single-duct and dual-duct portable air conditioners. It does not contain testing provisions for measuring the energy performance of spot coolers at this time.
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
(1) Has cycled off its main heating or cooling function by thermostat or temperature sensor signal;
(2) May or may not operate its fan or blower; and
(3) Will reactivate the main cooling or heating function according to the thermostat or temperature sensor signal.
2.10
2.11
2.12
2.13
2.14
(1) To facilitate the activation of other modes (including activation or deactivation of active mode) by remote switch (including remote control), internal sensor, or timer; or
(2) Continuous functions, including information or status displays (including clocks) or sensor-based functions. A timer is a continuous clock function (which may or may not be associated with a display) that provides regular scheduled tasks (
3.1 Active mode.
3.1.1
3.1.1.1
3.1.1.2
3.1.1.3
3.1.1.4
3.1.1.5
3.1.2
3.1.3
3.2 Standby mode and off mode.
3.2.1
3.2.2 Electrical energy supply.
3.2.2.1
3.2.2.2
3.2.3
3.2.4
3.2.5
3.2.6
4.1 Active mode.
4.1.1
4.1.1.1
Calculate the total heat transferred from the surface of the duct(s) to the indoor conditioned space while operating in cooling mode as follows.
j represents the condenser exhaust duct and, for dual-duct units, condenser inlet duct.
T
4.1.1.2
Calculate the surface area of each case side as the product of the two primary surface dimensions. Calculate the surface area of the case side according to the following:
Calculate the heat transferred from all case sides to the indoor conditioned space according to the following:
4.1.1.3
Calculate the sensible component of infiltration air heat contribution according to the following:
Calculate the latent heat contribution of the infiltration air according to the following::
The total heat contribution of the infiltration air is the sum of the sensible and latent heat:
4.1.2
4.2
4.3
4.3.1 If the portable air conditioner has an inactive mode, as defined in section 2.8 of this appendix, but not an off mode, as defined in section 2.10 of this appendix, measure and record the average inactive mode power of the portable air conditioner, P
4.3.2 If the portable air conditioner has an off mode, as defined in section 2.10 of this appendix, measure and record the average off mode power of the portable air conditioner, P
5.1
5.2
5.3
5.4
Total annual energy consumption in all modes except cooling and heating, is calculated according to the following:
5.5
5.6
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; harvest specifications and closures.
NMFS announces final 2015 and 2016 harvest specifications, apportionments, and Pacific halibut prohibited species catch limits for the groundfish fishery of the Gulf of Alaska (GOA). This action is necessary to establish harvest limits for groundfish during the 2015 and 2016 fishing years and to accomplish the goals and objectives of the Fishery Management Plan for Groundfish of the GOA. The intended effect of this action is to conserve and manage the groundfish resources in the GOA in accordance with the Magnuson-Stevens Fishery Conservation and Management Act.
Harvest specifications and closures are effective at 1200 hrs, Alaska local time (A.l.t.), February 25, 2015, through 2400 hrs, A.l.t., December 31, 2016.
Electronic copies of the Final Alaska Groundfish Harvest Specifications Environmental Impact Statement (EIS), Record of Decision (ROD), and the Supplementary Information Report (SIR) to the EIS prepared for this action are available from
Obren Davis, 907-586-7228.
NMFS manages the GOA groundfish fisheries in the exclusive economic zone of the GOA under the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP). The Council prepared the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801
The FMP and its implementing regulations require NMFS, after consultation with the Council, to specify the total allowable catch (TAC) for each target species, the sum of which must be within the optimum yield (OY) range of 116,000 to 800,000 metric tons (mt). Section 679.20(c)(1) further requires NMFS to publish and solicit public comment on proposed annual TACs, Pacific halibut prohibited species catch (PSC) limits, and seasonal allowances of pollock and Pacific cod. Upon consideration of public comment received under § 679.20(c)(1), NMFS must publish notice of final harvest specifications for up to two fishing years as annual target TAC, per § 679.20(c)(3)(ii). The final harvest specifications set forth in Tables 1 through 36 of this document reflect the outcome of this process, as required at § 679.20(c).
The proposed 2015 and 2016 harvest specifications for groundfish of the GOA and Pacific halibut PSC limits were published in the
In June 2013, the Council took final action to implement measures to control Chinook salmon PSC in all non-pollock trawl groundfish fisheries in the Western and Central GOA. This action, Amendment 97 to the FMP, would set an initial annual PSC limit of 7,500 Chinook salmon apportioned among the sectors of trawl catcher/processors, trawl catcher vessels participating in the Central GOA Rockfish Program, and trawl catcher vessels not participating in the Central GOA Rockfish Program fishing for groundfish species other than pollock. The pollock directed fishery is not included in the Council's recommended action, as that fishery is already subject to Chinook salmon PSC limits (§ 679.21(h)).
NMFS published a notice of availability for Amendment 97 on June 5, 2014 (79 FR 32525). On September 3, 2014, the Secretary of Commerce (Secretary) approved Amendment 97. The proposed rule that would implement Amendment 97 published on June 25, 2014 (79 FR 35971), with public comments accepted through July 25, 2014. The proposed rule contains a description of the affected management areas and groundfish fisheries, the non-pollock trawl groundfish fisheries and associated sectors, the history and goals of Amendment 97, and the provisions of the proposed action. Those provisions include proposed Chinook salmon PSC limits by sector, seasonal allocations, and other aspects associated with the implementation of Chinook salmon PSC limits for the non-pollock trawl groundfish fisheries in the Western and Central GOA. One provision that could affect the 2016 Chinook salmon PSC limits is the “incentive buffer.” This mechanism provides for an increased annual Chinook salmon PSC limit if sectors catch less than their limit of Chinook salmon in the previous year. The final rule to implement Amendment 97 published on December 2, 2014 (79 FR 71350). The Chinook salmon PSC limits implemented by Amendment 97 were effective on January 1, 2015. Specific sector limits for the non-pollock groundfish fisheries are described later in this preamble. NMFS will monitor the Chinook salmon PSC in the non-pollock GOA groundfish fisheries and close an applicable sector if it reaches its 2015 Chinook salmon PSC limit.
In December 2014, the Council, its Advisory Panel (AP), and its Scientific and Statistical Committee (SSC) reviewed the most recent biological and harvest information about the condition of groundfish stocks in the GOA. This information was compiled by the Council's GOA Groundfish Plan Team and was presented in the draft 2014 SAFE report for the GOA groundfish fisheries, dated November 2014 (see
In previous years, the largest changes from the proposed to the final harvest specifications have been based on recent NMFS stock surveys, which provide updated estimates of stock biomass and spatial distribution, and changes to the models used for producing stock assessments. At the November 2014 Plan Team meeting, NMFS scientists presented updated and new survey results, changes to stock assessment models, and accompanying stock assessment estimates for all groundfish species and species groups that are included in the final 2014 SAFE report. The SSC reviewed this information at the December 2014 Council meeting. Changes from the proposed to the final 2015 and 2016 harvest specifications are discussed below.
The final 2015 and 2016 OFLs, ABCs, and TACs are based on the best available biological and socioeconomic information, including projected biomass trends, information on assumed distribution of stock biomass, and revised methods used to calculate stock biomass. The FMP specifies the formulas, or tiers, to be used to compute OFLs and ABCs. The formulas applicable to a particular stock or stock complex are determined by the level of reliable information available to fisheries scientists. This information is categorized into a successive series of six tiers to define OFL and ABC amounts, with Tier 1 representing the highest level of information quality available and Tier 6 representing the lowest level of information quality available. The Plan Team used the FMP tier structure to calculate OFL and ABC amounts for each groundfish species. The SSC adopted the final 2015 and 2016 OFLs and ABCs recommended by the Plan Team for all groundfish species. The Council adopted the SSC's OFL and ABC recommendations and the AP's TAC recommendations. The final TAC recommendations were based on the ABCs as adjusted for other biological and socioeconomic considerations, including maintaining the sum of all TACs within the required OY range of 116,000 to 800,000 mt.
The Council recommended 2015 and 2016 TACs that are equal to ABCs for sablefish, deep-water flatfish, rex sole, Pacific ocean perch, northern rockfish, shortraker rockfish, dusky rockfish, rougheye rockfish, demersal shelf rockfish, thornyhead rockfish, “other rockfish,” big skates, longnose skates, other skates, sculpins, sharks, squids, and octopuses in the GOA. The Council recommended TACs for 2015 and 2016 that are less than the ABCs for pollock, Pacific cod, shallow-water flatfish in the Western GOA, arrowtooth flounder, flathead sole in the Western and Central GOA, “other rockfish” in the Southeast Outside district, and Atka mackerel. The Pacific cod TACs are set to accommodate the State's guideline harvest levels (GHLs) for Pacific cod so that the ABCs are not exceeded. The shallow-water flatfish, arrowtooth flounder, and flathead sole TACs are set to allow for increased harvest opportunities for these target species while conserving the halibut PSC limit for use in other, more fully utilized fisheries. The “other rockfish” TAC in the Southeast Outside District (SEO) is set to reduce the amount of discards. The Atka mackerel TAC is set to accommodate incidental catch amounts in other fisheries.
The final 2015 and 2016 harvest specifications approved by the Secretary are unchanged from those recommended by the Council and are consistent with the preferred harvest strategy alternative in the EIS (see
Tables 1 and 2 list the final 2015 and 2016 OFLs, ABCs, TACs, and area apportionments of groundfish in the GOA. The sums of the 2015 and 2016 ABCs are 685,597 mt and 731,049 mt, respectively, which are higher in 2015 and 2016 than the 2014 ABC sum of 640,675 mt (79 FR 12890, March 6, 2014).
NMFS' apportionment of groundfish species is based on the distribution of biomass among the regulatory areas over which NMFS manages the species. Additional regulations govern the apportionment of pollock, Pacific cod, and sablefish. Additional detail on the apportionment of pollock, Pacific cod, and sablefish are described below.
The ABC for the pollock stock in the combined Western, Central, and West Yakutat Regulatory Areas (W/C/WYK) includes the amount for the GHL established by the State for the Prince William Sound (PWS) pollock fishery. The Plan Team, SSC, AP, and Council recommended that the sum of all State and Federal water pollock removals from the GOA not exceed ABC recommendations. Based on genetic studies, fisheries scientists believe that the pollock in PWS is not a separate stock from the combined W/C/WYK population. Since 1996, the Plan Team has had a protocol of recommending that the GHL amount be deducted from the GOA-wide ABC. For 2015 and 2016, the SSC recommended and the Council approved the W/C/WYK pollock ABC including the amount to account for the State's PWS GHL. At the November 2014 Plan Team meeting, State fisheries managers recommended setting the PWS GHL at 2.5 percent of the annual W/C/WYK pollock ABC. For 2015, this yields a PWS pollock GHL of 4,783 mt, an increase of 620 mt from the 2014 PWS GHL of 4,163 mt. For 2016, the PWS pollock GHL is 6,271 mt, an increase of 2,108 mt from the 2014 PWS pollock GHL.
The Council also adopted the SSC's recommendation to revise the terminology used when apportioning pollock in the Western, Central, and West Yakutat Regulatory Areas. The SSC recommended describing apportionments of pollock to the Western, Central, and West Yakutat Regulatory Areas as “apportionments of annual catch limit (ACLs)” rather than “ABCs.” The SSC annually recommends a combined pollock ABC for the Western, Central, and West Yakutat Regulatory Areas based on factors such as scientific uncertainty in the estimate of the area-wide OFL, data uncertainty, and recruitment variability. Section 3.2.3.3.2 of FMP specifies that the ACL is equal to the ABC. Historically, the SSC has recommended apportioning the combined Western, Central, and West Yakutat ABC between these three individual Regulatory Areas. However, the subarea ABCs have not been based on scientific uncertainty in the OFL,
NMFS establishes pollock TACs in the Western, Central, West Yakutat Regulatory Areas, and the Southeast Outside District of the GOA (see Tables 1 and 2). NMFS also establishes seasonal apportionments of the annual pollock TAC in the Western and Central Regulatory Areas of the GOA among Statistical Areas 610, 620, and 630. These apportionments are divided equally among each of the following four seasons: The A season (January 20 through March 10), the B season (March 10 through May 31), the C season (August 25 through October 1), and the D season (October 1 through November 1) (§ 679.23(d)(2)(i) through (iv), and § 679.20(a)(5)(iv)(A) and (B)). Additional detail is provided below; Tables 3 and 4 list these amounts.
The 2015 and 2016 Pacific cod TACs are set to accommodate the State's GHL for Pacific cod in State waters in the Central and Western Regulatory Areas, as well as in PWS. The Plan Team, SSC, AP, and Council recommended that the sum of all State and Federal water Pacific cod removals from the GOA not exceed ABC recommendations. Accordingly, the Council set the 2015 and 2016 Pacific cod TACs in the Eastern, Central, and Western Regulatory Areas to account for State GHLs. Therefore, the 2015 and 2016 Pacific cod TACs are less than the ABCs by the following amounts: (1) Eastern GOA, 707 mt; (2) Central GOA, 15,330 mt; and (3) Western GOA, 11,611 mt. These amounts reflect the sum of the State's 2015 and 2016 GHLs in these areas, which are 25 percent of the Eastern and Central ABCs, and 30 percent of the Western GOA ABC.
NMFS establishes seasonal apportionments of the annual Pacific cod TAC in the Central and Western Regulatory Areas. Sixty percent of the annual TAC is apportioned to the A season for hook-and-line, pot, and jig gear from January 1 through June 10, and for trawl gear from January 20 through June 10. Forty percent of the annual TAC is apportioned to the B season for hook-and-line, pot, and jig gear from September 1 through December 31, and for trawl gear from September 1 through November 1 (§§ 679.23(d)(3) and 679.20(a)(12)). The Central and Western GOA Pacific cod TACs are allocated among various gear and operational sectors. The Pacific cod sector apportionments are discussed in detail in a subsequent section of this preamble.
The Council's recommendation for sablefish area apportionments takes into account the prohibition on the use of trawl gear in the SEO District of the Eastern Regulatory Area and makes available 5 percent of the combined Eastern Regulatory Area ABCs to trawl gear for use as incidental catch in other groundfish fisheries in the WYK District (§ 679.20(a)(4)(i)). Tables 7 and 8 list the final 2015 and 2016 allocations of sablefish TAC to hook-and-line and trawl gear in the GOA.
In October 2014, the Council's recommendations for the proposed 2015 and 2016 harvest specifications (79 FR 72593, December 8, 2014) were based largely on information contained in the final 2013 SAFE report for the GOA groundfish fisheries, dated November 2013 (see
As described previously, the SSC adopted the final 2015 and 2016 OFLs and ABCs recommended by the Plan Team. The Council adopted the SSC's OFL and ABC recommendations and the AP's TAC recommendations for 2015 and 2016. The final 2015 ABCs are higher than the proposed 2015 ABCs published in the proposed 2015 and 2016 harvest specifications (79 FR 72593, December 8, 2014) for pollock, Pacific cod, sablefish, shallow-water flatfish, deep-water flatfish, arrowtooth flounder, flathead sole, Pacific ocean perch, dusky rockfish, longnose skate, and “other skates.” The final 2015 ABCs are lower than the proposed 2015 ABCs for northern rockfish, rougheye rockfish, demersal shelf rockfish, and big skates. The final 2016 ABCs are higher than the proposed 2016 ABCs for pollock, Pacific cod, shallow-water flatfish, flathead sole, Pacific ocean perch, longnose skate, and “other skates.” The final 2016 ABCs are lower than the proposed 2016 ABCs for deep-water flatfish, rex sole, arrowtooth flounder, northern rockfish, dusky rockfish, rougheye rockfish, and big skates. For the remaining target species—Atka mackerel, sculpins, sharks, squids, and octopus—the Council recommended, and the Secretary approved, the final 2015 and 2016 ABCs that are the same as the proposed 2015 and 2016 ABCs.
Additional information explaining the changes between the proposed and final ABCs is included in the final 2014 SAFE report, which was not available when the Council made its proposed ABC and TAC recommendations in October 2014. At that time, the most recent stock assessment information was contained in the final 2013 SAFE report. The final 2014 SAFE report contains the best and most recent scientific information on the condition of the groundfish stocks, as previously discussed in this preamble, and is available for review (see
Based on changes to the assessment method (model) used by stock assessment scientists, for 2015 and 2016 the greatest TAC increase is for Pacific cod. Based on changes in the estimates of overall biomass, the greatest TAC increases are for shallow-water flatfish, longnose skate, other skates, and Pacific ocean perch. Based upon changes in the estimates of biomass, the greatest decreases in TACs are for rougheye rockfish, demersal shelf rockfish, and big skate. For all other species and species groups, changes from the
Additionally, based upon the Council's recommended changes in setting the TACs at amounts below ABCs, the greatest decreases in TACs are for shallow-water flatfish, arrowtooth flounder, flathead sole, and “other rockfish.” The Council believed, and NMFS concurs, that setting TACs for the three preceding flatfish species equal to ABCs would not reflect anticipated harvest levels accurately, as the Council and NMFS expect halibut PSC limits to constrain these fisheries in 2015 and 2016.
Detailed information providing the basis for the changes described above is contained in the final 2014 SAFE report. The final TACs are based on the best scientific information available. These TACs are specified in compliance with the harvest strategy described in the proposed and final rules for the 2015 and 2016 harvest specifications. The changes in TACs between the proposed rule and this final rule are compared in the following table.
The final 2015 and 2016 TAC recommendations for the GOA are within the OY range established for the GOA and do not exceed the ABC for any species or species group. Tables 1 and 2 list the final OFL, ABC, and TAC amounts for GOA groundfish for 2015 and 2016, respectively.
Section 679.20(b)(2) requires NMFS to set aside 20 percent of each TAC for pollock, Pacific cod, flatfish, sculpins, sharks, squids, and octopuses in reserve for possible apportionment at a later date during the fishing year. For 2015 and 2016, NMFS proposed reapportionment of all the reserves in the proposed 2015 and 2016 harvest specifications published in the
In the GOA, pollock is apportioned by season and area, and is further allocated for processing by inshore and offshore components. Pursuant to § 679.20(a)(5)(iv)(B), the annual pollock TAC specified for the Western and Central Regulatory Areas of the GOA is apportioned into four equal seasonal allowances of 25 percent. As established by § 679.23(d)(2)(i) through (iv), the A, B, C, and D season allowances are available from January 20 to March 10, March 10 to May 31, August 25 to October 1, and October 1 to November 1, respectively.
Pollock TACs in the Western and Central Regulatory Areas of the GOA are apportioned among Statistical Areas 610, 620, and 630, pursuant to § 679.20(a)(5)(iv)(A). In the A and B seasons, the apportionments are in proportion to the distribution of pollock biomass based on the four most recent NMFS winter surveys. In the C and D seasons, the apportionments are in proportion to the distribution of pollock biomass based on the four most recent NMFS summer surveys. However, for 2015 and 2016, the Council recommended, and NMFS approves, averaging the winter and summer distribution of pollock in the Central Regulatory Area for the A season instead of using the distribution based on only the winter surveys. The average is intended to reflect the migration patterns and distribution of pollock, and the anticipated performance of the fishery, in that area during the A season for the 2015 and 2016 fishing years. For the A season, the apportionment is based on an adjusted estimate of the relative distribution of pollock biomass of approximately 8 percent, 67 percent, and 25 percent in Statistical Areas 610, 620, and 630, respectively. For the B season, the apportionment is based on the relative distribution of pollock biomass at 8 percent, 83 percent, and 9 percent in Statistical Areas 610, 620, and 630, respectively. For the C and D seasons, the apportionment is based on the relative distribution of pollock biomass at 27 percent, 32 percent, and 41 percent in Statistical Areas 610, 620, and 630, respectively.
