| Page Range | 81155-81438 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 81155 - To Modify the Harmonized Tariff Schedule of the United States | |
| 80 FR 81346 - Proposed Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) | |
| 80 FR 81272 - National Residue Program: Monitoring Chemical Hazards | |
| 80 FR 81376 - Sunshine Act Meeting Notice | |
| 80 FR 81426 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel NEUVA OLA; Invitation for Public Comments | |
| 80 FR 81427 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel CARPE VITA; Invitation for Public Comments | |
| 80 FR 81428 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SHERYL ANN; Invitation for Public Comments | |
| 80 FR 81427 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel THE DUCHESS; Invitation for Public Comments | |
| 80 FR 81429 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel CALYPSO; Invitation for Public Comments | |
| 80 FR 81351 - Notice of a Federal Advisory Committee Meeting; Manufactured Housing Consensus Committee | |
| 80 FR 81346 - Announcement of Funding Awards; Fair Housing Initiatives Program Fiscal Year 2015 | |
| 80 FR 81199 - Energy Conservation Program: Certification and Enforcement-Import Data Collection | |
| 80 FR 81425 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel U TURN; Invitation for Public Comments | |
| 80 FR 81429 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LOWCOUNTRY NATIVE; Invitation for Public Comments | |
| 80 FR 81430 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ISLAND FLYER; Invitation for Public Comments | |
| 80 FR 81310 - Central Arizona Project-Rate Order No. WAPA-172 | |
| 80 FR 81431 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel THE GOLDFISCH; Invitation for Public Comments | |
| 80 FR 81430 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel EROS; Invitation for Public Comments | |
| 80 FR 81428 - Request for Comments of a Previously Approved Information Collection | |
| 80 FR 81356 - United States v. Gray Television, Inc., et al.; Proposed Final Judgment and Competitive Impact Statement | |
| 80 FR 81279 - Notice of Solicitation of Applications for the Section 533 Housing Preservation Grants for Fiscal Year 2016 | |
| 80 FR 81378 - Submission of Information Collection for OMB Review; Comment Request; Locating and Paying Participants | |
| 80 FR 81293 - Approval of Subzone Status; Nine West Holdings, Inc.; West Deptford, New Jersey | |
| 80 FR 81293 - Foreign-Trade Zone (FTZ) 183-Austin, Texas; Notification of Proposed Production Activity; Samsung Austin Semiconductor, LLC; Subzone 183B (Semiconductors); Austin, Texas | |
| 80 FR 81376 - Training and Qualification of Security Personnel at Nuclear Power Reactor Facilities | |
| 80 FR 81377 - Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating Unit Nos. 2 and 3 | |
| 80 FR 81438 - Proposed Information Collection; Comment Request; Treasury Financial Empowerment Innovation Fund Evaluation of a Near-Peer Counseling Program for High School and College Students on Pursuing and Financing Their Higher Education | |
| 80 FR 81317 - Alpha-Chlorohydrin, Registration Review Proposed Interim Decision; Notice of Availability | |
| 80 FR 81320 - Pesticide Product Registration; Receipt of an Application for New Uses | |
| 80 FR 81341 - Statement of Organization, Functions and Delegations of Authority | |
| 80 FR 81412 - Notice of Public Meeting | |
| 80 FR 81276 - Notice of Intent To Request Approval To Establish a New Information Collection and Record Keeping Requirement | |
| 80 FR 81279 - Submission for OMB Review; Comment Request | |
| 80 FR 81328 - 2016 Privately Owned Vehicle (POV) Mileage Reimbursement Rates; 2016 Standard Mileage Rate for Moving Purposes | |
| 80 FR 81251 - Trade Monitoring Procedures for Fishery Products; International Trade in Seafood; Permit Requirements for Importers and Exporters | |
| 80 FR 81262 - Fisheries of the Exclusive Economic Zone Off of Alaska; Observer Coverage Requirements for Small Catcher/Processors in the Gulf of Alaska and Bering Sea and Aleutian Islands Groundfish Fisheries | |
| 80 FR 81352 - Indian Gaming; Tribal-State Class III Gaming Compacts Taking Effect in the State of New Mexico | |
| 80 FR 81353 - Proclaiming Certain Lands as Reservation for the Tonto Apache Tribe of Arizona | |
| 80 FR 81352 - Draft Environmental Impact Statement for the Proposed Wilton Rancheria Fee-to-Trust and Casino Project, Sacramento County, California | |
| 80 FR 81321 - Notification of Teleconferences of the Science Advisory Board; Hydraulic Fracturing Research Advisory Panel | |
| 80 FR 81184 - Drawbridge Operation Regulation; Duwamish Waterway, Seattle, WA | |
| 80 FR 81181 - Drawbridge Operation Regulation; Lake Pontchartrain, Slidell, LA | |
| 80 FR 81179 - Drawbridge Operation Regulation; Missouri River, Atchison, KS | |
| 80 FR 81189 - Safety Zone; Closure of Morro Bay Harbor Bar Entrance; Morro Bay, CA | |
| 80 FR 81316 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Pulp and Paper Production (Renewal) | |
| 80 FR 81315 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Aluminum, Copper and Other Non-Ferrous Metals Foundries (Renewal) | |
| 80 FR 81321 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Petroleum Refineries for Which Construction, Reconstruction, or Modification Commenced After May 14, 2007 (Renewal) | |
| 80 FR 81316 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for the Wood Building Products Surface Coating Industry (Renewal) | |
| 80 FR 81314 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Hydrochloric Acid Production (Renewal) | |
| 80 FR 81367 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act | |
| 80 FR 81335 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development | |
| 80 FR 81340 - Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases | |
| 80 FR 81339 - Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability | |
| 80 FR 81375 - Agency Information Collection Activities: Comment Request | |
| 80 FR 81303 - Agency Information Collection Extension | |
| 80 FR 81381 - Proposed Collection; Comment Request | |
| 80 FR 81373 - Privacy Act of 1974; Privacy Act System of Records | |
| 80 FR 81324 - Agency Information Collection Activities: Final Collection; Comment Request | |
| 80 FR 81293 - New England Fishery Management Council; Public Meeting | |
| 80 FR 81294 - New England Fishery Management Council; Public Meeting | |
| 80 FR 81323 - Agency Information Collection Activities: Final Collection; Comment Request | |
| 80 FR 81423 - Proposed Agency Information Collection Activities; Comment Request | |
| 80 FR 81380 - International Mail Contract | |
| 80 FR 81379 - New Postal Product | |
| 80 FR 81381 - New Postal Product | |
| 80 FR 81415 - Qualification of Drivers; Exemption Applications; Diabetes Mellitus | |
| 80 FR 81436 - Proposed Collection of Information: Claim for United States Savings Bonds Not Received | |
| 80 FR 81436 - Proposed Collection of Information; Regulations Governing U.S. Treasury Securities-State and Local Government Series | |
| 80 FR 81437 - Proposed Collection of Information: Regulations Governing Book-Entry Treasury Bonds, Notes, and Bills. | |
| 80 FR 81437 - Proposed Collection of Information: Request by Owner or Person Entitled to Payment or Reissue of United States Savings Bonds/Notes Deposited in Safekeeping When Original Custody Receipts Are Not Available | |
| 80 FR 81298 - Vietnam War Commemoration Advisory Committee; Notice of Federal Advisory Committee Meeting | |
| 80 FR 81329 - Announcement of the Award of a Single-Source Expansion Supplement Grant to the Wisconsin Department for Children and Families in Madison, WI | |
| 80 FR 81324 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
| 80 FR 81309 - Reliability Standard for Transmission System Planned Performance for Geomagnetic Disturbance Events; Notice of Technical Conference | |
| 80 FR 81306 - Pelzer Hydro Company, LLC; Consolidated Hydro Southeast, LLC; Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments | |
| 80 FR 81304 - Pelzer Hydro Company, LLC; Consolidated Hydro Southeast, LLC; Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments | |
| 80 FR 81308 - Brookfield White Pine Hydro LLC; Notice of Application Tendered for Filing With the Commission and Establishing Procedural Schedule for Licensing and Deadline for Submission of Final Amendments | |
| 80 FR 81304 - Zapalac, Will; Notice of Filing | |
| 80 FR 81304 - Lotus Energy Group, LLC v. ISO New England Inc.; Notice of Complaint | |
| 80 FR 81308 - Sage Grouse Energy Project, LLC; Notice Rejecting Request for Extension of Time | |
| 80 FR 81305 - First ECA Midstream LLC; Notice of Application | |
| 80 FR 81307 - Combined Notice of Filings #2 | |
| 80 FR 81178 - Delegation of Authority for FERC Form No. 552 | |
| 80 FR 81309 - Combined Notice of Filings #1 | |
| 80 FR 81299 - Agency Information Collection Activities; Comment Request; National Longitudinal Transition Study 2012 Phase II | |
| 80 FR 81191 - Removal of Requirement To File Direct-Pay Fee Agreements With the Office of the General Counsel | |
| 80 FR 81233 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction | |
| 80 FR 81332 - Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs | |
| 80 FR 81292 - Agenda and Notice of Public Meeting of the Wyoming Advisory Committee | |
| 80 FR 81319 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Secondary Aluminum Production (Renewal) | |
| 80 FR 81318 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Synthetic Fiber Production Facilities (Renewal) | |
| 80 FR 81369 - Section 1201 Study: Notice and Request for Public Comment | |
| 80 FR 81355 - Request for Nominations for the Cedar Creek and Belle Grove National Historical Park Advisory Commission | |
| 80 FR 81355 - Notice of the Meeting Schedule for the Gateway National Recreation Area Fort Hancock 21st Century Advisory Committee Through June 2016 | |
| 80 FR 81328 - Submission for OMB Review; High Global Warming Potential Hydrofluorocarbons | |
| 80 FR 81297 - Charter Renewal of Department of Defense Federal Advisory Committees | |
| 80 FR 81162 - Community Reinvestment Act Regulations | |
| 80 FR 81353 - Proposed Renewal of Information Collection; Tribal Expression of Interest to the Land Buy-Back Program for Tribal Nations | |
| 80 FR 81294 - Fisheries of the Northeastern United States; Northeast Multispecies Fishery Management Plan; Notice of Intent To Prepare an Environmental Impact Statement; Scoping Process; Request for Comments; Extension of Comment Period | |
| 80 FR 81330 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Developmental Disabilities Protection and Advocacy Statement of Goals and Priorities | |
| 80 FR 81296 - National Commission on the Future of the Army; Notice of Federal Advisory Committee Meeting | |
| 80 FR 81368 - Technical Advisory Committee; Request for Nominations | |
| 80 FR 81344 - National Institute on Aging; Notice of Closed Meetings | |
| 80 FR 81345 - National Institute on Aging; Notice of Closed Meeting | |
| 80 FR 81344 - National Cancer Institute; Notice of Closed Meetings | |
| 80 FR 81345 - Center for Scientific Review; Notice of Closed Meetings | |
| 80 FR 81295 - TRICARE; Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); Fiscal Year 2016 Diagnosis Related Group (DRG) Updates | |
| 80 FR 81393 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing of Amendment Nos. 1 and 2 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, To Amend and Correct Phlx Rule 1080.07 | |
| 80 FR 81407 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NASDAQ Options Market-Fees and Rebates | |
| 80 FR 81387 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Modify the Level 2 Professional Subscriber Fee | |
| 80 FR 81405 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete Rule 1068, Execution of Multi-Part Orders | |
| 80 FR 81402 - Self-Regulatory Organizations; National Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Fee and Rebate Schedule Pursuant to Exchange Rule 16.1 | |
| 80 FR 81384 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To Revise the ICC Risk Management Framework and ICC Treasury Operations Policies and Procedures, and Adopt the ICC Risk Management Model Description Document | |
| 80 FR 81390 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend BOX Rule 2020 (Participant Eligibility and Registration) To Replace the Limited Representative-Proprietary Trader and Limited Principal-Proprietary Trader Registration Categories and Establish the Securities Trader and Securities Trader Principal Registration Categories | |
| 80 FR 81409 - Agency Information Collection Activities: Proposed Request and Comment Request | |
| 80 FR 81413 - Notice of Intent To Rule on a Request for Change in Designation of On-Airport Property Purchased With Airport Improvement Program (AIP) Funding From Aeronautical to Non-Aeronautical at the Lancaster Airport, Lititz, PA | |
| 80 FR 81367 - Importer of Controlled Substances Application: Johnson Matthey, Inc. | |
| 80 FR 81234 - Revisions to the Public Notice Provisions in Clean Air Act Permitting Programs | |
| 80 FR 81326 - Oracle Corporation; Analysis of Proposed Consent Order To Aid Public Comment | |
| 80 FR 81186 - Regulated Navigation Area; Reporting Requirements for Barges Loaded With Certain Dangerous Cargoes, Illinois Waterway System Located Within the Ninth Coast Guard District; Expiration of Stay (Suspension) and Administrative Changes | |
| 80 FR 81223 - Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses | |
| 80 FR 81330 - Electroconvulsive Therapy Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff; Availability | |
| 80 FR 81300 - Macroeconomic Impacts of LNG Exports Studies | |
| 80 FR 81194 - Establish a Single Small Business Size Standard for Commercial Fishing Businesses | |
| 80 FR 81220 - Airworthiness Directives; The Boeing Company Airplanes | |
| 80 FR 81216 - Airworthiness Directives; Airbus Airplanes | |
| 80 FR 81413 - Notice of Final Federal Agency Actions on State Highway (SH) 365 From Farm-to-Market Road (FM) 1016/Conway Avenue to U.S. Highway (US) 281/Military Highway in Hidalgo County, Texas | |
| 80 FR 81414 - Notice of Final Federal Agency Actions on Proposed Highway in Minnesota | |
| 80 FR 81251 - Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS | |
| 80 FR 81295 - Notice of Meeting | |
| 80 FR 81434 - Hazardous Materials: Notice of Application for Special Permits | |
| 80 FR 81435 - Hazardous Materials: Delayed Applications | |
| 80 FR 81431 - Hazardous Materials: Notice of Application for Modification of Special Permit | |
| 80 FR 81432 - Hazardous Materials: Actions on Special Permit Applications | |
| 80 FR 81159 - Common Crop Insurance Regulations; Cotton Crop Insurance Provisions, Extra Long Staple Cotton Crop Insurance Provisions | |
| 80 FR 81165 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
| 80 FR 81174 - Airworthiness Directives; Airbus Airplanes | |
| 80 FR 81168 - Airworthiness Directives; Airbus Airplanes |
Federal Crop Insurance Corporation
Food Safety and Inspection Service
National Institute of Food and Agriculture
Natural Resources Conservation Service
Rural Housing Service
Foreign-Trade Zones Board
National Oceanic and Atmospheric Administration
Energy Information Administration
Federal Energy Regulatory Commission
Western Area Power Administration
Children and Families Administration
Community Living Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Indian Affairs Bureau
National Park Service
Antitrust Division
Drug Enforcement Administration
Labor Statistics Bureau
Copyright Office, Library of Congress
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Maritime Administration
Pipeline and Hazardous Materials Safety Administration
Comptroller of the Currency
Fiscal Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Federal Crop Insurance Corporation, USDA.
Final rule with request for comments.
The Federal Crop Insurance Corporation (FCIC) amends the Common Crop Insurance Regulations, Cotton Crop Insurance Provisions and Extra Long Staple (ELS) Cotton Crop Insurance Provisions. The intended effect of this action is to provide policy changes and to clarify existing policy provisions to better meet the needs of policyholders. As discussed further within this rule, FCIC received requests to simplify program administration consistent with evolving farming practices in cotton crop production. The changes will be effective for the 2017 and succeeding crop years.
This final rule is effective December 29, 2015. However, FCIC will accept written comments on this final rule until close of business February 29, 2016. FCIC may consider the comments received and may conduct additional rulemaking based on the comments.
FCIC prefers interested persons submit their comments electronically through the Federal eRulemaking Portal. Interested persons may submit comments, identified by Docket ID No. FCIC-15-0001, by any of the following methods:
•
•
FCIC will post all comments received, including those received by mail, without change to
Tim Hoffmann, Product Management, Product Administration and Standards Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, PO 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, subchapter I), the collections of information in this rule have been approved by OMB under control number 0563-0053.
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. 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. Program requirements for the Federal crop insurance program are the same for all producers regardless of the size of their farming operation. For instance, all producers are required to submit an application and acreage report to establish their insurance guarantees and compute premium amounts, and all producers are required to submit a notice of loss and production information to determine the indemnity amount for an insured cause of crop loss. Whether a producer has 10 acres or 1000 acres, there is no difference in the kind of information collected. To ensure crop insurance is available to small entities, the Federal Crop Insurance Act (FCIA) authorizes FCIC to waive collection of administrative fees from limited resource farmers. FCIC believes this waiver helps to ensure that small entities are given the same opportunities as large entities to manage their risks through the use of crop insurance. A Regulatory Flexibility Analysis has not been prepared since this regulation does not have a significant impact on a substantial number of small entities, and, therefore, this regulation is exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605).
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 2 CFR part 415, subpart C.
This 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 action by FCIC directing 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 amends the Common Crop Insurance Regulations (7 CFR part 457) by revising 7 CFR 457.104 Cotton Crop Insurance Provisions and 7 CFR 457.105 Extra Long Staple Cotton Crop Insurance Provisions to be effective for the 2017 and succeeding crop years. FCIC received requests to simplify program administration consistent with evolving farming practices in cotton crop production.
FCIC is issuing this final rule without opportunity for prior notice and comment. The Administrative Procedure Act exempts rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” from the statutory requirement for prior notice and opportunity for public comment (5 U.S.C. 553(a)(2)). However, FCIC is providing a 60-day comment period and invites interested persons to participate in this rulemaking by submitting written comments. FCIC may consider the comments received and may conduct additional rulemaking based on the comments.
1. The changes to 7 CFR 457.104 Cotton Crop Insurance Provisions are as follows:
(a) Section 9 (“Duties in the Event of Damage or Loss”)—FCIC is revising paragraph (a). The provisions require, in the event of damage or loss, the insured must leave cotton stalks intact for the insurance provider's inspection. FCIC has received requests to remove these provisions. The primary reasons provided to FCIC for removing the provisions include the following reasons:
• University extension in some regions recommends destroying the stalks as soon as possible after harvest to mitigate the possibility of insect infestation (specifically boll weevil);
• The provision requires cotton to be treated differently than other row crops, which do not require the insured to leave stalks intact for inspection;
• The provision was originally written to address multiple harvests on the same acreage, but today producers manage their cotton crops to result in harvest occurring once a year. Years ago, producers planted more late-maturing varieties and the bolls would open at different times during the harvest season causing a producer to pick the same acreage twice.
• Cotton farming practices have changed in some regions over the years and producers have grown accustomed to mowing the stalks immediately following the cotton picker; and
• Producers mow or shred cotton stalks so they can plant their winter grazing or cover crops. Since cotton stalks are woody, the sooner they can mow or shred the stalks, the sooner the stalks will begin to break down. When a cotton stalk inspection is required, a producer may have to wait up to two weeks before the field can be mowed. Depending on weather and individual circumstances, the stalk inspection is an inconvenience to producers and may interfere with timely completion of their normal operations and preparation for the winter/cover crop.
FCIC recognizes the potential existence of these issues, but also recognizes there may be situations in which a cotton stalk inspection has merit or necessity. Therefore, FCIC is revising the provision to allow insurance companies discretion to require, in certain circumstances, that insureds leave the cotton stalks intact for company inspection. FCIC is also revising the provision to allow FCIC to include specific circumstances in the Special Provisions for which FCIC will require insureds to leave cotton stalks intact, and FCIC will require the company to conduct a cotton stalk inspection, making discretion inapplicable when any Special Provisions circumstance required by FCIC occurs.
(b) Section 10 (“Settlement of Claim”)—FCIC is revising paragraph (c)(1)(i)(E). The current provision states production to count will include, among other things, all appraised production for acreage on which cotton stalks were destroyed in violation of section 9. As discussed above, FCIC is revising section 9, which is applicable only if the AIP exercises its discretion under appropriate circumstances to require that insureds leave cotton stalks intact. FCIC is revising paragraph (c)(1)(i)(E) to state this provision applies only if section 9(a) applies.
2. The changes to 7 CFR 457.105 Extra Long Staple Cotton Crop Insurance Provisions are as follows:
(a) Section 6 (“Insurable Acreage”)—FCIC is revising paragraph (b) to correct a prior
(b) Section 9 (“Duties in the Event of Damage of Loss”)—FCIC is revising paragraph (a)(2). The provisions require, in the event of damage or loss, the insured must leave cotton stalks intact for the insurance provider's inspection. FCIC has received requests to remove these provisions. The primary reasons provided to FCIC for removing the provisions include the following reasons:
• University extension in some regions recommends destroying the stalks as soon as possible after harvest to mitigate the possibility of insect infestation (specifically boll weevil);
• The provision requires cotton to be treated differently than other row crops, which do not require the insured to leave stalks intact for inspection;
• The provision was originally written to address multiple harvests on the same acreage, but today producers manage their cotton crops to result in harvest occurring once a year. Years ago, producers planted more late-maturing varieties and the bolls would open at different times during the harvest season causing a producer to pick the same acreage twice.
• Cotton farming practices have changed in some regions over the years and producers have grown accustomed to mowing the stalks immediately following the cotton picker; and
• Producers mow or shred cotton stalks so they can plant their winter grazing or cover crops. Since cotton stalks are woody, the sooner they can mow or shred the stalks, the sooner the stalks will begin to break down. When a cotton stalk inspection is required, a producer may have to wait up to two weeks before the field can be mowed. Depending on weather and individual circumstances, the stalk inspection is an inconvenience to producers and may interfere with timely completion of their normal operations and preparation for the winter/cover crop.
FCIC recognizes the potential existence of these issues, but also recognizes there may be situations in which a cotton stalk inspection has merit or necessity. Therefore, FCIC is revising the provision to allow insurance companies discretion to require, in certain circumstances, that insureds leave the cotton stalks intact for company inspection. FCIC is also revising the provision to allow FCIC to include specific circumstances in the Special Provisions for which FCIC will require insureds to leave cotton stalks intact, and FCIC will require the company to conduct a cotton stalk inspection, making discretion inapplicable when any Special Provisions circumstance required by FCIC occurs.
(c) Section 10 (“Settlement of Claim”)—FCIC is revising paragraph (c)(1)(i)(E). The current provision says the production to count will include, among other things, all appraised production for acreage on which cotton stalks were destroyed in violation of section 9. As discussed above, FCIC is revising section 9, which is applicable only if the AIP exercises its discretion under appropriate circumstances to require that insureds leave cotton stalks intact. FCIC is revising paragraph (c)(1)(i)(E) to state this provision applies only if section 9(a)(2) applies.
(e) Section 12 (“Prevented Planting”)—FCIC is removing the reference to limited level of coverage in section 12(b) because it is no longer applicable.
Crop insurance, Cotton, Reporting and recordkeeping requirements.
Accordingly, as set forth in the preamble, the Federal Crop Insurance Corporation amends 7 CFR part 457 effective for the 2017 and succeeding crop years as follows:
7 U.S.C. 1506(l) and 1506(o).
The revisions read as follows:
9. Duties in the Event of Damage or Loss
(a) In addition to your duties under section 14 of the Basic Provisions, in the event of damage or loss, at our option or if required by FCIC in the Special Provisions, you may be required to leave the cotton stalks intact for our inspection. If applicable, the stalks must not be destroyed, and required samples must not be harvested, until the earlier of our inspection or 15 days after harvest of the balance of the unit is completed and written notice of probable loss given to us.
10. Settlement of Claim
(c) * * *
(1) * * *
(i) * * *
(E) If applicable, on which the cotton stalks are destroyed, in violation of section 9.
The revisions read as follows:
6. Insurable Acreage
(b) Any acreage of the insured crop damaged before the final planting date, to the extent that a majority of producers in the area would not normally further care for the crop, must be replanted unless we agree that it is not practical to replant.
9. Duties in the Event of Damage or Loss
(a) * * *
(2) At our option or if required by FCIC in the Special Provisions, you may be required to leave the cotton stalks intact for our inspection. If applicable, the stalks must not be destroyed, and required samples must not be harvested, until the earlier of our inspection or 15 days after harvest of the balance of the unit is completed and written notice of probable loss is given to us.
10. Settlement of Claim
(c) * * *
(1) * * *
(i) * * *
(E) If applicable, on which the cotton stalks are destroyed, in violation of section 9.
12. Prevented Planting
(b) * * * If you have additional coverage and pay an additional premium, you may increase your prevented planting coverage to a level specified in the actuarial documents.
Office of the Comptroller of the Currency, Treasury (OCC); Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC).
Joint final rule; technical amendment.
The OCC, the Board, and the FDIC (collectively, the Agencies) are amending their Community Reinvestment Act (CRA) regulations to adjust the asset-size thresholds used to define “small bank” or “small savings association” and “intermediate small bank” or “intermediate small savings association.” As required by the CRA regulations, the adjustment to the threshold amount is based on the annual percentage change in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). The Agencies also propose to make technical edits to remove obsolete references to the Office of Thrift Supervision (OTS) and update cross-references to regulations implementing certain Federal consumer financial laws in their CRA regulations.
January 1, 2016.
The Agencies' CRA regulations establish CRA performance standards for small and intermediate small banks and savings associations. The CRA regulations define small and intermediate small banks and savings associations by reference to asset-size criteria expressed in dollar amounts, and they further require the Agencies to publish annual adjustments to these dollar figures based on the year-to-year change in the average of the CPI-W, not seasonally adjusted, for each twelve-month period ending in November, with rounding to the nearest million. 12 CFR 25.12(u)(2), 195.12(u)(2), 228.12(u)(2), and 345.12(u)(2). This adjustment formula was first adopted for CRA purposes by the OCC, the Board, and the FDIC on August 2, 2005, effective September 1, 2005. 70 FR 44256 (Aug. 2, 2005). The Agencies noted that the CPI-W is also used in connection with other federal laws, such as the Home Mortgage Disclosure Act.
Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),
The threshold for small banks and small savings associations was revised most recently in December 2014, and became effective January 1, 2015 (79 FR 77852 (Dec. 29, 2014)). The current CRA regulations provide that banks and savings associations that, as of December 31 of either of the prior two calendar years, had assets of less than $1.221 billion are small banks or small savings associations. Small banks and small savings associations with assets of at least $305 million as of December 31 of both of the prior two calendar years and less than $1.221 billion as of December 31 of either of the prior two calendar years are intermediate small banks or intermediate small savings associations. 12 CFR 25.12(u)(1), 195.12(u)(1), 228.12(u)(1), and 345.12(u)(1). This joint final rule revises these thresholds.
During the period ending November 2015, the CPI-W decreased by 0.42 percent. As a result, the Agencies are revising 12 CFR 25.12(u)(1), 195.12(u)(1), 228.12(u)(1), and 345.12(u)(1) to make this annual adjustment. Beginning January 1, 2016, banks and savings associations that, as of December 31 of either of the prior two calendar years, had assets of less than $1.216 billion are small banks or small savings associations. Small banks and small savings associations with assets of at least $304 million as of December 31 of both of the prior two calendar years and less than $1.216 billion as of December 31 of either of the prior two calendar years are intermediate small banks or intermediate small savings associations. The Agencies also publish current and historical asset-size thresholds on the Web site of the Federal Financial Institutions Examination Council at
In addition, the Agencies are making technical edits to 12 CFR 25.42, 228.42, and 345.42 to remove obsolete references to the “Office of Thrift Supervision” and to 12 CFR 563e in the CRA rules. As explained above, Title III of the Dodd-Frank Act transferred the powers, authorities, rights, and duties of the OTS to the Agencies. Specifically, among other changes, Title III abolished the OTS; transferred rulemaking and supervisory authority over savings and loan holding companies and supervisory authority over their non-depository subsidiaries to the Board; transferred rulemaking authority over federal savings associations and state savings associations, and supervisory authority over federal savings associations, to the OCC; and transferred supervisory authority over state savings associations to the FDIC.
Further, the Agencies are updating references to certain regulations implementing Federal consumer financial laws in the CRA regulations, as Title X of the Dodd-Frank Act transferred rulemaking authority for a number of Federal consumer financial laws, including the Home Mortgage Disclosure Act (HMDA) and the Truth in Lending Act (TILA), to the Consumer Financial Protection Bureau (CFPB), effective July 21, 2011. The CFPB subsequently published an interim final rule to establish its own Regulation C to implement HMDA,
Under 5 U.S.C. 553(b)(B) of the Administrative Procedure Act (APA), an agency may, for good cause, find (and incorporate the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.
The amendments to the regulations to adjust the asset-size thresholds for small and intermediate small banks and savings associations result from the application of a formula established by a provision in the respective CRA regulations that the Agencies previously published for comment.
Accordingly, the Agencies' rules provide no discretion as to the computation or timing of the revisions to the asset-size criteria. Furthermore, deleting the obsolete references to the “Office of Thrift Supervision” and its CRA regulation and updating cross-references to reflect the transfer of rulemaking authority for many Federal consumer financial laws to the CFPB are technical and non-substantive revisions. For these reasons, the Agencies have determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary.
The effective date of this joint final rule is January 1, 2016. Under 5 U.S.C. 553(d)(3) of the APA, the required publication or service of a substantive rule shall be made not less than 30 days before its effective date, except, among other things, as provided by the agency for good cause found and published with the rule. Because this rule adjusts asset-size thresholds consistent with the procedural requirements of the CRA rules, the Agencies conclude that it is not substantive within the meaning of the APA's delayed effective date provision. Moreover, the Agencies find that there is good cause for dispensing with the delayed effective date requirement, even if it applied, because their current rules already provide notice that the small and intermediate small asset-size thresholds will be adjusted as of December 31 based on twelve-month data as of the end of November each year. In addition, the technical edits to remove obsolete references to the “Office of Thrift Supervision” and its CRA rule in the Agencies' CRA rules and update citations to certain regulations are not substantive within the meaning of the APA's delayed effective date provision.
The Regulatory Flexibility Act (RFA) does not apply to a rulemaking when a general notice of proposed rulemaking is not required. 5 U.S.C. 603 and 604. As noted previously, the Agencies have determined that it is unnecessary to publish a general notice of proposed rulemaking for this joint final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506; 5 CFR 1320), the Agencies reviewed this final rule. No collections of information pursuant to the Paperwork Reduction Act are contained in the final rule.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act), 2 U.S.C. 1532, requires the OCC to prepare a budgetary impact statement before promulgating any final rule for which a general notice of proposed rulemaking was published. As discussed above, the OCC has determined that the publication of a general notice of proposed rulemaking is unnecessary. Accordingly, this joint final rule is not subject to section 202 of the Unfunded Mandates Act.
Community development, Credit, Investments, National banks, Reporting and recordkeeping requirements.
Community development, Credit, Investments, Reporting and recordkeeping requirements, Savings associations.
Banks, Banking, Community development, Credit, Investments, Reporting and recordkeeping requirements.
Banks, Banking, Community development, Credit, Investments, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, 12 CFR parts 25 and 195 are amended as follows:
12 U.S.C. 21, 22, 26, 27, 30, 36, 93a, 161, 215, 215a, 481, 1814, 1816, 1828(c), 1835a, 2901 through 2908, and 3101 through 3111.
The revision reads as follows:
(u)
12 U.S.C. 1462a, 1463, 1464, 1814, 1816, 1828(c), 2901 through 2908, and 5412(b)(2)(B).
The revision is set forth below:
(u)
For the reasons set forth in the preamble, the Board of Governors of the Federal Reserve System amends part 228 of chapter II of title 12 of the Code of Federal Regulations as follows:
12 U.S.C. 321, 325, 1828(c), 1842, 1843, 1844, and 2901
The revision reads as follows:
(u)
For the reasons set forth in the preamble, the Board of Directors of the Federal Deposit Insurance Corporation amends part 345 of chapter III of title 12 of the Code of Federal Regulations to read as follows:
12 U.S.C. 1814-1817, 1819-1820, 1828, 1831u and 2901-2908, 3103-3104, and 3108(a).
The revision reads as follows:
(u)
By order of the Board of Directors.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 2011-07-10 for certain Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes. AD 2011-07-10 required revising the Airworthiness Limitations section of the Instructions for Continued Airworthiness; doing detailed visual inspections; removing discrepant material; cleaning the surfaces of the valves, the plug of the sensing port, and the cabin pressure-sensing port plug; securing the insulation; installing a new safety valve, and replacing certain cabin pressure-sensing port plugs. This new AD retains all requirements of AD 2011-07-10, and requires a detailed visual inspection of both safety valves and the surrounding area for foreign material, room temperature vulcanizing (RTV) silicone, contamination, foam on the bulkhead structure, tape or insulation, and loose material; and corrective actions if necessary. This AD was prompted by reports of in-flight loss of cabin pressurization that was attributed to partial blockage of a safety valve cabin pressure-sensing port in conjunction with a failed safety valve manometric capsule. We are issuing this AD to detect and correct blockage of a safety valve cabin pressure-sensing port, which could result in loss of cabin pressure.
This AD becomes effective February 2, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 2, 2016.
The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of May 5, 2011 (76 FR 17758, March 31, 2011).