Within any fishing year, the amount by which a seasonal allowance is underharvested or overharvested may be added to, or subtracted from, subsequent seasonal allowances in a manner to be determined by the Regional Administrator (§ 679.20(a)(5)(iv)(B)). The rollover amount is limited to 20 percent of the subsequent seasonal apportionment for the statistical area. Any unharvested pollock above the 20-percent limit could be further distributed to the other statistical areas, in proportion to the estimated biomass in the subsequent season in those statistical areas (§ 679.20(a)(5)(iv)(B)). The pollock TACs in the WYK and SEO District of 4,719 mt and 12,625 mt, respectively, in 2015, and 6,187 mt and 12,625 mt, respectively, in 2016, are not allocated by season.
Section 679.20(a)(6)(i) requires the allocation of 100 percent of the pollock TAC in all regulatory areas and all seasonal allowances to vessels catching pollock for processing by the inshore component after subtraction of amounts projected by the Regional Administrator to be caught by, or delivered to, the offshore component incidental to directed fishing for other groundfish species. Thus, the amount of pollock available for harvest by vessels harvesting pollock for processing by the offshore component is that amount that will be taken as incidental catch during directed fishing for groundfish species other than pollock, up to the maximum retainable amounts allowed by § 679.20(e) and (f). At this time, these incidental catch amounts of pollock are unknown and will be determined during the fishing year during the course of fishing activities by the offshore component.
Tables 3 and 4 list the final 2015 and 2016 seasonal biomass distribution of pollock in the Western and Central Regulatory Areas, area apportionments, and seasonal allowances. The amounts of pollock for processing by the inshore and offshore components are not shown.
Section 679.20(a)(12)(i) requires the allocation of the Pacific cod TACs in the Western and Central Regulatory Areas of the GOA among gear and operational sectors. Section 679.20(a)(6)(ii) requires the allocation of the Pacific cod TACs in the Eastern Regulatory Area of the GOA between the inshore and offshore components. NMFS allocates the 2015 and 2016 Pacific cod TAC based on these sector allocations annually between the inshore and offshore components in the Eastern GOA; seasonally between vessels using jig gear, catcher vessels (CVs) using hook-and-line gear, catcher/processors (C/Ps) using hook-and-line gear, CVs using trawl gear, and vessels using pot gear in the Western GOA; seasonally between vessels using jig gear, CVs less than 50 feet in length overall using hook-and-line gear, CVs equal to or greater than 50 feet in length overall using hook-and-line gear, C/Ps using hook-and-line gear, CVs using trawl gear, C/Ps using trawl gear, and vessels using pot gear in the Central GOA. The overall seasonal apportionments in the Western and Central GOA are 60 percent of the annual TAC to the A season and 40 percent of the annual TAC to the B season.
Under § 679.20(a)(12)(ii), any overage or underage of the Pacific cod allowance from the A season will be subtracted from, or added to, the subsequent B season allowance. In addition, any portion of the hook-and-line, trawl, pot, or jig sector allocations that NMFS determines is likely to go unharvested by a sector may be reapportioned to other sectors for harvest during the remainder of the fishery year.
Pursuant to § 679.20(a)(12)(i)(A) and (B), a portion of the annual Pacific cod TACs in the Western and Central GOA will be allocated to vessels with an FFP that use jig gear before TAC is apportioned among other non-jig sectors. In accordance with the FMP, the annual jig sector allocations may increase to up to 6 percent of the annual Western and Central GOA Pacific cod TACs, depending on the annual performance of the jig sector (See Table 1 of Amendment 83 to the FMP for a detailed discussion of the jig sector allocation process (76 FR 74670, December 1, 2011)). Jig sector allocation increases are established for a minimum of 2 years. NMFS has evaluated the 2014 harvest performance of the jig sector in the Western and Central GOA, and is revising the 2015 and 2016 Pacific cod apportionments to this sector as follows.
NMFS allocates the jig sector 3.5 percent of the annual Pacific cod TAC in the Western GOA, a 1.0 percent increase from the 2014 jig sector allocation. The 2015 and 2016 allocations include a base allocation of 1.5 percent, an addition of 1.0 percent and an additional 2.0 percent because this sector harvested greater than 90 percent of its initial 2012 and 2014 allocations in the Western GOA. NMFS also allocates the jig sector 1.0 percent of the annual Pacific cod TAC in the Central GOA, a 1.0 percent decrease from the 2014 jig sector allocation. The 2015 and 2016 allocations consist of a base allocation of 1.0 percent. The Central GOA jig sector harvested greater than 90 percent of its initial 2012 allocation in the Central GOA and received an additional 1.0 percent of the Central GOA Pacific cod TAC in 2013 and 2014. However, in both 2013 and 2014, the jig sector harvested less than 90 percent of the annual Central GOA
Section 679.20(a)(4)(i) and (ii) require allocations of sablefish TACs for each of the regulatory areas and districts to hook-and-line and trawl gear. In the Western and Central Regulatory Areas, 80 percent of each TAC is allocated to hook-and-line gear, and 20 percent of each TAC is allocated to trawl gear. In the Eastern Regulatory Area, 95 percent of the TAC is allocated to hook-and-line gear, and 5 percent is allocated to trawl gear. The trawl gear allocation in the Eastern Regulatory Area may only be used to support incidental catch of sablefish in directed fisheries for other target species (§ 679.20(a)(4)(i)).
In recognition of the prohibition against trawl gear in the SEO District of the Eastern Regulatory Area, the Council recommended and NMFS approves the allocation of 5 percent of the combined Eastern Regulatory Area sablefish TAC to trawl gear in the WYK District, making the remainder of the WYK sablefish TAC available to vessels using hook-and-line gear. NMFS allocates 100 percent of the sablefish TAC in the SEO District to vessels using hook-and-line gear. This action results in a 2015 allocation of 220 mt to trawl gear and 1,489 mt to hook-and-line gear in the WYK District, a 2015 allocation of 2,682 mt to hook-and-line gear in the SEO District, and a 2016 allocation of 199 mt to trawl gear in the WYK District. Table 7 lists the allocations of the 2015 sablefish TACs to hook-and-line and trawl gear. Table 8 lists the allocations of the 2016 sablefish TACs to trawl gear.
The Council recommended that the hook-and-line sablefish TAC be established annually to ensure that this Individual Fishery Quota (IFQ) fishery is conducted concurrently with the halibut IFQ fishery and is based on recent sablefish survey information. The Council also recommended that only a trawl sablefish TAC be established for two years so that retention of incidental catch of sablefish by trawl gear could commence in January in the second year of the groundfish harvest specifications. Since there is an annual assessment for sablefish and the final harvest specifications are expected to be published before the IFQ season begins March 14, 2015, the Council recommended that the hook-and-line sablefish TAC be set on an annual basis, rather than for two years, so that the best scientific information available could be considered in establishing the sablefish ABCs and TACs. With the exception of the trawl allocations that were provided to the Rockfish Program cooperatives, directed fishing for sablefish with trawl gear is closed during the fishing year. Also, fishing for groundfish with trawl gear is prohibited prior to January 20. Therefore, it is not likely that the sablefish allocation to trawl gear would be reached before the effective date of the final 2015 and 2016 harvest specifications.
The recommended 2015 and 2016 DSR TAC is 225 mt, and management of DSR is delegated to the State. The Alaska Board of Fish has apportioned the annual SEO District DSR TACs between the commercial fishery (84 percent) and the sport fishery (16 percent) after deductions were made for anticipated subsistence harvests (7 mt). This results in 2015 and 2016 allocations of 183 mt to the commercial fishery and 35 mt to the sport fishery.
The State deducts estimates of incidental catch of DSR in the commercial halibut fishery and test fishery mortality from the DSR commercial fishery allocation. In 2014, this resulted in 32 mt being available for the directed commercial DSR fishery apportioned in one DSR district. The State estimated that there was not sufficient DSR quota available to have orderly fisheries in the three other DSR districts. DSR harvest in the halibut fishery is linked to the annual halibut catch limits; therefore the State can only estimate potential DSR incidental catch because halibut catch limits are established by the International Pacific Halibut Commission (IPHC). Federally permitted CVs using hook-and-line or jig gear fishing for groundfish and Pacific halibut in the SEO District of the GOA are required to retain all DSR (§ 679.20(j)).
These final 2015 and 2016 harvest specifications for the GOA include the various fishery cooperative allocations and sideboard limitations established by the Central GOA Rockfish Program. Program participants are primarily trawl CVs and trawl C/Ps, with limited participation by vessels using longline gear. The Rockfish Program assigns quota share and cooperative quota to participants for primary and secondary species, allows participants holding a license limitation program (LLP) license with rockfish quota share to form a rockfish cooperative, and allows holders of C/P LLP licenses to opt out of the fishery. The Rockfish Program also has an entry level fishery for rockfish primary species for vessels using longline gear.
Under the Rockfish Program, rockfish primary species (Pacific ocean perch, northern rockfish, and dusky rockfish) in the Central GOA are allocated to participants after deducting for incidental catch needs in other directed groundfish fisheries. Participants in the Rockfish Program also receive a portion of the Central GOA TAC of specific secondary species (Pacific cod, rougheye rockfish, sablefish, shortraker rockfish, and thornyhead rockfish).
Additionally, the Rockfish Program establishes sideboard limits to restrict the ability of harvesters operating under the Rockfish Program to increase their participation in other, non-Rockfish Program fisheries. Besides groundfish species, the Rockfish Program allocates a portion of the trawl halibut PSC limit (191 mt) from the third season deep-water species fishery allowance for the GOA trawl fisheries to Rockfish Program participants (§ 679.81(d)), which includes 117 mt to the trawl CV sector and 74 mt to the trawl C/P sector.
Section 679.81(a)(2)(ii) requires allocations of 5 mt of Pacific ocean perch, 5 mt of northern rockfish, and 30 mt of dusky rockfish to the entry level longline fishery in 2015 and 2016. The allocation for the entry level longline fishery would increase incrementally each year if the catch exceeds 90 percent of the allocation of a species. The incremental increase in the allocation would continue each year until it is the maximum percent of the TAC for that species. In 2014, the catch did not exceed 90 percent of any allocated rockfish species. Therefore, NMFS is not increasing the entry level longline fishery 2015 and 2016 allocations in the Central GOA. Longline gear includes hook-and-line, jig, troll, and handline gear. The remainder of the TACs for the rockfish primary species would be allocated to the CV and C/P cooperatives. Table 9 lists the allocations of the 2015 and initial 2016 TACs for each rockfish primary species to the entry level longline fishery, the incremental increase for future years, and the maximum percent of the TAC for the entry level longline fishery.
Section 679.81(a)(2) requires allocations of the rockfish primary species among various sectors of the Rockfish Program. Tables 10 and 11 list the final 2015 and 2016 allocations of rockfish primary species in the Central GOA to the entry level longline fishery and Rockfish CV and C/P Cooperatives in the Rockfish Program. NMFS also is setting aside incidental catch amounts (ICAs) for other directed fisheries in the Central GOA of 2,000 mt of Pacific ocean perch, 200 mt of northern rockfish, and 250 mt of dusky rockfish. These amounts are based on recent average incidental catches in the Central GOA by other groundfish fisheries.
Allocations between vessels belonging to CV or C/P cooperatives are not included in these final harvest specifications. Rockfish Program applications for CV cooperatives and C/P cooperatives are not due to NMFS until March 1 of each calendar year, therefore, NMFS cannot calculate 2015 and 2016 allocations in conjunction with these final harvest specifications. NMFS will post these allocations on the Alaska Region Web site at (
Section 679.81(c) requires allocations of rockfish secondary species to CV and C/P cooperatives in the Central GOA. CV cooperatives receive allocations of Pacific cod, sablefish from the trawl gear allocation, and thornyhead rockfish. C/P cooperatives receive allocations of sablefish from the trawl allocation, rougheye rockfish, shortraker rockfish, and thornyhead rockfish. Tables 12 and 13 list the apportionments of the 2015 and 2016 TACs of rockfish secondary species in the Central GOA to CV and C/P cooperatives.
Section 679.21(d) establishes the annual halibut PSC limit apportionments to trawl and hook-and-line gear, and authorizes the establishment of apportionments for pot gear. Amendment 95 to the FMP (79 FR 9625, February 20, 2014) implemented measures establishing GOA halibut PSC limits in Federal regulations and reducing the halibut PSC limits in the GOA trawl and hook-and-line groundfish fisheries. These reductions are incorporated into the final 2015 and 2016 halibut PSC limits. For most gear and operational types, the halibut PSC limit reductions are phased-in over 3 years, beginning in 2014 and ending in 2016.
In December 2014, the Council incorporated these reductions into its recommended final 2015 and 2016 harvest specifications. The Council recommended 2015 halibut PSC limits of 1,759 mt for trawl gear, 261 mt for hook-and-line gear, and 9 mt for the DSR fishery. The Council also recommended 2016 halibut PSC limits of 1,706 mt for the trawl sector, 256 mt for the hook-and-line sector, and 9 mt for the DSR fishery.
The DSR fishery in the SEO District is defined at § 679.21(d)(2)(ii)(A). This fishery is apportioned 9 mt of the halibut PSC limit in recognition of its small-scale harvests of groundfish. NMFS estimates low halibut bycatch in the DSR fishery because 1) the duration of the DSR fisheries and the gear soak times are short, 2) the DSR fishery occurs in the winter when less overlap occurs in the distribution of DSR and halibut, and 3) the directed commercial DSR fishery has a low DSR TAC.
The FMP authorizes the Council to exempt specific gear from the halibut PSC limits. NMFS, after consultation with the Council, exempts pot gear, jig gear, and the sablefish IFQ hook-and-line gear fishery categories from the non-trawl halibut PSC limit for 2015 and 2016. The Council recommended, and NMFS approves, these exemptions because 1) the pot gear fisheries have low annual halibut bycatch mortality; 2) IFQ program regulations prohibit discard of halibut if any halibut IFQ permit holder on board a catcher vessel holds unused halibut IFQ (§ 679.7(f)(11)); 3) sablefish IFQ fishermen typically hold halibut IFQ permits and are therefore required to retain the halibut they catch while fishing sablefish IFQ; and 4) NMFS estimates negligible halibut mortality for the jig gear fisheries. NMFS estimates that halibut mortality is negligible in the jig gear fisheries given the small amount of groundfish harvested by jig gear, the selective nature of jig gear, and the high survival rates of halibut caught and released with jig gear.
The best available information on estimated halibut bycatch consists of data collected by fisheries observers during 2014. The calculated halibut bycatch mortality through December 20, 2014, is 1,394 mt for trawl gear and 199 mt for hook-and-line gear for a total halibut mortality of 1,593 mt. This halibut mortality was calculated using groundfish and halibut catch data from the NMFS Alaska Region's catch accounting system. This accounting system contains historical and recent catch information compiled from each Alaska groundfish fishery.
Section 679.21(d)(4)(i) and (ii) authorizes NMFS to seasonally apportion the halibut PSC limits after consultation with the Council. The FMP and regulations require the Council and NMFS to consider the following information in seasonally apportioning halibut PSC limits: 1) Seasonal distribution of halibut; 2) seasonal distribution of target groundfish species relative to halibut distribution; 3) expected halibut bycatch needs on a seasonal basis relative to changes in halibut biomass and expected catch of target groundfish species; 4) expected bycatch rates on a seasonal basis; 5) expected changes in directed groundfish fishing seasons; 6) expected actual start of fishing effort; and 7) economic effects of establishing seasonal halibut allocations on segments of the target groundfish industry. The Council considered information from the 2014 SAFE report, NMFS catch data, State of Alaska catch data, IPHC stock assessment and mortality data, and public testimony when apportioning the halibut PSC limits. NMFS concurs with the Council's recommendations listed in Tables 14 and 15, which respectively shows the final 2015 and 2016 Pacific halibut PSC limits, allowances, and apportionments.
Sections 679.21(d)(4)(iii) and (iv) specify that any underages or overages of a seasonal apportionment of a PSC limit will be deducted from or added to the next respective seasonal apportionment within the fishing year.
Section 679.21(d)(3)(ii) authorizes further apportionment of the trawl halibut PSC limit to trawl fishery categories. The annual apportionments are based on each category's proportional share of the anticipated halibut bycatch mortality during the fishing year and optimization of the total amount of groundfish harvest under the halibut PSC limit. The fishery categories for the trawl halibut PSC limits are 1) a deep-water species fishery, composed of sablefish, rockfish, deep-water flatfish, rex sole, and arrowtooth flounder; and 2) a shallow-water species fishery, composed of pollock, Pacific cod, shallow-water flatfish, flathead sole, Atka mackerel, skates, and “other species” (sculpins, sharks, squids, and octopuses) (§ 679.21(d)(3)(iii)). Tables 16 and 17 list, respectively, the final 2015 and 2016 apportionments of halibut PSC trawl limits between the trawl gear deep-water and the shallow-water species fishery categories.
Table 28d to 50 CFR part 679 specifies the amount of the trawl halibut PSC limit that is assigned to the CV and C/P sectors that are participating in the Central GOA Rockfish Program. This includes 117 mt of halibut PSC limit to the CV sector and 74 mt of halibut PSC limit to the C/P sector. These amounts are allocated from the trawl deep-water species fishery's halibut PSC third seasonal apportionment.
Section 679.21(d)(4)(iii)(B) limits the amount of the halibut PSC limit allocated to Rockfish Program participants that could be re-apportioned to the general GOA trawl fisheries to no more than 55 percent of the unused annual halibut PSC apportioned to Rockfish Program participants. The remainder of the unused Rockfish Program halibut PSC limit is unavailable for use by vessels directed fishing with trawl gear for the remainder of the fishing year.
Section 679.21(d)(2)(B) requires that the “other hook-and-line fishery” halibut PSC limit apportionment to vessels using hook-and-line gear must be apportioned between CVs and C/Ps in accordance with § 679.21(d)(2)(iii) in conjunction with these harvest specifications. A comprehensive description and example of the calculations necessary to apportion the “other hook-and-line fishery” halibut PSC limit between the hook-and-line CV and C/P sectors were included in the proposed rule to implement Amendment 83 (76 FR 44700, July 26, 2011) and are not repeated here.
For 2015, NMFS apportions halibut PSC limits of 145 mt and 116 mt to the hook-and-line CV and hook-and-line C/P sectors, respectively. For 2016, NMFS apportions halibut PSC limits of 140 mt and 116 mt to the hook-and-line CV and hook-and-line C/P sectors, respectively. Tables 18 and 19 list, respectively, the final 2015 and 2016 apportionments of halibut PSC limits between the hook-and-line CV and hook-and-line C/P sectors.
Pursuant to § 679.21(d)(2)(iii), the hook-and-line halibut PSC limit is apportioned between the CV and C/P sectors in proportion to the total Western and Central GOA Pacific cod allocations, which vary annually based on the proportion of the Pacific cod biomass. Pacific cod is apportioned among these two management areas based on the percentage of overall biomass per area, as calculated in the 2014 Pacific cod stock assessment. Updated information in the final 2014 SAFE report describes this distributional change, which is based on allocating ABC among regulatory areas on the basis of the three most recent stock surveys. The distribution of the total GOA Pacific cod ABC has changed to 36 percent Western GOA, 61 percent Central GOA, and 3 percent Eastern GOA. Therefore, the calculations made in accordance with § 679.21(d)(2)(iii) incorporate the most recent change in GOA Pacific cod distribution with respect to establishing the annual halibut PSC limits for the CV and C/P hook-and-line sectors. The annual halibut PSC limits are divided into three seasonal apportionments, using seasonal percentages of 86 percent, 2 percent, and 12 percent.