You may examine the AD docket on the Internet at
For service information identified in this final rule, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
Luke Walker, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7363; fax 516-794-5531.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2011-07-10, Amendment 39-16647 (76 FR 17758, March 31, 2011). AD 2011-07-10 applied to certain Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes. The NPRM published in the
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2010-06R1, dated August 8, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes. The MCAI states:
Investigation of a high altitude loss of cabin pressurization on a BD-100-1A10 aeroplane determined that it was caused by a partial blockage of a safety valve cabin pressure-sensing port, in conjunction with a dormant failure/leakage of the safety valve manometric capsule. The blockage, caused by accumulation of lint/dust on the grid of the port plug, did not allow sufficient airflow through the cabin pressure-sensing port to compensate for the rate of leakage from the manometric capsule, resulting in the opening of the safety valve. It was also determined that failure of the manometric capsule alone would not result in the opening of the safety valve.
The original issue of this [Canadian] AD mandated a revision of the maintenance schedule, the cleaning of the safety valves, the removal of material from the area surrounding the safety valves and the modification of the safety valves with a gridless cabin pressure-sensing port plug.
Since the original issue of this [Canadian] AD, there have been two additional reported events of in-flight loss of cabin pressurization that were attributed to partial blockage of a safety valve cabin pressure-sensing port in conjunction with a failed safety valve manometric capsule.
Bombardier Aerospace has determined that aeroplanes with a particular interior installation require improved instructions to
Revision 1 of this [Canadian] AD is issued to mandate inspection and cleaning of the safety valves and their surrounding area on the affected aeroplanes.
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We have changed the docket number specified in the NPRM from “Docket No. FAA-2015-0827” to “Docket No. FAA-2015-1199” in this final rule.
We reviewed the available data and determined that air safety and the public interest require adopting this AD with the change described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Bombardier has issued Service Bulletin 100-25-21, Revision 02, dated July 25, 2013. The service information describes procedures for a detailed visual inspection of both safety valves and the surrounding area for foreign material, RTV silicone, contamination, foam on the bulkhead structure, tape or insulation, and loose material, and applicable corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 67 airplanes of U.S. registry.
The actions required by AD 2011-07-10, Amendment 39-16647 (76 FR 17758, March 31, 2011), and retained in this AD take about 10 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $0 per product. Based on these figures, the estimated cost of the actions that were required by AD 2011-07-10 is $850 per product.
We also estimate that it will take about 4 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $22,780, or $340 per product.
According to the manufacturer, all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; 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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective February 2, 2016.
This AD replaces AD 2011-07-10, Amendment 39-16647 (76 FR 17758, March 31, 2011).
This AD applies to Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes, certificated in any category, serial numbers 20001 through 20274.
Air Transport Association (ATA) of America Code 25, Equipment/Furnishings.
This AD was prompted by reports of in-flight loss of cabin pressurization that were attributed to partial blockage of a safety valve cabin pressure-sensing port in conjunction with a failed safety valve manometric
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2011-07-10, Amendment 39-16647 (76 FR 17758, March 31, 2011), with no changes. For all airplanes: Within 30 days after June 1, 2010 (the effective date of AD 2010-10-18, Amendment 39-16297 (75 FR 27406, May 17, 2010)), revise the Airworthiness Limitations section of the Instructions for Continued Airworthiness by incorporating Tasks 21-31-09-101 and 21-31-09-102 in the Bombardier Temporary Revision (TR) 5-2-53, dated October 1, 2009, to Section 5-10-40, “Certification Maintenance Requirements,” in Part 2 of Chapter 5 of Bombardier Challenger 300 BD-100 Time Limits/Maintenance Checks.
(1) For the new tasks identified in Bombardier TR 5-2-53, dated October 1, 2009: For airplanes identified in the “Phase-in” section of Bombardier TR 5-2-53, dated October 1, 2009, the initial compliance with the new tasks must be carried out in accordance with the phase-in schedule detailed in Bombardier TR 5-2-53, dated October 1, 2009, except where that TR specifies a compliance time from the date of the TR, this AD requires compliance within the specified time after June 1, 2010 (the effective date of AD 2010-10-18, Amendment 39-16297 (75 FR 27406, May 17, 2010)).
Thereafter, except as provided by paragraph (n)(1) of this AD, no alternative to the task intervals may be used.
(2) When the information in Bombardier TR 5-2-53, dated October 1, 2009, has been included in the general revisions of the applicable Airworthiness Limitations section, that TR may be removed from that Airworthiness Limitations section of the Instructions for Continued Airworthiness.
This paragraph restates the requirements of paragraph (h) of AD 2011-07-10, Amendment 39-16647 (76 FR 17758, March 31, 2011), with certain clarified compliance times. For airplanes having S/Ns 20003 through 20173 inclusive, 20176, and 20177: Within 50 flight hours after June 1, 2010 (the effective date of AD 2010-10-18, Amendment 39-16297 (75 FR 27406, May 17, 2010)), do a detailed visual inspection of the safety valves and surrounding areas for discrepant material (
(1) If any discrepant material is found during the detailed visual inspection, before further flight, remove the discrepant material, clean the surfaces of the valves, and secure the insulation, as applicable, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 100-25-14, dated June 30, 2008 (for airplanes having S/Ns 20124, 20125, 20128, 20134, 20139, 20143, 20146, 20148 through 20173 inclusive, 20176, and 20177); or Bombardier Service Bulletin 100-25-21, dated June 30, 2008 (for airplanes having S/Ns 20003 through 20123 inclusive, 20126, 20127, 20129 through 20133 inclusive, 20135 through 20138 inclusive, 20140 through 20142 inclusive, 20144, 20145, and 20147).
(2) If contamination (
(i) If no RTV is found, clean the plug of the sensing port.
(ii) If any RTV is found, install a new safety valve.
This paragraph restates the requirements of paragraph (i) of AD 2011-07-10, Amendment 39-16647 (76 FR 17758, March 31, 2011), with no changes. For airplanes having S/Ns 20174, 20175, 20178 through 20189 inclusive, 20191 through 20228 inclusive, 20230 through 20232 inclusive, 20235, 20237, 20238, 20241, 20244, 20247, 20249 through 20251 inclusive, 20254, 20256 and 20259: Within 50 flight hours after June 1, 2010 (the effective date of AD 2010-10-18, Amendment 39-16297 (75 FR 27406, May 17, 2010)), clean the cabin pressure-sensing port plug in both safety valves, in accordance with Paragraph 2.B., “Part A—Modification—Cleaning,” of the Accomplishment Instructions of Bombardier Service Bulletin A100-21-08, dated June 18, 2009.
This paragraph restates the requirements of paragraph (j) of AD 2011-07-10, Amendment 39-16647 (76 FR 17758, March 31, 2011), with no changes. For airplanes having S/Ns 20003 through 20189 inclusive, 20191 through 20228 inclusive, 20230 through 20232 inclusive, 20235, 20237, 20238, 20241, 20244, 20247, 20249 through 20251 inclusive, 20254, 20256, and 20259: Within 50 flight hours after June 1, 2010 (the effective date of AD 2010-10-18, Amendment 39-16297 (75 FR 27406, May 17, 2010)), clean the cabin pressure-sensing port plug in both safety valves, in accordance with Paragraph 2.B., “Part A—Modification—Cleaning,” of the Accomplishment Instructions of Bombardier Service Bulletin A100-21-08, dated June 18, 2009. Repeat the cleaning thereafter at intervals not to exceed 50 flight hours until the actions specified by paragraph (k) of this AD are completed.
This paragraph restates the requirements of paragraph (k) of AD 2011-07-10, Amendment 39-16647 (76 FR 17758, March 31, 2011), with no changes. For airplanes having S/Ns 20003 through 20189 inclusive, 20191 through 20228 inclusive, 20230 through 20232 inclusive, 20235, 20237, 20238, 20241, 20244, 20247, 20249 through 20251 inclusive, 20254, 20256, and 20259: Within 12 months after May 5, 2011 (the effective date of AD 2011-07-10), replace the cabin pressure-sensing port plug having part number (P/N) 2844-060 in both safety valves with a new gridless plug having P/N 2844-19 and re-identify the safety valves, in accordance with Paragraph 2.C., “Part B—Modification—Replacement,” of the Accomplishment Instructions of Bombardier Service Bulletin A100-21-08, dated June 18, 2009. Doing the actions in this paragraph terminates the repetitive cleanings required by paragraph (j) of this AD.
For airplanes having S/Ns 20003 through 20123 inclusive, 20126, 20127, 20129 through 20133 inclusive, 20135 through 20138 inclusive, 20140 through 20142 inclusive, 20144, 20145, and 20147: Within 500 flight hours or 15 months after the effective date of this AD, whichever occurs first, do a detailed visual inspection of both safety valves and the surrounding area for foreign material, RTV silicone, contamination, foam on the bulkhead structure, tape or insulation, and loose material, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 100-25-21, Revision 02, dated July 25, 2013. Do all applicable corrective actions before further flight, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 100-25-21, Revision 02, dated July 25, 2013.
This paragraph provides credit for actions required by paragraph (l) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2010-06R1, dated August 8, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (p)(5) and (p)(6) of this AD.
(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 this AD specifies otherwise.
(3) The following service information was approved for IBR on February 2, 2016.
(i) Bombardier Service Bulletin 100-25-21, Revision 02, dated July 25, 2013.
(ii) Reserved.
(4) The following service information was approved for IBR on May 5, 2011, (76 FR 17758, March 31, 2011).
(i) Bombardier Service Bulletin A100-21-08, dated June 18, 2009.
(ii) Bombardier Service Bulletin 100-25-14, dated June 30, 2008.
(iii) Bombardier Service Bulletin 100-25-21, dated June 30, 2008.
(iv) Bombardier Temporary Revision (TR) 5-2-53, dated October 1, 2009, to Section 5-10-40, “Certification Maintenance Requirements,” in Part 2 of Chapter 5 of Bombardier Challenger 300 BD-100 Time Limits/Maintenance Checks.
(5) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) 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:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 2010-06-04, for certain Airbus Model A300 B2-1C, B2-203, B2K-3C, B4-103, B4-203, B4-2C airplanes; Model A310 series airplanes; Model A300 B4-600 series airplanes; and Model A300 B4-600R series airplanes. AD 2010-06-04 required repetitive inspections to detect cracks of the pylon side panels (upper section) at rib 8; and corrective actions if necessary. This new AD continues to require repetitive inspections for cracking of the pylons 1 and 2 side panels (upper section) at rib 8 with reduced compliance times, and corrective actions if necessary. This AD also requires repetitive post-repair and post-modification inspections and repair if necessary. This AD also removes certain airplanes having a certain modification from the applicability. This AD was prompted by reports of cracks found on pylon side panels at rib 8 and a fleet survey and updated fatigue and damage tolerance analyses. We are issuing this AD to detect and correct cracking of pylon side panels (upper section) at rib 8, which could lead to reduced structural integrity of the pylon primary structure, which could cause detachment of the engine from the fuselage.
This AD becomes effective February 2, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 2, 2016.
The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of April 15, 2010 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572)).
You may examine the AD docket on the Internet at
For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2010-06-04,
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0136R1, dated July 30, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Airbus Model A300 B2-1C, B2-203, B2K-3C, B4-103, B4-203, B4-2C airplanes; Model A310 series airplanes; Model A300 B4-600 series airplanes; and Model A300 B4-600R series airplanes. The MCAI states:
Cracks were found on pylon side panels (upper section) at rib 8 on Airbus A300, A310 and A300-600 aeroplanes equipped with General Electric engines. Investigation of these findings indicated that this problem was likely to also affect aeroplanes of this type design with other engine installations.
This condition, if not detected and corrected, could lead to reduced strength of the pylon primary structure, possibly resulting in pylon structural failure and in-flight loss of an engine.
Prompted by these findings, EASA issued AD 2008-0181 [
Since that [EASA] AD was issued, a fleet survey and updated Fatigue and Damage Tolerance analyses have been performed in order to substantiate the second A300-600 Extended Service Goal (ESG2) exercise. The results of these analyses have shown that the risk for these aeroplanes is higher than initially determined and consequently, the threshold and interval must be reduced to allow timely detection of these cracks and the accomplishment of applicable correction action(s).
EASA issued AD 2013-0136 [
After publication of EASA AD 2013-0136, it appeared that Airbus Mod 03599 had no influence on the aeroplane configuration affected by this AD. At the same time Airbus Service Bulletin (SB) A30-54-6015 Revision 3 was not integrally taken into account as this revision no longer identifies configuration 3 aeroplanes.
For the reasons described above, EASA [AD] 2013-0136 is revised to exclude Airbus Mod 03599 from the applicability and to delete the reference to the configuration 3 for A300-600 aeroplanes.
Corrective actions include doing a repair. This AD also provides an optional modification (installing a doubler), which would terminate the repetitive inspections. Required actions also include repetitive post-repair and post-modification inspections and repair if necessary. You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM (79 FR 56526, September 22, 2014) and the FAA's response.
United Parcel Service (UPS) requested that we revise the proposed compliance times to be less complex. UPS stated that the proposed compliance times contain a method known as “Average Flight Time” (AFT) which results in a variable flight hour limit and adds unnecessary complexity to the threshold table and subsequent inspection actions. UPS added that use of the AFT method, along with a lack of standard procedures for implementing the AFT method would create uncertainty for operators and inspectors trying to determine the correct compliance time. UPS stated that in review of prior FAA ADs, including AD 98-18-02, Amendment 39-10718 (63 FR 45689, August 27, 1998), that the FAA does not concur with the AFT compliance time methodology as “. . . such adjustments may not address the unsafe condition in a timely manner” and “. . . they (AFT compliance times) do not fit into the AD tracking process for operators or for Principle Maintenance Inspectors (PMIs) attempting to ascertain compliance with ADs.”
UPS compiled a table of fixed compliance times that it suggested would be simpler to use instead of the proposed AFT-based compliance times.
We disagree with the commenter's request to revise the compliance times in this AD. The compliance times, as proposed, use fixed flight-cycle and flight-hour compliance times. For only Model A310 series airplanes, the compliance times depend on whether airplanes are short range or long range airplanes. We acknowledge that this causes additional complexity in tracking and forecasting airplane utilization; however, the inspection schedule was created by Airbus to offer operators the greatest flexibility. Operators may elect to inspect within the range that complies with both the long range and short range utilization in order to reduce the complexity. We have not changed this AD in this regard.
Regarding AD 98-18-02, Amendment 39-10718 (63 FR 45689, August 27, 1998), at the time the FAA issued AD 98-18-02, the required actions in Airbus Industrie Service Bulletin A300-57-6027, Revision 2, dated September 13, 1994, contained inspection thresholds and intervals based on airplane flight cycles, and provided instructions for adjusting the flight cycle threshold and interval using each individual airplane's AFT utilization. The FAA did not agree with the AFT method because it could result in a different inspection threshold and interval for each individual airplane, and the FAA did not agree with adjusting a flight cycle based threshold and interval using the average flight time utilization without also having a related flight hour based threshold and interval.
We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (79 FR 56526, September 22, 2014) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 56526, September 22, 2014).
Airbus has issued the following service information. The service information describes procedures for repetitive inspections for cracking of the pylons 1 and 2 side panels (upper section) at rib 8 with reduced compliance times, and corrective actions if necessary. This service information also describes procedures for post-modification and post-repair detailed inspections for cracking, as applicable, of the left-hand (LH) and right-hand (RH) side panels of pylons 1 and 2, and repair if necessary. This
• Airbus Service Bulletin A300-54-0075, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated March 27, 2013.
• Airbus Service Bulletin A310-54-2018, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated April 11, 2013.
• Airbus Service Bulletin A300-54-6015, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated April 11, 2013.
Airbus has also issued the following service information. This service information describes procedures for modifying by installing a doubler on the LH pylon 1 and RH pylon 2, on pylon side panels (upper section), at rib 8. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
• Airbus Service Bulletin A300-54-0081, dated August 11, 1993.
• Airbus Service Bulletin A310-54-2024, dated August 11, 1993.
• Airbus Service Bulletin A300-54-6021, Revision 02, dated May 21, 2008.
We estimate that this AD affects 156 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary repairs that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these repairs:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; 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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective February 2, 2016.
This AD replaces AD 2010-06-04, Amendment 39-16228 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572)).
This AD applies to the airplanes identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in any category.
(1) Airbus Model A300 B2-1C, B2-203, B2K-3C, B4-103, B4-203, and B4-2C airplanes, on which Airbus Modification 02434 has been embodied in production.
(2) Airbus Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes, except those on which Airbus Modification 10432 has been embodied in production.
(3) Airbus Model A300 B4-601, B4-603, B4-605R, B4-620, B-622, and B4-622R airplanes, except those on which Airbus Modification 10432 has been embodied in production.
Air Transport Association (ATA) of America Code 54, Nacelles/Pylons.
This AD was prompted by reports of cracks found on pylon side panels at rib 8 and a fleet survey and updated fatigue and damage tolerance analyses. We are issuing this AD to detect and correct cracking of pylon side panels (upper section) at rib 8, which could lead to reduced structural integrity of the pylon primary structure, which could cause detachment of the engine from the fuselage.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (f) of AD 2010-06-04, Amendment 39-16228 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572)), with revised service information. Accomplishing the initial inspection required by paragraph (h) of this AD terminates the requirements of this paragraph.
(1) For Configuration 01 airplanes as identified in the applicable service bulletin identified in paragraph (g)(9) of this AD: At the applicable time specified in table 1 to paragraph (g) of this AD, except as required by paragraphs (g)(2) and (g)(3) of this AD, perform a detailed visual inspection of the pylons 1 and 2 side panels (upper section) at rib 8, in accordance with paragraph 3.B. of the Accomplishment Instructions of the applicable service bulletin identified in paragraph (g)(9)(i) through (g)(9)(iii) of this AD or paragraphs (k)(1), (k)(2), or (k)(3) of this AD. Repeat the inspection at the time specified in table 1 to paragraph (g) of this AD.
(2) For Model A300 and A300-600 airplanes that have accumulated more than 40,000 total flight hours as of April 15, 2010 (the effective date of AD 2010-06-04, Amendment 39-16228 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572))): Within 250 flight cycles after April 15, 2010, do the actions specified in paragraph (g)(1) of this AD.
(3) For Model A310 airplanes that have accumulated more than 55,500 total flight hours as of April 15, 2010 (the effective date of AD 2010-06-04, Amendment 39-16228 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572))): Within 250 flight cycles after April 15, 2010, do the actions specified in paragraph (g)(1) of this AD.
(4) For Configuration 01 airplanes, as identified in the applicable service bulletin identified in paragraph (g)(9) of this AD: If a crack is found during any inspection required by paragraph (g)(1) of this AD, before further flight, install a doubler, in accordance with paragraph 3.C. of the Accomplishment Instructions of the applicable service bulletin identified in paragraph (g)(9) of this AD.
(5) For Configuration 02 airplanes, as identified in the applicable service bulletin identified in paragraph (g)(9) of this AD: At the applicable time specified in paragraph 1.E.(2) of the applicable service bulletin identified in paragraphs (g)(9)(i) through (g)(9)(iii) of this AD, or within 250 flight cycles after April 15, 2010 (the effective date of AD 2010-06-04, Amendment 39-16228 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572))), whichever occurs later, perform a detailed visual inspection of the pylons 1 and 2 side panels (upper section) at rib 8, in accordance with paragraph 3.B. of the Accomplishment Instructions of the applicable service bulletin identified in paragraph (g)(9) of this AD.
(6) For Configuration 03 airplanes, as identified in the applicable service bulletin identified in paragraph (g)(9) of this AD: At the applicable time specified in paragraph 1.E.(2) of the applicable service bulletin identified in paragraphs (g)(9)(i) through (g)(9)(iii) of this AD, or within 250 flight cycles after April 15, 2010 (the effective date of AD 2010-06-04, Amendment 39-16228 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572))), whichever occurs later, perform a detailed visual inspection, and a high frequency eddy current inspection as applicable, of the pylons 1 and 2 side panels (upper section) at rib 8, in accordance with paragraph 3.B. of the Accomplishment Instructions of the applicable service bulletin identified in paragraph (g)(9) of this AD.
(7) For Configuration 02 and 03 airplanes, as identified in the applicable service bulletin identified in paragraph (g)(9) of this AD: If a crack is found during any inspection required by paragraph (g)(1), (g)(5), or (g)(6) of this AD, before further flight, repair in accordance with paragraph 3.C. of the Accomplishment Instructions of the applicable service bulletin identified in paragraph (g)(9) of this AD.
(8) For all airplanes, except those in Configuration 01, as identified in the applicable service bulletin identified in paragraph (g)(9) of this AD: Repeat the inspection specified in paragraph (g)(1), (g)(5), or (g)(6) of this AD, as applicable, at the intervals specified in paragraph 1.E.(2) of the applicable service bulletin identified in paragraph (g)(9)(i) through (g)(9)(iii) of this AD.
(9) For the actions specified in paragraph (g) of this AD, use the applicable service bulletin identified in paragraphs (g)(9)(i) through (g)(9)(iii) of this AD, or paragraph (k)(1), (k)(2), or (k)(3) of this AD.
(i) Airbus Mandatory Service Bulletin A300-54-0075, excluding Appendixes 1, 2, and 3, Revision 02, dated June 26, 2008 (For Model A300 B2-1C, B2-203, B2K-3C, B4-103, B4-203, and B4-2C airplanes).
(ii) Airbus Mandatory Service Bulletin A300-54-6015, excluding Appendixes 1, 2, and 3, Revision 02, dated June 26, 2008 (For Model A300 B4-601, B4-603, B4-605R, B4-620, B4-622, and B4-622R airplanes).
(iii) Airbus Mandatory Service Bulletin A310-54-2018, excluding Appendixes 1, 2, and 3, Revision 02, dated June 26, 2008 (for Model A310 series airplanes).
Except as required by paragraphs (l)(1) and (l)(2) of this AD, at the applicable times specified in paragraph 1.E., “Compliance,” of the applicable service bulletin identified in paragraph (k) of this AD: Do a detailed inspection for cracking of the pylons 1 and
(1) If any cracking is found, before further flight, do a high frequency eddy current (HFEC) inspection to confirm the crack, in accordance with the Accomplishment Instructions of the applicable service bulletin identified in paragraph (k) of this AD.
(i) If any crack indication is confirmed during the HFEC inspection specified in paragraph (h)(1) of this AD, and the crack is less than 20 mm, before further flight, repair, in accordance with the Accomplishment Instructions of the applicable service bulletin identified in paragraph (k) of this AD.
(ii) If any crack indication is confirmed during the HFEC inspection specified in paragraph (h)(1) of this AD and the crack is greater than or equal to 20 mm, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
(2) If no cracking is found, or if crack indication is not confirmed during the HFEC inspection required by paragraph (h)(1) of this AD, at the applicable interval specified in paragraph 1.E., “Compliance,” of the applicable service bulletin identified in paragraph (k) of this AD, repeat the inspection specified in paragraph (h) of this AD, in accordance with the Accomplishment Instructions of the applicable service bulletin identified in paragraph (k) of this AD until the modification specified in paragraph (i) is done.
Modifying by installing a doubler on the left hand (LH) pylon 1 and right hand (RH) pylon 2, on pylon side panels (upper section), at rib 8, in accordance with the Accomplishment Instructions of the service information identified in paragraph (i)(1), (i)(2), or (i)(3) of this AD; as applicable; terminates the repetitive inspections specified in paragraph (h)(2) of this AD.
(1) Airbus Service Bulletin A300-54-0081, dated August 11, 1993.
(2) Airbus Service Bulletin A310-54-2024, dated August 11, 1993.
(3) Airbus Service Bulletin A300-54-6021, Revision 02, dated May 21, 2008.
For airplanes on which the modification has been done as specified in paragraph (i) of this AD, and airplanes on which the repair has been done as specified in paragraph (h) of this AD: At the applicable compliance time specified in paragraph 1.E., Compliance,” of the applicable service bulletin identified in paragraph (k) of this AD, do the post-modification and post-repair detailed inspections for cracking, as applicable, of the LH and RH side panels of pylons 1 and 2, in accordance with the applicable service bulletins identified in paragraph (k) of this AD. Repeat the inspections thereafter at the times specified in paragraph 1.E., “Compliance” of the applicable service bulletin specified in paragraph (k) of this AD. If any cracking is found, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA. This repair is not a terminating action for the repetitive inspections required by this paragraph.
Use the applicable service bulletin identified in paragraphs (k)(1) through (k)(3) of this AD to accomplish the inspections required by paragraphs (g), (h), and (j) of this AD.
(1) Airbus Service Bulletin A300-54-0075, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated March 27, 2013 (for Model A300 B2-1C, B2-203, B2K-3C, B4-103, B4-203, and B4-2C airplanes).
(2) Airbus Service Bulletin A310-54-2018, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated April 11, 2013 (for Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes).
(3) Airbus Service Bulletin A300-54-6015, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated April 11, 2013 (for Model A300 B4-601, B4-603, B4-605R, B4-620, B4-622, and B4-622R airplanes).
(1) Where the compliance time column in the tables in paragraph 1.E., “Compliance,” of the applicable service bulletin identified in paragraph (k) of this AD specifies a “threshold” in “FC” or “FH,” and does not specify from repair or service bulletin embodiment, those compliance times are total flight cycles and total flight hours.
(2) Where the tables in paragraph 1.E., “Compliance,” of the applicable service bulletin specified in paragraph (k) of this AD specifies “grace period after the receipt of the service bulletin,” this AD requires compliance within the corresponding compliance time after the effective date of this AD.
(1) This paragraph restates the credit provided by paragraph (f)(9) of AD 2010-06-04, Amendment 39-16228 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572)) with no changes. This paragraph provides credit for initial inspections required by paragraph (g) of this AD, if those actions were performed prior to April 15, 2010 (the effective date of AD 2010-06-04) using the applicable service bulletins specified in paragraphs (m)(1)(i) through (m)(1)(vi) of this AD, which are not incorporated by reference in this AD.
(i) Airbus Service Bulletin A300-54-0075, dated August 11, 1993.
(ii) Airbus Service Bulletin A300-54-0075, Revision 01, dated November 9, 2007.
(iii) Airbus Service Bulletin A300-54-6015, dated August 11, 1993.
(iv) Airbus Service Bulletin A300-54-6015, Revision 01, dated November 9, 2007.
(v) Airbus Service Bulletin A310-54-2018, dated August 11, 1993.
(vi) Airbus Service Bulletin A310-54-2018, Revision 01, dated November 16, 2007.
(2) This paragraph provides credit for initial inspections required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using the applicable service bulletins specified in paragraphs (m)(2)(i) through (m)(2)(ix) of this AD.
(i) Airbus Service Bulletin A300-54-0075, dated August 11, 1993, which is not incorporated by reference in this AD.
(ii) Airbus Service Bulletin A300-54-0075, Revision 01, dated November 9, 2007, which is not incorporated by reference in this AD.
(iii) Airbus Service Bulletin A300-54-0075, Revision 02, dated June 26, 2008.
(iv) Airbus Service Bulletin A300-54-6015, dated August 11, 1993, which is not incorporated by reference in this AD.
(v) Airbus Service Bulletin A300-54-6015, Revision 01, dated November 9, 2007, which is not incorporated by reference in this AD.
(vi) Airbus Service Bulletin A300-54-6015, Revision 02, dated June 26, 2008.
(vii) Airbus Service Bulletin A310-54-2018, dated August 11, 1993, which is not incorporated by reference in this AD.
(viii) Airbus Service Bulletin A310-54-2018, Revision 01, dated November 16, 2007, which is not incorporated by reference in this AD.
(ix) Airbus Service Bulletin A310-54-2018, Revision 02, dated June 26, 2008.
(3) This paragraph provides credit for initial inspections required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using the applicable service bulletins specified in paragraphs (m)(3)(i) and (m)(3)(ii) of this AD.
(i) Airbus Service Bulletin A300-54-6021, dated August 11, 1993, which is not incorporated by reference in this AD.
(ii) Airbus Service Bulletin A300-54-6021, Revision 01, dated November 16, 2007, which is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(i) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager
(ii) AMOCs approved previously for AD 2010-06-04, Amendment 39-16228 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572)); are approved as AMOCs for the corresponding provisions of this AD.
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0136R1, dated July 30, 2013, for related information. You may examine the MCAI in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (p)(5) and (p)(6) of this AD.
(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 this AD specifies otherwise.
(3) The following service information was approved for IBR on February 2, 2016.
(i) Airbus Service Bulletin A300-54-0075, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated March 27, 2013.
(ii) Airbus Service Bulletin A300-54-0081, dated August 11, 1993.
(iii) Airbus Service Bulletin A300-54-6015, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated April 11, 2013.
(iv) Airbus Service Bulletin A300-54-6021, Revision 02, dated May 21, 2008.
(v) Airbus Service Bulletin A310-54-2018, Revision 03, excluding Appendixes 1, 2, 3, and 5; including Appendix 4; dated April 11, 2013.
(vi) Airbus Service Bulletin A310-54-2024, dated August 11, 1993.
(4) The following service information was approved for IBR on April 15, 2010 ((75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572)).
(i) Airbus Mandatory Service Bulletin A300-54-0075, excluding Appendixes 1, 2, and 3, Revision 02, dated June 26, 2008.
(ii) Airbus Mandatory Service Bulletin A300-54-6015, excluding Appendixes 1, 2, and 3, Revision 02, dated June 26, 2008.
(iii) Airbus Mandatory Service Bulletin A310-54-2018, excluding Appendixes 1, 2, and 3, Revision 02, dated June 26, 2008.
(5) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) 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:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. This AD was prompted by a report that, during a production flight test, the ram air turbine (RAT) did not pressurize the green hydraulic system. For certain airplanes, this AD requires identification of the part number, serial number, and standard of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly; replacement of the balance weight screw, modification of the actuator coil spring, modification of the actuator, an inspection of the anti-stall valve for correct installation in the RAT pump housing; and corrective actions if necessary. For certain other airplanes, this AD requires re-identification or replacement of the RAT module. We are issuing this AD to prevent loss of the impeller function and RAT pump pressurization capability, which, if preceded by a total engine flame-out, could result in the loss of control of the airplane.
This AD becomes effective February 2, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 2, 2016.
You may examine the AD docket on the Internet at
For Airbus service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. The NPRM
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0274, dated November 15, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. The MCAI states:
During a production flight test of an A330-300 aeroplane, the Ram Air Turbine (RAT) did not pressurize the green hydraulic system. Investigation revealed that the impeller drive (hex) shaft had a reduced length of engagement with the pump drive shaft. This caused the impeller drive shaft to disengage from the pump and disconnect the impeller. It was determined that the disconnection was the result of internal hex dimensions on the pump impeller shaft, which had been changed in a manufacturing drawing. From the investigation analysis, it was possible to identify a list of affected parts.
This condition, if not detected and corrected, could lead to the loss of impeller function and RAT pump pressurization capability, possibly resulting, in case of total engine flame out, to the loss of control of the aeroplane.
To address this unsafe condition, a new design RAT pump shaft has been developed with a decreased hexagonal shaft housing depth, which increases the hexagonal drive shaft engagement in the impeller shaft to carry the impeller torque. Airbus issued Service Bulletin (SB) A330-29-3122, SB A340-29-4093 and SB A340-29-5021 to provide instructions for in-service replacement of the affected RAT hydraulic pumps, or re-identification of the RAT pump and complete RAT module, as applicable.
For the reasons described above, this [EASA] AD requires identification and replacement [modification] or re-identification of all affected RAT hydraulic pumps on A330 and A340-200/300 aeroplanes, and replacement [modification] of all affected RAT modules on A340-500/-600 aeroplanes.
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 3513, January 15, 2015) and the FAA's response to each comment.
One commenter, Joseph P. Evans, supported the NPRM (80 FR 3513, January 15, 2015).
Delta Airlines (DAL) requested that paragraph (h) of the Proposed AD (80 FR 3513, January 15, 2015) be revised to include an option for operators to concurrently do the actions described in Airbus Service Bulletin A330-29-3126, dated June 12, 2014, which refers to Hamilton Sundstrand Service Bulletin ERPS06M-29-21, dated May 27, 2014, when doing any corrective actions required by paragraph (h) of the proposed AD. Based upon its requested revision to paragraph (h) of the proposed AD, DAL also requested that paragraph (j) of the proposed AD be revised to include a statement that if an operator did the optional concurrent actions specified in Airbus Service Bulletin A330-29-3126, dated June 12, 2014, the RAT module should be re-identified using the instructions in that service information.
We agree with the commenter's request to include an option for the reasons provided by the commenter. The actions described in Airbus Service Bulletin A330-29-3126, dated June 12, 2014, include concurrently doing the actions specified in paragraphs (h) and (j) of this AD. For similar reasons, we have also included options for operators to do the actions in Airbus Service Bulletin A340-29-4097, dated June 12, 2014; and Airbus Service Bulletin A340-29-5025, dated June 16, 2014; as applicable.
We have included a new paragraph (k) in this AD to allow operators the option to do the actions in Airbus Service Bulletin A330-29-3126, dated June 12, 2014; and Airbus Service Bulletin A340-29-4097, dated June 12, 2014, and re-designated the subsequent paragraphs accordingly. Paragraph (l) of this AD has been revised to include the option for operators to do the actions described in Airbus Service Bulletin A340-29-5025, dated June 16, 2014, for the Model A340-541 and A340-642 series airplanes.