No later than November 1 of each year, NMFS will calculate the projected unused amount of halibut PSC limit by either of the hook-and-line sectors for the remainder of the year. The projected unused amount of halibut PSC limit is made available to the other hook-and-line sector for the remainder of that fishing year if NMFS determines that an additional amount of halibut PSC is necessary for that sector to continue its directed fishing operations (§ 679.21(d)(2)(iii)(C)).
The IPHC annually assesses the abundance and potential yield of the Pacific halibut using all available data from the commercial and sport fisheries, other removals, and scientific surveys. Additional information on the Pacific halibut stock assessment may be found in the IPHC's 2014 Pacific halibut stock assessment (December 2014), available on the IPHC Web site at
To monitor halibut bycatch mortality allowances and apportionments, the Regional Administrator uses observed halibut incidental catch rates, discard mortality rates (DMRs), and estimates of groundfish catch to project when a fishery's halibut bycatch mortality allowance or seasonal apportionment is reached. The DMRs are based on the best information available, including information contained in the annual SAFE report.
NMFS is implementing the Council's recommendation that the halibut DMRs developed and recommended by the IPHC for the 2013 through 2015 GOA groundfish fisheries be used for monitoring the final 2015 and 2016 halibut bycatch mortality allowances (see Tables 14 through 19). The IPHC developed the DMRs for the 2013 through 2015 GOA groundfish fisheries using the 10-year mean DMRs for those fisheries. Long-term average DMRs were not available for some fisheries, so rates from the most recent years were used. For the skate, sculpin, shark, squid, and octopus target fisheries, where not enough halibut mortality data are available, the mortality rate of halibut caught in the Pacific cod fishery for that gear type was recommended as a default rate. The IPHC will analyze observer data annually and recommend changes to the DMRs when a fishery DMR shows large variation from the mean. A discussion of the DMRs and how the IPHC establishes them is available from the Council (see
In 2012, NMFS issued a final rule to implement Amendment 93 to the GOA FMP (77 FR 42629, July 20, 2012). Amendment 93 established separate Chinook salmon PSC limits in the Western and Central GOA in the directed pollock fishery. These limits require NMFS to close the pollock directed fishery in the Western and Central regulatory areas of the GOA if the applicable limit is reached (§ 679.21(h)(6)). The annual Chinook salmon PSC limits in the pollock directed fishery of 6,684 salmon in the Western GOA and 18,316 salmon in the Central GOA are set in regulation at § 679.21(h)(2)(i) and (ii). In addition, all salmon (regardless of species) taken in the pollock directed fisheries in the Western and Central GOA must be retained until an observer at the processing facility that takes delivery of the catch is provided an opportunity to count the number of salmon and to collect any scientific data or biological samples from the salmon (§ 679.21(h)(4)).
As described earlier in this preamble, NMFS issued a final rule to implement Amendment 97 to the FMP (79 FR 71350, December 2, 2014). That action established an initial annual PSC limit of 7,500 Chinook salmon for the non-pollock groundfish fisheries. This limit is apportioned among three sectors: 3,600 Chinook salmon to trawl catcher/processors, 1,200 Chinook salmon to trawl catcher vessels participating in the Central GOA Rockfish Program, and 2,700 Chinook salmon to trawl catcher vessels not participating in the Central GOA Rockfish Program that are fishing for groundfish species other than pollock (§ 679.21(i)(3)). NMFS will monitor the Chinook salmon PSC in the non-pollock GOA groundfish fisheries and close an applicable sector if it reaches its Chinook salmon PSC limit.
The Chinook salmon PSC limit for two sectors, trawl catcher/processors and trawl catcher vessels not participating in the Central GOA Rockfish Program, may be increased in subsequent years based on the performance of these two sectors and their ability to minimize their use of their respective Chinook salmon PSC limits. If either or both of these two sectors limits its use of Chinook salmon PSC to a certain threshold amount in 2015, that sector will receive an incremental increase to its 2016 Chinook salmon PSC limit (§ 679.21(i)(3)).
Section 679.64 establishes groundfish harvesting and processing sideboard limitations on AFA C/Ps and CVs in the GOA. These sideboard limits are necessary to protect the interests of fishermen and processors who do not directly benefit from the AFA from those fishermen and processors who receive exclusive harvesting and processing privileges under the AFA. Section 679.7(k)(1)(ii) prohibits listed AFA C/Ps from harvesting any species of groundfish in the GOA. Additionally, § 679.7(k)(1)(iv) prohibits listed AFA C/Ps from processing any pollock harvested in a directed pollock fishery in the GOA and any groundfish harvested in Statistical Area 630 of the GOA.
AFA CVs that are less than 125 ft (38.1 meters) length overall, have annual landings of pollock in the Bering Sea and Aleutian Islands less than 5,100 mt, and have made at least 40 groundfish landings from 1995 through 1997 are exempt from GOA sideboard limits under § 679.64(b)(2)(ii). Sideboard limits for non-exempt AFA CVs in the GOA are based on their traditional harvest levels of TAC in groundfish fisheries covered by the FMP. Section 679.64(b)(3)(iii) establishes the groundfish sideboard limitations in the GOA based on the retained catch of non-exempt AFA CVs of each sideboard species from 1995 through 1997 divided by the TAC for that species over the same period.
Tables 21 and 22 list the final 2015 and 2016 groundfish sideboard limits for non-exempt AFA CVs. NMFS will deduct all targeted or incidental catch of sideboard species made by non-exempt AFA CVs from the sideboard limits listed in Tables 21 and 22.
The halibut PSC sideboard limits for non-exempt AFA CVs in the GOA are based on the aggregate retained groundfish catch by non-exempt AFA CVs in each PSC target category from 1995 through 1997 divided by the retained catch of all vessels in that fishery from 1995 through 1997 (§ 679.64(b)(4)). Tables 23 and 24 list the final 2015 and 2016 non-exempt AFA CV halibut PSC limits for vessels using trawl gear in the GOA, respectively. The 2015 and 2016 seasonal apportionments of trawl halibut PSC limits between the deep-water and shallow-water species fisheries categories proportionately incorporate reductions made to the annual trawl halibut PSC limits and associated seasonal apportionments (see Tables 14 and 15).
Section 680.22 establishes groundfish catch limits for vessels with a history of participation in the Bering Sea snow crab fishery to prevent these vessels from using the increased flexibility provided by the Crab Rationalization Program to expand their level of participation in the GOA groundfish fisheries. Sideboard limits restrict these vessels' catch to their collective historical landings in each GOA groundfish fishery (except the fixed-gear sablefish fishery). Sideboard limits also apply to catch made using an LLP license derived from the history of a restricted vessel, even if that LLP license is used on another vessel.
The basis for these sideboard limits is described in detail in the final rules implementing the major provisions of Amendments 18 and 19 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (70 FR 10174, March 2, 2005), Amendment 34 to the Fishery Management Plan for Bering Sea/Aleutian Island King and Tanner Crabs (76 FR 35772, June 20, 2011), and Amendment 83 to the GOA FMP (76 FR 74670, December 1, 2011).
Tables 25 and 26 list the final 2015 and 2016 groundfish sideboard limitations for non-AFA crab vessels. All targeted or incidental catch of sideboard species made by non-AFA crab vessels or associated LLP licenses will be deducted from these sideboard limits.
The Rockfish Program establishes three classes of sideboard provisions: CV groundfish sideboard restrictions, C/P rockfish sideboard restrictions, and C/P opt-out vessel sideboard restrictions. These sideboards are intended to limit the ability of rockfish harvesters to expand into other fisheries.
CVs participating in the Rockfish Program may not participate in directed fishing for dusky rockfish, Pacific ocean perch, and northern rockfish in the West Yakutat district and Western GOA from July 1 through July 31. Also, CVs may not participate in directed fishing for arrowtooth flounder, deep-water flatfish, and rex sole in the GOA from July 1 through July 31 (§ 679.82(d)).
Catcher/processors participating in Rockfish Program cooperatives are restricted by rockfish and halibut PSC sideboard limits. These C/Ps are prohibited from directed fishing for dusky rockfish, Pacific ocean perch, and
Under the Rockfish Program, the C/P sector is subject to halibut PSC sideboard limits for the trawl deep-water and shallow-water species fisheries from July 1 through July 31. No halibut PSC sideboard limits apply to the CV sector, as vessels participating in cooperatives receive a portion of the annual halibut PSC limit. C/Ps that opt out of the Rockfish Program would be able to access that portion of the deep-water and shallow-water halibut PSC sideboard limit not assigned to C/P rockfish cooperatives. The sideboard provisions for C/Ps that elect to opt out of participating in a rockfish cooperative are described in § 679.82(c), (e), and (f). Sideboard limits are linked to the catch history of specific vessels that may choose to opt out. After March 1, NMFS will determine which C/Ps have opted-out of the Rockfish Program in 2015, and will know the ratios and amounts used to calculate opt-out sideboard ratios. NMFS will then calculate any applicable opt-out sideboards and post these allocations on the Alaska Region Web site at
Amendment 80 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (Amendment 80 Program) established a limited access privilege program for the non-AFA trawl C/P sector. The Amendment 80 Program established groundfish and halibut PSC catch limits for Amendment 80 Program participants to limit the ability of participants eligible for the Amendment 80 Program to expand their harvest efforts in the GOA.
Section 679.92 establishes groundfish harvesting sideboard limits on all Amendment 80 program vessels, other than the F/V GOLDEN FLEECE, to amounts no greater than the limits listed in Table 37 to 50 CFR part 679. Under regulations at § 679.92(d), the F/V GOLDEN FLEECE is prohibited from directed fishing for pollock, Pacific cod, Pacific ocean perch, dusky rockfish, and northern rockfish in the GOA.
Groundfish sideboard limits for Amendment 80 Program vessels operating in the GOA are based on their average aggregate harvests from 1998 through 2004. Tables 31 and 32 list the final 2015 and 2016 sideboard limits for Amendment 80 Program vessels. NMFS will deduct all targeted or incidental catch of sideboard species made by Amendment 80 Program vessels from the sideboard limits in Tables 31 and 32.
The PSC sideboard limits for Amendment 80 Program vessels in the GOA are based on the historic use of halibut PSC by Amendment 80 Program vessels in each PSC target category from 1998 through 2004. These values are slightly lower than the average historic use to accommodate two factors: Allocation of halibut PSC cooperative quota under the Central GOA Rockfish Program and the exemption of the F/V GOLDEN FLEECE from this restriction (§ 679.92(b)(2)). Tables 33 and 34 list the final 2015 and 2016 halibut PSC limits for Amendment 80 Program vessels, respectively. These tables incorporate the maximum percentages of the halibut PSC sideboard limits that may be used by Amendment 80 Program vessels as contained in Table 38 to 50 CFR part 679. These halibut PSC limits proportionately incorporate the reductions made to the annual trawl halibut PSC limits and associated seasonal apportionments (see Tables 14 and 15). Additionally, residual amounts of a seasonal Amendment 80 sideboard halibut PSC limit may carry forward to the next season limit (§ 679.92(b)(2)).
Pursuant to § 679.20(d)(1)(i), if the Regional Administrator determines (1) that any allocation or apportionment of a target species or species group allocated or apportioned to a fishery will be reached; or (2) with respect to pollock and Pacific cod, that an allocation or apportionment to an inshore or offshore component or sector allocation will be reached, the Regional Administrator may establish a directed fishing allowance (DFA) for that species or species group. If the Regional Administrator establishes a DFA and that allowance is or will be reached before the end of the fishing year, NMFS will prohibit directed fishing for that species or species group in the specified GOA regulatory area or district (§ 679.20(d)(1)(iii)).
The Regional Administrator has determined that the TACs for the species listed in Table 35 are necessary to account for the incidental catch of these species in other anticipated groundfish fisheries for the 2015 and 2016 fishing years.
Consequently, in accordance with § 679.20(d)(1)(i), the Regional Administrator establishes the DFA for the species or species groups listed in Table 35 as zero mt. Therefore, in accordance with § 679.20(d)(1)(iii), NMFS is prohibiting directed fishing for those species, areas, gear types, and components in the GOA listed in Table 35. These closures will remain in effect through 2400 hrs, A.l.t., December 31, 2016.
Section 679.64(b)(5) provides for management of AFA CV groundfish harvest limits and PSC bycatch limits using directed fishing closures and PSC closures according to procedures set out at §§ 679.20(d)(1)(iv), 679.21(d)(6), and 679.21(e)(3)(v). The Regional Administrator has determined that, in addition to the closures listed above, many of the non-exempt AFA CV sideboard limits listed in Tables 21 and 22 are necessary as incidental catch to support other anticipated groundfish fisheries for the 2015 and 2016 fishing years. In accordance with § 679.20(d)(1)(iv), the Regional Administrator sets the DFAs for the species and species groups in Table 36 at zero mt. Therefore, in accordance with § 679.20(d)(1)(iii), NMFS is prohibiting directed fishing by non-exempt AFA CVs in the GOA for the species and specified areas listed in Table 36. These closures will remain in effect through 2400 hrs, A.l.t., December 31, 2016.
Section 680.22 provides for the management of non-AFA crab vessel sideboards using directed fishing closures in accordance with § 680.22(e)(2) and (3). The Regional Administrator has determined that the non-AFA crab vessel sideboards listed in Tables 25 and 26 are insufficient to support a directed fishery and has set the sideboard DFA at zero mt, with the exception of Pacific cod pot CV sector apportionments in the Western and Central Regulatory Areas. Therefore, NMFS is prohibiting directed fishing by non-AFA crab vessels in the GOA for all species and species groups listed in Tables 25 and 26, with the exception of the Pacific cod pot CV sector apportionments in the Western and Central Regulatory Areas.
Closures implemented under the 2014 and 2015 GOA harvest specifications for groundfish (79 FR 12890, March 6, 2014) remain effective under authority of these final 2015 and 2016 harvest specifications, and are posted at the following Web site:
NMFS did not receive any comments in response to the proposed 2015 and 2016 harvest specifications (79 FR 72593, December 8, 2014).
NMFS has determined that these final harvest specifications are consistent with the FMP and with the Magnuson-Stevens Act and other applicable laws.
This action is authorized under 50 CFR 679.20 and is exempt from review under Executive Orders 12866 and 13563.
NMFS prepared an EIS for this action (see
An SEIS should be prepared if 1) the agency makes substantial changes in the proposed action that are relevant to environmental concerns, or 2) significant new circumstances or information exist relevant to environmental concerns and bearing on the proposed action or its impacts (40 CFR 1502.9(c)(1)). After reviewing the information contained in the SIR and SAFE reports, the Regional Administrator has determined that 1) approval of the 2015 and 2016 harvest specifications, which were set according to the preferred harvest strategy in the EIS, do not constitute a substantial change in the action; and 2) there are no significant new circumstances or information relevant to environmental concerns and bearing on the action or its
Section 604 of the Regulatory Flexibility Act requires that, when an agency promulgates a final rule under section 553 of Title 5 of the United States Code, after being required by that section, or any other law, to publish a general notice of proposed rulemaking, the agency shall prepare a final regulatory flexibility analysis (FRFA).
Section 604 describes the required contents of a FRFA: 1) A statement of the need for, and objectives of, the rule; 2) a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments; 3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; 4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; 5) a description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; 6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.
A description of this action, its purpose, and its legal basis are contained at the beginning of the preamble to this final rule and are not repeated here.
NMFS published the proposed rule on December 8, 2014 (79 FR 72593). NMFS prepared an Initial Regulatory Flexibility Analysis (IRFA) to accompany this action, and included a summary in the proposed rule. The comment period closed on January 7, 2015. No comments were received on the IRFA or the economic impacts of the rule more generally.
The entities directly regulated by this action include a) entities operating vessels with groundfish FFPs catching FMP groundfish in Federal waters; b) all entities operating vessels, regardless of whether they hold groundfish FFPs, catching FMP groundfish in the state-waters parallel fisheries; and c) all entities operating vessels fishing for halibut inside three miles of the shore (whether or not they have FFPs).
On June 12, 2014, the Small Business Administration issued an interim final rule revising the small business size standards for several industries effective July 14, 2014 (79 FR 33647, June 12, 2014). The rule increased the size standard for Finfish Fishing from $19.0 million to $20.5 million, Shellfish Fishing from $ 5.0 million to $5.5 million, and Other Marine Fishing from $7.0 million to $7.5 million.
Based on data from 2013 fishing activity, there were 1,156 individual catcher vessel entities with gross revenues meeting small entity criteria. Of these entities, 1,075 used hook-and-line gear, 116 used pot gear, and 33 used trawl gear (some of these entities used more than one gear type, thus the counts of entities using the different gear types do not sum to the total number of entities above). Three individual catcher/processors met the small entity criterion; two used hook-and-line gear, and one used trawl gear. Catcher/processor gross revenues were not reported for confidentiality reasons, however hook-and-line small entities had average gross revenues of $380,000, small pot entities had average gross revenues of $960,000, and small trawl entities had average gross revenues of $2.8 million.
Some of these vessels are members of AFA inshore pollock cooperatives, of GOA rockfish cooperatives, or of BSAI crab rationalization cooperatives and, therefore, under the Regulatory Flexibility Act (RFA) it is the aggregate gross receipts of all participating members of the cooperative that must meet the threshold. Vessels that participate in these cooperatives are considered to be large entities within the meaning of the RFA. These relationships are accounted for, along with corporate affiliations among vessels, to the extent that they are known, in the estimated number of small entities. If affiliations exist of which NMFS is unaware, or if entities had non-fishing revenue sources, the estimates above may overstate the number of directly regulated small entities.
This action does not modify recordkeeping or reporting requirements.
NMFS considered other, alternative harvest strategies when choosing the preferred harvest strategy (Alternative 2) in December 2006. These included the following:
• Alternative 1: Set TACs to produce fishing mortality rates, F, that are equal to maxFABC, unless the sum of the TACs is constrained by the OY established in the FMPs. This is equivalent to setting TACs to produce harvest levels equal to the maximum permissible ABCs, as constrained by OY. The term “maxFABC” refers to the maximum permissible value of FABC under Amendment 56 to the groundfish FMPs. Historically, the TAC has been set at or below the ABC, therefore, this alternative represents a likely upper limit for setting the TAC within the OY and ABC limits.
• Alternative 3: For species in Tiers 1, 2, and 3, set TAC to produce F equal to the most recent 5-year average actual F. For species in Tiers 4, 5, and 6, set TAC equal to the most recent 5-year average actual catch. For stocks with a high level of scientific information, TACs would be set to produce harvest levels equal to the most recent 5-year average actual fishing mortality rates. For stocks with insufficient scientific information, TACs would be set equal to the most recent 5-year average actual catch. This alternative recognizes that for some stocks, catches may fall well below ABCs, and recent average F may provide a better indicator of actual F than FABC does.
• Alternative 4: 1) Set TACs for rockfish species in Tier 3 at F75%. Set TACs for rockfish species in Tier 5 at F = 0.5M. Set spatially explicit TACs for shortraker and rougheye rockfish in the GOA. 2) Taking the rockfish TACs as calculated above, reduce all other TACs by a proportion that does not vary across species, so that the sum of all TACs, including rockfish TACs, is equal to the lower bound of the area OY (116,000 mt in the GOA). This alternative sets conservative and spatially explicit TACs for rockfish species that are long-lived and late to mature and sets conservative TACs for the other groundfish species.