If operators do the optional actions, the RAT actuators will be modified to the current standards and the RAT modules re-identified with the current part numbers. The service information for the optional actions specified in paragraph (k) of this AD states that the actions in the service information required by paragraphs (g), (h), and (j) of this AD, as applicable, should be done concurrently, as described below.
• Airbus Service Bulletin A330-29-3126, dated June 12, 2014, specifies that the actions in Airbus Service Bulletin A330-29-3122, dated October 25, 2012, be done concurrently.
• Airbus Service Bulletin A340-29-4097, dated June 12, 2014, specifies that the actions in Airbus Service Bulletin A340-29-4093, dated October 25, 2012, be done concurrently.
The service information for the optional actions specified in paragraph (l) of this AD states that the actions in the service information required by paragraph (l) of this AD should be done concurrently, as described as follows: Airbus Service Bulletin A340-29-5025, dated June 16, 2014, specifies that the actions in Airbus Service Bulletin A340-29-5021, dated October 2, 2012, be done concurrently.
Delta requested that the reference to Hamilton Sundstrand Service Bulletin ERPS06M-29-19 in paragraph (i) of the proposed AD (80 FR 3513, January 15, 2015) be changed to Hamilton Sundstrand Service Bulletin ERPS06M-29-13. Delta noted that Airbus Service Bulletin A330-29-3122, dated October 25, 2012, references Hamilton Sundstrand Service Bulletin ERPS06M-29-13.
We agree that the reference to Hamilton Sundstrand Service Bulletin ERPS06M-29-19 in paragraph (i) of the proposed AD (80 FR 3513, January 15, 2015) was incorrect. We inadvertently referred to Hamilton Sundstrand Service Bulletin ERPS06M-29-19, and we should have referred to Hamilton Sundstrand Service Bulletin ERPS06M-29-13. We have revised paragraph (i) of this AD to provide the correct reference, which is Hamilton Sundstrand Service Bulletin ERPS06M-29-13.
In the preamble of Airbus Service Bulletin A330-29-3122, dated October 25, 2012, there are two incorrect references to the Hamilton Sundstrand service information. The references incorrectly specify Hamilton Sundstrand Service Bulletin “EPRPS06M-29-13.” The first “P” in the citation should have been omitted. The correct reference is “ERPS06M-29-13.” As previously stated, we have
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (80 FR 3513, January 15, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 3513, January 15, 2015).
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Airbus has issued the following service information. This service information describes procedures for identifying the part number, serial number, and standard of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly; replacing the balance weight screw, modifying the actuator coil spring, modifying the actuator, and doing an inspection of the anti-stall valve for correct installation; and re-identifying the part numbers of the RAT hydraulic pump and RAT module.
• Airbus Service Bulletin A330-29-3122, dated October 25, 2012.
• Airbus Service Bulletin A340-29-4093, dated October 25, 2012.
Airbus also issued Service Bulletin A330-29-3126, dated June 12, 2104; and Service Bulletin A340-29-4097, dated June 12, 2104, which describe procedures for identifying the part number and serial number of the RAT actuator; modifying the RAT actuators; and re-identifying the part numbers of the RAT module.
Airbus has also issued Service Bulletin A340-29-5021, dated October 2, 2012; and Service Bulletin A340-29-5025, dated June 16, 2014, which describe procedures for identifying the part number and serial number of the RAT actuator, modifying the RAT actuators; and re-identifying the part numbers of the RAT module.
Hamilton Sundstrand has issued Service Bulletin ERPS06M-29-19, dated August 6, 2012, which identifies the serial numbers of the suspect hydraulic pump.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 66 airplanes of U.S. registry.
We also estimate that it will take about 14 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $78,540, or $1,190 per product.
In addition, we estimate that any necessary follow-on actions will take about 18 work-hours and require parts costing up to $427,301, for a cost of $428,831 per product. We have no way of determining the number of aircraft that might need this action.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; 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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective February 2, 2016.
This AD affects AD 2012-21-19, Amendment 39-17235 (77 FR 65812, October 31, 2012); and AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).
This AD applies to all Airbus airplanes, certificated in any category, identified in paragraphs (c)(1) and (c)(2) of this AD, all manufacturer serial numbers.
(1) Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(2) Model A340-211, -212, -213, -311, -312, -313, -541, and -642 airplanes.
Air Transport Association (ATA) of America Code 29, Hydraulic Power.
This AD was prompted by a report that, during a production flight test, the ram air turbine (RAT) did not pressurize the green hydraulic system. We are issuing this AD to prevent loss of the impeller function and RAT pump pressurization capability, which, if preceded by a total engine flame-out, could result in the loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, and -313 airplanes: Except as provided by paragraph (i) of this AD, within 36 months after the effective date of this AD, identify the part number, serial number, and standard (through the mod-dots) of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD. A review of airplane maintenance records is acceptable in lieu of this identification if the part number, serial number, and standard can be conclusively determined from that review.
(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes: Airbus Service Bulletin A330-29-3122, dated October 25, 2012.
(2) For Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes: Airbus Service Bulletin A340-29-4093, dated October 25, 2012.
If the serial number of the RAT hydraulic pump is included in table 7, “Suspect Hydraulic Pump Serial Numbers,” of Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012: Within 36 months after the effective date of this AD, do all applicable corrective actions, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD. Prior to or concurrently with doing the corrective actions required by this paragraph, do the actions specified in paragraphs (h)(1) through (h)(4) of this AD, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-29-3122, dated October 25, 2012 (for Model A330-200, -200 Freighter, and -300 series airplanes); or Airbus Service Bulletin A340-29-4093, dated October 25, 2012 (for Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes).
(1) Replace the balance weight screw.
(2) Modify the actuator coil spring.
(3) Modify the actuator.
(4) Do a general visual inspection of the anti-stall valve for correct installation in the RAT pump housing, and if any incorrect installation is found, before further flight, correctly install the anti-stall valve.
Airbus Service Bulletin A330-29-3122, dated October 25, 2012 (for Model A330-200, -200 Freighter, and -300 series airplanes), refers to Hamilton Sundstrand Service Bulletin “EPRPS06M-29-13” as an additional source of guidance for doing certain actions required by paragraph (h) of this AD. The first “P” in the citation should have been omitted; the correct reference is to Hamilton Sundstrand Service Bulletin “ERPS06M-29-13.”
If the serial number of the RAT hydraulic pump is not included in table 7, “Suspect Hydraulic Pump Serial Numbers,” of Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012: Within 36 months after the effective date of this AD, re-identify the part numbers of the RAT hydraulic pump and RAT module, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD.
Accomplishment of the actions required by paragraphs (g), (h), and (j) of this AD, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-29-3126, dated June 12, 2014; or Airbus Service Bulletin A340-29-4097, dated June 12, 2014, as applicable, constitutes compliance with the requirements of paragraphs (g), (h), and (j) of this AD.
For Airbus Model A340-541 and -642 airplanes having RAT module part number (P/N) 772722D, 772722E, 772722F, or 772722G: Within 36 months after the effective date of this AD, replace (modify) the RAT module, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-29-5021, dated October 2, 2012. As an option, accomplishment of the RAT module replacement (modification), in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-29-5025, dated June 16, 2014, constitutes compliance with the requirement of this paragraph.
The actions required by paragraphs (g), (h), and (j) of this AD are not required for airplanes on which Airbus Modification 202537 was embodied in production, provided it can be determined that, since the airplane's first flight, no RAT hydraulic pump or RAT module having a part number identified in paragraph (n) of this AD is installed on that airplane.
(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and A340-211, -212, -213, -311, -312, and -313 airplanes: Accomplishment of the actions required by paragraphs (g), (h), and (j) of this AD constitutes compliance with the requirements of paragraphs (g)(1) and (g)(2) of AD 2012-21-19, Amendment 39-17235 (77 FR 65812, October 31, 2012); and paragraphs (g)(1) and (g)(2) of AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).
(2) For Airbus Model A340-541 and -642 airplanes: Accomplishment of the actions required by paragraph (l) of this AD constitutes compliance with the requirements of paragraphs (h)(1) and (h)(2) of AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).
(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and A340-211, -212, -213, -311, -312, and -313 airplanes: After modification of the RAT module as required by paragraph (h) of this AD, no person may install any complete RAT module having a part number identified in paragraph (o)(1)(i) of this AD, or any RAT hydraulic pump having the part number identified in paragraph (o)(1)(ii) of this AD, on any airplane.
(i) RAT module P/N 766351, 768084, 770379, 770952, 770952A, 770952B, 1702934, 1702934A, or 1702934B.
(ii) RAT hydraulic pump P/N 5909522 (Parker P/N 4207902).
(2) For Airbus Model A340-541 and -642 airplanes: After modification of the RAT module as required by paragraph (l) of this AD, no person may install any complete RAT module having P/N 772722D, 772722E, 772722F, or 772722G, on any airplane.
The following provisions also apply to this AD:
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0274, dated November 15, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(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 this AD specifies otherwise.
(i) Airbus Service Bulletin A330-29-3122, dated October 25, 2012.
(ii) Airbus Service Bulletin A330-29-3126, dated June 12, 2014.
(iii) Airbus Service Bulletin A340-29-4093, dated October 25, 2012.
(iv) Airbus Service Bulletin A340-29-4097, dated June 12, 2014.
(v) Airbus Service Bulletin A340-29-5021, dated October 2, 2012.
(vi) Airbus Service Bulletin A340-29-5025, dated June 16, 2014.
(vii) Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012.
(3) For Airbus service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
(4) For Hamilton Sundstrand service information identified in this AD, contact Hamilton Sundstrand, Technical Publications, Mail Stop 302-9, 4747 Harrison Avenue, P.O. Box 7002, Rockford, IL 61125-7002; telephone 860-654-3575; fax 860-998-4564; email
(5) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(6) 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:
Federal Energy Regulatory Commission, Energy.
Final rule.
The Federal Energy Regulatory Commission (Commission) is amending its regulations governing delegations of authority to the Director of the Office of Enforcement. The amendment will provide clarity and consistency regarding the authority delegated to the Office of Enforcement.
This rule will become effective January 28, 2016.
Laura Vallance, Office of Enforcement, 888 First Street NE., Washington, DC 20426, 202-502-8395,
1. The Federal Energy Regulatory Commission (Commission) is amending its regulations governing delegations of authority to the Director of the Office of Enforcement.
2. The Commission has broad statutory authority to perform acts and make rules that are necessary or appropriate to carry out its statutory function.
3. In 2007, the Commission issued Order No. 704, which created FERC Form No. 552. FERC Form No. 552, Annual Report of Natural Gas Transactions, collects transactional information from natural gas market participants. FERC Form No. 552 is codified in section 260.401 of the Commission's regulations.
4. Part 375, Subpart C, of the Commission's rules and regulations sets our delegations of authority to the various office directors, such as the Director of the Office of Enforcement. Section 375.311 specifically includes delegations of authority to the Director of the Office of Enforcement. Section 375.311(r) includes the authority to deny or grant, in whole or in part, motions of extensions of time to file, or requests for the waiver of the requirements of the Form Nos, 1, 1-F, 2, 2-A and 6, the Form 60, 61, 730 and Electric Quarterly Reports.
5. Order No. 704 created the FERC Form No. 552 filing requirements. However, there is no delegated authority contained in the regulations similar to that found for the other forms administered by the Office of Enforcement. In order to create consistency among the delegations for forms administered by the Office of Enforcement, this rule amends 18 CFR 375.311(r) and (s) to add FERC Form No. 552 to the list of forms included in the delegations to the Director of the Office of Enforcement.
6. Review by the Office of Management and Budget, pursuant to section 3507(d) of the Paperwork Reduction Act of 1995, is not required since this final rule does not contain new or modified information collection or recordkeeping requirements.
7. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment. Part 380 of the Commission's regulations exempts certain actions from the requirement that an Environmental Analysis or Environmental Impact Statement be prepared. Included is an exemption for procedural, ministerial, or internal administrative actions. As this Final Rule falls within that exemption, issuance of the Rule does not represent a major federal action having a significant adverse effect on the human environment under the Commission's regulations implementing the National Environmental Policy Act, and, thus, does not require an Environmental Analysis or Environmental Impact Statement.
8. The Regulatory Flexibility Act of 1980 (RFA) generally requires a description and analysis of Final Rules that will have significant economic impact on a substantial number of small entities. Rules that are exempt from the notice and comment requirements of section 553(b) of the Administrative Procedure Act are exempt from the RFA requirements. This Final Rule concerns matters of internal agency procedure and, therefore, an analysis under the RFA is not required.
9. In addition to publishing the full text of this document in the
10. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.
11. User assistance is available for eLibrary and the FERC's Web site during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
12. These regulations are effective January 28, 2016. This rule is exempt from the Congressional Review Act
Authority delegations (Government agencies), Seals and insignia, Sunshine Act.
By the Commission.
In consideration of the foregoing, the Commission amends Part 375, Chapter I, Title 18,
5 U.S.C. 551-557; 15 U.S.C. 717-717w, 3301-3432; 16 U.S.C. 791-825r, 2601-2645; 42 U.S.C. 7101-7352.
(r) Deny or grant, in whole or in part, motions for extension of time to file, or requests for waiver of the requirements of the following forms, data collections, and reports: Annual Reports (Form Nos. 1, 1-F, 2, 2-A, and 6); Quarterly Reports (Form Nos. 3-Q and 6-Q); Annual Report of Centralized Service Companies (Form No. 60); Narrative Description of Service Company Functions (FERC-61); Annual Report of Natural Gas Transactions (Form No. 552); Report of Transmission Investment Activity (FERC-730); and Electric Quarterly Reports, as well as, where required, the electronic filing of such information (§ 385.2011 of this chapter, Procedures for filing on electronic media, paragraphs (a)(6), (c), and (e)).
(s) Provide notification if a submitted Annual Report (Form Nos. 1, 1-F, 2, 2-A, and 6), Quarterly Report (Form Nos. 3-Q and 6-Q), Annual Report of Centralized Service Companies (Form No. 60), Narrative Description of Service Company Functions (FERC-61), Annual Report of Natural Gas Transactions (Form No. 552), Report of Transmission Investment Activity (FERC-730), or Electric Quarterly Report fails to comply with applicable statutory requirements, and with all applicable Commission rules, regulations, and orders for which a waiver has not been granted, or, when appropriate, notify a party that a submission is acceptable.
Coast Guard, DHS.
Final rule.
The Coast Guard is changing the operating schedule that governs the Atchison Railroad Drawbridge, Mile 422.5, across the Missouri River at Atchison, KS. Under this rule the drawbridge will open on signal if at least a two-hour notification is given. This rule change allows the bridge to operate under the customary schedule
This rule is effective on January 28, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Eric Washburn, Bridge Administrator, Western Rivers, Bridge Branch, Coast Guard; telephone 314-269-2378, email
On April 10, 2015, we published a notice of proposed rulemaking (NPRM) entitled, “Drawbridge Operation Regulation; Missouri River, Atchison, KS” in the
The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
The Atchison Railroad Drawbridge crosses the Missouri River at mile 422.5 in Atchison, Kansas and operates in accordance with 33 CFR 117.411 and 117.687 which apply to all drawbridges over the Missouri River. The vertical clearance of the bridge in the closed position is 37.5 feet above zero on this gage. Due to very limited drawspan openings and to codify the operating schedule that has been adopted by the waterway usersc, the Union Pacific Railroad requested a two-hour advance notice of opening the bridge's drawspan during the commercial navigation season.
The Union Pacific Railroad has documented the limited number of vessel openings per year at this bridge. This information is available at the Coast Guard Western Rivers, Bridge Branch; see the aforementioned contact information.
Upon this request and further review by the Coast Guard, it was concluded that a two-hour advance notice on drawspan openings of the Atchison Railroad Drawbridge would not create a consistency issue with other bridges on the Missouri River nor adversely affect navigation.
The Coast Guard provided a comment period in which no comments were received.
This rule adds special operating requirements codifying the customary advance notice for openings of the Atchison Railroad Bridge under 33 CFR part 117, subpart B as required under 33 CFR 117.8. The proposed change will add a paragraph (b) to 33 CFR 117.411, a reference to this paragraph in 33 CFR 117.687, and allow for bridge drawspan openings to take place provided at least a two-hour advance notice is given.
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protesters.
E.O.s 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This proposed rule is not a significant regulatory action and does not require a full assessment. As a matter of custom in the area, commercial mariners already provide advance notice; therefore this rule has little, if any, impact on current navigation.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule is neutral to all business entities operating on the waterway and simply requires a two-hour advance notice to open the bridge. As stated above, it is custom in the area to provide advance notice for a requested opening. This rule simply codifies such notice already given as a customary practice. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(a) The draws of the bridges across the Missouri River shall open on signal; except during the winter season between the date of closure and the date of opening of the commercial navigation season as published by the Army Corps of Engineers, the draw need not open unless at least 24 hours advance notice is given.
(b) The draw of the Atchison Railroad Bridge, Mile 422.5, Missouri River need not open unless a two-hour advance notice is given during the commercial navigation season.
The draws of the bridges, except for the Atchison Railroad Bridge, Mile 422.5, see § 117.411(b) for further details, across the Missouri River shall open on signal; except during the winter season between the date of closure and date of opening of the commercial navigation season as published by the Army Corps of Engineers, the draws need not open unless at least 24-hours advance notice is given.
Coast Guard, DHS.
Interim rule with request for comments.
The Coast Guard is modifying the method of operation for the Norfolk Southern Railroad (Norfolk Southern or NSRR) Bascule Bridge across Lake Pontchartrain, mile 4.80, near Slidell, St. Tammany Parish, Louisiana. The bridge owner, Norfolk Southern, requested in writing to operate the draw of the bridge remotely. This interim rule codifies the change in method of operation and increases the efficiency of railroad operations, allowing for the operation of the draw from another location, while allowing for comments regarding remote operations during the interim period.
This interim rule is effective December 29, 2015.
Comments and related material must reach the Coast Guard on or before February 29, 2016.
You may submit comments or view documents mentioned in this preamble as being available in the docket, go to
See the “Public Participation and Request for Comments” portion of the
If you have questions on this interim rule, call or email Ms. Geri Robinson; Bridge Administration Branch, Eighth Coast Guard District; telephone 504-671-2128, email
The Coast Guard is issuing this interim rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because there will be no change to the operating schedule of
We are issuing this rule and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective in less than 30 days after publication in the
The Coast Guard is issuing this rule under the authority of 33 U.S.C. 499. The Norfolk Southern Railroad Bascule Bridge across Lake Pontchartrain at mile 4.80, near Slidell, St. Tammany Parish, Louisiana, has a horizontal clearance of 151 feet between fenders and a vertical clearance of 4.0 feet above Mean High Water, elevation 2.0 feet Mean Sea Level in the closed-to-navigation position. The vertical clearance of the bascule bridge in the open-to-navigation position is 68 feet for the full 151-foot horizontal clearance and unlimited from the tip of the bascule to the north fender system, a distance of 106 feet. Currently, the bridge opens on signal under 33 CFR 117.5.
In accordance with 33 CFR 117.42, the District Commander may authorize a drawbridge to operate under an automated system or from a remote location. The purpose of this rule is to allow the draw of this bridge to operate from a remote location. The draw will continue to open on signal for the passage of vessels, and mariners should not experience any changes in the level of service.
The Coast Guard, at the request of Norfolk Southern, is changing the method of operation for the Norfolk Southern Railroad Bascule Bridge across Lake Pontchartrain, mile 4.80, near Slidell, St. Tammany Parish, Louisiana. Due to the need for increased efficiency in railroad operations, Norfolk Southern requested a change to the method of operating the draw from on-site to a drawtender operating the bridge remotely.
Presently, the draw is maintained in the open-to-navigation position and closed only for the passage of trains or maintenance. The bridge owner would like to operate the draw remotely using a drawtender at another drawbridge in Decatur, Alabama, rather than maintaining the current on-site operation and drawtender. The implementation of this rule, in effect, removes the requirement that a drawtender be present on site at all times.
Under the new remote operation procedure, the draw will continue to be maintained in the open-to-navigation position and lowered only for the passage of trains or for maintenance. There will be no modifications to the operation of the bridge as it relates to the passage of vessels. Instead, this change will allow the bridge owner to increase efficiency of bridge operations and vessel transit by including this bridge in its current remote operation procedures located in Decatur, AL.
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protesters.
E.O.s 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This interim rule is not a significant regulatory action because the draw will be maintained in the open-to-navigation position and when closed to pass trains it will continue to open on signal as scheduled. Therefore, mariners will experience no changes in transiting through the bridge site. No new restrictions on or actions from the mariner are required by this rule.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, because the draw will be maintained in the open-to-navigation position and when closed to pass trains it will continue to open on signal as scheduled, no new restrictions or responsibilities are imposed on the mariner. Therefore, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice, and all public comments, are in our online docket at
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(b) The draw of the Norfolk Southern Railroad Bridge across Lake Pontchartrain, mile 4.80 near Slidell, St. Tammany Parish, Louisiana shall be maintained as follows:
(1) The draw shall be maintained in the fully open-to-navigation position for vessels at all times, except during periods when it is closed for the passage of rail traffic or to perform periodic maintenance authorized in accordance with subpart A of this part.
(2) The draw shall be remotely operated by the drawtender at Norfolk Southern's drawbridge in Decatur, Alabama. The estimated duration that the bridge will remain closed for the passage of rail traffic is 10 to 15 minutes per operation.
(3) When a train approaches the bridge, the drawtender will initiate the bridge closing warning signal, consisting of radio calls via VHF-FM-channels 13 and 16 and activation of flashing red warning lights at each end of the span. The radio calls will be broadcast at five (5) minutes prior to bridge closing and at two (2) minutes prior to bridge closing. Photoelectric (infrared) boat detectors will monitor the waterway beneath the bridge for the presence of vessels.
(4) The drawtender will continuously monitor waterway traffic in the area using closed-circuit cameras mounted on the bridge. The draw will only be closed if the drawtender's visual inspection indicates that the channel is clear and there are no vessels transiting in the area. The drawtender will maintain constant surveillance of the navigation channel to ensure that no conflict with maritime traffic exists. Additionally, the draw will not be closed if the S11 bascule bridge that is located immediately west of the railroad bridge is in the open-to-navigation position. If two or more closed-circuit cameras are inoperable or if there is inclement weather, the draw will only be operated by a drawtender located on site at the bridge.
(5) At the end of the two-minute warning period, if no vessels have been detected by the drawtender, the draw closing sequence will automatically proceed.
(6) Upon passage of the train, the draw will be returned to the fully open-to-navigation position to allow marine
(7) After the passage of each train, the draw must be returned to its fully open-to-navigation position.
(8) To request openings of the draw when the bascule span is in the closed-to-navigation position, mariners may contact Norfolk Southern Railway via VHF-FM channel 13 or by telephone at the number displayed on the signs posted at the bridge.
(9) The draw will be operated locally if:
(i) Communication is lost between the drawbridge and the drawtender in Decatur, Alabama;
(ii) More than two closed-circuit cameras are not working;
(iii) The marine radio is inoperable;
(iv) Weather conditions warrant; or
(v) Ordered by the Coast Guard.
Coast Guard, DHS.
Final rule.
The Coast Guard is modifying the operating schedule that governs the South Park Highway Bridge, on the Duwamish Waterway, mile 3.8, at Seattle, WA. This modification revises closure hours for the South Park Highway Bridge. This action improves movement of rush hour highway traffic while having minimal impact to maritime waterway traffic.
This rule is effective January 28, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District Bridge Program Office, telephone 206-220-7282; email
On May 14, 2015, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled “Drawbridge Operations: Duwamish Waterway, Seattle, WA” in the
The Coast Guard is issuing this rule under authority 33 U.S.C 499. The South Park Highway Bridge is a double bascule leaf drawbridge, and provides 34.8 feet of vertical clearance at center span while in the closed position, 30 feet of vertical clearance at the extreme east and west ends of the navigable channel, and unlimited vertical clearance in the fully open position. Vertical clearances are referenced to mean high-water elevation (MHW). Horizontal clearance is 128 feet. The South Park Highway Bridge is subject to tidal influence, and has at least 15 feet of water depth at the bridge site at mean lower low water.
The drawbridge operating regulations at 33 CFR 117.1041(a) (2) currently states that the South Park Highway Bridge need not be opened for the passage of vessels from 6:30 a.m. to 8:00 a.m. and 3:30 p.m. to 5 p.m., Monday through Friday, except Federal holidays.
The current drawbridge operating regulation was written to accommodate commuter patterns associated with morning and afternoon highway traffic associated with Boeing Plant number 2 shift changes. As of 2011, this plant is no longer operational and therefore highway traffic densities have changed. King County owns and operates the South Park Highway Bridge, and requested a permanent change to the existing operating regulation. The rule modification will update drawbridge closure times to better meet current highway traffic demands. Modifying the existing drawbridge regulation will better meet the needs of current highway users, and current commuter traffic patterns, while meeting reasonable needs to maritime navigation. This modification improves movement of rush hour highway traffic while having minimal impact to maritime waterway traffic.
Vessel traffic on the Duwamish waterway consists of vessels ranging from small pleasure craft, sailboats, small tribal fishing boats, and commercial tug and tow, and mega yachts.
The Coast Guard received one comment on the proposed operating schedule change from Delta Marine Industries. The rule change to the existing South Park Highway Bridge operating regulation would represent a restriction on navigation related to Delta Marine Industries' business. Currently, the closure hours of the 1st Avenue South Bridge (6:00-9:00 a.m. and 3:00-6:00 p.m., the same hours as now proposed for the South Park Highway Bridge) are the limiting factor for access of large vessels between Delta Marine Industries and Elliott Bay. With the change to the closure hours for the South Park Highway Bridge, vessels arriving and departing Delta Marine Industries would be delayed/impacted based on a half hour transit time between South Park Highway Bridge and 1st Avenue South Bridge.
Delta Marine Industries agrees with the concept of modifying the closure hours for the South Park Highway Bridge in a way that reflects current usage. However, Delta Marine Industries believes that matching the closure hours for the South Park Highway Bridge to those of the 1st Avenue South Bridge does not accommodate the needs of maritime users. Delta Marine Industries proposed revising the closure hours for the South Park Highway Bridge to 6:30-8:30 a.m. and 3:30-5:30 p.m., Monday through Friday except Federal holidays. King County agreed with Delta Marine Industries' proposal.
Therefore, the Coast Guard is modifying the drawbridge operating regulations at 33 CFR 117.1041(a) (2). The Coast Guard amends the opening schedule such that the bridge need not be opened for the passage of vessels from 6:30 a.m. to 8:30 a.m. and 3:30 p.m. to 5:30 p.m., Monday through Friday, except Federal holidays other
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on these statutes or E.O.s. and we discuss First Amendment rights of protestors.
E.O.s 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the fact that the change will add thirty minutes to each closure period for the drawbridge, minimally impacting vessels transiting the waterway. The change does not otherwise significantly alter the duration and time frame of the current closure schedule.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This action will not have a significant economic impact on a substantial number of small entities because this rule will be in effect twice a day for a total of four hours when vehicle traffic is high. Vessels that can safely transit under the bridge may do so at any time.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction, and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32) (e), of the Instruction.
Under figure 2-1, paragraph (32) (e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(a) * * *
(2) The draw of the South Park Bridge, mile 3.8, need not be opened for the
Coast Guard, DHS.
Interim rule; request for comments.
Through this interim rule, the Coast Guard is providing administrative changes to the existing reporting requirements under the Regulated Navigation Area (RNA) applicable to barges loaded with certain dangerous cargoes on the Illinois Waterway System in the Ninth District area of responsibility. The current stay of reporting requirements under the RNA is scheduled to expire on December 31, 2015. This interim rule limits the reporting requirements in that rule for an interim period while also requesting comments before proposing or finalizing any long term or permanent revisions to the existing reporting requirements.
This interim rule is effective beginning January 1, 2016. Comments and related material must be received by the Coast Guard on or before June 27, 2016. See
The docket for this interim rule and request for comments, [USCG-2013-0849], is available at
For information about this document call or email CDR Dan Somma at
The reporting requirements under 33 CFR 165.921 “Regulated Navigation Area; Reporting Requirements for Barges Loaded with Certain Dangerous Cargoes, Illinois Waterway System located within the Ninth Coast Guard District” were initially suspended (“stayed”) in January 2011 due to the expiration of the contract for the Inland River Vessel Movement Center (IRVMC). The IRVMC was the Coast Guard office responsible for collecting the information required by the regulated navigation area (RNA) at § 165.921. Upon expiration of the contract for the IRVMC, the Coast Guard was not able to receive and process reports. Therefore, the suspension of reporting requirements was published in the
In January 2015 the Coast Guard published a final rule, titled Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System (80 FR 5282). This rule implemented new and updated Notices of Arrival reporting requirements under 33 CFR 160 Subpart C by providing an exemption, at 33 CFR 160.204(a)(3) for any vessel required to report movements, its cargo, or the cargo in barges it is towing under 33 CFR 165.921 after December 31, 2015. This rule, which was initially proposed in 2008 before the RNA reporting requirements were suspended, relied on the existing reporting requirements at 33 CFR 165.921 to support the exemption. Starting on January 1, 2016, a vessel would only be eligible for the exemption if it is required to report its movements or cargo as specified in § 160.204(a)(3). This rule makes changes to limit the suspended reporting requirements, which would otherwise come into effect in full on January 1, 2016.
Also relevant to this interim rule and request for comments is the portion of 80 FR 5282 requiring that all vessels engaged in the movement of Certain Dangerous Cargos (CDC) have Class A Automatic Information System beginning in March 2016, pending Office of Management and Budget (OMB) approval of a collection of information associated with that regulatory requirement. These AIS requirements provided under 33 CFR 164.46, if enforced, may provide an alternative method of reporting that could potentially satisfy the requirements under 33 CFR 165.921 and qualify these vessels for the 33 CFR 160.204(a)(3) exemption. As indicated in the
The Coast Guard is issuing this interim rule to limit the RNA reporting requirements that will come into effect after December 31 when the stay of § 165.921 expires. This rule is necessary to stay compliance with certain provisions of the existing rule, and to make administrative changes replacing the references to IRVMC, which is no
The Coast Guard is issuing this interim rule without prior opportunity to comment, pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule for several reasons. It is unnecessary to publish an NPRM because this interim rule makes only administrative changes to the existing RNA regulation under 33 CFR 165.921, and does not propose or establish new restrictions or requirements. This interim rule merely stays compliance with portions of an existing requirement, allowing select existing provisions to resume upon expiration of a stay in effect through December 31, 2015, and makes the administrative changes necessary to redirect reporting from the IRVMC to the District. Additionally, publishing an NPRM was impracticable because of the relatively short time between the publication of the Notices of Arrival final rule and the expiration of the stay, as well as the uncertain enforcement date of certain provisions of the Automatic Information System portion of that rule. These circumstances did not allow adequate time to develop an NPRM, solicit and consider public comment, and develop and publish a final rule before the expiration of the stay. Instead, the Coast Guard is soliciting public comment with this interim rule while it is in effect and while the AIS requirement will be in effect, if that information collection is approved by OMB, so that the public's experience with this interim rule and the AIS requirement can be reflected in public comments.
This interim rule is effective January 1, 2016. We are making this rule effective in less than 30 days from the date of publication under the authority of 5 U.S.C. 553(d)(1) to the extent it relieves the reporting obligations that would otherwise come into effect upon the December 31, 2015 expiration of the stay, and under 5 U.S.C. 553(d)(3) because the Coast Guard finds that the imminent expiration of the stay constitutes good cause for forgoing the 30-day delay of effective date. Delaying the effective date of this interim rule to provide a 30 day notice would be impracticable and contrary to public interest because a January 1, 2016, effective date is necessary to avoid submission of reports to the IRVMC which is no longer in operation.
The Coast Guard's suspension of reporting requirements under 33 CFR 165.921 will expire as scheduled, in part, on December 31, 2015. On January 1, 2016, reporting requirements under 33 CFR 165.921 will become effective in a limited form. The Coast Guard is not reinstating reporting, 24 hours per day, 365 days per year, at 90-plus reporting points under the existing RNA currently published in the CFR. Under revisions made by this interim rule, reporting requirements will be enforced only when directed by the District Commander or a designated representative. This rule does not change the type of information to be reported.
This interim rule makes administrative changes that remove or revise references to the IRVMC, as it is no longer operational, and replace them with the new Coast Guard office, the Ninth District CDC Reporting Unit (D9 CDCRU), which when activated will be responsible for collecting reported information. The entities required to report, and the information required, remain the same. However, reporting is required only as directed by the District Commander or a designated representative, based on assessment of prevailing safety and security conditions to ensure and enhance maritime domain awareness. In effect, the Coast Guard is allowing existing paragraphs (d)(1)(ix), (d)(2)(iv), (f)(9), and (g)(4) to come into effect, with administrative changes to accommodate the closure of IRVMC. We will continue to use the reporting points listed in paragraph (e) to describe where reporting is required. This rule “stays” (suspends) compliance with the other existing reporting requirements.
The District Commander or designated representative will inform vessel operators and fleeting facilities when and where reporting is required, by using established coordination and communication mechanisms already in place and which are used to alert these same vessel operators and fleeting facilities of an increase in Maritime Security level. These notice mechanisms include, but are not limited to, coordination with industry trade organizations, Notices of Enforcement, Marine Safety Information Bulletins, and email notifications.
Reports required under this RNA may be provided via email at
The Coast Guard chose to suspend, rather than remove, several paragraphs of the existing rule in order to evaluate their necessity and to retain the ability to reinstate them (using appropriate administrative processes) if necessary. All public comments are welcome, but we specifically solicit comment on the following: The appropriate type and frequency of reporting related to CDC barges in D9; the potential to use AIS to satisfy reporting goals; and the extent to which complying with the AIS rule would render this rule unnecessary.
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
E.O.s 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
No new requirements are established or imposed by this rule. This interim rule suspends compliance with certain provisions of an existing regulation that will come into effect when the current stay expires on December 31, 2015 thereby continuing to relieve a reporting obligation while the Coast Guard solicits public comment regarding appropriate reporting. As a result, the currently-stayed requirement will resume only in a limited form. The rule also makes administrative changes affecting which Coast Guard entity directs and receives
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the RNA may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule does not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The existing collection is approved by the Office of Management and Budget under OMB control number 1625-0105.
A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves administrative changes to resuming reporting requirements in a limited form under an established RNA. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. This interim rule limits the existing, suspended, 24 hours a day, 7 days a week, 365 days a year reporting requirement throughout the entire RNA to require reporting only when and where directed by the District Commander, reducing the time frame and area that the reporting requirements are enforced. An environmental analysis checklist and categorical exclusion determination are not required. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential, and will consider all comments and material received during the comment period. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this interim rule as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, and Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
The revisions read as follows:
(b)
(2) This section applies to towing vessel operators and fleeting area managers responsible for CDC barges in the RNA. This section does not apply to:
(i) Towing vessel operators responsible for barges not carrying CDCs barges, or
(ii) Fleet tow boats moving one or more CDC barges within a fleeting area.
(d) * * *
(4) When required, reports under this section must be made either by email at
Coast Guard, DHS.
Temporary final rule.
The Coast Guard proposes to establish a temporary safety zone in the navigable waters of the Morro Bay Harbor Entrance. This temporary safety zone is being established to reduce significant hazards subject to the vessels, the harbor, and the public during periods of poor weather conditions. This proposed rulemaking would prohibit persons and vessels from being in this temporary safety zone unless specifically authorized by the Captain of the Port, Los Angeles—Long Beach, or her designated representative.
This rule is effective without actual notice from December 29, 2015 February 29, 2016 11:59 p.m. For the purposes of enforcement, actual notice will be used from 12:01 a.m. December 9, 2015, until December 29, 2015. The safety zone will only be enforced when the COTP or her designated representative deems it necessary because of hazardous, breaking, or rough bar conditions.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LT Jevon James, Waterways Management, U.S. Coast Guard Sector Los Angeles—Long Beach; telephone (310) 521-3860, email
The Coast Guard proposes to issue this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C.
The bar located in Morro Bay, California, is unique to the Southern California coastline. Throughout the year, the bar produces extremely hazardous navigation conditions for all types of maritime traffic within a small waterway. It is predicted that the Southern California coast will be impacted by a strong El Niño, in which abnormally large waves will be observed. On December 7, 2015, a 53′ commercial fishing vessel requested to transit the bar during extremely hazardous conditions, to include seas exceeding 20′. The COTP issued a COTP Order to restrict the fishing vessel from crossing the bar until the weather subsided, to prevent a potentially hazardous transit. Thus, waiting for the publishing of the NPRM would be impracticable because immediate action is needed to minimize potential danger to all vessels transiting across the bar. For these reasons, the Coast Guard finds that good cause exists for implementing this rule less than thirty days before the effective date.
The Coast Guard is issuing this rule under the authority of 33 U.S.C. 1231. The Captain of the Port Los Angeles—Long Beach has determined that a potential hazard exists during certain weather conditions for all recreational and commercial vessels operating in the vicinity of the Morro Bay Harbor Entrance. This temporary safety zone is necessary to ensure the safety of, and reduce the risk to, the persons and vessels that operate on and in the vicinity of the Morro Bay Harbor Entrance.
The U.S. Coast Guard has established a temporary safety zone encompassing all navigable waters near the inside and outside of the mouth of the Morro Bay Harbor entrance, from December 9, 2015, to February 29, 2016. When the Safety Zone is being enforced, the Coast Guard will turn on the Morro Bay Rough Bar Warning Light (LLNR 3877; 35°22.256′ N., 120°51.526 ′ W.). This indicates that rough bar conditions are taking place at the entrance. In addition, a Broadcast Notice to Mariner will be used to inform mariners of the enforcement of the safety zone. No vessel or person will be permitted to operate in the safety zone without obtaining permission from the Captain of the Port (COTP) or the COTP's designated representative. Sector Los Angeles—Long Beach may be contacted on VHF-FM Channel 16 or 310-521-3801.
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
E.O.s 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
The implementation of this temporary safety zone is necessary for the protection of all waterway users. The size of the zone is the minimum necessary to provide adequate protection for the waterways users, adjoining areas, and the public. Any hardships experienced by persons or vessels are considered minimal compared to the interest in protecting the public.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor within the designated area during the designated enforcement times. This temporary safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This zone will support the safety of vessel traffic through the area, (ii) this zone is limited in scope and duration, (iii) the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 while the safety zone is enforced.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) To seek permission to enter, hail Coast Guard Station Morro Bay on VHF-FM Channel 16 or call at (805) 772-2167. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is amending its regulations concerning the payment of fees for representation by agents and attorneys in proceedings before VA. Specifically, this rule removes the requirement that an agent or attorney file a direct-pay fee agreement with both the VA Office of the General Counsel and the agency of original jurisdiction. The intended effect of this final rule is to require that direct-pay fee agreements be submitted only to the agency of original jurisdiction, thereby eliminating duplicate filings by agents and attorneys.
Dana Raffaelli, Staff Attorney, Office of the General Counsel (022O), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-7699. (This is not a toll-free telephone number.)
This rule amends 38 CFR part 14 to remove the requirement that agents and attorneys file direct-pay fee agreements with the VA Office of the General Counsel in Washington, DC. Current provisions in 38 CFR 14.636(g) and (h) require agents and attorneys to file direct-pay fee agreements with both the Office of the General Counsel and the agency of original jurisdiction. Removal of this requirement will eliminate administrative burdens associated with these direct-pay fee agreements. Agents and attorneys will be relieved from filing direct-pay fee agreements with the Office of the General Counsel, and the
Current 38 CFR 14.636(g)(2) and (g)(3) requires agents and attorneys to file all fee agreements with the Office of the General Counsel in Washington, DC, and to clearly specify in the agreement whether VA is to directly pay the agent or attorney fees out of an award of past-due benefits. Current 38 CFR 14.636(h)(4) requires agents and attorneys to notify the agency of original jurisdiction, within 30 days of the date of execution of the agreement, of the existence of a direct-pay fee agreement and also provide the agency of original jurisdiction with a copy of the agreement.
The requirement that all fee agreements be filed with the Office of the General Counsel was established in 2008.
On May 22, 2008, VA implemented the statutory amendments regarding fees in § 14.636 (formerly § 20.609 (2007)), one of which directs attorneys and agents to file all fee agreements with the Office of the General Counsel in Washington, DC.
The revisions to § 14.636(g)(3) and (h)(4) eliminate the requirement for agents and attorneys to file a direct-pay fee agreement with the Office of the General Counsel. Any fee agreement calling for the direct payment of fees out of any past-due benefits now must be filed only with the agency of original jurisdiction. The agency of original jurisdiction is the most appropriate location for such filings as that entity must determine when direct payment of fees is called for and authorize the correct payment. The agency of original jurisdiction will file the fee agreement in the claimant's electronic claims file contained in Veterans Benefits Administration's electronic database, the Veterans Benefits Management System (VBMS), and associate the attorney or agent's Power of Attorney (POA) code—meaning the three digit code that was assigned to the attorney or agent at the time of his or her VA accreditation—with the claimant's claim file.
Fee agreements that do not provide for the direct payment of fees must still be filed with the Office of the General Counsel.
The Office of the General Counsel retains authority to review all fee agreements for reasonableness in light of the services that the attorney or agent provided on a claim and the authority to review any fee agreement for eligibility that has not undergone review by another agency of original jurisdiction.
VA also makes an additional conforming amendment to 38 CFR 14.637(b) to reference fee agreements filed with either the Office of the General Counsel or the agency of original jurisdiction under § 14.636.
This final rule is a procedural rule that does not impose new rights, duties, or obligations on affected individuals but, rather, eliminates duplicate filings under the statutory requirement that agents and attorneys file a copy of a fee agreement “with the Secretary.”
The Paperwork Reduction Act of 1995 (at 44 U.S.C. 3507) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number.
Section 14.636 of title 38 of the Code of Federal Regulations contains collections of information under the Paperwork Reduction Act of 1995, which OMB approved under control number 2900-0605. This final rule will amend § 14.636(g)(3) and (h)(4) to remove the requirement that an agent or attorney file a direct-pay fee agreement with both the Office of the General Counsel and the agency of original jurisdiction,
We also note that, in 2008, VA did not amend § 14.636 to reflect the OMB control number. Therefore, we are also
The initial and final regulatory flexibility analyses requirements of sections 603 and 604 of the Regulatory Flexibility Act, 5 U.S.C. 601-612, are not applicable to this rule, because a notice of proposed rulemaking is not required for this rule. Even so, the Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act. At a minimum, this rule will affect only the attorneys and agents who file fee agreements with the Office of the General Counsel. However, it will not have a significant economic impact on these individuals, as it will result in modest savings for affected attorneys and agents who will avoid the expense of duplicate filings. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
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,” requiring review by 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 final rule 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 one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.
There are no Federal Domestic Assistance programs associated with this final rule.
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. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on December 22, 2015, for publication.
Administrative practice and procedure, Claims, Courts, Foreign relations, Government employees, Lawyers, Legal services, Organization and functions (Government agencies), Reporting and recordkeeping requirements, Surety bonds, Trusts and trustees, Veterans.
For the reasons set out in the preamble, the Department of Veterans Affairs amends 38 CFR part 14 as follows:
5 U.S.C. 301; 28 U.S.C. 2671-2680; 38 U.S.C. 501(a), 512, 515, 5502, 5901-5905; 28 CFR part 14, appendix to part 14, unless otherwise noted.
The revisions read as follows:
(g) * * *
(3) A copy of a direct-pay fee agreement, as defined in paragraph (g)(2) of this section, must be filed with the agency of original jurisdiction within 30 days of its execution. A copy of any fee agreement that is not a direct-pay fee agreement must be filed with the Office of the General Counsel within 30 days of its execution by mailing the copy to the following address: Office of the General Counsel (022D), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420. Only fee agreements that do not provide for the direct payment of fees, documents related to review of fees under paragraph (i) of this section, and documents related to review of expenses under § 14.637, may be filed with the Office of the General Counsel. All documents relating to the adjudication of a claim for VA benefits, including any correspondence, evidence, or argument, must be filed with the agency of original jurisdiction, Board of Veterans' Appeals, or other VA office as appropriate.
(h) * * *
(4) As required by paragraph (g)(3) of this section, the agent or attorney must file with the agency of original jurisdiction within 30 days of the date of execution a copy of the agreement providing for the direct payment of fees out of any benefits subsequently determined to be past due.
(The Office of Management and Budget has approved the information collection requirements in this section under control number 2900-0605.)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues this final rule to establish a small business size standard of $11 million in annual gross receipts for all businesses in the commercial fishing industry (NAICS 11411), for Regulatory Flexibility Act (RFA) compliance purposes only. For the purposes of this final rule, a “commercial fishing business” is a business primarily engaged in commercial fishing, the “commercial fishing industry” is composed of all such businesses, and the $11 million standard only applies to this industry. This standard does not apply to businesses primarily engaged in seafood processing (NAICS 311170), seafood wholesale activities (NAICS 424460), or any other activity within the seafood industry. The $11 million standard will be used in RFA analyses in place of the U.S. Small Business Administration's (SBA) current standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors of the U.S. commercial fishing industry, respectively. Establishing a single size standard of $11 million for the commercial fishing industry will simplify the RFA analyses done in support of NMFS' rules, better meet the RFA's intent by more accurately representing expected disproportionate effects of NMFS' rules between small and large commercial fishing businesses, create a standard that more accurately reflects the size distribution of all businesses in the commercial fishing industry, and allow NMFS to determine when changes to the standard are necessary and appropriate.
This final rule is effective July 1, 2016.
Copies of the Regulatory Impact Review (RIR), proposed rule and associated comments are available via the Federal eRulemaking Portal:
Mike Travis, Industry Economist, at (727) 209-5982, or email:
For the purposes of this final rule, a “commercial fishing business” is a business primarily engaged in commercial fishing and the “commercial fishing industry” (NAICS 11411) is composed of all such businesses. Prior to 2013, SBA had established a single small business size standard for all businesses in the commercial fishing industry. Since 2005, this standard had been $4 million in annual gross receipts (revenues). Effective July 22, 2013, SBA established significantly different and higher size standards for the three separate sectors of the industry (78 FR 37398, June 20, 2013): $19 million for commercial finfish fishing businesses (NAICS 114111), $5.0 million for commercial shellfish fishing businesses (NAICS 114112), and $7.0 million for other commercial marine fishing businesses (NAICS 114119). These standards were subsequently adjusted for inflation to $20.5 million, $5.5 million, and $7.5 million, respectively, via an interim final rule, effective July 14, 2014 (79 FR 33647, June 12, 2014). The Small Business Jobs Act of 2010 requires SBA to review all size standards every five years to account for changes in industry structure and market conditions. SBA is also required to assess the impact of inflation on its monetary-based size standards at least once every five years (13 CFR 121.102). However, as reflected by the timing of the two recent rulemakings adjusting the size standards, SBA is not required to conduct the reviews for these two purposes simultaneously. Thus, these size standards are likely to change on a regular basis.
Under the RFA, an agency must prepare an initial and final regulatory flexibility analysis (IRFA/FRFA) for each proposed and final rule, respectively, unless it certifies that a rule will not have a significant economic impact on a substantial number of small entities. Agencies generally rely on the SBA size standards to identify small entities for RFA purposes. For NMFS, rulemaking activities that have been impacted by changes to the size standards for defining “small” businesses include, but are not limited to, regulatory actions and analyses undertaken pursuant to the Magnuson-Stevens Act (MSA), Endangered Species Act (ESA), Marine Mammal Protection Act (MMPA), and National Environmental Policy Act (NEPA). Between 2012 and 2014, NMFS published an average of 285 final rules per year, more than 40 percent of which required an RFA analysis, and a majority of those directly regulated commercial fishing businesses. Thus, NMFS' costs of complying with the RFA are significant even when the small business size standards are stable, and those costs increase substantially when the standards are changing on a recurring basis.
NMFS and the Regional Fishery Management Councils (Councils) have encountered significant difficulties implementing and adjusting to the new standards because: (1) The change was from a single size standard for all commercial fishing businesses to three very different standards, (2) many commercial fishing businesses participate in both finfish and shellfish fishing activities, making it unclear which standard to apply in the RFA analyses, and (3) a number of rules simultaneously implement regulations under fishery management plans for both finfish and shellfish species (for
Furthermore, one of the RFA's primary purposes is to determine if proposed regulations are expected to have disproportionate economic impacts on small businesses relative to large businesses and, if so, to consider alternatives that would minimize any significant adverse economic impacts on small businesses. Under SBA's current standards for commercial fishing businesses, practically all commercial fishing businesses, and particularly commercial finfish fishing businesses, would likely be determined to be small. Thus, in their RFA analyses, NMFS and the Councils would not be able to discern, consider, or address any disproportionate economic impacts that various regulatory alternatives might have on businesses NMFS and the Councils think are “small” in the commercial fishing industry. Such an
Section 601(3) of the RFA provides that an agency, after consultation with SBA's Office of Advocacy (Advocacy) and after an opportunity for public comment, may establish one or more definitions of “small business” which are appropriate to the activities of the agency and publish such definition(s) in the
SBA has expressed support for the idea of creating a single size standard in instances where industries are closely related, as is the case for the finfish and shellfish sectors of the commercial fishing industry. In the preamble to its proposed rule to change the size standard for businesses in manufacturing industries (79 FR 54146, Sept. 10, 2014), SBA stated: “To simplify size standards and for other reasons, SBA may propose a common size standard for closely related industries. Although the size standard analysis may support a separate size standard for each industry, SBA believes that establishing different size standards for closely related industries may not always be appropriate. For example, in cases where many of the same businesses operate in the same multiple industries, a common size standard for those industries might better reflect the Federal marketplace. This might also make size standards among related industries more consistent than separate size standards for each of those industries.” (79 FR 54146, 54150, Sept. 10, 2014).
NMFS has determined that the data used by SBA to develop the new standards are incomplete and, as a result, not representative of all commercial fishing businesses. Specifically, the data used by Size Standards only account for commercial fishing businesses that have employees (
Further, according to SBA, annual gross revenues for finfish and shellfish commercial fishing businesses with employees average $1.6 and $0.6 million, respectively. Conversely, NMFS determined the annual gross revenues for commercial fishing businesses without employees are only about $44,000 on average. Thus, NMFS concluded that the exclusion of commercial fishing businesses without employees is primarily responsible for the magnitude of the size standard increases, particularly for finfish fishing businesses, and the standards would have been very different if SBA had used data for all commercial fishing businesses. Because the size standards apply to all commercial fishing businesses, not just those with employees, when used to analyze the economic impacts of management actions on directly regulated entities under the RFA, NMFS thinks it is more appropriate to have size standards for RFA purposes that are based on all commercial fishing businesses.
In conjunction with its recent review of size standards, SBA developed a “Size Standards Methodology” for establishing, reviewing, and modifying size standards, where necessary. SBA included it as a supporting document (at
SBA's primary source of industry data used in the rule to establish the new size standards for the three sectors of the commercial fishing industry was a special tabulation of the 2007 County Business Patterns data from the U.S. Bureau of Census (Census Bureau). This special tabulation provided SBA with data on the number of employer firms, number of establishments, number of employees, annual payroll, and annual receipts of companies by U.S. industry (6-digit NAICS code). These data were arrayed by various classes of firms' size based on the overall number of employees and gross receipts of the entire enterprise (all establishments and affiliated firms) from all industries. These data allowed SBA to estimate average firm size, the four-firm concentration ratio, and the Gini coefficient.
SBA provided these data upon request to NMFS. NMFS subsequently requested and received from the Census Bureau comparable data for non-employer businesses. NMFS aggregated data to the industry level (
Specifically, NMFS used the data it received from SBA and the Census Bureau to generate estimates of simple average receipts, weighted average receipts, and the Gini coefficient. For simple average receipts, each firm's share of the industry's total receipts is weighted equally, whereas the shares of larger firms receive larger weights in estimating weighted average receipts. Weighted average receipts and the Gini coefficient were estimated using the equations provided in SBA's Size Standards Methodology document. NMFS generated the following estimates for the commercial fishing industry: $77,178 for simple average receipts, $12,322,365 for weighted average receipts, and 0.755 for the Gini coefficient. Based on the information in Table 2 of SBA's proposed rule to change the size standards for the finfish, shellfish, and other marine fishing sectors of the commercial fishing industry (77 FR 55755), these estimates
SBA also considers the average assets size of firms to be an important factor in establishing a size standard. NMFS does not possess and was not able to procure assets size data for non-employer businesses. SBA has such data for employer firms in the finfish and shellfish sectors, though not for employer firms in the other marine fishing sector because of the very small number of firms in that sector. The number of firms in the other marine fishing sector is very small because it includes firms primarily involved in the harvest of corals, sponges, reef associated plants (
According to SBA's proposed rule, the average assets sizes for the finfish and shellfish commercial fishing sectors are $1.4 million and $0.4 million, respectively. Finfish fishing firms and shellfish fishing firms represent approximately 54 percent and 46 percent, respectively, of the 2,039 employer firms in those two sectors combined. Based on these percentages, the weighted average assets size of the combined finfish and shellfish commercial fishing sectors is approximately $0.94 million. Based on Table 2 in SBA's proposed rule, this estimate supports a $7 million size standard.
SBA does not consider the average receipts of the four largest firms to be an important factor in establishing a size standard for industries where the four-firm concentration ratio is below 40 percent (
According to SBA's methodology, all factors should be weighted equally. Therefore, NMFS averaged the standards supported by the simple average receipts ($5 million), weighted average receipts ($5 million), Gini coefficient ($19 million), and average assets size ($7 million) estimates, which results in a size standard of $9 million. However, SBA only allowed for eight size standards in its final rule (79 FR 54146, September 10, 2014): $5 million, $7 million, $10 million, $14 million, $19 million, $25.5 million, $30 million, and $35.5 million. When the estimated size standard is not equivalent to one of these eight standards, SBA rounds up to the next highest size standard. For NMFS' estimated $9 million size standard, the next highest size standard would be $10 million. If the average assets size factor is not included, because it is based on aggregated employer data only rather than a combination of employer and non-employer data, the average of the other 3 factors is $9.67 million. Thus, the next highest size standard would still be $10 million.
NMFS is aware the Census Bureau has recently released the 2012 County Business Patterns data for employer firms. However, 2012 data for non-employer firms has not yet been released. As previously discussed, NMFS does not think it is prudent to establish a size standard based only on employer data because 97 percent of the commercial fishing businesses are non-employers. Further, even if the 2012 non-employer data is released and NMFS generates new estimates of the various industry factors, NMFS would still not be able to determine what standards are implied by the new estimates until SBA generates an updated version of Table 2 in its proposed rule to change the size standards for the finfish, shellfish, and other marine fishing sectors of the commercial fishing industry (77 FR 55755) using 2012 rather than 2007 data.
As previously stated, SBA recently implemented a final rule to adjust all of its receipts based size standards for inflation using the chain-type price index for the U.S. Gross Domestic Product (GDP price index) (79 FR 33647, June 12, 2014). According to that final rule, for all industries with a non-inflation-adjusted size standard of $10 million, the new inflation-adjusted size standard is $11 million.
Thus, this final rule establishes a small business size standard of $11 million for all businesses in the commercial fishing industry (NAICS 11411) for RFA compliance purposes only. The $11 million standard only applies to the commercial fishing industry and thus does not apply to businesses primarily engaged in seafood processing (NAICS 311170), seafood wholesale activities (NAICS 424460), or any other activity within the seafood industry. This single size standard for commercial fishing businesses would be used in all RFA analyses conducted in support of NMFS' regulatory actions. Establishing this single size standard would simplify the RFA analyses done in support of NMFS' rules, better meet the RFA's intent by more accurately representing expected disproportionate effects of NMFS' rules between small and large commercial fishing businesses, create a standard that more accurately reflects the size distribution of all businesses in the commercial fishing industry, and allow NMFS to determine when changes to the standard are necessary and appropriate.
NMFS and the Councils have numerous regulatory actions at various stages of the rulemaking process at any point in time, and thus RFA analyses at various stages in development. As a result, NMFS has chosen to delay the effective date of this rule until July 1, 2016, to allow sufficient time for the Councils and NMFS to transition to the $11 million size standard. The delayed effective date will allow regulatory actions that are relatively far along in the rulemaking process and which used SBA's current standards for commercial fishing businesses in their RFA analyses to be in compliance and thus proceed on their current timeline. However, RFA analyses conducted in association with all proposed and final rules published after July 1, 2016, should use the $11 million size standard for commercial fishing businesses.
Consistent with SBA's review requirements under the Small Business Jobs Act of 2010 and 13 CFR 121.102, NMFS will review this standard at least once every 5 years to determine if a change is warranted. A change may be warranted because of changes in industry structure, market conditions, inflation, or other relevant factors. The reviews for these potential reasons will be conducted simultaneously in order to minimize the frequency of changes to the standard and additional rulemakings.
On September 18, 2015, NMFS published a proposed rule to establish a single small business size standard of $11 million in annual gross receipts for the commercial fishing industry, for RFA compliance purposes only, and
NMFS received five public comment letters in response to the proposed rule. These letters were mostly from businesses which participate in commercial fishing activities but are primarily engaged in seafood processing or organizations representing such businesses. No change has been made to the proposed size standard or regulations as a result of these comments.
Pursuant to section 601(3) of the RFA, the NMFS Assistant Administrator has determined that this final rule is consistent with the RFA and other applicable law.
This final rule has been determined by the Office of Management and Budget to be not significant for purposes of Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the SBA during the proposed rule stage that this action, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is repeated below.
The purposes of the rule are to establish a single small business size standard of $11 million in annual gross receipts for the commercial fishing industry (NAICS 11411), for RFA compliance purposes only, and a requirement for NMFS to assess at least once every 5 years whether this size standard should be changed. The objectives of the rule are to simplify the RFA analyses done in support of NMFS' rules, better meet the RFA's intent by more accurately representing expected disproportionate effects of NMFS' rules between small and large businesses, create a standard that more accurately reflects the size distribution of all businesses in the commercial fishing industry, and allow NMFS to determine when changes to the standard are
The actions in this rule are administrative in nature and thus would only potentially generate indirect economic effects on commercial fishing businesses. Specifically, the $11 million size standard would only affect how NMFS and the Councils determine whether commercial fishing businesses directly regulated by future regulatory actions are small or large, whether and to what extent those actions have disproportionate economic impacts on those two classes of businesses, and when it is appropriate for NMFS to change the standard in the future. This rule would not impose any new requirements on commercial fishing businesses. Therefore, no small entities would be directly regulated by this rule. This rule would not be expected to affect the behavior or operations of commercial fishing businesses. As such, this rule is not expected to generate any direct economic effects on commercial fishing businesses.
Based on the information above, a reduction in profits for a substantial number of small entities is not expected. The Chief Counsel for Regulation of the Department of Commerce hereby certifies that the rule will not have a significant economic impact on a substantial number of small entities. Because this rule, if implemented, is not expected to have a significant economic impact on a substantial number of small entities and no comments were received on this certification, a final regulatory flexibility analysis is not required and none was prepared.
No duplicative, overlapping, or conflicting Federal rules have been identified. This rule would not establish any new reporting or record-keeping requirements.
Commercial fishing, Small businesses.
For the reasons set out in the preamble, under the authority of 5 U.S.C. 601
5 U.S.C. 601
(a) This part sets forth the National Marine Fisheries Service (NMFS) small business size standards for NMFS to use in conducting Regulatory Flexibility Act (RFA) analyses for NMFS actions subject to the RFA. This part also sets forth the timeframe for NMFS to review its small business size standards.
(b) NMFS has established the alternative size standards in this part, for RFA compliance purposes only, in order to simplify the RFA analyses done in support of NMFS' rules, better meet the RFA's intent by more accurately representing expected disproportionate effects of NMFS' rules between small and large businesses, create a standard that more accurately reflects the size distribution of all businesses in the industry, and allow NMFS to determine when changes to the standard are necessary and appropriate.
(a) NMFS' small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing is $11 million in annual gross receipts. This standard applies to all businesses classified under North American Industry Classification System (NAICS) code 11411 for commercial fishing, including all businesses classified as commercial finfish fishing (NAICS 114111), commercial shellfish fishing (NAICS 114112), and other commercial marine fishing (NAICS 114119) businesses.
(b) NMFS will review each of the small business size standards in paragraph (a) of this section at least once every 5 years to determine if a change is warranted. A change may be warranted because of changes in industry structure, market conditions, inflation, or other relevant factors.
Office of the General Counsel, Department of Energy.
Notice of proposed rulemaking.
The U.S. Department of Energy (DOE) is proposing a requirement that a person importing into the United States any covered product or equipment subject to an applicable energy conservation standard provide, prior to importation, a certification of admissibility to the DOE for the covered product or equipment. The certification would be submitted to DOE through the U.S. Customs and Border Protection's Automated Commercial Environment (ACE).
DOE will accept comments, data, and information regarding this notice of proposed rulemaking (NOPR) no later than February 12, 2016. See section V, “Public Participation,” of this NOPR for details.
Any comments submitted must identify the NOPR for Import Data Collection, and provide docket number EERE-2015-BT-CE-0019 and/or regulatory information number (RIN) number 1990-AA44. 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).
Docket: The docket, which includes
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 to request a public meeting, contact Ms. Brenda Edwards at (202) 586-2945 or by email:
Ms. Ashley Armstrong, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Program, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: 202-586-6590. Email:
Title III, Part B
EPCA further provides that any covered product or equipment “offered for importation in violation of section 6302 of this title shall be refused admission into the customs territory of the United States under rules issued by the Secretary of the Treasury,” except under certain terms and conditions authorized under those rules. (42 U.S.C. 6301) Under the regulations issued by the Department of Treasury and the U.S. Customs and Border Protection (CBP), if the DOE or the Federal Trade Commission “notifies CBP that a covered import does not comply with an applicable energy conservation or energy labeling standard, CBP will refuse admission to the covered import, or pursuant to paragraph (d) of this section, CBP may allow conditional release of the covered import so that it may be brought into compliance.” (19 CFR 12.50(b))
In addition, EPCA authorizes DOE to require importers of covered products and equipment “to submit information or reports” with respect to energy efficiency, energy use, or water use of covered products and equipment “as the Secretary determines may be necessary . . . to insure compliance with the requirements of this part.” (42 U.S.C. 6296(d))
In its current form, 10 CFR 429.5 requires that persons importing covered products or covered equipment comply with the provisions of 10 CFR parts 429, 430, and 431. Part 429 requires, among other things, that importers of covered products or covered equipment subject to an applicable energy conservation standard
In prior rulemakings, the DOE has received comments from a number of interested parties urging DOE to work with CBP to enforce EPCA and its implementing regulations. For example, in 1996, the National Electrical Manufacturers Association (NEMA) called on the DOE to “provide sufficient guidelines to Customs Officers in order to facilitate enforcement of requirements similar to those placed on U.S. manufacturers.” (Docket No. EE-RM-96-400, NEMA, No. 38 at p. 15). More recently, in April 2011, in response to a DOE Request for Information concerning “Increased Scope of Coverage for Electric Motors,” NEMA and the Appliance Standards Awareness Project (ASAP), addressed this issue in joint comments supported by the American Council for an Energy-Efficient Economy, the Alliance to Save Energy, Natural Resources Defense Council, Northeast Energy Efficiency Partnerships, Northwest Energy Efficiency Alliance and the Northwest Power and Conservation Council. The commenters estimated that more effective enforcement of standards vis-à-vis imported electric motors could produce as much as one billion kilowatt-hours in incremental savings each year, and further noted that “manufacturers who comply are placed at a competitive disadvantage. . . . Therefore, we strongly urge DOE to work with Customs to expedite efforts for improved monitoring and enforcement with respect to imported motors. Without improved enforcement, the benefits of both existing standards and future standards are jeopardized.” (Docket No. EERE-2010-BT-STD-0027, ASAP, NEMA, No. 20 at p. 5).
On February 19, 2014, the President issued Executive Order 13659, Streamlining the Export/Import Process for America's Businesses (EO 13659), which requires certain federal agencies to significantly enhance their use of technology to modernize and simplify the trade processing infrastructure. Specifically, EO 13659 requires applicable government agencies to use CBP's International Trade Data System (ITDS), and its supporting systems, such as the Automated Commercial Environment (ACE), to create a “single window” through which businesses will electronically submit import-related data for clearance. EO 13659 envisions and is working toward a simpler, more efficient portal for trade use, to the benefit of both the trade and those government agencies with related authorities and responsibilities.
Based upon its specific authority to require the submission of information by importers and its broader authority to regulate the importation of covered products and equipment, DOE seeks in this proposed rule to require importers to provide a certification of admissibility to DOE prior to importation of products or equipment subject to DOE regulations. Importers would be required to submit the certification to DOE through ACE, which currently is being deployed to support electronic data filing through its Automated Broker Interface (ABI).
In this NOPR, DOE proposes to require that importers of covered products or equipment subject to an applicable energy conservation standard set forth in 10 CFR part 430 or 431
All importers must provide the appropriate code for the products or equipment they are importing as explained in the Harmonized Tariff Schedule of the United States, Annotated for Statistical Reporting Purposes, (HTS) which is published by the U.S. International Trade Commission pursuant to section 1207 of the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. 100-418; 19 U.S.C. 3007) (Trade Act). The HTS code is meant in part to allow CBP to make classification distinctions of U.S. interest. Consistent with this practice, DOE would require importers of shipments containing covered products and equipment falling under specified classifications of the HTS to file a certification of admissibility with DOE. The relevant HTS codes that would require a certification filing to DOE are presented in Table III.1.
DOE requests comment on the requirement that importers importing covered products or equipment subject to DOE energy conservation standards that are within the above listed HTS codes provide a certification of admissibility to DOE. Further, DOE requests comment as to whether covered products or equipment subject to or being considered for energy conservation standards are currently imported using other HTS codes.
The requirement for a certification of admissibility would apply to all covered products and equipment subject to a DOE energy conservation standard set forth in 10 CFR part 430 or 431. The requirement would apply to all such products and equipment contained in the shipment, either as a final product or a component part of a final product. For example, an importer would need to submit an electronic record for all covered electric motors as defined in 10 CFR 431.12, provided that the electric motor is subject to a standard, regardless of whether the electric motor will be imported as a stand-alone product or as a component part of another product not subject to DOE regulations (a treadmill, for example). Similarly, an importer of a laptop computer that is bundled with an external power supply would be required to submit a certification of admissibility for the external power supply.