• Alternative 5: (No Action) Set TACs at zero.
These four alternatives do not meet the objectives of this action although they have a smaller adverse economic impact on small entities than the
Alternative 1 selected harvest rates that will allow fishermen to harvest stocks at the level of ABCs, unless total harvests are constrained by the upper bound of the GOA OY of 800,000 metric tons. The sums of ABCs in 2015 and 2016 are 685,597 mt and 731,049 mt, respectively. The sums of the TACs in 2015 and 2016 are 536,158 mt and 590,161 mt, respectively. Thus, although the sum of ABCs in each year is less than 800,000 metric tons, the sums of the TACs in each year are less than the sums of the ABCs.
In most cases, the Council has set TACs equal to ABCs. The divergence between aggregate TACs and aggregate ABCs reflects a variety of special species- and fishery-specific circumstances:
• Pacific cod TACs are set equal to 70 percent in the Western GOA and 75 percent in the Central GOA of the Pacific cod ABCs in each year to account for the guideline harvest levels (GHL) set by the State of Alaska for its GHL Pacific cod fisheries (30 and 25 percent, respectively, of the Western and Central GOA ABCs). Thus, the difference between the Federal TACs and ABCs does not actually reflect a Pacific cod harvest below the Pacific cod ABC, as the balance is available for the State's cod GHL fisheries.
• Shallow-water flatfish and flathead sole TACs are set below ABCs in the Western and Central GOA regulatory areas. Arrowtooth flounder TACs are set below ABC in all GOA regulatory areas. Catches of these flatfish species rarely, if ever, approach the proposed ABCs or TACs. Important trawl fisheries in the GOA take halibut PSC, and are constrained by limits on the allowable halibut PSC mortality. These limits routinely force the closure of trawl fisheries before they have harvested the available groundfish ABC. Thus, actual harvests of groundfish in the GOA routinely fall short of some ABCs and TACs. Markets can also constrain harvests below the TACs, as has been the case with arrowtooth flounder, in the past. These TACs are set to allow for increased harvest opportunities for these targets while conserving the halibut PSC limit for use in other, more fully utilized, fisheries.
• The other rockfish TAC is set below the ABC in the Southeast Outside district based on several factors. In addition to conservation concerns for the rockfish species in this group, there is a regulatory prohibition against using trawl gear east of 140° W. longitude. Because most species of other rockfish are caught exclusively with trawl gear, the catch of such species with other gear types, such as hook-and-line, is low. The commercial catch of other rockfish in the Eastern regulatory area, which includes the West Yakutat and Southeast Outside districts, has ranged from approximately 70 mt to 248 mt per year over the last decade.
• The GOA-wide Atka mackerel TAC is set below the ABC. The estimates of survey biomass continue to be unreliable in the GOA. Therefore, the Council recommended and NMFS agrees that the Atka mackerel TAC in the GOA be set at an amount to support incidental catch in other directed fisheries.
Alternative 3 selects harvest rates based on the most recent 5 years of harvest rates (for species in Tiers 1 through 3) or for the most recent 5 years of harvests (for species in Tiers 4 through 6). This alternative is inconsistent with the objectives of this action, because it does not take account of the most recent biological information for this fishery.
Alternative 4 would lead to significantly lower harvests of all species to reduce TACs from the upper end of the OY range in the GOA to its lower end of 116,000 mt. Overall, this would reduce 2015 TACs by about 78 percent. This would lead to significant reductions in harvests of species by small entities. While production declines in the GOA would undoubtedly be associated with price increases in the GOA, these increases would still be constrained by the availability of substitutes, and are very unlikely to offset revenue declines from smaller production. Thus, this action would have a detrimental economic impact on small entities.
Alternative 5, which sets all harvests equal to zero, may also address conservation issues, but would have a significant adverse economic impact on small entities.
Impacts on marine mammals resulting from fishing activities conducted under this rule are discussed in the EIS and SIR (see
Pursuant to 5 U.S.C. 553(d)(3), the Assistant Administrator for Fisheries, NOAA, finds good cause to waive the 30-day delay in effectiveness for this rule because delaying this rule would be contrary to the public interest. The Plan Team review occurred in November 2014, and Council consideration and recommendations occurred in December 2014. Accordingly, NMFS' review could not begin until January 2015. For all fisheries not currently closed because the TACs established under the final 2014 and 2015 harvest specifications (79 FR 12890, March 6, 2014) were not reached, it is possible that they would be closed prior to the expiration of a 30-day delayed effectiveness period, because their TACs could be reached within that period. If implemented immediately, this rule would allow these fisheries to continue because the new TACs implemented by this rule are higher than the ones under which they are currently fishing.
Certain fisheries, such as those for pollock and Pacific cod, are intensive, fast-paced fisheries. Other fisheries, such as those for sablefish, flatfish, rockfish, Atka mackerel, skates, sculpins, sharks, squids, and octopuses, are critical as directed fisheries and as incidental catch in other fisheries. U.S. fishing vessels have demonstrated the capacity to catch the TAC allocations in many of these fisheries. If this rule allowed for a 30-day delay in effectiveness and if a TAC were reached during those 30 days, NMFS would close directed fishing or prohibit retention for the applicable species. Any delay in allocating the final TACs in these fisheries would cause confusion to the industry and potential economic harm through unnecessary discards, thus undermining the intent of the rule. Waiving the 30-day delay allows NMFS to prevent economic loss to fishermen that could otherwise occur should the 2015 TACs be reached. Determining which fisheries may close is impossible because these fisheries are affected by several factors that cannot be predicted in advance, including fishing effort, weather, movement of fishery stocks, and market price. Furthermore, the closure of one fishery has a cascading effect on other fisheries by freeing-up fishing vessels, allowing them to move from closed fisheries to open ones, increasing the fishing capacity in those open fisheries, and causing them to close at an accelerated pace.
In fisheries subject to declining sideboard limits, a failure to implement the updated sideboard limits before initial season's end could deny the intended economic protection to the non-sideboarded sectors. Conversely, in fisheries with increasing sideboard limits, economic benefit could be denied to the sideboard limited sectors.
If the final harvest specifications are not effective by March 14, 2015, which is the start of the 2015 Pacific halibut season as specified by the IPHC, the hook-and-line sablefish fishery will not begin concurrently with the Pacific halibut IFQ season. This would result in confusion for the industry and economic harm from unnecessary discard of sablefish that are caught
In addition, the immediate effectiveness of this action is required to provide consistent management and conservation of fishery resources based on the best available scientific information. This is particularly true for those species that have lower 2015 ABCs and TACs than those established in the 2014 and 2015 harvest specifications (79 FR 12890, March 6, 2014). Immediate effectiveness also would give the fishing industry the earliest possible opportunity to plan and conduct its fishing operations with respect to new information about TACs. Therefore, NMFS finds good cause to waive the 30-day delay in effectiveness under 5 U.S.C. 553(d)(3).
This final rule is a plain language guide to assist small entities in complying with this final rule as required by the Small Business Regulatory Enforcement Fairness Act of 1996. This final rule's primary purpose is to announce the final 2015 and 2016 harvest specifications and prohibited species bycatch allowances for the groundfish fisheries of the GOA. This action is necessary to establish harvest limits and associated management measures for groundfish during the 2015 and 2016 fishing years, and to accomplish the goals and objectives of the FMP. This action affects all fishermen who participate in the GOA fisheries. The specific amounts of OFL, ABC, TAC, and PSC are provided in tables to assist the reader. NMFS will announce closures of directed fishing in the
16 U.S.C. 773
U.S. Citizenship and Immigration Services, Department of Homeland Security.
Final rule.
This final rule amends Department of Homeland Security (“DHS” or “Department”) regulations by extending eligibility for employment authorization to certain H-4 dependent spouses of H-1B nonimmigrants who are seeking employment-based lawful permanent resident (“LPR”) status. Such H-1B nonimmigrants must be the principal beneficiaries of an approved Immigrant Petition for Alien Worker (Form I-140), or have been granted H-1B status in the United States under the American Competitiveness in the Twenty-first Century Act of 2000, as amended by the 21st Century Department of Justice Appropriations Authorization Act. DHS anticipates that this regulatory change will reduce personal and economic burdens faced by H-1B nonimmigrants and eligible H-4 dependent spouses during the transition from nonimmigrant to LPR status. The final rule will also support the goals of attracting and retaining highly skilled foreign workers and minimizing the disruption to U.S. businesses resulting from H-1B nonimmigrants who choose not to pursue LPR status in the United States. By providing the possibility of employment authorization to certain H-4 dependent spouses, the rule will ameliorate certain disincentives for talented H-1B nonimmigrants to permanently remain in the United States and continue contributing to the U.S. economy as LPRs. This is an important goal considering the contributions such individuals make to entrepreneurship and research and development, which are highly correlated with overall economic growth and job creation. The rule also will bring U.S. immigration policies concerning this class of highly skilled workers more in line with those of other countries that are also competing to attract and retain similar highly skilled workers.
This final rule is effective May 26, 2015.
Jennifer Oppenheim, Adjudications Officer, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue NW., Suite 1100, Washington, DC 20529-2140; Telephone (202) 272-1470.
DHS does not currently extend eligibility for employment authorization to H-4 dependents (spouses and unmarried children under 21 years of age) of H-1B nonimmigrants.
In this final rule, DHS is amending its regulations to extend eligibility for employment authorization to certain H-4 dependent spouses of H-1B nonimmigrants to support the retention
The authority of the Secretary of Homeland Security (Secretary) for this regulatory amendment can be found in section 102 of the Homeland Security Act of 2002, Public Law 107-296, 116 Stat. 2135, 6 U.S.C. 112, and section 103(a) of the Immigration and Nationality Act (INA), 8 U.S.C. 1103(a), which authorize the Secretary to administer and enforce the immigration and nationality laws. In addition, section 274A(h)(3)(B) of the INA, 8 U.S.C. 1324a(h)(3)(B), recognizes the Secretary's authority to extend employment to noncitizens in the United States.
On May 12, 2014, DHS published a notice of proposed rulemaking, which proposed to amend DHS regulations at 8 CFR 214.2(h)(9)(iv) and 274a.12(c) to extend eligibility for employment authorization to H-4 dependent spouses of H-1B nonimmigrants if the H-1B nonimmigrants either: (1) Are the principal beneficiaries of an approved Immigrant Petition for Alien Worker (Form I-140); or (2) have been granted H-1B status pursuant to sections 106(a) and (b) of the American Competitiveness in the Twenty-first Century Act of 2000, Public Law 107-273, 116 Stat. 1758, as amended by the 21st Century Department of Justice Appropriations Act, Public Law 107-273, 116 Stat. 1758 (2002) (collectively referred to as “AC21”).
In preparing this final rule, DHS updated its estimates of the impacted population by examining more recent data, correcting data entry errors made in calculating the population of H-4 dependent spouses assumed to be in the backlog, and revising the estimate of the population eligible pursuant to AC21. This final rule is expected to result in as many as 179,600 H-4 dependent spouses being eligible to apply for employment authorization during the first year of implementation. As many as 55,000 H-4 dependent spouses will be eligible to apply for employment authorization each year after the first year of implementation. DHS stresses that these are maximum estimates of the number of H-4 dependent spouses who may become eligible to apply for employment authorization. Although the estimates are larger than those provided in the preamble to the proposed rule, the initial year estimate (the year with the largest number of potential eligible applicants) provided in this final rule still represents far less than one percent of the overall U.S. workforce. DHS's rationale for this rule thus remains unchanged, especially as the changes made in this rule simply alleviate the long wait for employment authorization that these H-4 dependent spouses endure through the green card process, and accelerate the timeframe within which they generally will become eligible to apply for employment authorization (such as when they apply for adjustment of status).
The costs associated with this final rule stem from filing fees and the opportunity costs of time associated with filing an Application for Employment Authorization, Form I-765 (“Application for Employment Authorization” or “Form I-765”), as well as the estimated cost of procuring two passport-style photos. These costs will only be borne by the H-4 dependent spouses who choose to apply for employment authorization. The costs to the Federal Government of adjudicating and processing the applications are covered by the application fee for Form I-765.
DHS expects these regulatory amendments to provide increased incentives to H-1B nonimmigrants and their families who have begun the immigration process to remain permanently in the United States and continue contributing to the Nation's economy as they complete this process. DHS believes these regulatory changes will also minimize disruptions to petitioning U.S. employers. A summary of the costs and benefits of the rule is presented in Table 1.
This final rule will be effective on May 26, 2015, 90 days from the date of publication in the
Under the H-1B nonimmigrant classification, a U.S. employer or agent may file a petition to employ a temporary foreign worker in the United States to perform services in a specialty occupation, services related to a Department of Defense (DOD) cooperative research and development project or coproduction project, or services of distinguished merit and ability in the field of fashion modeling.
If USCIS approves the H-1B petition, the approved H-1B status is valid for an initial period of up to three years. USCIS may grant extensions for up to an additional three years, such that the total period of the H-1B nonimmigrant's admission in the United States does not exceed six years.
For H-1B nonimmigrants seeking to adjust their status to or otherwise acquire LPR status through employment-based (EB) immigration, an employer generally must first file a petition on their behalf.
• First preference (EB-1)—Aliens with extraordinary ability, outstanding professors and researchers, and certain multinational executives and managers;
• Second preference (EB-2)—Aliens who are members of the professions holding advanced degrees or aliens of exceptional ability;
• Third preference (EB-3)—Skilled workers, professionals, and other workers;
• Fourth preference (EB-4)—Special immigrants (
• Fifth preference (EB-5)—Employment creation immigrants.
Generally, the second (EB-2) and third (EB-3) preference categories require employers to obtain an approved permanent labor certification from DOL prior to filing an immigrant petition with USCIS on behalf of the worker.
The EB-2 and EB-3 immigrant visa categories for certain chargeability areas are oversubscribed, causing long delays before applicants in those categories, including H-1B nonimmigrants, are able to obtain LPR status. U.S. businesses employing H-1B nonimmigrants suffer disruptions when such workers are required to leave the United States at the termination of their H-1B status as a result of these delays. To ameliorate those disruptions, Congress enacted provisions in AC21 that allow for the extension of H-1B status past the sixth year for workers who are the beneficiaries of certain pending or approved employment-based immigrant visa petitions or labor certification applications.
DHS cannot alleviate the delays in visa processing due to the numerical limitations set by statute and the resultant unavailability of immigrant visa numbers.
On May 12, 2014, DHS published a proposed rule in the
• 8 CFR 214.2(h)(9)(iv) to extend eligibility for employment authorization to H-4 dependent spouses of H-1B nonimmigrants if the H-1B nonimmigrants either: are the principal beneficiaries of an approved Immigrant Petition for Alien Worker (Form I-140);
• 8 CFR 274a.12(c) by adding paragraph (26) listing the H-4 dependent spouses described in revised 8 CFR 214.2(h)(9)(iv) as a new class of aliens eligible to request employment authorization from USCIS. Aliens within this class would only be authorized for employment following approval of their Application for Employment Authorization (Form I-765) by USCIS and receipt of an Employment Authorization Document (Form I-766) (“EAD”).
DHS received nearly 13,000 public comments to the proposed rule. An overwhelming percentage of commenters (approximately 85 percent) supported the proposal, while a small percentage of commenters (approximately 10 percent) opposed the proposal. Approximately 3.5 percent of commenters expressed a mixed opinion about the proposal.
In preparing this final rule, DHS considered all of the public comments contained in the docket. Although estimates of the current population of H-4 dependent spouses who will be eligible for employment authorization pursuant to this rule have changed, the effect of the revision does not affect the justification for the rule, and DHS is adopting the regulatory amendments set forth in the proposed rule with only minor, non-substantive changes to 8 CFR 214.2(h)(9)(iv) to improve clarity and readability. These technical changes clarify that an H-4 dependent spouse covered by this rule should include with his or her Application for Employment Authorization (Form I-765) evidence demonstrating that he or she is currently in H-4 status and that the H-1B nonimmigrant is currently in H-1B status. Also, in response to public comments regarding filing procedures for Applications for Employment Authorization (Forms I-765) under this rule, DHS is making conforming revisions to 8 CFR 214.2(h)(9)(iv) and 8 CFR 274a.13(d) to permit H-4 dependent spouses under this rule to concurrently file the Form I-765 with an Application to Extend/Change Nonimmigrant Status (Form I-539).
The rationale for the proposed rule and the reasoning provided in its background section remain valid with respect to these regulatory amendments. This final rule does not address comments seeking changes in U.S. laws, regulations, or agency policies that are unrelated to this rulemaking. This final rule also does not change the procedures or policies of other DHS components or federal agencies, or resolve issues outside the scope of this rulemaking. Comments may be reviewed at the Federal Docket Management System (FDMS) at
In response to the proposed rule, DHS received nearly 13,000 comments during the 60-day public comment period. Commenters included, among others, individuals, employers, academics, labor organizations, immigrant advocacy groups, attorneys, and nonprofit organizations. More than 250 comments were also submitted through mass mailing campaigns.
While opinions on the proposed rule varied, a substantial majority (approximately 85 percent) of commenters supported the extension of employment authorization to the class of H-4 dependent spouses described in the proposed rulemaking. Supporters of the proposed rule agreed that it would help the United States to attract and retain highly skilled foreign workers; alleviate economic burdens on H-1B nonimmigrants and their families during the transition from nonimmigrant to LPR status; and promote family unity. Some supporters also stated that the rule furthers women's rights, noting the impact the rule's change will have on promoting financial independence for the H-4 dependent spouse, potentially reducing factors which could lead to domestic violence, and assuaging negative health effects (such as depression).
Commenters commonly stated that if spouses are authorized for employment, families would be more stable, contribute more to their local communities, and more fully focus on their future in the United States. Additionally, commenters outlined ways they thought this proposal would help the U.S. economy, such as by increasing disposable income, promoting job creation, generating greater tax revenue, and increasing home sales. Several commenters agreed that extending employment authorization as described in the rule will promote U.S. leadership in innovation by strengthening the country's ability to recruit and retain sought-after talent from around the world. Finally, some commenters noted that this rule would facilitate U.S. businesses' ability to create additional U.S. jobs by improving the retention of workers with critical science, technology, engineering and math (STEM) skills.
The approximately 10 percent of commenters who opposed the proposed rule cited to potential adverse effects of the rule, including displacement of U.S. workers, increasing U.S. unemployment, and lowering of wages. Some commenters expressed concern that the rule may negatively affect other nonimmigrant categories. Other commenters were concerned that this rule may cause the lowering of minimum working standards in certain sectors of the economy, such as in the Information Technology sector. Some commenters questioned DHS's legal authority to promulgate this regulatory change.
About 3.5 percent of commenters had a mixed opinion about the proposed regulation. Some of these commenters were concerned about the size and scope of the class made eligible for employment authorization under the rule; some argued that the described class is too restrictive, while others argued that it is too broad. Other commenters expressed concern about the possibility of fraud. Approximately 200 commenters (about 1.5 percent of commenters) submitted responses that are beyond the scope of this rulemaking, such as comments discussing U.S. politics but not addressing immigration, submissions from individuals who sent in their resumes or discussed their professional qualifications without opining on the proposed rule, and comments on the merits of other commenter's views, but not on the proposed changes.
DHS has reviewed all of the public comments received in response to the proposed rule and addresses relevant comments in this final rule. DHS's responses are grouped by subject area, with a focus on the most common issues and suggestions raised by commenters.
The comments supporting the proposed rule largely underscored the positive socioeconomic benefits this rule would have for certain H-1B nonimmigrants and their H-4 dependent spouses. For example, several commenters noted that while they knew about the restriction on H-4 employment before coming to the United States, they did not anticipate such a long wait to apply for LPR status or the emotional toll that long-term unemployment would take on them and their families. Other commenters noted they have not been able to apply for a social security card or a driver's license in certain states because they do not have an Employment Authorization Document (EAD) (Form I-766). Approximately 200 commenters noted that the current policy of allowing only the H-1B nonimmigrant to work often led to family separation or the decision to immigrate to other countries that authorize employment for dependent spouses.
A few commenters described their families as dual H-1B nonimmigrant households and supported the principle of both spouses working. These commenters voiced appreciation for the changes in the proposed rule, which will allow the H-4 dependent spouse to seek employment while the H-1B nonimmigrant continues to pursue permanent residence.
More than a thousand commenters believe this change will help U.S. businesses retain highly skilled H-1B nonimmigrants. More than 500 commenters asserted that the addition of skilled H-4 dependent spouses into the workforce will help U.S. employers. More than 60 commenters stated that they had planned to move out of the United States, but will instead remain and pursue LPR status as a result of this rule change. Approximately two dozen commenters noted that they had already moved out of the United States due to the prohibition on employment for H-4 dependent spouses. Several commenters stated that they are planning to leave the United States in the near future because H-4 dependent spouses cannot work under the current rules.
Nearly 400 commenters who supported the final rule also asserted that the regulation should be implemented without change as a matter of fairness. According to the comments, the regulation will help H-1B nonimmigrants and their families who have maintained legal status for years, contributed to the economy, and demonstrated the intent to permanently remain in the United States.
The overwhelmingly positive responses from the public to the proposed rule has strengthened DHS's view, as expressed in the proposed rule,
A handful of commenters supporting the proposed rule requested clarification on whether H-4 dependent spouses will be permitted to file for employment authorization based on their classification as an H-4 dependent spouse if they have a pending adjustment of status application. DHS confirms that under this rule, H-4 dependent spouses with pending adjustment of status applications are still eligible for employment authorization on the basis of their H-4 classification. They may choose to apply for employment authorization based on either the H-4 dependent spouse category established by this rule under new 8 CFR 274a.12(c)(26) or the adjustment of status category under 8 CFR 274a.12(c)(9).
Another commenter asked if H-4 dependent spouses of H-1B nonimmigrants who have extended their stay under section 104(c) of AC21 would be eligible for work authorization. DHS confirms that H-4 dependent spouses of H-1B nonimmigrants who have extended their stay under section 104(c) of AC21 are eligible for employment authorization under this rule. Section 104(c) of AC21 applies to a subset of H-1B nonimmigrants who are the principal beneficiaries of approved Form I-140 petitions.
Slightly over 200 commenters requested that DHS extend eligibility for employment authorization to the H-4 dependent spouses of H nonimmigrants who are not in H-1B status (H-1B1, H-2 and H-3 nonimmigrants), and not only to the spouses of certain H-1B nonimmigrants who have begun the process of permanent residence through employment.
DHS has determined that expansion of employment authorization beyond the class of H-4 dependent spouses described in the proposed rule is not appropriate at this time, and it has therefore not included such an expansion in this final rule. First, the Department believes this rule best achieves DHS's goals of helping U.S. employers minimize potential disruptions caused by the departure from the United States of certain highly skilled workers, enhancing U.S. employer's ability to attract and retain such workers, and increasing America's economic competitiveness.
Second, DHS notes two significant differences between H-1B nonimmigrants and other H nonimmigrants under the immigration laws. The INA explicitly permits H-1B nonimmigrants to have what is known as “dual intent,” pursuant to which an H-1B nonimmigrant may be the beneficiary of an immigrant visa petition filed under section 204 of the INA or otherwise seek LPR status without evidencing an intention to abandon a foreign residence for purposes of obtaining or maintaining H-1B status.
Finally, as noted in the proposed rule, DHS may consider expanding H-4 employment eligibility in the future.
Over 150 commenters noted that all dependent spouses of other nonimmigrant categories, such as the spouses of L-1 (intracompany transferee), E-1 (treaty trader), E-2 (treaty investor), and E-3 (Australian specialty occupation workers) nonimmigrants, are eligible to apply for employment authorization These commenters stated that because the employment-based nonimmigrant categories are similar to each other, all H-4 dependent spouses of H-1B nonimmigrants—rather than only certain subclasses of H-4 dependent spouses—likewise should be eligible for employment authorization.
DHS, however, recognizes an important difference between the dependent spouse category of H-1B nonimmigrants and those of L-1, E-1, E-2, and E-3 nonimmigrants. Specifically, Congress directed by statute that DHS grant employment authorization to all spouses of L-1, E-1, E-2, and E-3 nonimmigrants.
In extending such employment authorization through regulation, DHS studied congressional intent with respect to H-1B nonimmigrants. Although Congress has not specifically required extending employment authorization to dependent spouses of H-1B nonimmigrants, Congress did recognize in AC21 the importance of addressing the lengthy delays faced by such workers seeking to obtain LPR status. Consistent with this congressional concern, and the legal authorities vested in the Secretary of Homeland Security described in Section C, below, DHS has chosen to limit this regulation within that statutory framework, and the Department declines to extend the changes made by this rule to the H-4 dependent spouses of all H-1B nonimmigrants at this time.
Over 60 commenters requested that H-4 dependent spouses be granted employment authorization “incident to status,” which would relieve the need to apply for employment authorization before receiving it. These commenters generally recommended that DHS provide employment authorization incident to status by authorizing the employment of H-4 dependent spouses through amendment to 8 CFR 274a.12(a) instead of 8 CFR 274a.12(c), which provides employment authorization through case-by-case, discretionary adjudications of each individual request.
DHS is unable to classify H-4 dependent spouses described in this rule as employment authorized incident to status. Unlike other noncitizens who are employment authorized incident to status, H-4 dependent spouses will not be eligible for employment authorization based solely on their immigration status. Rather, H-4 dependent spouses must meet certain additional conditions before they can be granted employment authorization, and current USCIS systems cannot automatically and independently determine whether such conditions have been met. USCIS systems, for example, cannot independently or automatically determine whether an H-4 dependent spouse has the requisite spousal relationship to an H-1B nonimmigrant who either is the beneficiary of an approved Form I-140 petition or has been granted H-1B nonimmigrant status under sections 106(a) and (b) of AC21; that determination must be made by a USCIS adjudicator. DHS has therefore determined that it must require the filing of an application requesting employment authorization,
More than a dozen commenters requested that the class of H-4 dependent spouses who are eligible for employment authorization be expanded by permitting them to file at points in time different from those provided in the proposed rule. DHS carefully considered these suggestions for determining when an H-4 dependent spouse should be eligible for employment authorization. For the reasons that follow, DHS has determined that it will not adopt the commenters' suggestions in this final rule.
Some commenters requested that DHS make H-4 dependent spouses eligible for employment authorization when their H-1B nonimmigrant spouses have filed permanent (PERM) labor certifications with DOL.
DHS believes that the basis for eligibility in the proposed rule reasonably addresses H-4 dependent spouses' interests in obtaining employment authorization at the earliest possible time in advancing the Department's policy goals of attracting and retaining highly skilled workers and promoting compliance with U.S. immigration laws. In furtherance of these goals, DHS has chosen to limit eligibility for employment authorization to cases where the H-1B nonimmigrant either: (1) Is the principal beneficiary of an approved Form I-140 and thus is on a path to lawful permanent residence that is reasonably likely to conclude successfully; or (2) has been granted H-
Among other things, the approach allows DHS to confirm a significant record of compliance with U.S. immigration laws, which indicates the likelihood of continued compliance in the future. Requiring an approved Form I-140 petition, for example, reduces the risk of frivolous labor certification and immigrant visa petition filings for the purpose of making H-4 dependent spouses eligible for employment authorization, because the approval of the petition generally signifies that the foreign worker is eligible for the underlying immigrant classification. In contrast, authorizing employment immediately upon the filing of a PERM application or Form I-140 petition (rather than after the 365-day waiting period or the approval of the Form I-140 petition) could produce a reasonable possibility of granting employment authorization to an H-4 dependent spouse where the H-1B nonimmigrant's case might not be approvable and the H-1B nonimmigrant has a relatively shorter record of compliance with U.S. immigration laws. The eligibility requirements in this rule also allow for better control of processing, as it is difficult for USCIS to track another agency's filings, such as PERM applications. Finally, with respect to the comment suggesting that employment should be authorized at the point when an adjustment of status application is pending, Department regulations already provide eligibility for employment authorization in that situation.
Some commenters expressed support for an alternative policy that would extend employment authorization to certain H-4 dependent spouses of H-1B nonimmigrants who are eligible for, but have not yet been approved for, extensions of status under sections 106(a) and (b) of AC21. DHS declines to adopt such a policy because it creates the possibility of granting employment authorization to H-4 dependent spouses of H-1B nonimmigrants who are later denied the extension of H-1B status. For instance, a labor certification or Form I-140 petition may have been timely filed on behalf of the H-1B nonimmigrant 365 days prior to the prospective expiration of his or her six-year limitation of stay, thus making the H-1B nonimmigrant eligible for an extension under AC21. But the labor certification or Form I-140 petition ultimately may be denied before the H-1B nonimmigrant files for and receives the AC21 extension. Additionally, if the individual is determined to be ineligible for the H-1B extension, he or she would no longer be maintaining H-1B status and the U.S. employer will be unable to retain the worker. Accordingly, DHS believes the sounder policy is to extend employment authorization to H-4 dependent spouses of H-1B nonimmigrants who have been
Fewer than a dozen commenters requested that DHS extend employment authorization to H-4 dependent spouses in cases where the H-1B nonimmigrants have transferred their employment to a new employer and are in the process of obtaining approval of a new Form I-140 petition. As noted above, however, authorizing employment based solely on the filing (rather than the approval) of a PERM application or Form I-140 petition is likely to encourage frivolous filings to allow the H-4 dependent spouse to obtain employment authorization while the filings remain pending. DHS thus is not extending this rule on the basis of pending PERM applications or Form I-140 petitions. By requiring that a Form I-140 petition first be approved, DHS will further disincentivize frivolous filings and better serve the goal of extending the immigration benefit of this rule to only those spouses of H-1B nonimmigrants who are genuinely on the path to lawful permanent residence.
Less than 40 commenters requested that DHS authorize employment for certain H-4 dependent minor children whose H-1B nonimmigrant parent is the beneficiary of an approved Form I-140 or has been granted an extension of his or her authorized period of admission in the United States under AC21. These commenters cited concerns about H-4 dependent children being unable to obtain the same types of work experience as their peers, being unable to afford post-secondary education in the United States, and losing eligibility for H-4 status through age (known as “aging-out”
DHS declines to adopt the commenters' suggestions to expand eligibility for employment authorization to H-4 dependent minor children. As reflected by the comments, DHS does not view the employment of dependent minor children in the United States as a significant deciding factor for an H-1B nonimmigrant considering whether to remain in the United States and seek LPR status while continuing employment with his or her U.S. employer. Also, as stated in the proposed rule, extending employment eligibility to certain H-4 dependent spouses will alleviate a significant portion of the potential economic burdens that H-1B nonimmigrants currently may face, such as paying for academic expenses for their children, during the transition from nonimmigrant to LPR status as a result of the inability of their dependent family members to work in the United States.
Additionally, limiting employment authorization to H-4 dependent spouses is consistent with the treatment of dependent minors in other nonimmigrant employment categories (such as the L and E nonimmigrant categories), which provide employment authorization to dependent spouses but not dependent children. And in the instances where DHS has extended eligibility for employment authorization to minor children, foreign policy reasons have been an underlying consideration. DHS has extended eligibility for employment authorization to minors within the following nonimmigrant categories: Dependents of Taipei Economic and Cultural
DHS also declines to extend employment authorization to H-4 dependent children who age out and lose their H-4 status. Providing work authorization in such circumstances would encourage such individuals to violate the terms of their authorized stay. Moreover, comments suggesting that the Department should make changes to prevent H-4 dependent minor children from aging out are outside the scope of this rulemaking, which in no way involves the ability of a minor to maintain H-4 status or eligibility for LPR status as a derivative beneficiary of a parent's immigrant petition.
Finally, the circumstances of persons eligible for consideration of Deferred Action for Childhood Arrivals (“DACA”) are distinct from those of H-4 dependent minor children, and the policy for authorizing employment for individuals who have received deferred action has no bearing on whether H-4 dependent minor children should be eligible to apply for employment authorization. The DACA program concerns the departmental exercise of prosecutorial discretion with the aim of ensuring that limited DHS enforcement resources are appropriately focused on the Department's highest enforcement priorities. The policy aims underlying this rule, as described above, are different, and for the reasons already discussed do not justify extending employment authorization to the H-4 dependent children of H-1B nonimmigrants.
A few dozen commenters requested that the rule also allow H-1B nonimmigrants to receive Employment Authorization Documents (EADs), which authorize employment without regard to employer, incident to status.
DHS declines to adopt the commenters' suggestions regarding EADs for H-1B nonimmigrants. If an H-1B nonimmigrant would like to apply for an EAD as the dependent spouse of an eligible H-1B nonimmigrant, he or she must first change to H-4 status. Moreover, issuance of an EAD to an H-1B nonimmigrant authorizing employment other than with his or her petitioning employer is incompatible with the H-1B classification, which allows employment only with the petitioning employer.
Less than 20 commenters requested a carve-out for H-4 dependent spouses who had filed an H-1B petition but who were not selected in the H-1B computer-generated random selection process (“H-1B lottery”).
Less than 20 commenters requested that DHS authorize employment for the dependents of principals in other employment-based nonimmigrant classifications, such as dependents of O-1 nonimmigrants (O-3)
DHS declines to expand eligibility for employment authorization in this rule to the dependents of principals with other nonimmigrant classifications. DHS is narrowly tailoring the expansion of eligibility for employment authorization to meet several policy objectives, including the goal of helping U.S. businesses retain highly skilled H-1B nonimmigrants who are on the path to lawful permanent residence. DHS may consider expanding employment authorization to other dependent nonimmigrant categories in the future.
Moreover, there are significant differences between the H-1B nonimmigrant classification on the one hand, and the O-1 and TN classifications on the other, that inform the Department's decision to limit applicability of this rule to only H-4 dependent spouses. The spouses of H-1B nonimmigrants, for example, generally have greater need for the benefits of this rule than the spouses of O-1 nonimmigrants. O-1 nonimmigrants typically apply for LPR status through the EB-1 immigrant visa preference category, which has not historically suffered from visa backlogs. This allows the spouses of O-1 nonimmigrants to generally obtain employment authorization much more quickly than the spouses of H-1B nonimmigrants who typically seek LPR status through the EB-2 and EB-3 preference categories, which have historically been subject to lengthy backlogs.
The spouses of TN nonimmigrants are also not similarly situated to the spouses of H-1B nonimmigrants. Unlike H-1B status, TN status stems from an international agreement—the North American Free Trade Agreement (NAFTA)—negotiated between the United States and foreign nations. As such, changes to that status implicate reciprocal international trade and foreign policy concerns that are generally not implicated with respect to the H-1B classification and are beyond the scope of this rulemaking.
Approximately ten percent of commenters opposed extending employment authorization to the class of H-4 dependent spouses described in the proposed rule. Many of these commenters were generally concerned that the rule would result in the displacement of U.S. workers; exacerbation of the nation's unemployment rate; and a decrease in wages. All comments discussing economic issues, both in opposition to and in support of the proposed rule, are discussed in Part III, Public Comments on Proposed Rule, Section D, Comments on Executive Orders 12866 and 13563.
Commenters also questioned whether the change in the proposed rule is actually necessary in light of other provisions of U.S. immigration law. Other commenters suggested that the proposed rule would have an adverse impact on other immigration categories or nationalities. DHS has carefully considered these concerns. But for the reasons that follow, DHS has decided to finalize the rule as proposed.
More than 20 commenters believed that because current immigration laws provide the ability for H-4 dependent spouses to change status to an employment-authorized category, the proposed rule would not provide any additional incentives for H-1B nonimmigrants to remain in the United States and continue to pursue LPR status. One commenter stated that most of the comments posted on
DHS disagrees with these commenters and believes that the changes made by this rule are warranted. DHS acknowledges that thousands of commenters who voiced support for the rule did not provide specific reasons for their support, including whether H-1B nonimmigrants were abandoning their applications for LPR status. DHS notes, however, that more than 60 commenters specifically indicated they planned to abandon their pursuit of lawful permanent residence without the changes in the proposed rule. Approximately, two dozen commenters stated that they left the United States because the current regulations preclude H-4 dependent spouses from engaging in employment. And several U.S. employers submitted comments in which they describe the loss of valued H-1B nonimmigrants because of the restriction on spousal employment. These employers noted that the changes in the proposed rule would help to align America's immigration laws with the policies of other countries that allow spousal employment. DHS agrees with these employers and other commenters who supported the proposed rule, and the Department believes that this change will support U.S. businesses and strengthen U.S. competitiveness. DHS also believes that this rule will fulfill its intended purpose and encourage certain highly skilled H-1B nonimmigrants to remain in the United States and continue to pursue their efforts to become LPRs.
Less than 80 commenters suggested that the proposed rule would harm persons in other nonimmigrant categories or with certain nationalities. A few commenters who had changed status from H-4 status to F-1 nonimmigrant student status, for example, thought the rule was unfair because F-1 nonimmigrant graduates who had exhausted their Optional Practical Training had no path to employment authorization except through another principal nonimmigrant classification, such as the H-1B classification. These commenters argued that the rule would put recent F-1 nonimmigrant graduates at a disadvantage because they would have to go through the H-1B petition process whereas the qualifying H-4 dependent spouses would be eligible for an EAD authorizing employment without regard to employer.
DHS appreciates these commenters' concerns but does not believe that the changes made by this rule will adversely affect other classifications or specific nationalities. Rather, DHS expects that this rule will help to partially alleviate the adverse impact of oversubscription of certain chargeability categories in the EB-2 and EB-3 categories on certain H-1B nonimmigrants and their families, without negatively impacting others. DHS has narrowly tailored this rule to provide employment authorization to only those H-4 dependent spouses of H-1B nonimmigrants who have taken active steps to become LPRs. The rule does not affect any other nonimmigrant category, nor does the rule make distinctions among persons of different nationalities. Moreover, as noted throughout this rule, DHS expects that because of the small size of the newly eligible class of workers, the rule should not negatively impact the employment of persons in other nonimmigrant categories. DHS also notes that the H-4 dependent spouses at issue may already obtain employment authorization when they file their applications to adjust status; this rule simply accelerates the timeframe in which they may enter the labor market.
Several commenters suggested that because it is common for H-4 dependent spouses to change status to F-1 nonimmigrant student status to enhance their marketability and use their time productively, universities may lose revenue from decreased enrollment if such H-4 dependent spouses are allowed to work pursuant to this rule. DHS carefully considered but declined to address these concerns. First, this rule does not directly regulate U.S. institutions of higher education or its students (including F-1 nonimmigrants), and any impacts on university enrollments or revenues would be an indirect impact of this rule. Second, the rule merely expands the choices available to H-4 dependent spouses. While the rule expands the ability for such individuals to obtain employment authorization, it does nothing to restrict or otherwise change their ability to engage in study to the extent authorized by the Department in accordance with law. Third, even if the opportunity for employment authorization may mean that fewer H-4 dependent spouses eventually choose to enroll as nonimmigrant students, it is not clear how this rule could significantly impact revenues at colleges and universities considering the relatively small number of people impacted by this rule.