If the shipment contains any such covered products or equipment, the importer would be required to state whether the product or equipment has been certified to DOE as compliant with all applicable energy conservation standards and, if so, the CCMS ticket number, the CCMS attachment identification number assigned to the certification submission, and the line number in the submission corresponding to the basic model certified. As discussed above, EPCA authorizes the Secretary of Energy to require importers of covered products and equipment “to submit information or reports to the Secretary” with respect to energy efficiency, energy use, or water use of covered products and equipment. (42 U.S.C. 6296(d)(1)) 10 CFR part 429 requires, among other things, that importers submit a certification report to DOE prior to distributing their products in U.S. commerce, and the failure to properly certify covered products and covered equipment subject to DOE energy conservation standards is a prohibited act under those regulations. 10 CFR 429.12, 429.102(a)(1). Part of the certification report is a statement whereby the manufacturer (including an importer) certifies that the basic models listed in the certification report comply with the applicable energy conservation standard and have been tested according to the applicable test requirements. 10 CFR 429.12. DOE requests comment on its proposal to require, for a shipment that contains covered products or equipment subject to a DOE energy conservation standard, that the importer state whether the product or equipment has been certified to DOE as compliant with all applicable energy conservation standards and, if so, provide the CCMS ticket number, the CCMS attachment identification number assigned to the certification submission, and the line number in the submission corresponding to the basic model certified.
If any covered product or equipment contained in the shipment has not been certified to DOE through CCMS, the importer would be required to include in its certification of admissibility; (1) the type of product or equipment; (2) the brand name of the covered product or equipment; (3) the individual model number of the covered product or equipment; (4) the original equipment manufacturer (OEM) of the covered product or equipment; and (5) a contact name and email address for the importer of record.
Currently, 10 CFR part 429 uses the terms “individual model number,” “manufacturer's individual model number,” and “manufacturer's model number” interchangeably and, of the three terms, only defines the term “manufacturer's model number.” For clarity, DOE proposes to replace the term “manufacturer's model number” with the term “individual model number” in the definitions at 10 CFR 429.2.
DOE initially considered requiring importers to provide all of the product-specific information specified above for all covered products and equipment subject to energy conservation standards. However, importers are already required to provide this information to DOE, prior to importation, when certifying that basic models of covered product and equipment meet applicable energy conservation standards. (10 CFR 429.12(a)) DOE proposes, therefore, to collect this additional information only regarding imported covered products and equipment subject to energy conservation standards that the importer has not certified to DOE as meeting applicable energy conservation standards. DOE believes this would be less burdensome to importers who have certified the basic models of covered products and equipment being imported, and therefore have already provided this information to DOE. DOE requests comment on its proposal to collect this additional information only regarding imported covered products and equipment subject to energy conservation standards that the importer has not certified to DOE as meeting applicable energy conservation standards.
Currently, importers are not required, in certifying a covered product or equipment that is a component product of a final product, to provide the brand name and individual model number of the final product. Thus, an importer may certify a basic model once in CCMS but import that basic model as a component of a variety of different final products. In order to facilitate, as necessary, identification of covered products or equipment being imported
As an alternative to this proposal, DOE would consider requiring this information from all manufacturers, including importers, as part of the process of certifying covered products or equipment. That requirement would not be adopted in this rulemaking, but rather in a separate rulemaking that DOE is preparing to revise its certification, compliance, and enforcement regulations applicable to consumer products and commercial and industrial equipment.
As in the case of products or equipment that are not “covered,” importers of products or equipment that are “covered” but not subject to standards (either DOE has not set standards or compliance with standards is not yet required) would not be required to provide a certification of admissibility. For example, although EPCA defines “covered equipment” to include “electric motors” (42 U.S.C. 6311(1)(A)), a small electric motor that is a component of a covered product or covered equipment is not subject to DOE energy conservation standards. (42 U.S.C. 6317(b)(3)). In addition, certain electric motors, such as NEMA Design C and IEC Design H, are not
The regulations issued by the Department of Treasury and CBP pursuant to EPCA, discussed herein, provide that, “[u]pon a determination that a covered import is not in compliance with applicable energy conservation or labeling standards, DOE . . ., will provide CBP with a written or electronic notice that identifies the importer and contains a description of the noncompliant covered import that is sufficient to enable CBP to identify the subject merchandise and refuse admission thereof into the customs territory of the United States.” (19 CFR 12.50(c)) The requirement for a certification of admissibility would ensure that DOE is aware of all shipments containing covered products and equipment subject to energy conservation standards prior to importation into the United States. This information will allow DOE to notify CBP if an importer is attempting to import a covered product or equipment that DOE has determined fails to meet the applicable energy conservation standard. Requiring importers to state whether the covered product or equipment being imported has been certified to DOE would allow DOE to identify importers that have not complied with these requirements, including potentially the failure to test; ensure that the product or equipment does, in fact, meet the applicable standards; and, if not, take appropriate enforcement action.
DOE requests comment on the proposed requirement that importers submit a certification of admissibility to DOE for all covered products and equipment subject to energy conservation standards contained in the shipment, either as a final product or a component part of a final product.
If the product or equipment is covered and subject to a DOE energy conservation standard, and the basic model of the product or equipment has not been certified to DOE as compliant with all applicable energy conservation standards, then the certification of admissibility must include: (1) the type of product or equipment; (2) the brand name of the covered product or equipment; (3) the individual model number of the covered product or equipment; (4) whether the covered product or equipment is a final product or a component part of a final product and, if the covered product or equipment is a component, the brand name and individual model number of the final product; (5) the original equipment manufacturer (OEM) of the covered product or equipment, and in the case of electric motors, the Compliance Certification number;
The specific products and equipment covered by DOE regulations found in 10 CFR parts 430 and 431 are divided into various types. DOE regulations refer to these types by the headers found in the applicable sections of 10 CFR part 429, subpart B. For example, to identify the type of product or equipment being imported, an importer would provide one of the following three-digit codes
For example, an importer of a consumer refrigerator would provide the code “014,” while an importer of a laptop bundled with an external power supply would provide code “037.” Collecting this information is essential to DOE's ability to identify possibly noncompliant products or equipment before they are imported into the United States. Once the type of product is identified, DOE can then focus its search of the relevant DOE databases to determine the compliance of the specific product or equipment being imported. DOE requests comment on requiring importers to identify the type of product or equipment being imported using a product-specific code in the certification of admissibility to DOE.
The certification of compliance information DOE collects pursuant to 10 CFR 429.12 is brand-specific. A manufacturer provides the relevant information demonstrating compliance of their product or equipment specific to each brand under which a basic model may be labeled. Collecting information in the certification of admissibility regarding the brand of the covered product or equipment being imported would facilitate the DOE's determination of compliance of the product or equipment with applicable energy conservation standards and certification requirements. Moreover, collecting information as to the brand of the covered product or equipment is essential for DOE to provide CBP a description sufficient for CBP to identify the covered product and equipment and take appropriate action based upon the non-compliance of the product or equipment. DOE requests comment on requiring importers to provide the brand of the covered product or equipment being imported in their certification of admissibility to DOE.
The certification of compliance information DOE collects pursuant to 10 CFR 429.12 also includes the individual model number(s) within each basic model. By requiring importers to provide the individual model number of the covered product or equipment, DOE will be better able to determine if the product or equipment has, in fact, been certified as compliant or has been found noncompliant. Moreover, collecting information as to the individual model number of the covered product or equipment is essential for DOE, when required, to provide CBP a description sufficient for CBP to identify the product or equipment and take appropriate action based upon the non-compliance of the product or equipment. DOE requests comment on requiring importers to provide the individual model number of the covered product or equipment subject to DOE energy conservation standards in their certification of admissibility to DOE.
As a practical matter, a description of covered product or equipment subject to DOE energy conservation standards that is a component of a final product must include information (
DOE routinely identifies noncompliant products by the original producer or assembler of the product (OEM). Collecting the OEM's name is therefore essential to DOE's ability to identify noncompliant products or equipment before they are imported into the United States. Once the OEM is identified, DOE can use that information to compare to the lists of products certified as compliant by that same OEM or, conversely, found to be noncompliant from the OEM. Identifying the OEM of the product will further help avoid confusion between similar products in the case where one OEM produces a compliant product while another does not. DOE requests comment on requiring importers to provide the name of the OEM for covered products and equipment subject to DOE energy conservation standards they are importing and, in the case of electric motors, the Compliance Certification number on the electric motor nameplate.
In cases where a certification of admissibility raises questions of possible noncompliance with energy conservation standards, DOE will
All importers would be required to submit their certifications of admissibility to DOE via CBP's ACE system. Importers are encouraged by CBP to use ACE as it allows them to file manifests electronically; make periodic payments on an interest-free monthly basis; file and process formal consumption entries and informal entries, including ABI Census Warning Overrides; view and respond to certain CBP forms through the ACE Portal; and file and process AD/CVD entries (also known as type 03 entries) and track the lifecycle of their AD/CVD cases. Participating in ACE also supports the U.S. Department of Homeland Security's dual mission to facilitate legitimate trade and secure the nation's borders. Importers will be able to provide required information to multiple federal agencies through ACE, thereby simplifying the paperwork submission process for importers. DOE requests comment on requiring importers to file the certification of admissibility to DOE through the ACE system.
If adopted, the effective date for this rule would be 30 days after publication of the final rule in the
The Office of Management and Budget (OMB) has determined that today's regulatory action is not a “significant regulatory action” 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 has prepared an IRFA for this rulemaking. As presented and discussed below, the IRFA describes potential impacts on importers of covered products or equipment subject to DOE energy conservation standards and the associated compliance costs.
A statement of the objectives of, and reasons and legal basis for, the proposed rule are set forth elsewhere in the preamble and not repeated here.
For companies classified in different NAICS codes, the Small Business Administration (SBA) has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule. The size standards are listed by North American Industry Classification System (NAICS) code and industry description available at:
No comprehensive list of importers of covered products or equipment subject to DOE energy conservation standards exists. DOE evaluated many information sources to assess the availability of data needed to estimate the number of companies that could be both importers of products covered by this rulemaking
After assessing the data available, DOE relied on a three-step process for estimating the number of small business importers: (1) Determine the potentially affected industries; (2) Find the number of small businesses in each industry; (3) Estimate the number of those small businesses that import covered products or equipment subject to DOE energy conservation standards.
Determination of potentially affected industries. To calculate the number of small businesses potentially impacted by this rule, DOE first screened out the sectors listed in Table IV.1 (using two-digit NAICS code) from consideration based on the nature of their business (
The industries that passed the screening are shown in Table IV.2.
Next, DOE evaluated each of the two-digit sectors that passed the first screening at the most granular five-digit NAICS code level.
Calculation of small businesses in affected industries. Second, DOE used firm-size data from the United States Census to determine the number of small businesses in each five-digit NAICS code sector that passed the screening. DOE used 2012 data because it was the most recently available data and, as mentioned above, DOE used the 500-employee threshold as the small business cut off.
Calculation of the number of small business importers. Step 3 provides the total number of small businesses in the industries that may be affected by this rulemaking. DOE is not aware of data on the share of these small businesses that act as importers. To estimate this share, DOE divided the total number of importers—Department of Commerce data from 2011 shows that there were 183,960 U.S. businesses importing to the United States—by the total number of businesses in those sectors that might be engaged in importing (1,318,818)
This represents a conservative upper-bound estimate because there are companies contained in some NAICS sectors (
DOE assumes small businesses that import covered products or equipment will have already complied with their legal obligation to certify to DOE, through CCMS, all basic models of such products or equipment, and therefore would be required to report only the following information regarding the most recent certification of the basic model of covered products or equipment subject to DOE energy conservation standards they import:
1. The CCMS ticket number;
2. The CCMS attachment identification number assigned to the certification submission;
3. The line number in the submission corresponding to the basic model certified; and
4. If the covered product or equipment is a component of a final product, the brand name and individual model number of the final product.
The role of customs brokers. In assessing the burden of any new reporting requirements on importers, it is important to understand the process by which the typical importer complies with existing customs requirements. The vast majority of importers use customs brokers for a bundle of import-related services, including notification of regulatory requirements and aid in completing and submitting the required paperwork. For importers, who typically operate on tight schedules, delays at port can cause missed deliveries and result in heavy financial and reputational penalty. For these reasons, the job of negotiating the regulatory terrain of the import business is usually entrusted to third-party customs brokers who specialize in importation reporting requirements (among other services). Customs brokers are familiar with the necessary regulatory filings and procedures required to ensure that a shipment clears customs in a timely manner. Typically, an importer will contract with a broker who will file all necessary paperwork including the commercial invoice and any supplemental information required by various regulatory bodies. Additionally, brokers already have bond coverage to cover any duties associated with the importation and can save importers from having to post a separate bond for each shipment.
Because this proposed rule entails only an electronic reporting requirement through ACE, DOE does not anticipate any significant incremental investment in product or capital conversion costs to comply. Currently, more than 96 percent of all entries filed with CBP are already being filed through the ABI. By the end of 2016, ACE will become the Single Window—the primary system through which the trade community will report imports and exports and the
While the ABI interface helps to facilitate the process, there are new data elements proposed as reporting requirements in this NOPR. Those fall into two categories: (1) data fields that are already typically collected during the importation process and (2) those that are not.
Data Already Collected: Based on interviews with customs brokers, DOE believes that the brand name of the final product being imported, which would be required in the instances where the covered product or equipment is a component of the final product, is on the commercial invoice that is already filed with the customs broker as part of the importation process. When required, this data can be keyed in during the electronic filing process that brokers and importers already go through and thus should have minimal impact on both the importer and customs broker.
Data Not Currently Collected: The individual model number, required in the instances where the covered product or equipment is a component of the final product, the CCMS ticket number, the CCMS attachment identification number assigned to the certification submission, and the line number in the submission corresponding to the basic model certified are the only data fields proposed as a new reporting requirement that are not typically on any of the invoices. Depending on the product, the individual model numbers may be included on the invoice. In any case, customs brokers indicated they would most likely go to their client (the importer) to ask them for any missing information, which the importer would have as part of the process of certifying compliance to DOE.
Furthermore, brokers maintain databases of their customers and associated products, and one of their service offerings is to be proactive with their clients in notifying them of new regulations. In interviews, brokers indicated they would likely review their customer databases to determine which companies are subject to new requirements and alert them to the additional data requirements discussed above. By contacting customers prior to the regulations going into effect, brokers can minimize the likelihood of any delays due to new DOE reporting requirements and also give customers time to prepare for the new requirements, particularly given the proposed two-year lead time.
Therefore, DOE estimates a one-time burden of approximately twenty hours per small business importer to learn the reporting requirements and set up a system of information flow internally. DOE notes that all information should be readily available, as importers of covered products or equipment subject to energy conservation standards are already required to certify compliance.
Because importers are currently required to submit certifications of compliance annually through CCMS, the information that would be submitted in a certification of admissibility prior to each importation of a basic model covered product or equipment (the most recent CCMS ticket number, attachment number, and line number) would need to be obtained and keyed in only once per year, for the first shipment of the covered product or equipment following the annual CCMS filing. Because this information would be readily available to the importer, DOE estimates annual burden of 0.03 hours per basic model of covered product or equipment imported by the small business importer to obtain and enter the data required for a certification of admissibility. For all subsequent certifications of admissibility submitted over the course of the year, the importer would only be required to electronically resubmit the same data, and the burden imposed by these subsequent electronic submissions would be negligible.
Based upon information in the CCMS database, DOE estimates that, on average, each small business importer submits compliance certification reports for 157 basic models of covered product or equipment annually. Therefore, DOE estimates that the requirement of submission of certifications of admissibility proposed in this rule would result in an annual burden of approximately 4.71 hours per small business importer.
DOE seeks comments on the following topics regarding this IRFA:
(1) The five-digit NAICS codes believed to include importers of covered products or equipment subject to DOE energy conservation standards or such products or equipment with covered components.
(2) The availability of data on the number of small business importers in sectors covered by DOE regulations.
(3) The estimated burden associated with the reporting of individual model numbers for both importers and customs brokers.
(4) How brokers will react to the necessary reporting requirements and if there will be any increase in costs.
DOE is not aware of any rules or regulations that duplicate, overlap, or conflict with the rule being proposed.
This section considers alternatives to the proposals for the submission of certifications of admissibility in this rulemaking. As noted in Section III.B, DOE initially considered requiring importers to provide, in their certifications of admissibility, detailed product-specific information for all covered products and equipment subject to energy conservation standards. However, in order reduce the potential burden on importers, DOE proposes to collect this additional information only where the importer has not already certified to DOE the compliance of the product or equipment through CCMS.
DOE could further mitigate the potential impacts on small business importers by not requiring a certification of admissibility prior to the importation of any covered consumer product or commercial and industrial equipment subject to an applicable energy conservation standard. However, DOE strongly believes the proposals in this rulemaking are essential to a sustainable and consistent enforcement program vis-à-vis imports of covered products and covered equipment. While the alternative may mitigate the potential economic impacts on small entities compared to the proposed provisions, the ability for DOE to enforce its energy conservation regulations far exceeds any potential burdens. Furthermore, small businesses may benefit from stronger enforcement against noncompliant imports. Thus, DOE rejected this alternative and is adopting the provisions set forth in this rulemaking for all importers of covered products and covered equipment. DOE continues to seek input from businesses that would be affected by this rulemaking and will consider comments received in the development of any final rule.
DOE is proposing to require persons importing into the United States any covered consumer product or industrial equipment subject to an applicable energy conservation standard to provide a certification of admissibility to the DOE. DOE assumes that importers will have already complied with their legal obligation to certify to DOE, through CCMS, all basic models of products or
The certification of admissibility would be required to be submitted to DOE through CPB's ACE system.
The following are DOE estimates of the total annual reporting burden imposed on persons importing into the United States any covered product or equipment subject to an applicable energy conservation standard. These estimates take into account the time necessary to obtain and enter the required electronic information to be submitted to ACE. As explained in Section IV.B.3, for each basic model of covered product and equipment, the data required for a certification of admissibility would need to be obtained and entered only once per year. Subsequent certifications during the same year would only require electronic resubmission of the same data previously submitted, and the burden of each resubmission would be negligible.
Public comment is sought regarding: Whether this proposed collection of information is necessary for the proper performance of the functions of DOE, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to Chad Whiteman, Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503 and by email to
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.
DOE anticipates that this proposed 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 have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has determined that it would 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. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.
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, the 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
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 proposal 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 proposal 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 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 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 OIRA at 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 promulgates 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.
DOE has tentatively concluded that today's proposed regulatory action, which sets forth a proposed requirement for the submission of a certification of admissibility to DOE by importers of products or equipment subject to energy conservation standards, is not a significant energy action because the requirement is not likely to have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as such by the Administrator at OIRA. Accordingly, DOE has not prepared a Statement of Energy Effects on the proposed rule.
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
Submitting comments via
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DOE processes submissions made through regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that regulations.gov provides after you have successfully uploaded your comment.
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a compact disk (CD), if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and are free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.
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. DOE requests comment on the requirement that importers importing covered products or equipment subject to DOE energy conservation standards that are within the listed HTS codes provide a certification of admissibility to DOE. Further, DOE requests comment as to whether covered products or equipment subject to or are being considered for DOE energy conservation standards are currently imported using other HTS codes.
2. DOE requests comment on its proposal to require, for a shipment that contains covered products or equipment subject to a DOE energy conservation standard, that the importer state whether the product or equipment has been certified to DOE as compliant with all applicable energy conservation standards and, if so, provide the CCMS ticket number, the CCMS attachment identification number, and line number associated with the specific basic model.
3. DOE requests comment on the requirement that importers submit a certification of admissibility to DOE for all covered products and equipment subject to an energy conservation standard that is contained in the shipment, either as a final product or a component part of a final product.
4. DOE requests comment on requiring importers to indicate in the import declaration to DOE whether the covered product or equipment being imported and subject to DOE energy conservation standards is a final product or a component of a final product and, if the covered product or equipment is a component, the brand name and individual model number of the final product. DOE also requests comment regarding whether the reporting burden on importers would be less to provide this information as part of the certification of admissibility or as part of a compliance certification report submitted through CCMS.
5. DOE requests comment on its proposal to collect additional product-specific information only (
6. DOE requests comment on requiring importers to file the certification of admissibility through ACE.
The Secretary of Energy has approved publication of this proposed rule.
Confidential business information, Energy conservation, Household appliances, Imports, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, DOE is proposing to amend part 429 of chapter II, subchapter D of title 10, Code of Federal Regulations, as set forth below:
42 U.S.C. 6291-6317
(c) Any person importing a unit of a covered product or covered equipment subject to an applicable energy conservation standard set forth in parts 430 or 431 of this chapter for entry into the United States on or after [2 YEARS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], whether the unit is a component part of another product or a final product, must provide a certification of admissibility to the Secretary in accordance with § 429.500.
(b) An individual model number is public information unless:
(1) The individual model number is a unique model number of a commercial packaged boiler, commercial water heating equipment, commercial HVAC equipment or commercial refrigeration equipment that was developed for an individual customer,
(2) The individual model number is not displayed on product literature, and
(3) Disclosure of the individual model number would reveal confidential business information as described at § 1004.11 of this title—in which case, under these limited circumstances, a manufacturer may identify the individual model number as a private model number on a certification report submitted pursuant to § 429.12(b)(6).
(b) * * *
(6) For each brand, the basic model number and the individual model number(s) in that basic model with the following exceptions: For walk-in coolers, the basic model number for each brand must be submitted. For distribution transformers, the basic model number or kVA grouping model number (depending on the certification method) for each brand must be submitted. For commercial HVAC, WH, and refrigeration equipment, an individual model number may be identified as a “private model number” if it meets the requirements of § 429.7(b).
(a) A certification of admissibility submitted pursuant to § 429.5(c) must meet the provisions of this section.
(b) The certification must be submitted through the Automated Commercial Environment (ACE) of the U.S. Customs and Border Protection (CBP) before the entry of the unit(s) at the port of arrival.
(c) The certification must include whether the basic model of the product or equipment being imported has been certified to DOE as compliant with all applicable energy conservation standards;
(d) If the importer has not submitted a certification report for the basic model of the product or equipment being imported pursuant to § 429.12, the certification of admissibility must include:
(1) The type of product or equipment (using a three-digit code corresponding to the applicable section in 10 CFR part 429, subpart B);
(2) The brand name of the covered product or equipment;
(3) The individual model number of the covered product or equipment;
(4) Whether the covered product or equipment being imported is a final product or a component of a final product and, if the covered product or equipment is a component, the brand name and individual model number of the final product;
(5) The original equipment manufacturer (OEM) of the covered product or equipment being imported as defined in § 429.2 and, in the case of electric motors, the Compliance Certification number; and
(6) A contact name and email address of the importer of record.
(e) If the importer has submitted a certification report for the basic model of the product or equipment being imported pursuant to § 429.12, the certification of admissibility must include:
(1)The CCMS ticket number of the most recent certification submission;
(2)The CCMS attachment identification number assigned to the certification submission;
(3) The line number in the submission corresponding to the basic model certified; and
(4) If the covered product or equipment is a component of a final product, the brand name and individual model number of the final product.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A330-200 and -300 series airplanes, Model A330-200 Freighter series airplanes, and Airbus Model A340-541 and A340-642 airplanes. This proposed AD was prompted by a report of an under-torqued forward engine mount bolt. This proposed AD would require a one-time torque check of the forward and aft engine mount bolts, and corrective actions if necessary. We are proposing this AD to detect and correct improperly torqued engine mount bolts, which could lead to detachment of the engine from the airplane during flight; and consequent damage to the airplane and injury to persons on the ground.
We must receive comments on this proposed AD by February 12, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency, which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0082, dated May 11, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Airbus Model A330-200 and -300 series airplanes, Model A330-200 Freighter series airplanes, and Airbus Model A340-541 and A340-642 airplanes. The MCAI states:
In 2013, during a pre-delivery test on an A330 aeroplane fitted with Pratt & Whitney (PW) PW4170 engines, an issue with N1 vibrations level on [engine] ENG1 was identified. While performing an engine removal, one forward engine mount bolt was found improperly torqued. The investigation concluded this was due to a production line engine installation quality issue. Further analysis showed that some aeroplanes, delivered between June 2006 and January 2014, may have had the rear (AFT) and forward (FWD) engine mount bolts improperly torqued.
This condition, if not detected and corrected, could ultimately lead to an in-flight detachment of the engine from the aeroplane, possibly resulting in damage to the aeroplane and/or injury to persons on the ground.
Prompted by these findings, Airbus issued four Alert Operators Transmissions (AOT) A71L004-14 (for A330 aeroplanes fitted Pratt & Whitney (PW) engines), AOT A71L006-14 (for A330 aeroplanes fitted with General Electric (GE) engines), AOT A71L005-14 (for A330 aeroplanes fitted with Rolls Royce (RR) Trent 700 engines) and AOT A71L008-14 (for A340 aeroplanes fitted with RR Trent 500 engines) to provide torque check instructions.
For the reasons described above, this [EASA] AD requires a one-time torque check of the FWD and AFT engine mount bolts and, depending on findings, [corrective actions] re-torque of the affected bolt(s) and/or replacement of all four bolts and associated nuts.
Findings (or discrepancies) include one bolt that is loose or able to rotate, two or more bolts that are loose or able to rotate, or one or more pylon bolts that are fully broken. Corrective actions include re-torqueing the affected bolt(s), and replacing all bolts and associated nuts with new bolts and nuts on the engine where the loose or fully broken bolt(s) were detected. This proposed AD specifies reporting of all findings (including no discrepancies). The corrective actions include re-torqueing loose bolts before further flight. The compliance times for replacing loose or fully broken bolts ranges, depend on airplane configuration, and range from before further flight if more than one bolt rotates or is fully broken to no later than 2,350 flight cycles or 24,320 flight hours since first flight of the airplane, if only one bolt rotates. You may examine the MCAI in the AD docket on the Internet at
We have reviewed the following service information.
• Airbus AOT A71L004-14, Revision 01, dated April 7, 2014. The service information describes procedures for doing a one-time torque check to determine if there are any loose or fully broken engine mount pylon bolts at four positions at the forward engine pylon 1 and pylon 2 of Airbus Model A330 series airplanes having Pratt and Whitney engines, doing corrective actions, and reporting all findings.
• Airbus AOT A71L005-14, Revision 01, dated December 11, 2014. The service information describes procedures for doing a one-time torque check to determine if there are any loose or fully broken engine mount pylon bolts at four positions at the forward engine pylon 1 and pylon 2 of Airbus Model A330 series airplanes having Trent 700 engines, doing corrective actions, and reporting all findings.
• Airbus AOT A71L006-14, dated July 22, 2014. The service information describes procedures for doing a one-time torque check to determine if there are any loose or fully broken engine mount pylon bolts at five FWD and four AFT positions at the forward engine pylon 1 and pylon 2 of Airbus Model A330 series airplanes having GE engines, doing corrective actions, and reporting all findings.
• Airbus AOT A71L008-14, Revision 01, dated December 18, 2014. The service information describes procedures for doing a one-time torque check to determine if there are any loose or fully broken engine mount pylon bolts at four positions at the forward engine pylon 1 and pylon 2 of Airbus Model A340 series airplanes having Trent 500 engines, doing corrective actions, and reporting all findings.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
On June 21, 2013, we issued AD 2013-14-04, Amendment 39-17509 (78 FR 68352, November 14, 2013). AD 2013-14-04 requires a torque check of forward engine mount bolts, and replacement if necessary on all Airbus Model A330-223F, -223, -321, -322, and -323 airplanes. AD 2013-14-04 was
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 55 airplanes of U.S. registry.
We also estimate that it would take about 12 work-hours per product to comply with the basic requirements of this proposed AD, and 1 work-hour per product to report torque check findings. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $60,755, or $1,105 per product.
In addition, we estimate that any necessary follow-on actions would take about 20 work-hours and require parts costing $90,200 for a cost of $91,900 per product. We have no way of determining the number of aircraft that might need these actions.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this proposed AD is 2120-0056. The paperwork cost associated with this proposed AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this proposed AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.
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 proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by February 12, 2016.
None.
This AD applies to the Airbus airplanes specified in paragraphs (c)(1) through (c)(5) of this AD, certificated in any category, from manufacturer serial number (MSN) 0715 through MSN 1507 inclusive, and MSN 1509, except airplanes on which all engines have been removed and/or replaced since the date of the first flight of the airplane.
(1) Airbus Model A330-201, -202, -203, -223, and -243 airplanes.
(2) Airbus Model A330-223F and -243F airplanes.
(3) Airbus Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(4) Airbus Model A340-541 airplanes.
(5) Airbus Model A340-642 airplanes.
Air Transport Association (ATA) of America Code 71, Powerplant.
This AD was prompted by a report of an under-torqued forward engine mount bolt. We are issuing this AD to detect and correct improperly torqued engine mount bolts, which could lead to detachment of the engine from the airplane during flight; and consequent damage to the airplane and injury to persons on the ground.
Comply with this AD within the compliance times specified, unless already done.
For the purpose of this AD, an affected engine is an engine that has never been removed and/or replaced since first flight of the airplane.
(1) For Model A330-200, -200 Freighter, and -300 series airplanes equipped with PW engines: At the earlier of the times specified in paragraph (h)(1)(i) and (h)(1)(ii) of this AD, accomplish a one-time torque check of the forward (FWD) and rear (AFT) engine mount bolts on each affected engine, at the locations
(i) Within 2,000 flight hours after the effective date of this AD.
(ii) During the accomplishment of Airbus Service Bulletin A330-71-3028, Revision 01, dated February 20, 2012, if done after the effective date of this AD.
(2) If, during the torque check required by paragraph (h)(1) of this AD, only one FWD bolt is found that rotates: Do the actions specified in paragraph (h)(2)(i), (h)(2)(ii), (h)(2)(iii), or (h)(2)(iv) of this AD, as applicable.
(i) For Model A330-200 and -300 series airplanes with an average flight time of greater than 132 minutes and having accumulated less than 2,350 flight cycles and less than 24,320 flight hours since first flight of the airplane: Before further flight, re-torque the affected bolt, and, within 2,350 flight cycles or 24,320 flight hours since first flight of the airplane, whichever occurs first, replace the 4 bolts and associated nuts, in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L004-14, Revision 01, dated April 7, 2014.
(ii) For Model A330-200 and -300 series airplanes with an average flight time of 132 minutes or lower and having accumulated less than 1,950 flight cycles and less than 20,210 flight hours since first flight of the airplane: Before further flight, re-torque the affected bolt, and within 2,350 flight cycles or 24,320 flight hours since first flight of the airplane, whichever occurs first, replace the 4 bolts and associated nuts, in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L004-14, Revision 01, dated April 7, 2014.
(iii) For Model A330-200 Freighter series airplanes having accumulated less than 2,140 flight cycles and less than 6,600 flight hours since first flight of the airplane: Before further flight, re-torque the affected bolt and within 2,140 flight cycles or 6,600 flight hours since first flight of the airplane, whichever occurs first, replace the 4 bolts and associated nuts, in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L004-14, Revision 01, dated April 7, 2014.
(iv) For airplanes identified in paragraphs (h)(2)(iv)(A), (h)(2)(iv)(B), and (h)(2)(iv)(C) of this AD: Before further flight, replace the 4 bolts and associated nuts in accordance with the instructions of Section 4.2.3, “Findings,” of AOT A71L004-14, Revision 01, dated April 7, 2014.
(A) Model A330-200 and -300 series airplanes with an average flight time of greater than 132 minutes and having accumulated 2,350 flight cycles or more or 24,320 flight hours or more since first flight of the airplane.
(B) Model A330-200 and -300 series airplanes with an average flight time of 132 minutes or lower and having accumulated 1,950 flight cycles or more or 20,210 flight hours or more since first flight of the airplane.
(C) Model A330-200 Freighter series airplanes having accumulated 2,140 flight cycles or more or 6,600 flight hours or more since first flight of the airplane:
(3) If, during the torque check required by paragraph (h)(1) of this AD, two or more FWD bolts are found that rotate: Before further flight, replace the 4 bolts and associated nuts in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L004-14, Revision 01, dated April 7, 2014.
(4) If, during the torque check required by paragraph (h)(1) of this AD, one or more FWD pylon bolts are found fully broken: Before further flight, replace the 4 bolts and associated nuts in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L004-14, Revision 01, dated April 7, 2014, except as required by paragraph (m)(2) of this AD.
(5) If, during the torque check required by paragraph (h)(1) of this AD, only one AFT bolt is found that rotates: Before further flight, re-torque the affected bolt, and replace the 4 bolts and associated nuts at the next engine removal, in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L004-14, Revision 01, dated April 7, 2014.
(6) If, during the torque check required by paragraph (h)(1) of this AD, two or more AFT bolts are found that rotate: Before further flight, replace the 4 bolts and associated nuts in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L004-14, Revision 01, dated April 7, 2014.
(7) If, during the torque check required by paragraph (h)(1) of this AD, one or more AFT pylon bolts are found fully broken: Before further flight, replace the 4 bolts and associated nuts in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L004-14, Revision 01, dated April 7, 2014, except as required by paragraph (m)(2) of this AD.
AD 2013-14-04, Amendment 39-17509 (78 FR 68352, November 14, 2013), requires a torque check of forward engine mount bolts using Airbus Service Bulletin A330-71-3028, Revision 01, dated February 20, 2012. If accomplishing the torque check of FWD engine mount bolts within the compliance times specified in paragraph (g) of the FAA AD 2013-14-04 using Airbus Service Bulletin A330-71-3028, Revision 01, dated February 20, 2012, perform the torque check of the AFT engine mount bolts at the same time.