Slightly over 180 commenters suggested limiting employment authorization to a more restricted class of H-4 nonimmigrants. For the reasons discussed below, DHS has determined that it will not adopt the commenters' suggestions in this final rule.
A number of commenters recommended granting employment authorization only to H-4 dependent spouses who have certain skills or work in certain sectors of the economy. Other commenters requested that DHS limit employment authorization under the rule to H-4 dependent spouses who hold advanced degrees from U.S. universities or have degrees in certain subjects, such as subjects in STEM fields. Some commenters were concerned that eligible H-4 dependents will be able to compete across all occupations, not just skilled professions.
DHS declines to restrict employment authorization eligibility to H-4 dependent spouses with certain skills or degrees. A primary purpose of this rule is to help U.S. employers retain H-1B nonimmigrant employees who have demonstrated the intent to become LPRs, which would provide substantial benefits to these employers and the U.S. economy. This rule is intended to provide this incentive to H-1B nonimmigrants regardless of the academic backgrounds of their H-4 dependent spouses. Limiting the rule to benefit only H-1B nonimmigrants whose H-4 dependent spouses have certain skills or hold certain educational credentials would undermine the effectiveness of this rule.
A number of commenters recommended limiting employment authorization to H-4 dependent spouses who are from countries that authorize employment for spouses of U.S. citizens in a similar immigration status abroad (
A few commenters requested that DHS extend eligibility for employment authorization only to the H-4 dependent spouses of H-1B nonimmigrants who are beneficiaries of AC21 extensions. DHS discussed this option in the proposed rule. The Department appreciates this suggestion, but believes that also extending employment authorization to the spouses of H-1B nonimmigrants who are the beneficiaries of approved Form I-140 petitions more effectively accomplishes the goals of this rulemaking. For the benefit of U.S. businesses and the U.S. economy, DHS believes the rule should provide incentives for those workers who have established certain eligibility requirements and demonstrated intent to reside permanently in the United States and contribute to the U.S. economy. Extending employment authorization to H-4 dependent spouses of H-1B nonimmigrants with either approved Form I-140 petitions or H-1B status granted pursuant to sections 106(a) and (b) of AC21 encourages a greater number of professionals with high-demand skills to remain in the United States. Moreover, by tying eligibility for employment authorization to approved Form I-140 petitions, DHS is reaching the H-4 dependent spouses of H-1B nonimmigrants granted status under section 104(c) of AC21. DHS thus declines to exclude from this rule the spouses of H-1B nonimmigrants who have approved Form I-140 petitions.
Over 40 commenters questioned DHS's legal authority to extend employment authorization to certain H-4 dependent spouses, often emphasizing that employment for spouses of L and E nonimmigrants is expressly authorized by statute.
DHS disagrees with the view that this rule exceeds the Secretary's authority. In the INA, Congress provided the Secretary with broad authority to administer and enforce the immigration laws. The Secretary is expressly authorized to promulgate rules and “perform such other acts as he deems necessary for carrying out his authority” based upon considerations rationally related to the immigration laws. INA section 103(a)(3), 8 U.S.C. 1103(a)(3). Congress also provided the Secretary with the more specific statutory authority to set by regulation the conditions of nonimmigrant admission. INA section 214(a), 8 U.S.C. 1184(a). These provisions grant the Secretary broad discretion to determine the most effective way to administer the laws.
More specifically, section 274A(h)(3)(B) of the INA, 8 U.S.C. 1324a(h)(3)(B), recognizes that employment may be authorized by statute or by the Secretary.
Of the approximately ten percent of commenters who generally opposed the rule, a majority of those commenters asserted that allowing eligible H-4 dependent spouses to receive employment authorization would have negative economic impacts. Chief among these concerns was the impact of the proposed rule on the U.S. labor market. Many commenters believed that the proposed rule would increase competition for jobs; exacerbate the nation's unemployment rate; drive down wages; and otherwise negatively impact native U.S. workers. A few commenters also suggested that allowing H-4 dependent spouses to enter the labor market would negatively impact highly skilled H-1B nonimmigrants.
DHS appreciates these viewpoints and has carefully considered the potential for negative labor market impacts throughout this rulemaking. DHS affirms its belief expressed in the proposed rule that any labor market impacts will be minimal. As a preliminary matter, this regulatory change applies only to the H-4 dependent spouses of H-1B nonimmigrants who have actively taken certain steps to obtain LPR status. As such, the rule simply accelerates the timeframe by which these spouses are able to enter the U.S. labor market. Importantly, the rule does not require eligible H-4 spouses to submit an application for an EAD, nor does the granting of an EAD guarantee that H-4 spouses will obtain employment. Further, the relatively small number of people affected by the rule limits any impact the rule may have on the labor market. Although DHS, in this final rule, increased its estimate of the number of H-4 dependent spouses who might benefit from the rule, the maximum number of such spouses who could request employment authorization and actually enter the labor market in the initial year (the year with the largest number of potential applicants) represents only 0.1156 percent of the overall U.S. civilian labor force. This increased estimate does not change the Department's conclusion that this rule will have minimal labor market impacts.
Moreover, with respect to the potential that this rule and the policy goals of retaining certain highly skilled H-1B nonimmigrants may cause native-worker displacement and wage reduction, DHS notes that there is a large body of research that supports the findings that immigration of highly skilled workers is beneficial to the U.S. economy and labor market in the long-term. For example, several commenters provided studies that refuted arguments that highly skilled immigrants are used for “cheap labor,”
From a labor market perspective, it is important to note that there are not a fixed number of jobs in the United States. Basic principles of labor market economics recognize that individuals not only fill jobs, but also stimulate the economy and create demand for jobs through increased consumption of goods and services. On this point, approximately 2,600 commenters thought that the regulation as proposed will stimulate the U.S. economy through the spillover effects associated with dual-income households, thus leading to increased spending throughout the economy, greater investments in real estate, the potential for job creation, and increased tax revenue. Relatedly, other commenters expressed their belief that the rule will bolster U.S. competitiveness, economic strength and innovation. A few commenters noted that the proposal will enhance the ability of U.S. businesses to attract and retain highly skilled immigrants, resulting in potential economic gains to U.S. companies and the U.S. economy.
In addition, commenters also highlighted several social benefits of the proposed rule, including: Family unification; overall family financial security and stability; providing a means for H-4 dependent spouses to be financially independent; and significantly aiding the H-1B nonimmigrant and his or her family in integrating into American culture and communities. DHS appreciates these comments and agrees that the rule will provide economic and social benefits to the H-1B nonimmigrant worker and his or her family as they wait to obtain LPR status.
Finally, a few commenters suggested that allowing H-4 dependent spouses to enter the labor market would negatively impact the job prospects of highly skilled H-1B nonimmigrants. These commenters generally suggested, without providing empirical support, that by allowing H-4 dependent spouses to have an EAD, U.S. employers will prefer to hire such individuals rather than to go through the additional effort of hiring an H-1B nonimmigrant. DHS appreciates these concerns but lacks data on the skillsets or educational levels of H-4 dependent spouses to indicate that they will take jobs that are typically held by highly skilled H-1B nonimmigrants. Nor, as noted above, is the U.S. labor market static; individuals who supply labor also create demand for labor through increased consumption and other spending. The fact that this rule provides employment authorization only to H-4 dependent spouses who are tied to an H-1B nonimmigrant who is sufficiently on the path to LPR status further mitigates the possibility that this rule will cause employers to hire H-4 dependent spouses over H-1B nonimmigrants. DHS anticipates that employers will continue to fully utilize the H-1B program and does not believe that this rule will adversely affect the job prospects of H-1B nonimmigrants.
Of the ten percent of commenters who opposed the rule, many felt that the Department's estimates of the potential eligible population were too low. Two commenters suggested that DHS employ a different methodology to arrive at the estimated number of likely eligible H-4 dependent spouses. One commenter provided highlighted excerpts of the Yearbook of Immigration Statistics, as published by the DHS Office of Immigration Statistics, containing statistics on individuals who had obtained LPR status under employment-based preference categories. The commenter highlighted the total number of spouses who had adjusted status to lawful permanent residence and the total number of individuals who adjusted to LPR status under the first through third employment-based preference categories. DHS assumes that the commenter was suggesting that DHS simply apply that historical average to estimate the number of H-4 dependent spouses who will be eligible to apply for employment authorization under this rule.
DHS appreciates this response and carefully considered this approach. However, that approach fails to account for those H-1B nonimmigrants and their families who are currently in the backlog waiting for immigrant visas. Furthermore, that approach would also overstate the likely number of H-4 dependent spouses who would be eligible to apply for employment authorization under this rule. That is so because the approach does not account for the proportion of employment-based adjustment applicants who are in H-1B status as compared to those adjusting from another nonimmigrant status. Moreover, not all spouses of H-1B nonimmigrants are currently in H-4 nonimmigrant status. For these reasons, DHS disagrees with the commenters' suggested approach to estimating the volume of H-4 dependent spouses who will be eligible to apply for employment authorization under this rule. Estimating the eligible population by taking into account the backlog of H-1B nonimmigrants who have approved I-140 petitions but are unable to adjust status due to a lack of available immigrant visas, along with the estimated future flow of newly eligible spouses, is a more accurate methodology for estimating the number of H-4 dependent spouses whom this rule may impact.
DHS has carefully considered ways to estimate the volume of potential H-4 dependent spouses who will be eligible to apply for employment authorization under this rule. Based on comments received that questioned whether the estimated volume of such spouses was too low, DHS reviewed and updated its estimates in preparing this final rule. DHS acknowledges that there is some uncertainty in this analysis, but believes its methodology offers the best available estimates.
Although the estimate of H-4 dependent spouses who could be eligible to apply for employment authorization increased in this final rule,
Notwithstanding the revised volume estimates, the basis for this rule, as discussed throughout the proposed rule and this final rule, remains accurate. DHS is taking this action to further incentivize H-1B nonimmigrants and their families to continue to wait and contribute to the United States through an often lengthy waiting period for an immigrant visa to become available. DHS expects that these actions will also benefit U.S. employers by decreasing the labor disruptions that occur when H-1B nonimmigrants abandon the permanent resident process.
One commenter believed that the proposed rule overstated the potential costs and understated the benefits of the rule. Specifically, the commenter alleged that DHS' estimates for cost per applicant were exaggerated because DHS included the monetized opportunity costs associated with applying for employment authorization. That same commenter also believed that DHS failed to stress the economic and social benefits of the rule. Another commenter believed that the proposed rule failed to acknowledge the economic losses incurred by the current inability of H-4 dependent spouses to work.
DHS has carefully considered these comments and does not believe that the potential costs and benefits were either under- or overestimated. In the proposed rule, DHS highlighted the economic benefits to both the H-4 dependent spouse and the H-1B family unit that would accrue from additional income. In addition, in the proposed rule DHS discussed the societal integration benefits that would accrue to the H-4 dependent spouse and the H-1B family that would come from the spouse's ability to participate in the U.S. labor market. DHS disagrees with comments that the application costs were inflated because we assigned a valuation to the H-4 dependent spouse's time. DHS acknowledged in the proposed rule that these spouses do not currently work. DHS decided to use the minimum wage as a reasonable proxy to estimate the opportunity costs of their time. DHS disagrees with the questionable notion that just because these spouses are not currently able to participate in the labor market, they do not face opportunity costs and/or assign valuation in deciding how to allocate their time. As such, DHS utilized a reasonable approach in assigning value to their time.
Over 180 commenters raised issues related to employment authorization, including filing procedures, premium processing, validity periods, renewals, evidentiary documentation, concurrent filings for extension of stay/change of status, automatic extensions of employment authorization, and filing fees. DHS carefully considered these comments and addresses them below.
Commenters urged DHS and USCIS to utilize streamlined or modernized filing procedures for Applications for Employment Authorization (Forms I-765) submitted by H-4 dependent spouses. USCIS is moving from a paper-based application and adjudication process to an electronic one through the development of an Electronic Immigration System (“USCIS ELIS”). When complete, USCIS ELIS will allow customers to electronically view their applications, petitions or requests, receive electronic notification of decisions, and electronically receive real-time case status updates. This is a global effort affecting all USCIS benefit request programs and, therefore, is outside the scope of this rulemaking. DHS will notify the public when USCIS is prepared to begin accepting electronic filings of Applications for Employment Authorization by eligible H-4 dependent spouses. DHS will begin accepting Applications for Employment Authorization (Forms I-765) submitted by certain H-4 dependent spouses on the effective date of this rule, May 26, 2015. This effective date is intended to prevent an overlap of H-1B cap season and an initial filing surge of Forms I-765 under 8 CFR 274a.12(c)(26). As a result, USCIS will be able to implement this program in a manner that will avoid prolonged delays of processing other petition and application types, in particular those H-1B petitions seeking an FY 2016 cap number. It will also allow USCIS to maintain excellent customer service for all USCIS stakeholders, including H-1B employers, H-1B nonimmigrants and their families.
Nine commenters requested that DHS issue the Employment Authorization Document (EAD) (Form I-766) with a validity period that matches the H-4 dependent spouse's status. Related to this request, another commenter requested a three-year validity period to match the H-1B and H-4 authorized periods of admission. DHS agrees with commenters that to reduce possible cases of unauthorized employment, the EAD validity period should match the H-4 dependent spouse's length of authorized admission. Thus, in issuing an EAD to an otherwise eligible H-4 dependent spouse, DHS generally will authorize a validity period that matches the H-4 spouse's remaining authorized period of admission, which may be as long as three years in cases not involving DOD-related services. This policy will ensure that USCIS does not grant employment authorization to an H-4 dependent spouse who is not eligible for the benefit. It will also likely reduce the number of times that H-4 dependent spouses may need to request renewal of their employment authorization.
One commenter requested that DHS issue a probationary EAD with a six-to twelve-month validity period, at the end of which the H-4 dependent spouse would have to prove that he or she is working legally and paying taxes. DHS declines to adopt this suggestion. The EAD that DHS will issue H-4 dependent spouses pursuant to this rule is evidence of employment authorization to lawfully work in the United States for any employer. DHS is not aware of any risk factors—such as fraud, criminal activity, or threats to public safety or national security—associated with H-4 dependent spouses as a whole that would support imposing a six-month validity period. Moreover, the administrative burden resulting from additional adjudications and the possibility of gaps in employment authorization, together with the burdens this limitation would place on the H-4 dependent spouse, make imposing a six-month validity period unreasonable.
Regarding the suggestion that H-4 dependent spouses should be required to prove that they pay taxes as a condition of obtaining or maintaining work authorization, DHS does not require proof of payment of taxes for any of the classes of aliens eligible to file the Application for Employment Authorization. As a preliminary matter, issuance of an EAD does not require an H-4 dependent spouse to work. Nor does issuance of the EAD guarantee that an H-4 dependent spouse will find employment and therefore be required to pay taxes on any income earned through such employment. Moreover, DHS is not aware of any evidence, and the commenter provided none, indicating that H-4 dependent spouses are likely to engage in tax evasion or other tax-related unauthorized activity if they are provided employment authorization pursuant to this rule. At the same time, USCIS would face significant operational burdens if it were required to collect and verify tax documents for each H-4 dependent spouse seeking employment authorization under this rule.
Five commenters requested that DHS allow H-4 dependent spouses to apply for EAD renewals up to six months in advance, in part to align with the time frame permitted for filing of the Petition for a Nonimmigrant Worker (Form I-129) to extend the H-1B nonimmigrant's status. As explained below in Section III.E.5, DHS will permit those H-4 dependent spouses seeking to concurrently file their Form I-765 application with their Application to Extend/Change Nonimmigrant Status (Form I-539), and if applicable their spouses' Form I-129 petition, to file up to six months in advance of the requested start date. Please note, however, that USCIS will not adjudicate the Form I-765 application until a determination has been made on the underlying Form I-539 application and/or Form I-129 petition. The time at which an H-4 dependent spouse will be eligible to apply for an EAD renewal will vary, as it is dependent on actions taken by the H-1B nonimmigrant, including actions to maintain and extend his or her H-1B status, as well as the H-4 dependent spouse's status.
Several commenters submitted comments related to the Application for Employment Authorization (Form I-765) and to the evidence required to be submitted by applicants with the application. One commenter asked DHS to make changes to assist applicants in obtaining acceptable evidentiary documentation. This commenter requested that USCIS provide the H-4 dependent spouse, upon request, with his or her immigration case related paperwork, such as the original underlying petition. Another commenter requested that DHS provide clarification about the evidentiary standard relating to AC21 eligibility.
In conjunction with the proposed rule, DHS proposed conforming revisions to the Form I-765 application to add H-4 dependent spouses described in this rule to the classes of aliens eligible to file the form. Concurrent with publication of this final rule, DHS has made further changes to the form. DHS has made clarifying changes to improve readability of the form instructions describing the types of
DHS appreciates the concerns regarding the difficulty that some applicants may face in obtaining the necessary documentation to support the Form I-765 application. DHS's revisions in this final rule to 8 CFR 214.2(h)(9)(iv) and the instructions to Form I-765 provide for flexibility in the types of evidentiary documentation that may be submitted by applicants. If the H-4 dependent spouse cannot submit the primary evidence listed in the form instructions, he or she may submit secondary evidence, such as an attestation that lists information about the underlying Form I-129 or Form I-140 petition, so that an adjudicator may be able to match the Form I-765 application with the underlying petition(s). Such information may include the petition receipt number, the beneficiary's name and/or the petitioner's name. If secondary evidence does not exist or cannot be obtained, an applicant may demonstrate this and submit two or more sworn affidavits by non-parties who have direct knowledge of the relevant events and circumstances. This approach should address the situation where the H-4 dependent spouse is unable to access the immigration paperwork relating to the H-1B nonimmigrant. Notwithstanding the option for submitting secondary evidence, if an applicant prefers to obtain the primary evidence listed in the form instructions from USCIS for submission with the Form I-765, the applicant may make a request for documents maintained by USCIS by following established procedures for making such requests under the Freedom of Information Act (FOIA).
Finally, in response to the comment on the evidentiary standard that will apply to H-4 dependent spouses, DHS notes that such spouses will have to meet the same burden of proof (
A couple of commenters requested that DHS allow eligible H-4 dependent spouses to file the Application for Employment Authorization (Form I-765) concurrently with an Immigrant Petition for Alien Worker (Form I-140) or an Application to Extend/Change Nonimmigrant Status (Form I-539). For the reasons that follow, DHS agrees to allow Form I-765 to be concurrently filed with Form I-539, but not with Form I-140.
DHS currently permits an H-4 dependent spouse to file Form I-539 concurrently with a Petition for a Nonimmigrant Worker (Form I-129) filed on behalf of the H-1B nonimmigrant. This provides several efficiencies, as the status of the H-4 dependent spouse is based on the resolution of the H-1B nonimmigrant's Form I-129 petition and both forms may be processed at the same USCIS locations. For similar reasons, DHS has decided to permit H-4 dependent spouses to file Applications for Employment Authorization (Forms I-765) concurrently with certain related benefit requests: Applications to Extend/Change Nonimmigrant Status (Forms I-539) and, if applicable, with Petitions for a Nonimmigrant Worker (Form I-129). As noted previously, DHS has decided to issue EADs to eligible H-4 dependent spouses with validity dates that match their authorized periods of admission. That period of admission is determined as part of the Form I-539 application adjudication, which, in turn, is largely dependent on the H-1B nonimmigrant's period of admission determined as part of the Form I-129 adjudication. Because adjudication of those forms are interrelated, and because they are submitted to the same USCIS locations, DHS has determined that it is reasonable to allow those forms to be concurrently filed.
DHS, however, cannot extend the courtesy of concurrent filing with Form I-140 immigrant visa petitions filed on behalf of the H-1B nonimmigrant. Presently, Forms I-129 and I-539 are not processed at the same USCIS locations in which Form I-140 petitions are adjudicated. As a result, each form must be filed separately at the USCIS Service Center location having jurisdiction over the relevant form. Additionally, determining the spousal relationship between the H-1B nonimmigrant and the H-4 dependent spouse is not a necessary part of the adjudication of the Form I-140 petition.
DHS also notes that it cannot adjudicate a Form I-765 filed by an H-4 dependent spouse until the Department has made a determination regarding the H-1B nonimmigrant's eligibility for H-1B status under sections 106(a) and (b) of AC21 or until a Form I-140 petition has been approved. Prior to adjudicating such Form I-765, DHS must also make a determination that the H-4 dependent spouse remains eligible for H-4 status. As such, DHS amends the current rule to clarify that the 90-day clock specified in 8 CFR 274a.13(d) authorizing DHS to issue interim employment authorization if the Form I-765 is not adjudicated within 90 days is not triggered until necessary eligibility determinations have been made on the underlying nonimmigrant status for the H-1B nonimmigrant and the H-4 dependent spouse. If the H-4 dependent spouse's employment authorization is based on a favorable eligibility determination relating to the nonimmigrant status of either the H-1B nonimmigrant or the H-4 dependent spouse, the 90-day clock is triggered when that eligibility determination is made. Alternatively, if employment authorization is based on a favorable eligibility determination relating to the nonimmigrant status of both the H-1B nonimmigrant and the H-4 dependent spouse, the 90-day clock is not triggered until an eligibility determination is made on both. Accordingly, DHS is making conforming amendments to 8 CFR 214.2(h)(9)(iv) and 8 CFR 274a.13(d) in this final rule and the instructions to Form I-765. These amendments permit H-4
Three commenters requested premium processing service for H-4 dependent spouses seeking to file Applications for Employment Authorization (Forms I-765). These commenters highlighted the benefit that the extra premium processing fees could bring to USCIS. DHS appreciates these comments, but has decided not to extend premium processing to Form I-765 applications filed by H-4 dependent spouses in conjunction with this rulemaking. DHS currently offers premium processing service for certain employment-based petitions and applications, including H-1B, L, and E nonimmigrant worker petitions and certain EB-1, EB-2 and EB-3 immigrant visa petitions. Extending premium processing to Form I-765 applications, however, presents operational concerns and would be inconsistent with procedural realities for USCIS. The agency, for example, would be unable to comply with premium processing requirements on any Form I-765 application that is contingent on the adjudication of a concurrently filed Application to Extend/Change Nonimmigrant Status (Form I-539). Due to these and other operational concerns, DHS will not extend premium processing service to Form I-765 applications, including applications filed by H-4 dependent spouses under this rule at this time.
One commenter requested an automatic extension of work authorization for 240 days after an H-4 dependent spouse's EAD expires. DHS, however, is concerned with improperly granting employment authorization to an H-4 dependent spouse who is ineligible for it. As the validity of the H-4 dependent spouse's eligibility for employment authorization will be tied to his or her authorized period of admission, automatic extensions of employment authorization without review of the underlying extension of stay applications for the H-1B nonimmigrant and H-4 dependent spouse could result in employment authorization being extended to individuals who will eventually be determined ineligible for this benefit. DHS thus declines to adopt this recommendation.
To avoid any potential gaps in employment authorization when seeking an extension of employment authorization, DHS recommends that the H-4 dependent spouse timely file all necessary applications. DHS's policy to permit concurrent filing of Forms I-539, I-129, and I-765 should also help H-4 dependent spouses avoid gaps in employment authorization, as these forms may be filed concurrently up to six months in advance of date of need.
Several commenters submitted remarks on the filing fees without expressing support for or opposition to the fees. Additionally, some commenters asserted that USCIS would benefit from an increased volume of fees, and another commenter requested that the U.S. Government help pay for immigration-related application fees.
DHS is bound by statutes and regulations governing its collection of fees in connection with immigration benefit requests.
For the reasons that follow, DHS believes that it would be unlikely that H-4 dependent spouses would be unable to pay the prescribed fee for the Application for Employment Authorization (Form I-765). By definition, H-4 dependent spouses are married to H-1B nonimmigrants who are employed and earning a salary of at least the prevailing wage in their occupation. H-4 dependent spouses will thus generally be unable to establish that they cannot pay the fee prescribed for the Form I-765 application. For these reasons, DHS declines to establish a general fee waiver for the Form I-765 filed by eligible H-4 dependent spouses under this rule.
A few commenters recommended imposing certain restrictions on employment authorization issued to H-4 dependent spouses, such as: Creating a cap on the number of EADs that could be granted to H-4 dependent spouses; prohibiting the H-1B nonimmigrant and H-4 dependent spouse from having the same employer or working in the same occupation; prohibiting employers from replacing an American veteran with an H-1B nonimmigrant; restricting H-4 work authorization to certain employers; creating a National Registry of Jobs that H-4 dependent spouses would be allowed to apply for; forcing individuals to surrender their foreign passports when they obtain U.S. citizenship as a way of proving allegiance; allocating EADs in a proportionate manner based on nationality; and requiring H-4 dependent spouses to pay for training programs for U.S. citizens.
DHS declines to incorporate the suggested restrictions into this final rule. A primary purpose of this rule is to assist U.S. employers in retaining certain highly skilled H-1B nonimmigrants. Allowing certain H-4 dependent spouses to apply for employment authorization removes a disincentive that currently undermines this goal. Imposing the suggested restrictions, such as numerical caps or per-country quotas, would limit the effectiveness and purpose of this rule. Additionally, DHS believes that EADs provide inherent protections that mitigate the risk of abuse and exploitation. Because these EADs may be used to work for any employer, workers are free to find new employment at any point during the EAD's validity, including if they are dissatisfied with their pay or working conditions. Finally, DHS reiterates that the individuals being provided employment authorization under this rule belong to a class of aliens that is already likely to enter the U.S. labor market with EADs. In sum, DHS does not believe that extending eligibility for employment authorization to H-4 dependent spouses will lead to the broad exploitation of EADs.
One commenter noted that this rule could lead to “circular EADs,” whereby spouses who are both eligible for H-1B status may switch status (H-1B to H-4 and vice versa) so that one spouse may maintain an EAD at all times. This commenter conveyed the concern that H-1B nonimmigrants might initiate the primary steps towards permanent residence, then switch back and forth between H-1B and H-4 statuses to stay in the United States forever.
DHS acknowledges that H-1B nonimmigrants will be able to change status, as permitted by law. DHS believes it is extremely unlikely, however, that an H-1B nonimmigrant will seek to remain in the United States forever by switching between nonimmigrant statuses as a result of this rule. The rule is intended to benefit those H-1B nonimmigrants who are already well on the path to lawful permanent residence and, therefore, seek to remain in the United States permanently on this basis. Although the waiting period for an immigrant visa may be lengthy, there is an end date as indicated on the Department of State's Visa Bulletin. So any incentive to switch between statuses indefinitely would be weighed by the nonimmigrant against the benefits of obtaining LPR status, including the ability to work in the United States without being tied to a specific employer and the ability of the H-4 dependent spouse to work without needing to periodically apply and pay for an EAD. Moreover, with lawful permanent residency, an individual is eligible to apply for U.S. citizenship, generally after five years, and to petition for relatives to immigrate to the United States, benefits that are not available to persons with H-1B or H-4 status.
One commenter expressed concern that H-4 dependent spouses would need to demonstrate economic need for employment because of the reference in the Paperwork Reduction Act section of the proposed rule to the Form I-765 Worksheet (Form I-765WS). DHS is clarifying that H-4 dependent spouses are not required to establish economic need for employment authorization. H-4 dependent spouses are not required to submit Form I-765WS with their Application for Employment Authorization (Form I-765). DHS has corrected this error in the form instructions to the Application for Employment Authorization (Form I-765).
Several commenters sought guidance on issues tangential to the issuance of employment authorization to H-4 dependent spouses. For example, one commenter asked for clarification on the type of status that an H-4 dependent spouse will receive when readmitted into the United States after traveling abroad. Another commenter wanted to know if an H-4 dependent spouse could work from home in the United States for his or her native country employer on the native country salary. Because this rulemaking is limited to extending eligibility for employment authorization to H-4 dependent spouses and does not make changes to admission requirements or conditions of employment authorization, DHS considers these questions outside the scope of this rulemaking. Please consult the USCIS Web site at
Finally, several commenters requested clarification about EAD processing and adjudication times. USCIS posts current processing times on its Web site and encourages interested stakeholders to consult
Over 100 commenters raised concerns related to fraud and public safety, including issues related to resume fraud, marriage fraud, participation by individuals with criminal records, unauthorized employment, and employer abuse in the H-1B program. Strict consequences are already in place for immigration-related fraud and criminal activities, including inadmissibility to the United States, mandatory detention, ineligibility for naturalization, and removability.
Over 100 commenters anticipated that certain H-4 dependent spouses would falsify their resumes or qualifications or marry for immigration purposes. With respect to potential resume fraud, DHS notes that eligibility for employment authorization for H-4 dependent spouses will not depend in any way on their professional or educational qualifications or their resumes. It will be up to potential employers to verify the qualifications of H-4 dependent spouses they may be seeking to hire. This concern is therefore outside the scope of this rulemaking.
With respect to marriage fraud, DHS is revising 8 CFR 214.2(h)(9)(iv) to clarify that establishing eligibility for employment authorization under this rule requires evidence of the spousal relationship between the H-4 dependent spouse and the H-1B nonimmigrant. DHS is also making conforming revisions to the form instructions to Form I-765 to require that H-4 dependent spouses submit proof of marriage to the H-1B nonimmigrant with the form. USCIS officers are specially trained to recognize indicia of fraud, including marriage fraud and falsified documents, and review other immigration petitions for these circumstances as well. If such fraud is suspected, the relevant USCIS officer may refer the case to the local fraud unit for further inquiry. USCIS may also submit leads related to significant fraud to U.S. Immigration and Customs Enforcement for criminal investigation. DHS believes that current fraud-detection training, mechanisms for detecting and investigating fraud, and fraud-related penalties are sufficient for deterring and detecting marriage fraud in this context.
Two commenters requested a prohibition against participation by anyone charged with, awaiting trial for, or convicted of a felony. DHS appreciates the commenters' concerns over public safety and notes that the eligibility for employment authorization extended by this rule to certain H-4 dependent spouses is discretionary. DHS officers will consider any adverse information—including criminal convictions, charges, and other criminal matters—on a case-by-case basis.
A few commenters thought that this rule would help curb any unauthorized employment in which H-4 dependent spouses are currently engaging. Additionally, several commenters raised concerns that this rule could encourage illegal immigration and increase the number of undocumented workers in
A number of commenters raised concerns over potential employer abuse of H-1B nonimmigrants and H-4 dependent spouses. These concerns included failure to pay prevailing wages and demanding long hours without adequate compensation. DHS appreciates these concerns and maintains that employers must not intimidate, threaten, restrain, coerce, blacklist, discharge or otherwise discriminate or take unlawful action against any employee. Violators face severe penalties.
Over 300 commenters submitted feedback about general immigration issues. A few commenters expressed support for or opposition to immigration. Comments ranged from requesting DHS to discontinue all types of immigration to underscoring the need for comprehensive reform of the immigration laws to general support of immigration. DHS is charged with administering the immigration laws enacted by Congress, and only Congress can change those laws. The comments described above are therefore outside the scope of this rulemaking. DHS, however, is committed to comprehensive immigration reform that creates a workable system that strengthens border security, improves the U.S. economy, unites families, and preserves national security and public safety.
Additionally, fewer than a dozen commenters objected to the ability of non-U.S. citizens to submit comments on the proposed rule. As noted in that rule, DHS welcomed comments from all interested parties and did not place any restrictions based on citizenship or nationality.
A few commenters suggested that employers may try to exploit this regulation by using it to avoid the H-1B numerical cap and hiring more foreign specialty occupation workers than permitted by the statute. As a preliminary matter, DHS cannot agree with the premise that hiring an individual with general (rather than employer-specific) employment authorization constitutes circumvention of the cap on H-1B nonimmigrants. This is particularly so when such employment authorization is contingent on being married to an individual who was selected in the H-1B program and is subject to the cap. Moreover, commenters provided no evidence or data that would support the contention that this rule will be used by employers and H-4 dependent spouses to circumvent the cap. For example, DHS does not have, and commenters did not provide, data on the skillsets or educational levels of H-4 dependent spouses to indicate that they will generally qualify for jobs that are typically held by highly skilled H-1B nonimmigrants. Finally, it is unlikely that highly skilled individuals who could independently qualify under the H-1B program will instead opt to enter the United States as H-4 dependent spouses and subject themselves to lengthy periods of unemployment with the intent to circumvent the H-1B cap. As noted previously, this rule provides eligibility for employment authorization only to those H-4 dependent spouses who are married to certain H-1B nonimmigrants who have taken substantial steps, generally taking many years, towards obtaining permanent residence. Such an individual may eventually obtain a job for which an H-1B nonimmigrant could possibly have qualified, but the Department does not consider this a circumvention of the H-1B cap.
More than a dozen commenters requested that the H-1B program be terminated. An approximately equal number of commenters requested that the H-1B visa cap be eliminated or modified in various ways. Several commenters requested that DHS increase the number of visas available, other commenters asked DHS to eliminate the H-1B visa cap, while others recommended decreasing the number of visas available.
DHS cannot address the commenters' suggestions in this rulemaking. The H-1B program is required by statute, which also sets the current cap on H-1B visa numbers. Congressional action is thus required to address the commenters' concerns, as the Secretary does not have the authority to eliminate the program or change the visa cap without congressional action. The suggested changes are thus outside the scope of this rulemaking.
Additionally, one commenter requested that DHS allow for more flexible filing times for H-1B visas. This request would require DHS to amend its H-1B regulations, which currently provide that an H-1B petition may not be filed or approved earlier than six months before the date of actual need for the beneficiary's services.
One commenter requested a modification of the H-1B program to allow a family member who has been in the United States for more than five years to choose between H-1B and H-4 status. To some extent, H-1B nonimmigrants currently have this option. An H-4 dependent spouse may seek classification as an H-1B nonimmigrant if an employer files a petition on his or her behalf. As long as one of the spouses maintains H-1B status, the other is eligible for H-4 status. However, the underlying H-1B status is connected to the need of a U.S.
One commenter recommended that H-4 dependent spouses be allowed to apply for H-1B visas and be exempt from the cap. This final rule does not prohibit H-4 dependent spouses from seeking and obtaining H-1B status. Once an H-4 spouse seeks to change to H-1B status, he or she is subject to annual limitations on H-1B nonimmigrants. Only Congress can exempt groups of individuals from the statutory H-1B numerical limitations. This request is therefore beyond the scope of this rulemaking.
One commenter requested that DHS change its G visa regulations to allow dependents of principal G visa holders to more freely obtain a different visa classification (such as H-1B classification). Such a change is outside the scope of this rulemaking.
Over 30 commenters requested the elimination of the worldwide quotas for immigrant visas.
DHS appreciates feedback from the public regarding possible changes to the immigration laws and the system for obtaining LPR status. DHS, however, will not respond to these comments as they do not address changes to the regulations made by this rulemaking and are therefore outside the scope of this rulemaking.
Several commenters asked for more information about the effect that an H-1B nonimmigrant's loss of employment or change of employer would have on the H-4 dependent spouse's employment authorization. As stated in the proposed rule, the H-4 dependent's status is tied to the H-1B nonimmigrant's status. Thus, if the H-1B nonimmigrant fails to maintain status, the H-4 dependent spouse also fails to maintain status and would therefore no longer be eligible for employment authorization. Under current regulations, DHS may seek to revoke employment authorization if, prior to the expiration date of such authorization, any condition upon which it was granted has not been met or no longer exists.
In the proposed rule, DHS requested comments relating to the environmental effects that might arise from the proposed rule. Nine commenters submitted related feedback, noting general environmental issues that come with an increased population. DHS appreciates these comments but notes that the vast majority of the population immediately affected by the rule is already in the United States and has been here for a number of years while waiting for their immigrant visas. The H-4 dependent spouses affected by this rule generally will eventually be able to seek employment even without this rule, as immigrant visa numbers become available and H-1B nonimmigrant families become eligible to file for adjustment of status. As noted previously, this rule simply accelerates the timeframe in which these individuals are able to enter the labor market.
A few commenters requested more information about how DHS will monitor the outcome of the final rule, such as by tracking EAD adjudications for H-4 dependent spouses and publishing annual reports. DHS maintains statistics on all immigration benefit programs and will monitor H-4 EAD adjudications and include relevant information in its annual reports in accordance with current reporting protocols.
Several hundred commenters requested that the rule be implemented as soon as possible. One commenter requested that a sunset provision be included in the rule. At the end of the sunset period, the commenter recommended that DHS evaluate the program, and, if the results are positive, expand it. DHS believes that a general sunset provision would not be practicable or fair as it would require DHS to provide different periods of employment authorization to H-4 dependent spouses depending on when they become eligible to apply. Further, DHS considers a sunset provision to be at odds with the rule's purpose, which is to retain highly skilled workers who often have a multi-year wait before being eligible to apply for permanent residence.
With respect to implementation of this rule, DHS must consider the 30-day effective date requirement at 5 U.S.C. 553(d) as well as USCIS's implementation requirements. Based on these factors, DHS has decided that this rule will be effective 90 days from the date of publication, May 26, 2015.
The Unfunded Mandates Reform Act of 1995 (UMRA) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. The value equivalent of $100,000,000 in 1995 adjusted for inflation to 2014 levels by the Consumer Price Index for All Urban Consumers is $155,000,000.
This rule does not exceed the $100 million expenditure in any one year when adjusted for inflation ($155,000,000 in 2014 dollars), and this rulemaking does not contain such a mandate. The requirements of Title II of the Act, therefore, do not apply, and DHS has not prepared a statement under the Act.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States companies to compete with foreign-based companies in domestic and export markets.
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 (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. This rule has been designated a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.
DHS is amending its regulations to extend eligibility for employment authorization to certain H-4 dependent spouses of H-1B nonimmigrants who either: (1) Are principal beneficiaries of an approved Immigrant Petition for Alien Worker (Form I-140); or (2) have been granted H-1B status under sections 106(a) and (b) of AC21.
Currently, USCIS does not issue work authorization to H-4 dependent spouses. To obtain work authorization, the H-4 dependent spouse generally must have a pending Application to Register Permanent Resident Status or Adjust Status or have changed status to another nonimmigrant classification that permits employment. AC21 provides for an authorized period of admission and employment authorization beyond the typical six-year limit for H-1B nonimmigrants who are seeking permanent residence. This final rule will extend eligibility for employment authorization to H-4 dependent spouses where: the H-1B nonimmigrant is the principal beneficiary of an approved Form I-140 petition; or the H-1B nonimmigrant has been granted status pursuant to sections 106(a) and (b) of AC21.