(1) For Airbus Model A330-200, -200 Freighter, and -300 series airplanes equipped with GE engines: Within 2,000 flight hours after the effective date of this AD, accomplish a one-time torque check of the FWD and AFT engine mount bolts on each affected engine, at the locations specified in, and in accordance with the instructions of Section 4.2.2, “Inspection Requirements,” of Airbus AOT A71L006-14, dated July 22, 2014.
(2) If, during the torque check required by paragraph (j)(1) of this AD, only one FWD bolt is found that rotates: Do the actions specified in paragraphs (j)(2)(i) and (j)(2)(ii) of this AD, as applicable.
(i) For airplanes that have accumulated less than 4,000 flight cycles and less than 30,800 flight hours since first flight of the airplane: Before further flight, re-torque affected FWD engine mount bolt(s), in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L006-14, dated July 22, 2014, and, within 4,000 flight cycles or 30,800 flight hours since first flight of the airplane, whichever is first, replace the 5 bolts, as applicable, and their associated nuts with new bolts and nuts in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L006-14, dated July 22, 2014.
(ii) For airplanes that have accumulated 4,000 flight cycles or more or 30,800 flight hours or more since first flight of the airplane: Before further flight, replace the 5 FWD engine mount bolts, as applicable, and their associated nuts with new bolts and nuts in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L006-14, dated July 22, 2014.
(3) If, during the torque check required by paragraph (j)(1) of this AD, two or more FWD bolts are found that rotate: Repair before further flight using a method approved in accordance with the procedures specified in paragraph (p)(1) of this AD.
(4) If, during the torque check required by paragraph (j)(1) of this AD, one or more FWD pylon bolts are found fully broken: Repair before further flight using a method approved in accordance with the procedures specified in paragraph (p)(1) of this AD.
(5) If, during the torque check required by paragraph (j)(1) of this AD, only one AFT bolt is found that rotates: Before further flight, re-torque the affected AFT engine mount bolt(s) in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L006-14, dated July 22, 2014, and, at the next engine removal, replace the 4 bolts and associated nuts with new bolts and nuts in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L006-14, dated July 22, 2014.
(6) If, during the torque check required by paragraph (j)(1) of this AD, two or more AFT bolts are found that rotate: Repair before further flight using a method approved in accordance with the procedures specified in paragraph (p)(1) of this AD.
(7) If, during the torque check required by paragraph (j)(1) of this AD, one or more AFT pylon bolts are found fully broken: before further flight, do all applicable corrective actions in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L006-14, dated July 22, 2014, except as required by paragraph (m)(2) of this AD.
(1) For Airbus Model A330-200, -200 Freighter, and -300 series airplanes equipped with RR Trent 700 Engines: Within 2,000 flight hours after the effective date of this AD, accomplish a one-time torque check of the FWD and AFT engine mount bolts on each affected engine, at the locations specified in,
(2) If, during the torque check required by paragraph (k)(1) of this AD, any discrepancy is detected (one bolt rotates, two or more bolts rotate, or one or more bolts are fully broken): Within the compliance time specified in Airbus AOT A71L005-14, Revision 01, dated December 11, 2014, accomplish all applicable corrective actions in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L005-14, Revision 01, dated December 11, 2014, except as required by paragraphs (m)(1) and (m)(2) of this AD.
(1) For Airbus Model A340-541 and -642 airplanes equipped with Rolls-Royce Trent 500 Engines: Within 2,000 flight hours after the effective date of this AD, accomplish a one-time torque check of FWD and AFT engine mount bolts on each affected engine, at the locations specified in, and in accordance with the instructions of Section 4.2.2, “Inspection requirements,” of Airbus AOT A71L008-14, Revision 01, dated December 18, 2014.
(2) If, during the torque check required by paragraph (l)(1) of this AD, any discrepancy is detected (one bolt rotates, two or more bolts rotate, or one or more bolts are fully broken): Within the compliance time specified in Airbus AOT A71L008-14, Revision 01, dated December 18, 2014, accomplish all applicable corrective actions, in accordance with the instructions of Section 4.2.3, “Findings,” of Airbus AOT A71L008-14, Revision 01, dated December 18, 2014, except as required by paragraphs (m)(1) and (m)(2) of this AD.
(1) Where Airbus AOTs A71L005-14, Revision 01, dated December 11, 2014; A71L006-14, dated July 22, 2014; and A71L008-14, dated September 29, 2014, specify to contact Airbus for further actions, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
(2) Where Airbus AOT A71L004-14, Revision 01, dated April 7, 2014; AOT A71L005-14, Revision 01, dated December 11, 2014; AOT A71L006-14, dated July 22, 2014; and AOT A71L008-14, Revision 01, dated December 18, 2014, specify actions “if one pylon bolt fully broken,” this AD requires that those actions be done if one or more pylon bolt is found fully broken during any torque check required by paragraph (h)(1), (j)(1), (k)(1) or (l)(1) of this AD.
At the applicable time specified in paragraphs (n)(1) and (n)(2) of this AD: After accomplishment of any torque check required by paragraphs (h), (j), (k), and (l) of this AD, report all inspection results to Airbus, including no findings, in accordance with the “Reporting” section of the applicable service information specified in paragraphs (h), (j), (k), and (l) of this AD.
(1) If the torque check was done on or after the effective date of this AD: Submit the report within 30 days after the torque check.
(2) If the torque check was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.
(1) This paragraph provides credit for the actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus AOT A71L004-14, dated April 1, 2014 (for Airbus Model A330 Airplanes Equipped with Pratt and Whitney Engines), which is not incorporated by reference in this AD.
(2) This paragraph provides credit for the actions required by paragraph (k) of this AD, if those actions were performed before the effective date of this AD using Airbus AOT A71L005-14, dated September 29, 2014 (for Airbus Model A330 Airplanes Equipped with Rolls-Royce Trent 700 Engines), which is not incorporated by reference in this AD.
(3) This paragraph provides credit for the actions required by paragraph (l) of this AD, if those actions were performed before the effective date of this AD using Airbus AOT A71L008-14, dated September 29, 2014 (for Airbus Model A340 Airplanes Equipped with Rolls-Royce Trent 500 Engines), which is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0082, dated May 11, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 airplanes. This proposed AD was
We must receive comments on this proposed AD by February 12, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
• Federal eRulemaking Portal: Go to
• Fax: 202-493-2251.
• Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
• Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For Boeing service information identified in this proposed AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may view this referenced service information at the FAA, FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
You may examine the AD docket on the Internet at
Eric Brown, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6476; fax: 425-917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We received reports of electrical shorts of the motor stator wiring burning a hole through the housing of the motor of the CAC. The pack bay is classified as a flammable fluid leakage zone and the burn-through would be classified as an ignition source. This condition, if not corrected, could result in a fire in the pack bay, and consequent reduced controllability of the airplane.
We reviewed Boeing Alert Service Bulletin B787-81205-SB210055-00, Issue 001, dated March 12, 2015. This service information describes procedures for installing modified inboard and outboard CAC modules on the left side and right side CACTCS packs. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We are proposing 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 the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at
The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (ARC), to enhance the AD system. One enhancement was a new process for annotating which steps in the service information are required for compliance with an AD. Differentiating these steps from other tasks in the service information is expected to improve an owner's/operator's understanding of crucial AD requirements and help provide consistent judgment in AD compliance. The steps identified as RC in any service information identified previously have a direct effect on detecting, preventing, resolving, or eliminating an identified unsafe condition.
For service information that contains steps that are labeled as RC, the following provisions apply: (1) the steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD, and an AMOC is required for any deviations to RC steps, including substeps and identified figures; and (2) steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
We estimate that this proposed AD affects 22 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
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 proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by February 12, 2016.
None.
This AD applies to The Boeing Company Model 787-8 airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin B787-81205-SB210055-00, Issue 001, dated March 12, 2015.
Air Transport Association (ATA) of America Code 21, Air conditioning.
This AD was prompted by reports of electrical shorts of the motor stator wiring burning a hole through the housing of the motor of the cabin air compressor (CAC). We are issuing this AD to prevent an electrical short from burning through the housing of the motor of the CAC, which could result in a fire in the pack bay and consequent reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 5 years after the effective date of this AD, install modified inboard and outboard CAC modules on the left side and right side cabin air conditioning and temperature control system (CACTCS) packs, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB210055-00, Issue 001, dated March 12, 2015.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (i)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact Eric Brown, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6476; fax: 425-917-6590; email:
(2) For Boeing service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
Food and Drug Administration, HHS.
Proposed order.
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls) based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECT devices for other intended uses specified in this proposed order. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements for other intended uses specified in this proposed order. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.
Submit either electronic or written comments on this proposed order by March 28, 2016. See section XVII of this document for the proposed effective date of a final order based on this proposed order.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Michael J. Ryan, Center for Devices and
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629), Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). One type of general control provided by the FD&C Act is a restriction on the sale, distribution, or use of a device under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)). A restriction under section 520(e) of the FD&C Act must be implemented through rulemaking procedures, unlike the administrative order procedures that apply to this proposed reclassification under section 513(e) of the FD&C Act, as amended by FDASIA.
Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.
Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.
Although, under the FD&C Act, the manufacturer of a class III preamendments device may respond to the call for PMAs by filing a PMA or a notice of completion of a PDP, in practice, the option of filing a notice of completion of a PDP has not been used. For simplicity, although corresponding requirements for PDPs remain available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for the filing and receiving approval of a PMA.
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 Stat. 1056) amended section 513(e) of the FD&C Act, changing the process for reclassifying a device from rulemaking to an administrative order. Section 608(b) of FDASIA amended section 515(b) of the FD&C Act changing the process for requiring premarket approval for a preamendments class III device from rulemaking to an administrative order.
FDA is publishing this document to propose the reclassification of ECT devices for use in treating severe MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition from class III to class II.
Section 513(e) of the FD&C Act governs reclassification of classified preamendments devices. This section provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See,
Reevaluation of the data previously before the Agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see
FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information,
Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order for reclassifying a device. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the
FDAMA added a section 510(m) to the FD&C Act. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&C Act if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device.
FDA is proposing to require PMAs for ECT devices for the intended uses listed in section IX of this proposed order. For the purposes of this proposed order, the term, “Certain Specified Intended Uses,” refers to the listing of the intended uses in section IX of this proposed order and includes the following: schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia.
Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order requiring PMAs. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) Publication of a proposed order in the
Section 515(b)(2) of the FD&C Act provides that a proposed order to require premarket approval shall contain: (1) The proposed order, (2) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved PMA or a declared completed PDP and the benefit to the public from the use of the device, (3) an opportunity for the submission of comments on the proposed order and the proposed findings, and (4) an opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
Under section 501(f) of the FD&C Act (21 U.S.C. 351(f)), a preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order (or a final rule issued under section 515(b) of the FD&C Act prior to the enactment of FDASIA) requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act, whichever is later. For ECT devices, the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period. Since these devices were classified in 1979, the 30-month period has expired (44 FR 51776, September 4, 1979). Therefore, if the proposal to require premarket approval for ECT devices for Certain Specified Intended Uses is finalized, section 501(f)(2)(B) of the FD&C Act requires that a PMA for such device be filed within 90 days of the date of issuance of the final order. If a PMA is not filed for such device within 90 days after the issuance of a final order, the device would be deemed adulterated under section 501(f) of the FD&C Act.
Also, a preamendments device subject to the order process under section 515(b) of the FD&C Act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final order requiring the filing of a PMA for the device. At that time, an IDE is required only if a PMA has not been filed. If the manufacturer, importer, or other sponsor of the device submits an IDE application and FDA approves it, the device may be distributed for investigational use. If a PMA is not filed by the later of the two dates, and the device is not distributed for investigational use under an IDE, the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if its distribution continues. Other enforcement actions include, but are not limited to, the following: Shipment of devices in interstate commerce will be subject to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and the individuals responsible for such shipment will be subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 333). In the past, FDA has requested that manufacturers take action to prevent the further use of devices for which no PMA has been filed and may determine that such a request is appropriate for the class III devices that are the subject of this proposed order, if finalized.
In accordance with section 515(b)(2)(D) of the FD&C Act, interested persons are being offered the opportunity to request reclassification of ECT devices for Certain Specified Intended Uses.
In the preamble to the proposed rule (43 FR 55729, November 28, 1978), FDA described the recommendation of the Neurological Device Classification Panel (the Panel) that ECT be classified into class II because: “Although the use of this device involves a substantial risk to the patient, the Panel believes that the benefit of the treatment outweighs the risks involved if the patients are selected carefully and the devices are designed and used properly. The Panel believes that a standard will provide reasonable assurance of the safety and effectiveness of the device and that there is sufficient information to establish a standard to provide such assurance.” However, in 1979 (44 FR 51776, September 4, 1979), FDA classified ECT into class III after receiving several comments on the proposed rule, and reconvening the Panel to discuss these comments (May 29, 1979). The Panel discussed whether there was sufficient evidence to establish a performance standard for ECT. Several panel members expressed doubt that such information was available, and the Panel voted to recommend that ECT be classified into class III. FDA agreed with the Panel stating that FDA did not believe that the characteristics of ECT devices had been
On August 13, 1982, the American Psychiatric Association (APA) submitted a reclassification petition to FDA requesting that ECT be classified into class II. The reclassification petition was discussed at a Panel meeting on November 4, 1982 (47 FR 44611, October 8, 1982). The Panel recommended that ECT be reclassified from class III to class II. FDA tentatively agreed that there was sufficient evidence to reclassify to class II for severe depression and schizophrenia and published a notice of intent to reclassify (48 FR 14758, April 5, 1983). Several comments received by the Agency argued that research and data did not support that ECT is an effective therapy for schizophrenia, and after careful review of the scientific literature and the APA's petition, FDA agreed with the comments. In the subsequent proposed rule (55 FR 36578, September 5, 1990), FDA determined that the evidence of effectiveness for schizophrenia was inconclusive, and proposed that ECT be reclassified to class II only for severe depression and remain class III for all other indications. In 1995, FDA published an order for the submission of safety and effectiveness information on ECT devices (60 FR 41986, August 14, 1995). In 2003, FDA published an intent to withdraw the 1990 proposed rule (68 FR 19766, April 22, 2003) followed by withdrawal in 2004 (69 FR 68831, November 26, 2004) of the proposed rule for reclassification of ECT, along with other FDA proposed rules that had been outstanding for more than 5 years because the proposals were no longer considered viable candidates for final action. Thus, ECT devices remain in class III for all indications.
In 2009, FDA published an order for the submission of safety and effectiveness information on ECT devices by August 7, 2009 (74 FR 16214, April 9, 2009). In response to that order, FDA received two submissions from ECT manufacturers suggesting that ECT devices could be reclassified to class II. The manufacturers stated that safety and effectiveness of these devices may be assured by reducing the frequency of treatments, temporary or permanent interruption of treatments, reduction of stimulus dose, electrode placement, dosage or type of anesthetic (or other) medications, including minimizing psychotropic medications, brief pulse or ultra-brief pulse waveform stimulus, EEG monitoring, proper preparation (including conductive gel) and contact of the electrodes to the skin, changing anesthetic medications or doses, and changing concurrent medications.
In 2009, FDA also opened a public docket to receive information and comments regarding the current classification process for ECT by January 8, 2010 (74 FR 46607, September 10, 2009). FDA received over 3,000 submissions to the docket, with the majority of respondents, approximately 80 percent, opposing reclassification of ECT. The majority of those opposing reclassification of ECT cited adverse events from ECT treatment as the basis for their opposition. The most common type of adverse event mentioned in the public docket were memory adverse events, followed by other cognitive complaints, brain damage, and death.
On January 27-28, 2011, a meeting of the Neurological Devices Panel was held to discuss the classification of ECT devices for treatment of several disorders. There was panel consensus recommending class III for Schizophrenia, Bipolar manic states, Schizoaffective, and Schizophreniform disorder. The Panel did not reach consensus on the classification of ECT for depression (unipolar and bipolar) and catatonia. The Panel transcript and other meeting materials are available on FDA's Web site (
The ECT device consists of an electrical generator and a pair of electrodes that apply a brief intense electrical current to the head in order to induce a generalized seizure. In addition to generating and modulating the electrical functions of the stimulus, the box enclosing the generator also has capabilities and displays for physiological monitoring. The device parameters such as voltage, pulse width, frequency, and treatment (train) duration are adjustable. The typical display may provide information such as Electroencephalograph (EEG) activity, stimulus administration, total charge, energy, and impedance. These devices are currently regulated under § 882.5940 (21 CFR 882.5940), product code GXC.
FDA is proposing in this order to modify the identification language from how it is presently written in § 882.5940(a). FDA is clarifying in the identification that these are prescription devices and clarifying that this device type includes the ECT pulse generator and its stimulation electrodes and accessories.
FDA is proposing that ECT devices intended for treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition be reclassified from class III to class II. In this proposed order, the Agency has identified special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls applicable to the devices, would provide reasonable assurance of safety and effectiveness. Absent the special controls identified in this proposed order, general controls applicable to the device are insufficient to provide reasonable assurance of the safety and effectiveness of the device.
Therefore, in accordance with sections 513(e) and 515(i) of the FD&C Act and21 CFR 860.130, based on new information with respect to the devices and taking into account the public health benefit of the use of the device and the nature and known incidence of the risk of the device, FDA, on its own initiative, is proposing to reclassify this preamendments class III device into class II when the device is intended to treat severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. FDA believes that this new information is sufficient to demonstrate that the proposed special controls can effectively mitigate the risks to health identified in the next section, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for ECT devices intended for treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
Section 510(m) of the FD&C Act authorizes the Agency to exempt class II devices from premarket notification (510(k)) submission. FDA has considered ECT devices intended for treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition and decided that the device does require premarket notification. Therefore, the Agency does not intend to exempt this
After considering the available information from the reports and recommendations of the advisory committees (panels) for the classification of these devices, FDA has evaluated the risks to health associated with the use of ECT devices and determined that the following risks to health are associated with its use:
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FDA believes that ECT devices indicated for severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition should be reclassified from class III to class II because, in light of new information about the effectiveness of these devices, special controls, in addition to general controls, can be established to provide reasonable assurance of safety and effectiveness of the device, and because general controls themselves are insufficient to provide reasonable assurance of its safety and effectiveness. FDA believes that in the specified patient population, and with the application of general and special controls as described in this document, the probable benefit to health from use of the device outweighs the probable injury or illness from such use. FDA acknowledges significant risks associated with ECT but believes that for the specified population—patients age 18 years of age and older experiencing a severe MDE associated with MDD or BPD for whom other treatment options have not been successful or for whom rapid, definitive response is needed due the severity of a psychiatric or medical condition—the probable benefit of ECT outweighs these risks. FDA is inviting comments on whether the term “treatment resistant” and the phrase “require rapid response” provide sufficient clarity to the population for which ECT benefits outweigh risks.
Since the time of the original ECT device classification, sufficient evidence has been developed to support a reclassification of ECT to class II with special controls for severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. FDA's review of the clinical literature has been previously summarized in the Executive Summary to the January 27-28, 2011, Neurological Device Panel meeting to discuss ECT classification (
FDA also examined other conditions, including bipolar mania, schizophrenia, schizoaffective disorder, schizophreniform disorder, and catatonia, but there were insufficient clinical data to support effectiveness for these conditions. FDA relied upon literature describing clinical study data collected largely in patients age 18 and older. Data on the use of ECT in children and adolescents is limited and hence the recommended reclassification is limited to patients 18 years of age and older. Most of the published literature FDA is aware of and reviewed focused on subject populations that did not receive benefit from prior treatments; therefore, the recommended reclassification is limited to treatment resistant populations as well as those patients who require a rapid response due to the severity of their psychiatric or medical condition. Further, practice guidelines published by the APA task force on ECT and the NICE in the United Kingdom recommend that ECT be considered for primary use (
Panel deliberations focused heavily on ECT versus sham meta-analysis for treatment of depression. Discussion focused on the clinical meaningfulness of the effect size, the wide confidence interval which included 0 (
While medical/physical risks may occur with ECT, they vary in frequency, with the most severe risks being quite rare. Death associated with ECT appears to occur at a very low rate comparable to that of minor surgical procedures. Recent estimates of the mortality rate associated with ECT treatment are 1 per 10,000 patients or 1 per 80,000 treatments (Refs. 1, 10).
The risks of greatest concern to clinicians and patients remain cognitive and memory impairment. Both the FDA review of literature and the meta-analyses of the randomized controlled studies indicate that while post-procedure disorientation occurs frequently, it is transient, typically resolving within minutes after the procedure is complete. The systematic meta-analyses of the randomized controlled clinical trials data by FDA revealed that there is no evidence that disorientation following ECT is long-term or persistent. The primary areas of concern for persistent changes are anterograde and retrograde autobiographical memory. While rates of occurrence are difficult to estimate, it appears that both types of memory impairment are not uncommon. The literature review suggests that anterograde memory declines immediately post-ECT and then returns to baseline within 3 months post-ECT. Retrograde autobiographical memory declines immediately post-ECT and then appears to improve over time. It is important to note that while improvement is seen, impairment may persist past 6 months post-ECT. Data on persistent retrograde autobiographical memory deficits beyond 6 months is lacking in the scientific literature. Therefore, it cannot be concluded that retrograde autobiographical memory returns to baseline over time. (See tables 6 and 7 and Figures 2-24 from FDA's Executive Summary, Ref. 11.)
Despite the occurrence and uncertainty of duration of memory impairment, FDA believes that the potential benefits of ECT outweigh the risks in patients 18 years of age or older for MDE associated with MDD or BPD in patients who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
FDA believes that special controls, in addition to the general controls, are necessary to provide a reasonable assurance of safety and effectiveness for ECT devices indicated for severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. FDA believes that the risks to health identified in section V associated with ECT devices indicated for severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition can be mitigated with general and special controls.
Several of the risks associated with ECT, including adverse reaction to anesthetic agents/neuromuscular blocking agents, cardiovascular complications, death, and pulmonary complications, are medical/physical risks related to the procedure involving use of the device. For these risks, safe use of the device is based on appropriate directions for use. FDA believes that labeling provisions are adequate to mitigate these risks, including:
• Disclosure of contraindications, precautions, warnings, and potential adverse effects/complications in both physician and patient labeling so that users and patients can be advised of conditions under which ECT treatment should not proceed, and
• Specific device use instructions including information regarding conduct of pre-ECT patient assessments; and information on appropriate patient monitoring during an ECT procedure) to minimize potential ECT procedural complications.
Other ECT risks are specific to the medical/physical effects of the induced seizure and potentially severe muscle contractions that result from use of the device (dental/oral trauma, physical trauma, prolonged or tardive seizures, pain/discomfort). FDA believes that appropriate labeling provisions are adequate to mitigate these risks, including:
• Disclosure of contraindications, precautions, warnings, and adverse effects/complications in both physician and patient labeling so that users and patients can be advised of conditions under which ECT treatment should not proceed and are aware of potential adverse effects associated with ECT treatment, and
• Specific device use instructions including information regarding conduct of pre-ECT assessments, use of mouth protection during the procedure, use of general anesthetic agents and neuromuscular blocking agents, and information on appropriate patient monitoring during the procedure to minimize potential post-ECT complications.
The risks of skin burns can be mitigated by performance testing of the device to demonstrate safe electrical performance, adhesive integrity, and physical and chemical stability of the
The risk of cognitive and memory impairment can be mitigated by establishing the technical parameters for the device along with non-clinical testing data to confirm the electrical characteristics of the output waveform to ensure that the device performance characteristics are consistent with existing clinical performance data that supports a reasonable assurance of safety and effectiveness (see information on review of clinical performance data in section VII). This risk is further mitigated by providing information to both the user and patient on the potential adverse effects of the device, alternative treatments, and a prominent warning that ECT device use may be associated with: Disorientation, confusion, and memory problems and limited in its long-term effectiveness (greater than 3 months). These risks can also be mitigated by providing instructions to the user that include recommendations on cognitive status monitoring prior to beginning ECT and during the course of treatment. Providing this information helps patients and providers to make informed choices about how and when to use ECT to maximize benefits and minimize potential adverse effects.
The risks associated with malfunction of the device can be mitigated by data demonstrating electrical and mechanical safety and the functioning of all safety features built into the device (including the static and dynamic impedance monitoring system); appropriate analysis/testing of electromagnetic compatibility such that electromagnetic interference does not cause device malfunction; and appropriate software verification, validation, and hazard analysis to ensure that any device software has been adequately designed.
The potential for manic symptoms or worsening of the condition being treated can be mitigated by labeling provisions, including:
• The clinical training needed by users of the device to ensure appropriate use of ECT and appropriate ongoing medical management of the patient, and
• Information on the patient population in which the device is intended to be used, including a detailed summary of the clinical testing pertinent to use of the device, information on the potential adverse effects of treatment, and information on the typical course of treatment such that users and patients can make informed decisions regarding the appropriate use of ECT.
The risks of adverse skin reactions can be mitigated with biocompatibility testing to ensure that the materials used in patient-contacting components of the device are safe for skin contact as well as labeling that provides information on validated methods for reprocessing any reusable components between uses.
Specifically, FDA believes that special controls in § 882.5940(b)(1), together with general controls, are sufficient to mitigate the risks to health described in section V:
Table 1 shows how FDA believes that the risks to health identified in section V can be mitigated by the proposed special controls.
In addition, FDA is proposing to limit this reclassification to prescription use devices under 21 CFR 801.109. Under 21 CFR 807.81, the device would continue to be subject to 510(k) notification requirements. Elsewhere in this issue of the
In accordance with section 515(b) of the FD&C Act, FDA is proposing to require that a PMA be filed with the Agency within 90 days after issuance of any final order based on this proposal for ECT devices intended for Certain Specified Intended Uses. An applicant whose device was legally in commercial distribution before May 28, 1976, or whose device has been found to be substantially equivalent to such a device, will be permitted to continue marketing such class III devices during FDA's review of the PMA provided that the PMA is timely filed. FDA intends to review any PMA for the device within 180 days of the date of filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA
FDA intends that under § 812.2(d), the preamble to any final order based on this proposal will state that, as of the date on which the filing of a PMA or a notice of completion of a PDP is required to be filed, the exemptions from the requirements of the IDE regulations for preamendments class III devices in § 812.2(c)(1) and (2) will cease to apply to any device that is: (1) Not legally on the market on or before that date or (2) legally on the market on or before that date but for which a PMA or notice of completion of a PDP is not filed by that date, or for which PMA approval has been denied or withdrawn.
If a PMA for a class III device is not filed with FDA within 90 days after the date of issuance of any final order requiring premarket approval for the device, the device would be deemed adulterated under section 501(f) of the FD&C Act (21 U.S.C. 351(f)). The device may be distributed for investigational use only if the requirements of the IDE regulations are met. The requirements for significant risk devices include submitting an IDE application to FDA for its review and approval. An approved IDE is required to be in effect before an investigation of the device may be initiated or continued under § 812.30. FDA, therefore, cautions that IDE applications should be submitted to FDA at least 30 days before the end of the 90-day period after the issuance of the final order to avoid interrupting investigations.
FDA proposes that following the effective date of any final order, ECT devices intended for use in treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition must comply with the special controls. FDA notes that a firm whose ECT device was legally in commercial distribution before May 28, 1976, or whose device was found to be substantially equivalent to such a device and who does not intend to market such device for uses other than use in treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, may remove such intended uses from the device's labeling. FDA proposes that such ECT devices must comply with the special controls, and, as part of the special controls, anyone who wishes to continue to market an ECT device for these uses must submit an amendment to their previously cleared premarket notification (510(k)) that demonstrates compliance with the special controls within 60 days after the effective date of the final order. Such amendment will be added to the 510(k) file but will not serve as a basis for a new substantial equivalence review. A submitted 510(k) amendment in this context will be used solely to demonstrate to FDA that an ECT device is in compliance with the special controls. If a 510(k) amendment is not submitted within 60 days after the effective date or if FDA determines that the amendment does not demonstrate compliance with the special controls, the device may be considered adulterated under section 501(f)(1)(B) of the FD&C
As required by section 515(b) of the FD&C Act, FDA is publishing its proposed findings regarding: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that this device have an approved PMA or a declared completed PDP when intended for use in treating any condition other than MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition and (2) the benefits to the public from the use of ECT devices for other specified intended uses.
These findings are based on the reports and recommendations of the advisory committees (panels) for the classification of these devices along with information submitted in response to the 515(i) Order (74 FR 16214), the public docket (74 FR 46607) and any additional information that FDA has obtained. Additional information regarding the risks as well as classification associated with this device type can be found in 43 FR 55729, 44 FR 51776, 48 FR 14758, and 55 FR 36578.
An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.
For intended uses other than the treatment of MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, FDA concludes that the safety and effectiveness of ECT devices have not been established by adequate scientific evidence. Given the FDA analysis and the advisory panel deliberations (see
FDA believes that insufficient information exists regarding the risks and benefits of the device in order for FDA to determine that general and/or special controls will provide reasonable assurance of the safety and effectiveness of ECT for Certain Specified Intended Uses. As established in section 513(a)(1)(C) of the FD&C Act and 21 CFR 860.3(c)(3), a device is in class III if insufficient information exists to determine that general controls and/or special controls are sufficient to provide reasonable assurance of its safety and effectiveness and the device is purported or represented to be for a use that is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury. FDA believes that the risks to health identified in section V for the use of ECT devices for Certain Specified
The risks to health for ECT devices for intended uses other than the treatment of MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition are the same as outlined in section V.
As discussed previously, there is limited scientific evidence regarding the effectiveness of ECT devices for intended uses other than the treatment of MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. Because the benefits of these devices for such uses are unknown, it is impossible to estimate the direct effect of the devices on patient outcomes. However, based on claims made about the devices, the devices have the potential to benefit the public by providing additional treatment options for schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia.
A PMA for ECT devices Certain Specified Intended Uses must include the information required by section 515(c)(1) of the FD&C Act. Such a PMA should also include a detailed discussion of the risks identified previously, as well as a discussion of the effectiveness of the device for which premarket approval is sought. In addition, a PMA must include all data and information on: (1) Any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.
A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use (see § 860.7(c)(1)). Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use. Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness. (§ 860.7(c)(2)).
Before requiring the filing of a PMA or notice of completion of a PDP for a device, FDA is required by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for interested persons to request a change in the classification of the device based on new information relevant to the classification. Any proceeding to reclassify the device will be under the authority of section 513(e) of the FD&C Act.
A request for a change in the classification of ECT devices is to be in the form of a reclassification petition containing the information required by 21 CFR 860.123, including new information relevant to the classification of the device.
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices and section 515(b) of the FD&C Act provided for FDA to issue regulations to require approval of an application for premarket approval for preamendments devices or devices found to be substantially equivalent to preamendments devices. Because sections 513(e) and 515(b) of the FD&C Act as amended require FDA to issue final orders rather than regulations, FDA will continue to codify reclassifications and requirements for approval of an application for premarket approval, resulting from changes issued in final orders, in the Code of Federal Regulations (CFR). Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this proposed order, we are proposing to codify the reclassification of ECT devices for use in treating severe Major Depressive Episode (MDE) associated with Major Depressive Disorder (MDD) or Bipolar Disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition into class II by amending § 882.5940.
The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed order refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (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 812 have been approved under OMB control number 0910-0078. The collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231.
The device and patient warning labeling provisions in this proposed rule are not subject to review by OMB because they do not constitute a “collection of information” under the PRA. Rather, the recommended labeling is a “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).
FDA is proposing that any final order based on this proposal become effective 90 days after the date of publication in the
Interested persons may submit either electronic comments regarding this document to
The following references are on display in the Division of Dockets Management (see
1. American Psychiatric Association. 2001. The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging—A Task Force Report, 2nd ed. American Psychiatric Press, Washington, DC.
2. Royal College of Psychiatrists. The ECT Handbook. Ed. A.I.F. Scott. The Third Report of the Royal College of Psychiatrists' Special Committee on ECT. 2004. Available at:
3. NICE (National Institute for Health and Clinical Excellence). Guidance on the Use of Electroconvulsive Therapy. Technology Appraisal Guidance: 59:1-37, 2003. Available at:
4. NICE (National Institute for Health and Clinical Excellence). Depression in Adults (update). National Clinical Practice Guideline: 90:1-585, 2009. Available at:
5. U.S. Department of Health and Human Services. Mental Health: A Report of the Surgeon General. Rockville, MD: Substance Abuse and Mental Health Services Administration/Center for Mental Health Services; National Institutes of Health/National Institute of Mental Health, 1999. Available at:
6. Semkovska, M., D.M. McLoughlin, “Objective Cognitive Performance Associated with Electroconvulsive Therapy for Depression: A Systematic Review and Meta-Analysis.”
7. Greenhalgh, J., C. Knight, D. Hind, C. Beverley, S. Walters, “Clinical and Cost-effectiveness of Electroconvulsive Therapy for Depressive Illness, Schizophrenia, Catatonia and Mania: Systematic Reviews and Economic Modelling Studies.
8. Kirsch, I., B.J. Deacon, T.B. Huedo-Medina, A. Scoboria, T.J. Moore, B.T. Johnson, “Initial Severity and Antidepressant Benefits: A Meta-analysis of Data Submitted to the Food and Drug Administration.”
9. Watts, B.V., et al. “An Examination of Mortality and Other Adverse Events Related to Electroconvulsive Therapy Using a National Adverse Event Report System.”
10. Girish, K., N.S. Gill, “Electroconvulsive Therapy in Lorazepam Non-Responsive Catatonia.”
11. FDA Executive Summary, Prepared for the January 27-28, 2011 meeting of the Neurological Devices Panel, Meeting to Discuss the Classification of Electroconvulsive Therapy Devices (ECT), available at
Medical devices, Neurological devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 882 be amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
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(b)
(i) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy, and the type of impedance monitoring system must be fully characterized.
(ii) Non-clinical testing data must confirm the electrical characteristics of the output waveform.
(iii) Components (and accessories) of the device that come into human contact must be demonstrated to be biocompatible.
(iv) Performance data must demonstrate electrical and mechanical safety and the functioning of all safety features built into the device including the static and dynamic impedance monitoring system.
(v) Appropriate analysis/testing must validate electromagnetic compatibility.
(vi) Appropriate software verification, validation, and hazard analysis must be performed.
(vii) Performance data must demonstrate electrical performance, adhesive integrity, and physical and chemical stability of the stimulation electrodes.
(viii) The labeling for the device must include the following:
(A) Information related to generic adverse events associated with ECT treatment.
(B) Instructions must contain the following specific recommendations to the user of the device:
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(C) Clinical training needed by users of the device.
(D) Information on the patient population in which the device is intended to be used.
(E) Information on how the device operates and the typical course of treatment.
(F) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device.
(G) A detailed summary of the device technical parameters;
(H) Where appropriate, validated methods and instructions for reprocessing of any reusable components.
(I) The following statement, prominently placed: “Warning: ECT
(J) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.”
(ix) Patient labeling must be provided and include:
(A) Relevant contraindications, warnings, precautions.
(B) A summation of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device.
(C) Information on how the device operates and the typical course of treatment.
(D) The potential benefits.
(E) Alternative treatments.
(F) The following statement, prominently placed: “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems.”
(G) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.”
(H) The following statements on known risks of ECT, absent performance data demonstrating that these risks do not apply:
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Food and Drug Administration, HHS.
Notification of public hearing; request for comments; correction.
The Food and Drug Administration (FDA or Agency) is correcting a notification of a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” that appeared in the
Lori Jo Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
In FR Doc. 2015-27703, appearing on pages 66845 and 66847 in the
1. On page 66845, in the third column under
2. On page 66847, in the first column under section IV. Attendance and Registration, the third sentence is revised to read: “Individuals who wish to attend (including FDA employees) or present at the public hearing must
Environmental Protection Agency (EPA).
Proposed rule.
The U.S. Environmental Protection Agency (EPA) proposes to revise the public notice rule provisions for the New Source Review (NSR), title V and Outer Continental Shelf (OCS) permit programs of the Clean Air Act (CAA) and the corresponding onshore area (COA) determinations for implementation of the OCS air quality regulations. This action would remove the mandatory requirement to provide public notice of a draft air permit, as well as certain other program actions, through publication in a newspaper and would instead allow for electronic noticing (e-notice) of these actions. The proposed rule revisions would apply to major source air permits issued by the EPA, by EPA-delegated air agencies, and by air agencies with EPA-approved programs (with the exception of permits that are issued pursuant to the Tribal NSR Rule, which already allows for e-notice methods).
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2015-0090, at
For general information on this proposed rule for NSR and OCS programs, please contact Mr. Dave Svendsgaard, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, by phone at (919) 541-2380 or by email at
The information presented in this document is organized as follows:
Entities potentially affected by this proposed rule include air agencies responsible for the permitting of stationary and OCS sources of air pollution or for determining COA designation for implementation of the OCS Air Regulations. This includes the EPA Regions, and both EPA-delegated air programs and EPA-approved air programs that are operated by state, local and tribal governments. Entities also potentially affected by this proposed rule include owners and operators of stationary and OCS sources that are subject to air pollution permitting under the CAA, as well as the general public who would have an interest in knowing about permitting actions, public hearings and other agency actions.
2.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions. The proposed rule may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree, suggest alternatives and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used to support your comment.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns wherever possible, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
To request a public hearing or information pertaining to a public hearing on this document, contact Ms. Pamela Long, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, by phone at (919) 541-0641 or by email at
In addition to being available in the docket, an electronic copy of this
The CAA authorizes the EPA to administer and oversee the permitting of stationary and other sources of air pollution. To accomplish this obligation, the EPA has promulgated permitting regulations for construction of sources pursuant to NSR under title I of the CAA, for operation of major and certain other sources of air pollutants under title V of the CAA; and for OCS sources under CAA § 328. These regulations are contained in 40 CFR parts 51, 52, 55, 70, 71 and 124, and cover the requirements for federal permit actions (
In general, prior to issuing a permit to a major stationary source
This action addresses the method by which the permitting agency provides the required notice of the permitting action and access to the information supporting the action. We specifically propose to remove from the EPA rules the mandatory requirement that draft permits under CAA permitting programs for major sources be noticed in a newspaper of general circulation and instead allow—and, in some cases, require (as explained below)—the use of electronic methods to provide notice of and access to these draft permits. We are not changing the majority of the existing procedural requirements for processing permit applications and the requirement to keep a record of the materials that support the permit decisions. We also are not changing existing requirements as to the substance of the information that must be made available when the permitting agency notifies the public of the draft permitting action.
We are also not proposing to revise the federal rules for public notice that apply to minor NSR permits under 40 CFR part 51.161, which require “notice by prominent advertisement.”
We are also not proposing to revise the public participation requirements for permits that establish a Plantwide Applicability Limitation (PAL), which cross reference the public participation procedures at § 51.161.
In addition, these proposed revisions would not change the requirements for nonattainment NSR (NNSR), minor NSR, and synthetic minor NSR permits in Indian country, which are contained in 40 CFR part 49 and allow for other means of public noticing beyond a newspaper of general circulation.
This action addresses the public notice requirements for all air agencies. For the noticing of major source permits by the EPA and other air agencies that implement the federal permitting rules, e-notice would be required under this proposed rule. For major source permits issued by air agencies that implement their own rules approved by EPA, this proposed rule would allow additional flexibility such that these permitting authorities would have the option to provide e-notice or to continue to provide traditional newspaper notice, although they must adopt a single, “consistent noticing method” to be used for all of their major source permits. Thus, where an agency opts to post notices of draft permits on a Web site in lieu of newspaper publication, it must post all notices to this Web site in order to ensure that the public has a consistent and reliable location to turn to for all permit notices. If the agency does not maintain a consistent noticing method (
In addition, to satisfy the proposed requirements for e-notice, except for programs that implement part 51 regulations for PSD and NNSR permits and states that issue OCS permits, the air agency must maintain a mailing list that will notify any person on the list of any new public notice. This approach is consistent with the current noticing requirements in the federal rules for NSR and EPA-issued OCS permits, and for federal and state operating permits under parts 70 and 71 (and OCS permits subject to these requirements), which all require that a copy of the notice be mailed to persons who have subscribed to the appropriate mailing list. The EPA believes that continuing with this approach will maintain the current efforts to reach communities through a variety of methods. This proposed rule clarifies that distributing the public notice information to the persons on the mailing list can be by way of email or the more traditional mailing methods (
This proposed action also requires that, when a permitting authority adopts the e-notice approach, it also must provide e-access. For the purpose of this proposed rule, e-access means that the permitting authority must make the draft permit available electronically (
In addition to the proposed approach described above for EPA-approved permitting programs, we are requesting comment on an alternative approach. In the alternative approach, permitting programs that implement 40 CFR part 51 or 70 and that select e-notice as their
Additionally, we are soliciting comment on including a provision in the regulations to allow air agencies to temporarily use an alternative noticing method if their Web site is unavailable for a period of time. This may be necessary during periods when a Web site is temporarily offline due to, for example, malfunctions, transitions to a different Web site platform, or emergency situations that result in prolonged electrical system outages. As with the Web site noticing method, the permitting agency would need to assure that the alternative noticing method provides adequate notice to the affected public. We specifically seek comment on the criteria for determining when the alternative method should be available, the length of time it could be used, and how the transition to the method would be conveyed to the public.
Finally, we are proposing to extend the use of e-notice methods to three non-permitting actions. In each case, the regulatory provision currently requires notice of the action by way of newspaper publication. We briefly describe each provision below.
• The “OCS Air Regulations” at 40 CFR part 55 apply to more than just OCS permitting actions. Specifically, when the EPA makes a COA designation determination, it must do so by way of a process that allows for public comment on the draft determination. Through this action, we are proposing to require electronic notice of the COA designation.
• The existing federal PSD regulations contain a provision for “permit rescission” that only refers to newspaper notification. Specifically, paragraph 40 CFR 52.21(w)(4) requires that, if an agency rescinds a permit, it shall give “adequate notice of the rescission,” and that newspaper publication “shall be considered adequate notice.” We are proposing in this action to revise the provision to specifically require that the Administrator notify the public of a permit rescission by e-notice.
• Paragraph 40 CFR 71.4(g) provides that, when the EPA takes action to administer and enforce, or to delegate, a federal operating permits program, it will publish a notice in the
• It is important to note that the EPA is not proposing additional public participation where existing rules do not require public participation. Thus, the minimum notice and access requirements being proposed in this rule would apply to the public participation procedures of air quality permits issued by EPA and other air agencies in cases where the current rules require public participation in a permitting decision.
While the CAA requires permitting authorities to offer the opportunity for public participation in the processing of air permits, it does not specify the best or preferred method for providing notice to the public.
When the EPA first developed public notice provisions for the major NSR program in the late 1970s and early 1980s, newspaper advertisement was the most commonly accepted method for providing notice of permits and other agency actions in the community. The EPA, therefore, finalized rules that contained, among other things, requirements for newspaper notice of permitting and other actions. When the title V rules were first issued in 1992, the EPA considered the public notice requirements for PSD permits and similarly required in part that the public be notified of a permitting action by way of “a newspaper of general circulation in the area where the source is located or in a State publication designed to give general public notice.” 40 CFR 70.7(h)(1).
Permitting authorities typically have met the required newspaper notice provision by publishing a single-day legal notice of availability of the draft permit action in a local newspaper. In some cases, depending on the location of the source and the demographics of the affected community, some permitting agencies may publish the notice in multiple newspapers to reach the intended audience, or may provide bilingual newspaper notices of their permitting actions. The specific contents of the newspaper notice are specified for some programs, and they tend to vary with different permitting authorities. Most notices typically contain basic information about the draft permit, such as the permit number, the name and physical address of the facility, and the name and contact information of a person from whom interested persons may obtain additional information on the draft permit. Depending on the permitting authority, the notice may include more detailed information on the draft permit, such as the anticipated emissions increase from the proposed project. The public notice for the permit also informs interested parties on how to request and/or attend a public hearing and how to access additional information relevant to the draft permit. This additional information is typically
Over the years, however, availability of and access to the basic forms of electronic media—namely, the Internet and email—have increased significantly across the United States. More recently, sophisticated mobile devices and high-speed wireless networks are transforming the Internet and how our society interacts with it.
The EPA believes that having the notice of availability and the draft permit remain electronically available on an agency's Web site for an extended period of time, as compared to a one-time publication in an area newspaper that directs the public to a reading room at the permitting agency, or at a library or other location near the source, results in a significant increase in public awareness of the proposed permitting action and access to the draft permit. Even without this additional electronic access to the draft permit, posting the notice for the duration of the public comment period provides more widespread public notice than a single-day publication in a newspaper of general circulation.
We note that, in some instances, communities that are potentially affected by a proposed permitting action may have limited access to the Internet, and therefore may rely more on newspapers for receiving their information. In these cases, newspaper publication can still provide a means to convey permitting information to these communities. However, we expect that in many cases these communities would have access to a public library with Internet access that would provide access to the online permit notices and draft permits. Furthermore, because many permitting authorities are now supplementing their newspaper notices with electronic posting of the notice on their agency Web site, it seems unlikely that the public would continue to seek out permitting announcements in newspapers in the future. As discussed later in this preamble, a report issued by the National Environmental Justice Advisory Council (NEJAC) found that publication in the legal section of a newspaper is antiquated and ineffective and is not ideal for providing notice to affected environmental justice (EJ) communities. Given this significant shift away from the public's reliance on traditional newspapers for information, and the corresponding increased reliance on the Internet, the EPA recognizes that newspaper notice is no longer the only, or most effective, method of announcing permitting actions to reach the public.
To this end, the EPA has identified the need to allow for more noticing options than just newspaper publication. In 2011, the EPA issued the Tribal NSR Rules that contained, among other things, requirements for noticing of permits in Indian country that allowed for options other than newspaper and print media.
This action proposes to remove the mandatory requirement that draft permits for sources subject to the major NSR, title V or OCS programs be noticed in a newspaper of general circulation and instead allow the use of electronic methods to provide notice of draft permits. This action also proposes these same revisions for COA designations in the OCS program, permit rescissions under the federal PSD program, and noticing of federal operating permits programs. In the case of permits issued by the EPA or other agencies implementing 40 CFR parts 52 or 71, we are proposing to require that the EPA provide e-notice for all draft permits. For permits issued by other air agencies—specifically, agencies that implement 40 CFR parts 51 or 70—we are proposing that those permitting authorities would have the option to adopt either e-notice or traditional newspaper notice; however, they must select one of the noticing methods as their consistent noticing method to be used to notice all of their draft permits and their rules must reflect this selection.
This proposed action also requires that, if the permitting authority adopts the e-notice approach, it would also provide e-access as described in this rule. Specifically, the agency would make the draft permit available electronically for the duration of the public comment period. Furthermore, this rule proposes specific minimum requirements for satisfying the meaning of the terms “e-notice” and “e-access.” While e-access in this rule pertains only to the availability and access to the draft permit, nothing in this rule nullifies the requirement for the permitting authority to maintain a record of the permit
More specifically, this proposed action includes revisions to 40 CFR part 51.166 (state/local PSD permits), part 52.21 (EPA/delegated agency-issued PSD permits), part 70 (state/local/tribal operating permits), part 71 (EPA/delegated agency-issued operating permits), part 55 (EPA-issued OCS permits and COA designations), and part 124 (EPA-issued permits applying generally to a number of media programs, including EPA-issued PSD and OCS permits). In addition, this action proposes to add specific public notice provisions in 40 CFR 51.165 (for state/local major NNSR permits), which currently does not contain section-specific public notification requirements (except for PAL permits).
It is important to note that some of the rule sections that we are proposing to amend have existing noticing and access requirements that are specific to the section and may not appear in other sections. We are not proposing to alter these specific rule provisions in this action. For example, the notice requirements in § 51.166(q) relate to the “degree of increment consumption” that is expected from the source or modification, but these requirements are not in other sections. Similarly, parts 70 and 71 have differing requirements for what information the notice should identify. In the federal PSD and the OCS permitting sections, there are currently no specific provisions for permit noticing—nor are we proposing specific requirements through this action—but these sections cross reference the procedural requirements in part 124 for which amendments are being proposed in this action. Consequently, the proposed rule revisions that would allow for e-notice and e-access appear differently in each rule section, but the basic effect of the changes is the same across all of the sections being revised.
In specifying that an agency electronically post the notice and draft permit “for the duration of the public comment period,” we note that there may be instances during the comment period when the Web site is unavailable. This may occur due to, among other things, Web site failures or power outages. While we expect that these situations would be infrequent and short in duration, they would nonetheless temporarily interrupt the noticing of the draft permit and the electronic posting would be less than “the duration of the comment period.” We do not interpret “the duration of the comment period” to be a requirement for uninterrupted web access, but rather to mean that, to the extent that interruptions to the accessibility of the posted notice and draft permit occur, they would be short and infrequent. Further, we expect that the permitting authority or webmaster would be in a good position to make a reasonable assessment, based on experience, regarding unusual interruptions that would significantly affect the noticing of the permit. In general, we do not expect that short interruptions would significantly affect the noticing of the permit, and we do not expect these situations to result in a need for the comment period to be extended to account for the time during which the Web site is unavailable. On the other hand, for an agency that is providing only electronic access to the permit record (
In addition to the proposed rule approach, we are taking comment on an alternative approach for air agencies that implement 40 CFR parts 51 and 70 that would not require these agencies to couple e-notice with e-access. In other words, if an agency adopts e-notice as its consistent noticing method, it would not be required to provide e-access (although the agency could provide e-access at its discretion—
These proposed rules provide flexibility to air agencies with EPA-approved programs, such that they are no longer required to use newspaper noticing, although they can continue to use the newspaper method for noticing if they choose. In the case of EPA and other air agencies that implement the federal permitting rules, we are proposing that these programs are required to use e-notice and e-access, but these terms are limited in scope to require only minimal electronic noticing and access and to allow the agency the flexibility to use either its own Web site or another publicly available Web site that it identifies. We believe the proposed rule revisions, once final, will lead to more effective noticing of air permitting actions and will likely promote additional public participation in the permitting process, while also avoiding the higher costs of newspaper advertisement.
For the purpose of this proposed rule, the term “e-notice” means the notice of availability of the draft permitting action is provided on the permitting agency's Web site or another public Web site identified by the permitting agency for the purpose of noticing permits. The Web site should be easily accessible by the public, and the noticing section of the Web site should be “user friendly”—
In some of the rule sections proposed for revision, the permitting authority must maintain a mailing list that will be used to notify persons on the list of any new public notice of a draft permit. This requirement exists in part 124 for EPA-issued PSD and OCS permits and in parts 70 and 71 for title V permits. We are proposing that the mailing list requirement would continue to apply for the noticing of these permits, and we are proposing that the mailing list requirement would not apply to programs that currently do not have a mailing list requirement—namely, agencies that follow part 51 regulations for PSD and NNSR permits and for state-issued OCS permits. Although the mailing list provisions were originally created with the idea that authorities would use the postal service to physically convey the notice to the recipients on the list, it has evolved over time such that many agencies that maintain a mailing list use electronic notification rather than mailing the notice through the postal service. In general, email notification has become a common practice among air agencies that currently provide supplemental notice via their agency Web site. Furthermore, many of these agencies' Web sites are equipped with a hyperlink or a radio button that facilitates convenient and easy sign up for interested persons to subscribe to the mailing list. Thus, we are not changing the current rule sections that require mailing lists, but we are updating the provisions to also allow agencies to use electronic methods to administer the activities of the mailing list, to include subscribing to the list, maintaining the list, and distributing the required information to the parties on the list. We expect that some agencies may use both electronic methods and more traditional methods (
Part 71.11(d)(3) currently requires the EPA and delegated agencies to affirmatively solicit for their mailing lists. As part of this proposed rulemaking, we are proposing revised language for part 71 to explain that the permitting authority will notify the public via Web site of the opportunity to be included or removed from its mailing list. We expect that many agencies will add a generally accepted method (
Also, it is important to reiterate that we are not proposing to alter any existing requirements regarding the content of the public notice. We are, however, expressly requiring that the notice direct interested parties to information on how to request and/or attend a public hearing and how to access additional information relevant to the draft permit. Requirements regarding additional information in the notice vary across the different sections of the permitting rules, and may further vary among different individual permitting authorities. Most notices of availability will contain, at a minimum, the permit number, name and physical address of the facility, and the name and contact information of a person from whom interested persons may obtain additional information on the draft permit.
We request comment on this approach to defining e-notice as it applies to this proposed rule. In particular, we request comment on whether this approach and the corresponding rule text preclude some forms of electronic noticing that are currently being used or under development.
To clarify what this action is proposing for e-notice, in the following section we provide a summary of the proposed rule requirements. In addition, we are providing recommended “best practices” for electronic notice. These best practices recommendations are intended to foster improved communication and outreach of permit notices beyond the minimum requirements being proposed in this action.
In order to satisfy the requirement for e-notice of a permit, the permitting authority shall electronically post, for the duration of the public comment period, the following information on a public Web site identified by the permitting authority:
(1) notice of availability of the draft permit for public comment;
(2) information on how to access the permit record (either electronically and/or physically);
(3) information on how to request and/or attend a public hearing on the draft permit; and
(4) all other information currently required to be included in the public notice under the existing regulations.
In addition, where already required by the current rules, the permitting authority shall maintain a mailing list of persons who request to be notified of permitting activity and shall distribute (
While not proposed as a requirement of this rule, the EPA is recommending best practices that can be used to augment the above requirements for electronic notice. These best practice methods are not required to satisfy the e-notice requirements for this proposed rule, but may be helpful in the course of providing the fullest communication to the public on permitting actions. The recommended best practices of e-notice include:
• Providing notice of the final permit issuance on the Web site.
• Soliciting actively for the mailing list on the Web site (
• Providing options for email notification that enable subscribers to tailor the types of notifications they receive (
For the purpose of this proposed rule, the term “e-access” means the permitting authority shall post on its Web site (or a Web site identified by the permitting authority) the draft permit for the duration of the public comment period. As with e-notice, the posting of the draft permit should be in a prominent location on the Web site, and the Web site should allow user-friendly
In defining the requirements for e-access and authorizing the use of e-access for major source permits that are undergoing public notice, we are proposing to add new paragraphs to certain program rules and specifically revise other program rules that have draft permit access requirements containing language that could be read to suggest that access requirements could not be met through electronic availability of the permit materials.
As noted above, nothing in this proposed rule affects the requirement for an agency to maintain a record to support the decisions of the permitting actions and to make it available to the public. Furthermore, nothing in this proposed rule affects the record retention policies and requirements of governmental agencies that provide schedules for retention and disposal of paper and electronic records. Finally, the electronic posting of draft and final permits, including information supporting the permit decisions (
We request comment on this approach to defining e-access as it applies to this proposed rule. In particular, we request comment on whether this approach and the corresponding regulatory text preclude some forms of electronic access that are currently being used or under development. Also, as noted above, we are requesting comment on an alternative proposal that does not require air agencies with EPA-approved programs to electronically post the draft permit (
To clarify what this action is proposing for e-access, in the following section we provide a summary of the proposed rule requirements. As we provided in the preceding section on e-notice, we are also sharing what we consider to be recommended best practices for electronic access.
In order to satisfy the requirement for electronic access, the permitting authority shall electronically post, for the duration of the public comment period, the draft permit on a public Web site identified by the permitting authority, which may include the permitting authority's public Web site, an online state permits register, or a publicly-available electronic document management Web site that allows for downloading documents. The draft permit file should be in a format that can be opened and viewed by the public using commonly accepted computer software (
The Federal Docket Management System (FDMS) at
While not proposed as a requirement of this rule, the EPA is recommending best practices that can be used to augment the above requirement for electronic access. These best practice methods are not required to satisfy the e-access provision for this proposed rule, but may be helpful in the course of providing the fullest communication to the public on permitting actions. The recommended best practices of e-access include:
• Continued posting of the draft permit on the Web site past the public comment period (
• Posting the final permit on the Web site for a specified period of time after issuance of the permit (
• Posting (or hyperlinking to) other key permit support documents on the agency Web site or on a publicly-available online document management site (
For programs in which the permits are issued by the EPA or by an air agency that implements the EPA's federal permitting rules (
As noted in the above sections of this preamble, if an agency is satisfying the requirements of e-notice and e-access, the permitting authority would retain the discretion to supplement the e-notice with any other noticing method (
With respect to title V in particular, the rule revisions include additional changes in order to support the movement to e-notice. Currently, the title V regulations in part 71 include the use of a mailing list for public notice purposes. This proposal includes regulatory revisions to amend the EPA's solicitation obligations associated with the mailing list, but it otherwise keeps the mailing list in place. The EPA interprets its rules, and understands that many air agencies do as well, to allow for the mailing list to be maintained in an electronic format. Further, the EPA recognizes that many air agencies also maintain their part 70 mailing lists in an electronic format and that such a format is generally supported by stakeholders as well.
Similar changes are proposed for 40 CFR part 124, which are “general program requirements” that apply to federally-issued PSD and OCS permits, as well as permits issued for other media programs. 40 CFR 52.21(q), 40 CFR 55.6(a)(3). Due to the existing language in part 124 covering a number of permit programs other than air permitting, the EPA is proposing minor revisions to part 124 in order to maintain the current provisions for the other permit programs and to specifically clarify public notice requirements associated with EPA-issued PSD permits (and PSD permits issued by any program that implements 40 CFR 52.21). In this action, we are proposing to establish a new paragraph within paragraph 124.10(c)(2) that applies exclusively to PSD permits (and OCS permits, which use the PSD provisions) with clearly identified public notice requirements that will require e-notice rather than newspaper notice. The part 124 provisions would continue to require the agency to solicit the public to be added to a mailing list and to provide specific notifications (
The OCS regulations specify that EPA will use the applicable administrative and procedural requirements in 40 CFR part 124 and the federal title V rules (part 71 is incorporated by reference), and that the Administrator will follow the procedures used to issue PSD permits when using 40 CFR part 124. 40 CFR 55.6(a)(3), 40 CFR 55.13(f), 40 CFR 55.14(c)(5). Hence, as e-notice flexibility is added to parts 71 and 124, it will be incorporated by reference into the OCS regulations for EPA-issued OCS permits. In addition, specific language referencing the administrative procedures of 40 CFR 71 is proposed to be added to the Administrative Procedures and Public Participation requirements provisions of the OCS regulations to clarify that EPA may use either the applicable administrative procedures of 40 CFR 71 or 40 CFR 124 when issuing OCS permits.
We note that some air programs with EPA-approved plans for implementing the PSD program incorporate by reference the federal rule provisions—
In addition, we are proposing to delete a superfluous provision from 40 CFR 52.21(q) “
We solicit comment on this “mandatory e-notice and e-access” approach for permit programs implemented by the EPA and by other agencies implementing the federal air permitting rules.
For the noticing of major source permits issued pursuant to EPA-approved air agency programs under 40 CFR part 51 or 70, we are proposing to
As with the proposed mandatory requirements for e-notice for the federal programs, if the e-notice option is chosen as the consistent noticing method for a particular state program, the state must use e-notice to provide the information required under existing public notification regulations and must provide e-access to the draft permit. All other permit documents required under existing regulations can be accessible either electronically or physically (
We are aware that many states already have Web sites that are actively used for permitting purposes—
With regard to part 70, the proposed revisions would affect only the mandatory newspaper language, and would not change any other obligations such as the requirement to have or maintain a mailing list. The EPA interprets the existing mailing list obligations to include either electronic or hardcopy mailing list, or both, at the reasonable discretion of the air agency.
Furthermore, nothing in these proposed revisions to parts 51 and 70 prevents the air agency from also providing public notice through other methods including, but not limited to, a newspaper notice. As with our proposal for noticing of permitting actions under the federal rules, under this proposed option, agencies would have the discretion to provide public notice through other methods—in addition to their consistent noticing method—if a particular permit action warrants it and ensure that the notice of the draft permit reaches the affected community and stakeholders. We encourage all air agencies to consider facility- and permit-specific facts in determining the appropriate methods of public notice, such as expected public interest, location and type of source being permitted, environmental justice considerations, including the language that will be understood by the affected community.
To summarize, we propose that for air agencies that implement 40 CFR part 51 or 70, for the noticing of their major source draft permits, they either provide: (1) Mandatory e-notice and e-access, as these terms are used in the context of this proposed rule, or (2) newspaper notice with either electronic access (
As noted above, since many air agencies with EPA approved programs currently have a Web site and notice draft permits and provide permit documents on their Web sites, we do not believe that the e-notice requirement would impose any additional burden on most agencies. We are specifically seeking comment on whether (and how significantly) this rule imposes additional burden on air agencies that already provide postings of permits on their Web sites and those air agencies that do not already use a Web site for permit postings.
Finally, the EPA is requesting comment on two alternative approaches to the ones being proposed in this rule and described above, one for providing notice and the other for providing access. In the first alternative approach, an agency implementing rules pursuant to either part 51 or 70 would not be required to choose a consistent noticing method. Thus, the agency could potentially provide one noticing method for some permits (or some types of permits) and another noticing method for other permits. This approach is analogous to the “media neutral” approach that is available under § 51.161 for the noticing of minor NSR permits, as well as the approach adopted in the Tribal NSR Rule.
The EPA also requests comments on a second alternative approach to providing access, under which e-notice would not need to be coupled with e-access for state agency programs implementing approved rules pursuant to parts 51 and 70. This may help some states that notice permits using an online permits register (which would qualify for e-notice), but where the state may not have its own Web site to satisfy the “e-access” requirement of making the draft permit available electronically. As noted elsewhere in this preamble, the state would still be required to provide access to the draft permit, as well as any other documents that are part of the permit record.
We are requesting comments on adding a provision to each of the program rules that would allow an agency that is relying on e-notice (and/or e-access) to temporarily use another noticing medium for a reasonable period of time during which its Web site is unavailable. This may be necessary during planned Web site outages (
If an alternative noticing method is used, it would need to be publicly announced in some way before they occur, so that the public has reasonable notice of where to look for permit notices during such outages. It would also need to assure adequate notice to the affected public. Noticing either in the newspaper or State Register could be an agency's alternative noticing method, since each method is generally presumed to provide adequate notice to the public.
Given the broad range of situations that could lead to problems with a Web site, it may be difficult to specify the limits of the duration of the “temporary” period. We expect that most agencies would generally have an incentive to restore operations to their Web site as soon as possible for cost purposes and to ensure that they continue to provide the most effective notice of their permitting actions. We request comment as to whether providing specific boundaries around the use of the alternative noticing method should be required, and how those boundaries should be established and what criteria should be used to judge their adequacy. We specifically seek comment on the appropriate criteria for invoking the alternative noticing method, the length of time it could be used, and how the transition to the alternative method would be conveyed to the public.
As noted earlier in this preamble, this rule proposal is not revising any regulatory requirements for minor NSR permits. Notably, this rule proposal is not revising the requirement for “notice by prominent advertisement” in 40 CFR 51.161(b)(3), because the prominent advertisement term, as discussed in the EPA's 2012 Memorandum, is sufficiently broad to allow for e-notice. However, while we are reaffirming the guidance provided in the EPA's 2012 Memorandum, we are proposing to amplify its policy guidance in two respects.
This rule is proposing to clarify that the EPA's 2012 Memorandum's interpretation of “prominent advertisement” in paragraph 51.161(b)(3) as “media neutral” also applies to paragraph 51.161(b)(1). The provision currently reads: “[a]vailability for public inspection in at least one location in the area affected of the information submitted by the owner or operator and of the State or local agency's analysis of the effect on air quality.” Thus, paragraph 51.161(b)(1) does not expressly require that permitting information be made available in the form of paper records, and we are proposing to clarify that it allow for electronic access to the permitting information. More specifically, we are proposing that allowing electronic access to the information submitted by the owner or operator and to the agency's analysis of the effect on air quality by way of a Web site identified by the permitting authority would satisfy the requirement of “availability for public inspection in at least one location in the area affected . . .” We believe this approach is consistent with the memorandum with respect to allowing use of electronic and other methods to provide notice of minor NSR actions, and it is reasonable for the same reasons discussed in this preamble for allowing electronic access to permit documents for major source permits. We specifically request comment on this clarification for the minor NSR program rules.
In addition, in issuing the EPA's 2012 Memorandum, the EPA indicated that our guidance on the meaning of the term “prominent advertisement” in 40 CFR part 51.161(b)(3) applies only to minor sources and not to synthetic minor sources.
We seek comment on these two proposed revisions to the policy guidance provided by the EPA's 2012 Memorandum. Through the preamble to the final rule for this action, we intend to provide amplifying guidance with regard to the EPA's noticing policies for permits subject to 40 CFR 51.161.
In addition to the existing mandatory newspaper notice required for draft permits, part 71 permits programs and COA designations, the permitting program rules contain another regulatory provision that provides for newspaper notification. In the federal PSD regulations, a provision titled “permit rescission” requires that “[i]f the Administrator rescinds a permit under this paragraph, the public shall be given adequate notice of the rescission” and that notice “in a newspaper of general circulation in the affected region . . .” is considered adequate. 40 CFR 52.21(w)(4). While this language does not foreclose the notion that another type of noticing method could also be “adequate,” we are proposing to revise the rule provision to specifically require that the permitting authority notify the public of a permit rescission electronically—
This proposal to revise these CFRs to allow permitting authorities to provide public notice of permits and other actions on a publicly available Web site in lieu of the newspaper publication requirement, when final and effective, would reduce burden to all air agencies. In addition, the proposed requirements are consistent with practices some permitting agencies currently follow to supplement existing requirements for noticing permits, and they would provide flexibility for agencies to use the noticing methods that they determine are appropriate, reasonable and effective without the need for newspaper notice. These proposed changes are consistent with the approaches taken in EPA's permitting rule for Indian country and in EPA's minor NSR regulations, and with broad stakeholder input regarding more effective advertisement of permitting actions.
As noted earlier in this preamble, Internet Web sites have become an increasingly effective and widely employed avenue for broadly disseminating information to the public and many agencies currently supplement the required newspaper publication by posting draft and final permits on their agency Web sites. Since the Internet is generally available at all times, it allows for the noticing of a permit, and for the information that supports the permit, to be available and accessible over a longer period of time, rather than a one-day newspaper publication of the notice. As noted above, most states are already using the Internet (to varying degrees) for noticing permitting actions, so we do not anticipate many agencies having to spend a lot of time or funding on upgrading their existing Web sites to meet the proposed requirements. For agencies currently without a Web site for noticing permits and hearings, the use of e-notice and other applicable alternatives may allow the permitting authority to redirect funds that were being used for newspaper publication in order to establish and maintain a Web site where permit information could be posted. Thus, the EPA anticipates these proposed rule revisions, when finalized, would result in more effective dissemination of permitting and hearing information to the surrounding communities (including the underserved and environmental justice (EJ) communities) and possibly substantial cost savings for both the EPA and for state and local program permitting authorities.
We believe these proposed requirements are consistent with CAA goals of providing public notice and promoting access to information in permitting, and they would enhance the permitting process. With respect to preconstruction permit actions, CAA § 160(1) establishes a statutory policy of providing for informed public participation in the permitting process, and CAA § 165(a)(2) precludes issuing a PSD permit without an opportunity for the public to review the decision and submit comments. These proposed revisions enable the use of e-notice and e-access for both EPA-issued and other agency-issued permits and further the statutory policies these provisions establish. With respect to operating permits, the 1990 CAA Amendments require that the EPA rules for permitting programs provide “adequate, streamlined and reasonable procedures” including an opportunity for the general public to have informed participation in the air permitting process in the areas affected by a proposed permit. CAA § 502(b)(6). Also, § 502(b)(8) provides that procedures to make information available should be consistent with the need for expeditious action on permit applications or related matters. The proposed revisions, which enable the use of e-notice for both EPA-issued and other agency-issued permits, would improve implementation of the statutory policy of ensuring public notice of title V permits by providing more effective noticing procedures in affected areas across the country.
Another basis for, and benefit from, the proposed action would come from the cost savings associated with the move to electronic notification instead of legal notice advertisements in newspapers. The EPA's annual costs for publishing notices in newspapers is a significant annual expenditure, and it is the EPA's understanding that the newspaper publication for noticing permits has become costly for states as well. The EPA's proposal intends to reduce those costs by allowing the permitting authority to notice draft permits using a publicly available Web site in lieu of newspaper publication. While e-notice may pose a burden for certain states that do not already have a permitting Web site, the EPA is not mandating that permitting authorities that implement 40 CFR part 51 or 70 adopt the e-notice and e-access approaches, so these agencies can continue with the current program of newspaper publication if they prefer. In addition, permitting authorities that incorporate by reference the federal PSD rules at 40 CFR 52.21 that wish to continue to use newspaper notice as their primary method of notice can undertake a SIP revision to remove the reference to the federal provisions and adopt their own noticing rules that conform to § 51.166.
As an example of the approximate costs for publishing permit and hearing notices in the newspaper, in Fiscal Year 2013, the EPA Regions incurred a cost of over $40,000 to publish newspaper notices for NSR, title V and OCS permits. In Fiscal Year 2014, newspaper notice for the EPA regional permits exceeded $35,000. Newspaper publication costs vary widely depending on a number of factors, but for most permits the cost to notice averages between $600 and $1,000 per notice. While these costs vary on a yearly basis in each EPA Region, the overall annual costs are significant for the EPA. Moreover, given that state and local air agencies generally process more air permits than the EPA, it is reasonable to expect that the annual costs incurred for newspaper publication by state and local permitting agencies exceed the annual costs incurred by the EPA. (We note, however, that some air agencies require that the applicant bear the cost of newspaper publication.)
While we recognize that there is a cost associated with developing and maintaining an agency Web site for the purpose of noticing permits, the incremental cost to upload permit notices is expected to be very low, and we expect the overall burden would be less than that of the existing rules that mandate newspaper publication. This is because most agencies already have their own Web sites (or some other means to electronically notice draft permits and hearings) and they will continue to have their Web sites regardless of the requirements that are being proposed by this action. Thus, even though the costs of creating, upgrading and maintaining a Web site and providing web security may very well be many times higher than the cost of an agency's annual newspaper notice, states are choosing to continue to have a Web site due to the convenience of noticing and the ability to level out the overall costs of the Web site across all of the program areas of the agency. Furthermore, for agencies that already do web postings and posting of the draft permit, the newspaper requirement is duplicative and consequently the
A broad range of stakeholders has identified e-notice as a more efficient, more prominent, less costly and more cost-effective, and more reasonable approach to public notice of permitting actions, as compared to newspaper notice. For example, e-notice is responsive to recommendations from the CAAAC's Title V Task Force Report, which includes a number of recommendations for implementation improvements, such as public notice. Importantly, task force members agreed unanimously on two recommendations related to the means of providing public notice. First, task force members recommended that state program rules should be allowed to include alternatives to newspaper notification, provided the alternative is more effective in informing a cross section of the affected public. (A remaining concern mentioned was that members of the public may lack routine access to the Internet.)
As noted in the previous sections, providing e-notice is consistent with noticing requirements of the EPA's Tribal NSR Rule issued in 2011 and with the EPA's 2012 Memorandum that clarified the term “prominent advertisement” is media neutral for the minor NSR program. This action also supports Executive Orders 13563 and 13610 (issued in 2011 and 2012, respectively), which direct the Agency to modernize its rules periodically in order to achieve regulatory objectives more effectively, considering the agency resources and priorities.
Once this rule becomes final, it will become effective within 30 days for air permitting programs that implement the federal program rules at 40 CFR parts 52, 55 and 124. This includes EPA Regions, air agencies that are delegated authority by the EPA to issue permits on behalf of the EPA (via a delegation agreement), and air agencies that have their own rules approved by EPA in a SIP and the SIP incorporates by reference the federal program rules and automatically updates when EPA's rules are amended. Under this rule proposal, these programs would be required to implement e-notice and e-access, with the exception of states that are delegated authority to issue permits under part 55 (as described earlier in this preamble).
While we expect that most programs that implement the federal permitting rules are in a position to comply with the proposed requirements for e-notice and e-access once this rule is finalized, some programs may need more time. More time may be necessary if, for example, a delegated air program needs to upgrade or improve its Web site to allow for e-notice and/or e-access. We request comment on whether any air programs that would be required to immediately implement 40 CFR 52.21 would need a “phase in” period, beyond the 30 days, in order to implement e-notice and e-access.
For an air agency with an approved SIP that implements 40 CFR part 51 and that chooses e-notice and e-access as its consistent noticing method, it may need to revise its applicable program rules and seek the EPA's approval of a SIP revision in order to begin to implement e-notice in lieu of newspaper notice. (However, NNSR programs under § 51.165 are subject to the public participation requirements at § 51.161 and may be able to interpret their state rules and SIP to currently allow for implementing e-notice in lieu of newspaper notice.) Similarly, for an agency that implements rules that incorporate by reference our federal program regulations (40 CFR 52), and if its rules do not automatically update upon the EPA amending its federal rules, it may need to amend its regulations and seek the EPA's approval of a SIP revision in order to implement e-notice and e-access in lieu of newspaper notice.
Under this proposed rule it is voluntary for these programs to move to e-notice and e-access, and we are not proposing to impose a deadline for submission of SIP revisions for those programs that are choosing to adopt e-notice and e-access instead of newspaper notice. Furthermore, nothing in the current or proposed 40 CFR part 51 rules prevents an agency from beginning to implement e-notice and e-access methods once the agency is ready, but depending on the air agency's rules there may be ongoing obligations to continue with newspaper notices until the agency revises its rules. We request comment on whether agencies believe they have the ability to implement e-notice and e-access in lieu of newspaper notice without amending their state rules.
Consistent with title V and the part 70 regulations for initial program submittals, approved part 70 programs must provide for implementation of 40 CFR 70.7, including subsection “h” which sets forth the public participation obligations including “adequate procedures for public notice.”
As previously noted in this preamble, this proposal would not change the requirement to provide “adequate procedures for public notice.” Consequently, we believe that a program revision will not necessarily be required for all approved programs and that certain agency programs could implement e-notice and e-access upon approval of the rules at the state level. We propose that, for an agency that needs only to revise the agency program rules to clarify its implementation of e-notice and e-access but does not otherwise require a program change because the current program practice
With regard to the proposed part 71 program revisions, once the rules are finalized, an air agency that is delegated the part 71 program would likely need to update its delegation agreement to update its notice procedures consistent with the e-notice requirement in the federal rules.
The 1990 CAA Amendments generally require that the EPA or the permitting authority provide for adequate procedural opportunity for the general public to have informed participation in the air permitting process in the areas affected by a proposed permit. These areas include EJ communities.
The effectiveness of noticing methods for reaching underserved and EJ communities is a substantial concern to the EPA. A 2011 report issued by NEJAC found that publication in the legal section of a regional newspaper is antiquated and ineffective, and is not ideal for providing notice to affected EJ communities.
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control numbers 2060-0003 (for PSD and NNSR permit programs) and 2060-0243 and 2060-0336 (for operating permit programs).
In this action, the EPA is proposing to revise regulations to address public noticing method requirements for permits for major sources of air pollution. It is important to note that the proposed rule revisions would not require air agencies that implement the permitting program through an EPA-approved title V program or SIP to use e-notice. These agencies may continue to provide notice by newspaper publication or they can adopt e-notice as their consistent noticing method. Only in the latter case would an agency be required to revise the title V program rules or undertake a SIP revision. For EPA-delegated agencies, and for agencies that incorporate by reference the federal rules and their rules automatically update when the EPA revises its rules, no rulemaking action would be required by the agency to adopt the e-notice requirements. In addition, an agency delegated a part 71 program may need to update its delegation agreement. However, if any of these agencies desire to continue to provide notice by way of newspaper publication, they could request removal of delegation, revise their program rules consistent with the rules for state programs (
In addition, the proposed rule would not create any new requirements for regulated entities, since air agencies are responsible for the noticing of permits. Some industry sources could experience a reduction in costs for permitting in cases where the permitting agency requires that the cost of the newspaper public notice be incurred by the permit applicant.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Entities potentially affected directly by this proposal include state, local and tribal governments, and none of these governments would qualify as a small entity. Other types of small entities are not directly subject to the requirements of this action.
This action does not contain any unfunded federal mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It 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.
This action does not have tribal implications as specified in Executive Order 13175. Specifically, these proposed public notice revisions do not affect the relationship or distribution of
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment. The results of this evaluation are contained in Section VII of this preamble titled, “Environmental Justice Considerations.”
The statutory authority for this action is provided by 23 U.S.C. 101; 42 U.S.C. 6901,
Environmental protection, Administrative practice and procedure, Air pollution control.
Environmental protection, Air pollution control, Incorporation by reference.
Environmental protection, Administrative practice and procedure, Air pollution control.
Environmental protection, Administrative practice and procedure, Air pollution control.
Environmental protection, Administrative practice and procedure, Air pollution control.
Environmental protection, Administrative practice and procedure, Air pollution control.
For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is proposed to be amended as follows:
23 U.S.C. 101; 42 U.S.C. 7401—7671q.
(i)
(1) Post the information in paragraphs (i)(1)(i) through (iv) of this section, for the duration of the public comment period, on a public Web site(s) identified by the reviewing authority.
(i) A notice of availability of the draft permit for public comment;
(ii) The draft permit;
(iii) Information on how to access the record for the permit; and
(iv) Information on how to request and/or attend a public hearing on the permit.
(2) Publish a notice of availability of the draft permit for public comment in a newspaper of general circulation in the area where the source is located. The notice shall include information on how to access the draft permit and the record for the permit and how to request and/or attend a public hearing on the draft permit.
(q) * * *
(2) * * *
(ii) Make available in at least one location in each region in which the proposed source would be constructed a copy of all materials the applicant submitted, a copy of the preliminary determination, and a copy or summary of other materials, if any, considered in making the preliminary determination. This requirement can be met by making these materials available at a physical location or on a public Web site identified by the reviewing authority.
(iii) Notify the public, by advertisement in a newspaper of general circulation in each region in which the proposed source would be constructed, of the application, the preliminary determination, the degree of increment consumption that is expected from the source or modification, and of the opportunity for comment through a public hearing and through written public comment. Alternatively, these notifications can be made on a public Web site identified by the reviewing authority; however, the reviewing authority's selected notification method (
(iv) Distribute (
(vi) Consider all written comments submitted within a time specified in the notice of public comment and all comments received at any public hearing(s) in making a final decision on the approvability of the application. The reviewing authority shall make all comments available for public inspection in the same physical location(s), or the same Web site(s), where the reviewing authority made available preconstruction information relating to the proposed source or modification.
(viii) Notify the applicant in writing of the final determination and make such notification available for public inspection at the same location(s) or Web site(s) where the reviewing authority made available preconstruction information and public comments relating to the proposed source or major modification.
42 U.S.C. 7401,
(q) Public participation. The administrator shall follow the applicable procedures of 40 CFR part 124 in processing applications under this section.
(w) * * *
(4) If the Administrator rescinds a permit under this paragraph, the Administrator shall post a notice of the rescission determination on a public Web site identified by the Administrator within 60 days of the rescission.
Section 328 of the Clean Air Act (42 U.S.C. 7401,
(f) * * *
(1) * * *
(i) Make available, in at least one location in the NOA and in the area requesting COA designation, which can be a public Web site identified by the EPA, a copy of all materials submitted by the requester, a copy of the Administrator's preliminary determination, and a copy or summary of other materials, if any, considered by the Administrator in making the preliminary determination; and
(ii) Notify the public, by prominent advertisement in a newspaper of general circulation in the NOA and the area requesting COA designation or on a public Web site identified by the EPA, of a 30-day opportunity for written public comment on the available information and the Administrator's preliminary COA designation.
(2) A copy of the notice required pursuant to paragraph (f)(1)(ii) of this section shall be sent (or emailed) to the requester, the affected source, each person from whom a written request of such notice has been received, and the following officials and agencies having jurisdiction over the COA and NOA: State and local air pollution control agencies, the chief executive of the city and county, the Federal Land Manager of potentially affected Class I areas, and any Indian governing body whose lands may be affected by emissions from the OCS source.
(4) The Administrator will make a final COA designation within 60 days after the close of the public comment period. The Administrator will notify, in writing (which includes email), the requester and each person who has requested notice of the final action and will set forth the reasons for the determination. Such notification will be made available for public inspection.
(a) * * *
(3)
(f) * * *
(4) * * *
(ii) Make available, in at least one location in the COA and NOA, which can be a public Web site identified by the permitting authority, a copy of all materials submitted by the requester, a copy of the preliminary determination, and a copy or summary of other materials, if any, considered in making the preliminary determination.
(iii) Notify the public, by prominent advertisement in a newspaper of general circulation in the COA and NOA or on a public Web site identified by the permitting authority, of a 30-day opportunity for written public comment on the information submitted by the owner or operator and on the preliminary determination.
42 U.S.C. 7401,
(h) * * *
(1) Notice shall be given by one of the following methods that is selected by the permitting authority as its “consistent noticing method”: by publishing the notice in a newspaper of general circulation in the area where the source is located (or in a State publication designed to give general public notice) or by posting the notice, for the duration of the public comment period, on a public Web site identified
(2) The notice shall identify the affected facility; the name and address of the permittee; the name and address of the permitting authority processing the permit; the activity or activities involved in the permit action; the emissions change involved in any permit modification; the name, address, and telephone number of a person (or an email or Web site address) from whom interested persons may obtain additional information, including copies of the permit draft, the application, all relevant supporting materials, including those set forth in § 70.4(b)(3)(viii) of this part, and all other materials available to the permitting authority (except for otherwise publically available materials and publications) that are relevant to the permit decision; a brief description of the comment procedures required by this part; and the time and place of any hearing that may be held, including a statement of procedures to request a hearing (unless a hearing has already been scheduled).
42 U.S.C. 7401,
(g)
(d) * * *
(3) * * *
(i) By mailing (or emailing) a copy of a notice to the following persons (any person otherwise entitled to receive notice under paragraph (d) of this section may waive his or her rights to receive notice for any permit):
(ii) By posting a notice on a public Web site identified by the permitting authority for the duration of the public comment period. The notice shall be consistent with paragraph (d)(4)(i) of this section and be accompanied by a copy of the draft permit.
(4) * * *
(i) * * *
(G) The physical location and/or Web site address of the administrative record, the times at which the record will be open for public inspection, and a statement that all data submitted by the applicant are available as part of the administrative record; and
(d) * * *
(3) * * *
(i) By mailing (or emailing) a copy of a notice to the following persons (any person otherwise entitled to receive notice under this paragraph (d) may waive his or her rights to receive notice for any permit):
(ii) By posting a notice of availability and a copy of the draft permit on a public Web site identified by the permitting authority for the duration of the public comment period.
(4) * * *
(i) * * *
(E) The physical location and/or Web site address of the administrative record, the times at which the record will be open for public inspection, a statement that all data submitted by the applicant are available as part of the administrative record, and the name, address, and telephone number of a person (or an email or Web site address) from whom interested persons may obtain additional information, including copies of the draft permit, the application, all relevant supporting materials, and all other materials available to the Administrator that are relevant to the permit decision;
Resource Conservation and Recovery Act, 42 U.S.C. 6901
(c) * * *
(2) * * *
(iii) For PSD permits:
(A) In lieu of the requirement in paragraphs (c)(1)(ix)(B) and (C) of this section regarding soliciting persons for “area lists” and notifying the public of the opportunity to be on a mailing list, the Director may use generally accepted methods (
(B) In lieu of the requirement in paragraph (c)(2)(i) of this section to publish a notice in a daily or weekly newspaper, the Director shall notify the public by posting the following information, for the duration of the public comment period, on a public Web site identified by the Director: a notice of availability of the draft permit for public comment (or the denial of the permit application), the draft permit, information on how to access the administrative record, and information on how to request and/or attend a public hearing on the permit.
(C) In lieu of the requirement in paragraph (d)(1)(vi) of this section to specify a location of the administrative record, the Director may post the administrative record on a public Web site identified by the Director.
Environmental Protection Agency (EPA).
Proposed rule; extension of comment period.
The Environmental Protection Agency (EPA) is extending the comment period for the proposed rule titled “Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS” that was published in the
The comment period for the proposed rule published December 3, 2015, at 80 FR 75706, is extended. Comments, identified by docket identification (ID) number EPA-HQ-OAR-2015-0500, must be received on or before February 1, 2016.
Follow the detailed instructions as provided under
Mr. David Risley, Clean Air Markets Division, Office of Atmospheric Programs (Mail Code 6204M), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 343-9177; email address:
This document extends the public comment period for the proposed Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS (80 FR 75706, December 3, 2015) in order to ensure that the public has sufficient time to review and comment on the proposal.
Environmental protection, Administrative practice and procedure, Air pollution control, Electric power plants, Incorporation by reference, Nitrogen oxides, Reporting and record keeping requirements.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes regulations to revise procedures and requirements for filing import, export, and re-export documentation for certain fishery products to meet requirements for the SAFE Port Act of 2006, the Magnuson-Stevens Fishery Conservation and Management Act (MSA), other applicable statutes, and obligations that arise from U.S. participation in regional fishery management organizations (RFMOs) and other arrangements to which the United States is a member or contracting party. Specifically, NMFS proposes to integrate the collection of trade documentation within the government-wide International Trade Data System (ITDS) and require electronic information collection through the automated portal maintained by the Department of Homeland Security, Customs and Border Protection (CBP). Under this integration, NMFS would require annually renewable International Fisheries Trade Permits (IFTP) for the import, export, and re-export of certain regulated seafood commodities that are subject to trade monitoring programs of RFMOs and/or subject to trade documentation requirements under domestic law. These trade monitoring programs enable the United States to exclude products that do not meet the criteria for admissibility to U.S. markets, including products resulting from illegal, unregulated, and unreported (IUU) fishing activities. This proposed rule would consolidate existing international trade permits for regulated seafood products under the Antarctic Marine Living Resources (AMLR) and Highly Migratory Species International Trade Permit (HMS ITP) programs and expand the scope of the permit requirement to include regulated seafood products under the Tuna Tracking and Verification Program (TTVP). This proposed rule would also stipulate data and trade documentation for the above programs which must be provided electronically to CBP and address recordkeeping requirements for these programs in light of the proposed changes. Trade documentation excludes any programmatic documents that are not required at the time of entry/export (
Written comments must be received by February 29, 2016.
You may submit comments on this document, identified by docket NOAA-NMFS-2009-0124, by any of the following methods:
Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to
Mail: Mark Wildman, International Fisheries Division, Office for International Affairs and Seafood Inspection, NOAA Fisheries, 1315 East-West Highway, Silver Spring, MD 20910.
Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to the Office for International Affairs and Seafood Inspection (see
Mark Wildman, International Trade and Marine Stewardship Division, Office for International Affairs and Seafood Inspection, NOAA Fisheries (phone 301-427-8386, or email
The Security and Accountability For Every Port Act of 2006 (SAFE Port Act, Pub. L. 109-347) requires all Federal agencies with a role in import admissibility decisions to collect information electronically through the ITDS. The Department of the Treasury has the U.S. Government lead on ITDS development and Federal agency integration. CBP developed Automated Commercial Environment (ACE) as an internet-based system for the collection and dissemination of information for ITDS. The Office of Management and Budget (OMB), through its e-government initiative, oversees Federal agency participation in ITDS, with a focus on reducing duplicate reporting across agencies and migrating paper-based reporting systems to electronic information collection.
The term ITDS refers to the integrated, government-wide project for the electronic collection, use, and dissemination of the international trade and transportation data Federal agencies need to perform their missions, while the term ACE refers to the “single window” system through which the trade community will submit data related to imports and exports. Detailed information on ITDS is available at:
Numerous Federal agencies are involved in the regulation of international trade and many of these agencies participate in the import, export and transportation-related decision-making process. Agencies also use trade data to monitor and report on trade activity. NMFS is a partner government agency in the ITDS project because of its role in monitoring the trade of certain fishery products. Electronic collection of seafood trade data through a single portal will result in an overall reduction of the public reporting burden and the agency's data collection costs, will improve the timeliness and accuracy of admissibility decisions, and increase the effectiveness of applicable trade restrictive measures.
NMFS is responsible for implementation of trade measures and monitoring programs for fishery products subject to RFMO documentation requirements and/or documentation requirements under domestic laws. RFMOs are international fisheries organizations, established by treaties, to promote international cooperation to achieve effective and responsible marine stewardship and ensure sustainable fisheries management. The United States is a signatory to many RFMO treaties, and Congress has passed implementing legislation to carry out U.S. obligations under those treaties. Trade measures and monitoring programs enable the United States to exclude products that do not meet the criteria for admissibility to U.S. markets.
NMFS notes that the MSA defines “import” to mean “land on, bring into, or introduce into, or attempt to land on, bring into, or introduce into, any place subject to the jurisdiction of the United States, whether or not such landing, bringing or introduction constitutes an importation within the meaning of the customs laws of the United States; but . . . does not include any activity described [above] with respect to fish caught in the exclusive economic zone or by a vessel of the United States.” 16 U.S.C. 1802(22). This definition of “import” covers a broad range of activities, including but not limited to, customs entry for consumption, withdrawal from warehouse for consumption, or entry for consumption from a foreign trade zone. The following sections outline NMFS authorities for the various trade measures and trade monitoring programs that apply to fishery products.
The High Seas Driftnet Fishing Moratorium Protection Act (HSDFMPA) (16 U.S.C. 1826d-k) requires U.S. actions to address IUU fishing activity, bycatch of protected living marine resources (PLMR) and shark catch. Specifically, the HSDFMPA requires the Secretary of Commerce (Secretary) to identify in a biennial report to Congress foreign nations whose vessels engaged in IUU fishing or fishing practices that result in PLMR bycatch or shark catch on the high seas without a regulatory program comparable to that of the United States. The Secretary has established procedures to certify whether nations identified in the biennial report are taking appropriate corrective actions to address the activities for which they were identified (50 CFR 300, Subpart N). Certain fish and fish products from identified nations that do not receive positive certifications could be subject to import prohibitions under the authority provided in the High Seas Driftnet Fisheries Enforcement Act (HSDFEA) (16 U.S.C. 1826a-c).
Additionally, there are identification and/or certification procedures in other statutes, including the Pelly Amendment to the Fishermen's Protective Act (22 U.S.C. 1978) and the Atlantic Tunas Convention Act (ATCA) (16 U.S.C. 971
Multilateral efforts to combat IUU fishing may also result in requirements to take trade action. The United States is a member or contracting party to several RFMOs. Many of these RFMOs have established procedures to identify nations and/or vessels whose fishing activities undermine the effectiveness of the conservation and management measures adopted by the organization. Fishery products exported by such
Although the proposed rule would not amend existing regulations pertaining to any of the above trade measure authorities, import filing through ACE will facilitate U.S. Government implementation of trade measures when and if imposed. ITDS will facilitate sharing of data between agencies and allow for improved targeting of suspected illegal (or embargoed) shipments.
Pursuant to domestic statutory authorities and/or multilateral agreements, NMFS has implemented a number of monitoring programs to collect information from the seafood industry regarding the origin of certain fishery products. The purpose of these programs is to determine the admissibility of the products in accordance with the specific criteria of the trade measure or documentation requirements in effect. The three NMFS trade monitoring programs subject to this proposed rule are the HMS ITP program which regulates trade in specified commodities of tuna, swordfish, billfish, and shark fins; the AMLR trade program which regulates trade in Antarctic and Patagonian toothfish and other fishery products caught in the area where the Convention on the Conservation of Antarctic Marine Living Resources (CCAMLR) applies; and the TTVP, which regulates trade in frozen and/or processed tuna products, as well as certain other fishery products under the authority of the HSDFEA (refer to 50 CFR 216.24(f)(2)(iii) for a complete list). Generally, these trade monitoring programs require anyone who intends to import, export, and/or re-export regulated species to: Obtain a permit from NMFS; obtain documentation on the flag-nation authorization for the harvest from the foreign exporter; and submit this information to NMFS. Depending on the commodity, specific information may also be required, for example the flag state of the harvesting vessel, the ocean area of catch, the fishing gear used, the harvesting vessel name, and details and authorizations related to harvest, landing, transshipment and export.
In most cases, these trade monitoring programs require the importer to submit documentation that provides catch and/or other statistical information to NMFS, while other relevant information on the inbound shipments is provided by the dealer, importer, shipper, carrier, or customs broker to CBP by electronic means. NMFS reviews and reconciles the information reported by importers with the information obtained from CBP and, where applicable, from the relevant RFMO or harvesting or exporting/re-exporting nation to determine if the admissibility requirements have been satisfied. If documentation is incomplete, fraudulent or missing, or if the shipment is not admissible given its ocean area of harvest, flag country of the harvesting vessel, harvesting vessel or the circumstances under which it was harvested, entry into U.S. commerce may be prohibited for that shipment and the shipment may be subject to forfeiture. In addition, the importer or other responsible party may be subject to enforcement action. Likewise, U.S. exporters must provide similar documentation for use by other importing nations.
As an ITDS partner government agency, access to the ACE system and ITDS data has improved NMFS' ability to evaluate trends and identify potential problems with seafood imports, including potential cases of seafood fraud (
Under the proposed rule (50 CFR 300.320), an IFTP would be established which would consolidate existing international trade permits for regulated seafood products under the AMLR and HMS ITP programs and expand the scope of the permit requirement to include regulated seafood products under the TTVP. To obtain the IFTP, U.S. importers, exporters, and re-exporters of seafood products covered under the TTVP, AMLR, and HMS ITP programs would be required to electronically submit their application and fee for the IFTP via a Web site designated by NMFS. As explained above, currently, the TTVP, AMLR and HMS ITP regulations require submission of specific information and documentation for trade monitoring. Under this proposed rule, the IFTP holder, or his or her representative, would need to electronically provide CBP via ACE with certain data sets (
While this proposed rule only applies to the three programs described above, proposed § 300.320 provides that the IFTP and ACE requirements may be incorporated by reference in other regulations pertaining to documentation and reporting of imports and/or exports.
Because NMFS will have access to the ITDS, importers, exporters, re-exporters and/or their customs agents would no longer be required to provide NMFS with paper copies of trade documentation. However, they would still need to maintain, and make
When deliberating how best to implement ITDS, NMFS also considered several alternatives to the proposed action described above. Under the first alternative, rather than require entry filers to submit scanned images of documentation and a limited data set, such filers would be required to enter all data elements necessary for the authentication and authorization of each shipment into the CBP's automated ACE system. Although this alternative would not require the submission of scanned images of documentation for two of the three trade monitoring programs (scanned images would still be required for the TTVP), it would require entry filers to provide most of the data contained in such documentation at the time of import or export rather than providing a data set limited to only those elements absolutely necessary to determine admissibility. NMFS considers this alternative to be too burdensome for entry filers in terms of the additional time that would be required to enter such data into ACE.
A second alternative would involve the submission of a limited electronic data set with no scanned documentation provided electronically. In this scenario, NMFS would require entry filers to submit a limited message set into ACE, but entry filers would also need to separately provide NMFS with any additional documentation and data necessary for NMFS to complete dolphin-safe tuna verification at the time of, or in advance of, importation and periodic reports for RFMOs. This alternative is not preferred as it would create an unnecessary burden on both NMFS and the trade since it would require entry filers to both complete ACE entry procedures and also submit admissibility documents to NMFS outside of ACE, the ITDS single window.
A third alternative would be for NMFS to require an electronic data set consisting solely of the international fisheries trade permit number with scanned documentation provided electronically via ITDS. This alternative would not be preferred as it would place a significant burden on NMFS to manually convert scanned document images to data sets so that NMFS could make decisions regarding product admissibility. Such an approach would require considerable NMFS staff time and would inevitably create burdens on industry as such an alternative would result in post-release seizures or re-delivery orders to the trade for products later determined by NMFS to be inadmissible.
A fourth alternative would be to implement the IFTP requirement for the HMS ITP and AMLR trade program but not for the TTVP which currently has no permit requirement. The rationale for instituting the IFTP for the TTVP is to identify the business entities that are engaged in the trade activities subject to monitoring, for the purposes of informing them of requirements and any changes thereto. Lack of education/notification could increase noncompliance, resulting in delayed release, seizures or other enforcement actions, and/or blocked shipments when requirements are not met at the border. In addition, not requiring an IFTP for the TTVP participants, would preclude the imposition of permit sanctions in the event of serious infractions of reporting or recordkeeping requirements in the TTVP. For all the above-stated reasons, this alternative is not preferred.
As a Member of the Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR), the United States is obligated to implement conservation measures adopted by CCAMLR, unless the United States objects, pursuant to Article IX of the CCAMLR Convention. NMFS has implemented CCAMLR-adopted conservation measures in 50 CFR part 300, subpart G. Under these regulations, a person that intends to import or re-export AMLR must obtain a dealer permit. To integrate the collection of information on the trade of AMLR within the ITDS, NMFS proposes to revise the AMLR regulations to require a dealer importing or exporting AMLR to possess a valid IFTP issued under the proposed § 300.322 discussed below. These proposed revisions to 50 CFR part 300 subpart G would replace the AMLR dealer permit procedures with a reference to the proposed IFTP procedures (see below). Where appropriate, the term “AMLR dealer permit” and references to that permit would be replaced with “IFTP.” Section 300.114(k) of the AMLR regulations regarding registered agents would be removed because § 300.322 provides for the designation of resident agents who would be authorized to act on behalf of foreign entities.
NMFS established permitting, reporting, and recordkeeping regulations to implement various RFMO trade monitoring programs under the HMS ITP program in 50 CFR part 300 subpart M. As noted above, a person trading in fishery commodities covered by the current HMS ITP program would need to obtain the newly established IFTP and the program-specific HMS ITP permit will be retired. Submission of consignment documents such as the International Commission for the Conservation of Atlantic Tuna (ICCAT) bluefin tuna catch document would be through ACE and the CBP Document Imaging System (DIS). Using the ACE system rather than submitting hardcopy documents to NMFS would result in reduced reporting burdens for the seafood industry and reduced data processing time for the government as documents would be submitted only once, to CBP, instead of to both CBP and NMFS.
As noted above, a person trading in fishery commodities covered under the TTVP would need to obtain an IFTP. Such a trade permit is currently not a requirement under the TTVP. NMFS believes the benefits and efficiencies resulting from ITDS implementation and establishing a single consolidated IFTP covering all three of the NMFS trade monitoring programs would greatly exceed the fee charged to cover administrative costs associated with NMFS issuance of the IFTP.
In addition, under current regulations at 50 CFR 216.24(f)(3)(ii), TTVP
This proposed rule also makes minor edits to the regulatory text in order to update an internet Web site address, harmonize regulatory text in part 216, Subpart H, Dolphin Safe Tuna Labeling, with the regulatory text being revised as part of ITDS implementation in 50 CFR 216.24(f), and allow importers to submit documentation to the ACE system at the time of, or in advance of, importation. Revisions to the tables in § 216.24(f)(2)(i) through (iii) have been made to reflect the latest updates to harmonized tariff codes.
This current rulemaking does not propose measures to implement recommendations 14 and 15 (seafood traceability) of the Presidential Task Force on Combatting Illegal, Unreported, and Unregulated (IUU) Fishing and Seafood Fraud (Task Force). There will be a separate opportunity for public comment on the proposed regulations pertaining to these Task Force recommendations.
This proposed rule is published under the authority of AMLRCA of 1984, 16 U.S.C. 2431
The NMFS Assistant Administrator has determined that this proposed rule is consistent with the provisions of these and other applicable laws, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866. NMFS