DHS has updated its estimate of the population of H-4 dependent spouses who will be impacted by the rule. DHS estimates the current population of H-4 dependent spouses who will be eligible for employment authorization could initially be as many as 179,600 after taking into account the backlog of H-1B nonimmigrants who have approved I-140 petitions, or who are likely to have such petitions approved, but who are unable to adjust status because of the lack of immigrant visas. For ease of analysis, DHS has assumed that those H-4 dependent spouses in the backlog population will file for employment authorization in the first year of implementation. DHS estimates the flow of new H-4 dependent spouses who could be eligible to apply for initial employment authorization in subsequent years may be as many as 55,000 annually. Even with the increased estimate of H-4 dependent spouses who could be eligible to apply for employment authorization, DHS still affirms in the initial year (the year with the largest number of eligible applicants) that the rule will result in much less than a one percent change in the overall U.S. labor force.
DHS is unable to determine and does not include in this analysis the filing volume of H-4 dependent spouses who will need to renew their employment authorization documents under this rule as they continue to wait for immigrant visas. Eligible H-4 dependent spouses who wish to apply for employment authorization must pay the $380 filing fee to USCIS, provide two passport-style photos, and incur the estimated 3-hour-and-25-minute opportunity cost of time burden associated with filing an Application for Employment Authorization (Form I-765). After monetizing the expected opportunity cost and combining it with the filing fee
The maximum anticipated annual cost to eligible H-4 dependent spouses applying for initial employment authorization in Year 1 is estimated at $78,337,928 (non-discounted), and $23,989,900 (non-discounted) in subsequent years. The 10-year discounted cost of this rule to eligible H-4 dependent spouses applying for employment authorization is $257,403,789 at 3 percent and $219,287,568 at 7 percent. Table 2 shows the maximum anticipated estimated costs over a 10-year period of analysis for the estimate of 179,600 applicants for initial employment authorization, and the 55,000 applicants expected to file for initial employment authorization annually in subsequent years.a25fe0.078
According to the most recently released reports prepared by the DHS Office of Immigration Statistics, in Fiscal Year (FY) 2013 a total of 990,553 persons became LPRs of the United States.
Employment-based immigrant visas accounted for approximately 16 percent of the total number of persons obtaining LPR status, and 30 percent of total LPRs who adjusted status in FY 2013. In FY 2013, there were a total of 161,110 LPRs admitted under employment-based preference visa categories. Of these 161,110 individuals, “priority workers” (first preference or EB-1) accounted for 24 percent; “professionals with advanced degrees” (second preference or EB-2) accounted for 39 percent; and “skilled workers, professionals, and other workers” (third preference or EB-3) accounted for 27 percent.
Based on historical trends, H-1B nonimmigrants seeking to adjust status to lawful permanent residence will most likely adjust under the EB-2 and EB-3 preference categories, with a much smaller amount qualifying under the EB-1 preference category. As of January 2015, the employment-based preference categories are “current” and have visas available,
In many cases, the timeframe associated with seeking lawful permanent residence is lengthy, extending well beyond the six-year period of stay allotted by the H-1B nonimmigrant visa classification. As a result, retention of highly educated and highly skilled nonimmigrant workers can become challenging for U.S. employers. Retaining highly skilled persons who intend to acquire LPR status is important when considering the contributions they make to the U.S. economy, including advances in research and development and other entrepreneurial endeavors, which are highly correlated with overall economic growth and job creation. By some estimates, immigration was responsible for one quarter of the explosive growth in patenting in past decades, and these innovations have the potential to contribute to increasing U.S. gross domestic product (GDP).
As noted above, this rule is intended to reduce the disincentives to pursue lawful permanent residence due to the potentially long wait for immigrant visas for many H-1B nonimmigrants and their families. Also, this rule will encourage those H-1B nonimmigrants who have already started the process for permanent residence not to abandon their efforts because their H-4 dependent spouses are unable to work.
Due to current data limitations, DHS is unable to precisely track the population of H-4 dependent spouses tied to H-1B nonimmigrants who have an approved Immigrant Petition for Alien Worker (Form I-140) or who have been granted H-1B status under the provisions of AC21. DHS databases are currently “form-centric” rather than “person-centric.” As USCIS transforms its systems to a more fully electronic process, there will be a shift from application- and form-based databases to one database that tracks information by the applicant or petitioner and which will improve DHS's ability to track the number of potential H-4 employment authorization applicants.
In the proposed rule, DHS estimated that as many as 100,600 H-4 dependent spouses would be eligible to apply for employment authorization in the first year, and as many as 35,900 H-4 dependent spouses would be eligible to apply annually in subsequent years. The estimates provided in the proposed rule have been updated in this final rule. In an effort to provide a reasonable approximation of the number of H-4 dependent spouses who will be eligible for employment authorization under this final rule, DHS has compared historical data on persons obtaining LPR status against employment-based immigrant demand estimates. Based on current visa availability, DHS believes that dependent spouses of H-1B nonimmigrants who are seeking employment-based visas under the second or third preference categories will be the group most impacted by the provisions of this rule, because certain chargeability areas in these preference categories are currently oversubscribed. In addition, in line with the goals of this rule and AC21, and based on immigration statistics, we assume that the large majority of H-4 dependent spouses who will be eligible for this provision are residing in the United States and will seek to acquire LPR status by applying to adjust status with USCIS rather than by departing for an indeterminate period to pursue consular processing of an immigrant visa application overseas. This assumption is supported by immigration statistics on those obtaining LPR status. In FY 2013, there were a total of 161,110 employment-based immigrant visa admissions, of which 140,009 (or 86.9 percent) obtained LPR status through adjustment of status in the United States.
DHS will extend eligibility to apply for employment authorization to the H-4 dependent spouses of H-1B nonimmigrants who are principal beneficiaries of approved Form I-140 petitions or who have been granted H-1B status pursuant to sections 106(a) and (b) of AC21. Therefore, DHS assumes that the volume of H-4 dependent spouses newly eligible for employment authorization is comprised of two estimates: (1) an immediate, first year estimate due to the current backlog of Form I-140 petitions; and (2) an annual estimate based on future demand to immigrate under employment-based preference categories. Extending eligibility for employment authorization to H-4 dependent spouses is ultimately tied to the actions taken by the H-1B nonimmigrant; therefore, the overall volume estimate is based on the population of H-1B nonimmigrants who have taken steps to acquire LPR status under employment-based preference categories.
DHS has estimated the number of persons waiting for LPR status in the first through third employment-based preference categories as of June 30, 2014. In this analysis, the estimated number of persons waiting for an immigrant visa is referred to as the “backlog” and includes those with an approved Form I-140 petition as of June 30, 2014 and those with a filed Form I-140 petition that is pending as of June 30 but is likely to be approved in the future.
The estimate of the number of individuals who are the principal beneficiaries of either an approved Form I-140 petition or a Form I-140 petition that is likely to be approved and who are waiting for an immigrant visa in the EB-1, EB-2, and EB-3 categories is shown in Table 3. Importantly, the number of principal workers shown in Table 3 is not limited only to those individuals who are currently in H-1B status. The estimates in Table 3 include aliens who are currently in H-1B and other nonimmigrant statuses, as well as those seeking to immigrate under employment-based preference categories who are currently abroad.
DHS is unable to precisely determine the number of H-1B nonimmigrants in the backlog who will be impacted by this rule. Instead, DHS examined detailed statistics of those obtaining LPR status from FY 2009-2013, and used this information as a proxy to refine the estimate of principal workers in the backlog that DHS expects to be married H-1B nonimmigrants seeking to adjust status. That estimate provides the basis for approximating the number of H-4 dependent spouses who will be impacted by this rule.
As shown
The annual demand flow of H-4 dependent spouses who will be eligible to apply for initial employment authorization under the final rule is based on: (1) The number of Form I-140 petitions approved where the principal beneficiary is currently in H-1B status; and (2) the number of extensions of stay petitions approved for H-1B nonimmigrants pursuant to AC21.
In the preamble of the proposed rule, DHS used colloquial language to describe the basis for H-1B nonimmigrants to be eligible for extensions of their stay under section 106 of AC21. It is typical to describe H-1B nonimmigrants who are eligible for AC21 extensions as those H-1B nonimmigrants who are the beneficiaries of a labor certification application or Form I-140 petition that
It may be helpful to illustrate this description using a graphical illustration of a case where an H-1B nonimmigrant would generally be eligible for an extension of his or her maximum period of stay pursuant to AC21, even though neither the labor certification application nor the Form I-140 petition remain pending with DOL or DHS, respectively, for a year or more.
In this final rule's preamble, DHS is correcting the description of how H-1B nonimmigrants become eligible for extensions of stay pursuant to sections 106(a) and (b) of AC21. Importantly, this language change does not impact who ultimately qualifies to apply for employment authorization under this final rule. The informal language used in the preamble of the proposed rule also does not impact the USCIS adjudication of petitions to authorize H-1B status pursuant to AC21. Accurately describing the statutory conditions of AC21 does, however, necessitate that DHS amend its estimate of the annual flow projections of H-4 dependent spouses who may be eligible to apply for employment authorization. In the proposed rule, DHS estimated the number of H-4 dependent spouses who would be eligible to apply for work authorization pursuant to AC21 by examining historical data of labor certifications or Form I-140 petitions pending for a year or more with the DOL and DHS, respectively. In contrast, this final rule examines the historical data of extensions of stay petitions approved for nonimmigrants currently in H-1B status to estimate the volume of H-4 dependent spouses eligible to apply for work authorization pursuant to AC21.
To recap, this rule will permit certain H-4 dependent spouses of H-1B nonimmigrants to be eligible to apply for employment authorization provided that the H-1B nonimmigrants are: (1) The principal beneficiaries of an approved Form I-140 petition, or (2) granted H-1B status pursuant to sections 106(a) and (b) of AC21. The annual flow estimate will therefore be based on historical data of these two categories. USCIS began tracking those cases that were approved for an extension pursuant to AC21 on October 17, 2014; in the past, USCIS databases have not captured and stored this information.
The number of approved Form I-140 petitions and approved Form I-129 extension of stay petitions where the beneficiary currently has H-1B status is presented in Table 5.
To refine the annual flow projection estimates, DHS has chosen to estimate the proportion of applications filed in the first through third employment-based preference categories. Additionally, since DHS has already limited the historical counts in Table 5 to those approved petitions where the beneficiary's current nonimmigrant classification is H-1B, DHS has made the assumption that the petitions shown in Table 5 represent H-1B nonimmigrants who are physically present in the United States and intend to adjust status. As shown in Table 4, the historical proportion of H-1B nonimmigrants obtaining LPR status under EB-1, EB-2, and EB-3 categories who reported being married was 81.1 percent, 72.6 percent, and 67.2 percent, respectively, resulting in an average of 73.6 percent. Applying this percentage to the baseline projection results in an annual flow estimate of 55,000 (rounded).
Therefore, DHS estimates that this rule will result in a maximum initial estimate of 179,600
The final rule will permit certain H-4 dependent spouses to apply for employment authorization in order to work in the United States. Therefore, only H-4 dependent spouses who decide to seek employment while residing in the United States will face the costs associated with obtaining employment authorization. The costs of the rule will stem from filing fees and the opportunity costs of time associated with filing Form I-765.
The current filing fee for Form I-765 is $380. The fee is set at a level to recover the processing costs to DHS. Applicants for employment authorization are required to submit two passport-style photos along with the application, which is estimated to cost $20.00 per application based on Department of State estimates.
The Federal minimum wage is currently $7.25 per hour.
The INA provides for the collection of fees at a level that will ensure recovery of the full costs of providing adjudication and naturalization services, including administrative costs and services provided without charge to certain applicants and petitioners.
Currently, once visas are determined to be immediately available, H-1B nonimmigrants and their dependent family members may be eligible to apply for adjustment of status to that of a lawful permanent resident. Upon filing an adjustment of status application, the H-4 dependent spouse is eligible to request employment authorization. This rule will significantly accelerate the timeframe by which qualified H-4 dependent spouses are eligible to enter the U.S. labor market. As a result of the changes made in this rule, certain H-4 dependent spouses will be eligible to request employment authorization well before they are eligible to apply for adjustment of status. Even with the change in the maximum number of H-4 dependent spouses who may be impacted as reported in the proposed rule and this final rule, DHS maintains that the expected outcomes are the same. DHS believes that this regulatory change will encourage families to stay committed to the immigrant visa process during the often lengthy wait for employment-based visas whereas, otherwise, they may leave the United States and abandon immigrant visa processing altogether. As such, DHS presents the geographic labor impact of this rule even though this rule does not result in “new” additions to the labor market; it simply accelerates the timeframe by which they can enter the labor market. As mentioned previously, DHS estimates this rule can add as many as 179,600 additional persons to the U.S. labor force in the first year of implementation, and then as many as 55,000 additional persons annually in subsequent years. As of 2013, there were an estimated 155,389,000 people in the U.S. civilian labor force.
The top five States where persons granted LPR status have chosen to reside are: California (20 percent), New York (14 percent), Florida (10 percent), Texas (9 percent), and New Jersey (5 percent).
As previously mentioned, once this rule is finalized, these amendments will increase incentives of certain H-1B nonimmigrants who have begun the process of becoming LPRs to remain in the United States and contribute to the U.S. economy as they complete this process. Providing the opportunity for certain H-4 dependent spouses to obtain employment authorization during this process will further incentivize H-1B nonimmigrants to not abandon their intention to remain in the United States while pursuing LPR status. Retaining highly skilled persons who intend to become LPRs is important when considering the contributions of these individuals to the U.S. economy, including advances in research and development and other entrepreneurial endeavors. As previously discussed, much research has been done to show the positive impacts on economic growth and job creation from highly skilled immigrants. In addition, these regulatory amendments will bring U.S. immigration policies more in line with the policies of other countries that seek to attract skilled foreign workers. For instance, in Canada spouses of temporary workers may obtain an “open” work permit allowing them to accept employment if the temporary worker meets certain criteria.
This final rule will result in direct, tangible benefits for the spouses who will be eligible to enter the labor market earlier than they would have otherwise been able to do so due to the lack of immigrant visas. While there will be obvious financial benefits to the H-4 dependent spouse and the H-1B nonimmigrant's family, there is also evidence that participating in the U.S. workforce and improving socio-economic attainment has a high correlation with smoothing an
Prior to this rule being effective, H-4 dependent spouses were not able to apply for employment authorization until they were eligible to submit their applications for adjustment of status or otherwise acquire a nonimmigrant status authorizing employment. The amendments to the regulations made by this final rule accelerate the timeframe by which H-4 dependent spouses of H-1B nonimmigrants who are on the path to being LPRs are able to enter into the U.S. labor market.
One alternative considered by DHS was to permit employment authorization for all H-4 dependent spouses. As explained in both the proposed rule and in response to public comments, DHS declines to extend the changes made by this rule to H-4 dependent spouses of all H-1B nonimmigrants at this time. Such an alternative would offer eligibility for employment authorization to those spouses of nonimmigrant workers who have not taken steps to demonstrate a desire to continue to remain in and contribute to the U.S. economy by seeking lawful permanent residence. In enacting AC21, Congress was especially concerned with avoiding the disruption to U.S. businesses caused by the required departure of H-1B nonimmigrants (for whom the businesses intended to file employment-based immigrant visa petitions) upon the expiration of the workers' maximum six-year period of authorized stay.
Another alternative considered was to limit employment eligibility to just those H-4 dependent spouses of H-1B nonimmigrants who extended their status under the provisions of AC21. As discussed in Section 3.b of this Executive Order 12866/13563 assessment, DHS databases began tracking the number of extensions of H-1B status that were approved pursuant to AC21 on October 17, 2014. Historically DHS did not capture this information. Based on approximately 90 days of case history, DHS believes that approximately 18.3 percent of all extension of stay applications filed on behalf of H-1B nonimmigrants are approved pursuant to AC21. DHS estimates that there could be as many as 27,643
USCIS examined the impact of this rule on small entities under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601(6). A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business under the Small Business Act, 15 U.S.C. 632), a small not-for-profit organization, or a small governmental jurisdiction (locality with fewer than fifty thousand people). After considering the impact of this rule on such small entities, DHS has determined that this rule will not have a significant economic impact on a substantial number of small entities. The individual H-4 dependent spouses to whom this rule applies are not small entities as that term is defined in 5 U.S.C. 601(6). Accordingly, DHS certifies that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will not 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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
Under the Paperwork Reduction Act of 1995, Public Law 104-13, all Departments are required to submit to the Office of Management and Budget (OMB), for review and approval, any reporting requirements inherent in a rule.
DHS submitted the proposed revisions to Form I-765 to OMB for review. DHS has considered the public comments received in response to the publication of the proposed rule. Over 180 commenters raised issues related to employment authorization requests, including filing procedures, premium
DHS's responses to these comments appear under Part III.E. and F. USCIS has submitted the supporting statement to OMB as part of its request for approval of this revised information collection instrument.
DHS has revised the originally proposed Form I-765 and form instructions to clarify the supporting documentation that applicants requesting employment authorization pursuant to this rule must submit with the form to establish eligibility, and to state that USCIS will accept Forms I-765 filed by such applicants concurrently with Forms I-539. DHS has also revised the Form I-765 to include a check box for the applicant to identify him or herself as an H-4 dependent spouse. The inclusion of this box will aid USCIS in its efforts to more efficiently process the form for adjudication by facilitating USCIS's ability to match the application with related petitions integral to the adjudication of Form I-765. DHS does not anticipate any of these changes will result in changes to the previously reported time burden estimate. The revised materials can be viewed at
Lastly, DHS has updated the supporting statement to reflect a change in the estimate for the number of respondents that USCIS projected would submit this type of request from 1,891,823 respondents to 1,981,516 respondents. This change of the initially projected number of respondents is due to better estimates regarding the general population of I-765 filers, in addition to this final rule's revised estimate on the new number of applicants that will request EADs, which results in a change of the estimated population of aliens that DHS expects could file Form I-765. Specifically, in the proposed rule USCIS estimated that approximately 58,000 new respondents would file requests for EADs as a result of the changes prompted by this rule. USCIS has revised that estimate and projects in this final rule that approximately 117,300 new respondents will be able to file a Form I-765. With this change on the number of Form I-765 application filers, the estimate for the total number of respondents has been updated. The current hour inventory approved for this form is 7,140,900 hours, and the requested new total hour burden is 8,159,070 hours, which is an increase of 1,018,170 annual burden hours.
DHS adopted most of the proposed regulatory amendments without change, except for conforming amendments to 8 CFR 214.2(h)(9)(iv) and 8 CFR 274a.13(d) and minor punctuation and wording changes in 8 CFR 214.2(h)(9)(iv) to improve clarity and readability.
Administrative practice and procedure, Aliens, Employment, Foreign officials, Health professions, Reporting and recordkeeping requirements, Students.
Administrative practice and procedure, Aliens, Employment, Penalties, Reporting and recordkeeping requirements.
Accordingly, DHS amends chapter I of title 8 of the Code of Federal Regulations as follows:
8 U.S.C. 1101, 1102, 1103, 1182, 1184, 1186a, 1187, 1221, 1281, 1282, 1301-1305 and 1372; sec. 643, Public Law 104-208, 110 Stat. 3009-708; Public Law 106-386, 114 Stat. 1477-1480; section 141 of the Compacts of Free Association with the Federated States of Micronesia and the Republic of the Marshall Islands, and with the Government of Palau, 48 U.S.C. 1901 note and 1931 note, respectively; 48 U.S.C. 1806; 8 CFR part 2.
(h) * * *
(9) * * *
(iv)
8 U.S.C. 1101, 1103, 1324a; Title VII of Public Law 110-229; 48 U.S.C. 1806; 8 CFR part 2.
(c) * * *
(26) An H-4 nonimmigrant spouse of an H-1B nonimmigrant described as eligible for employment authorization in 8 CFR 214.2(h)(9)(iv).
(d)
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |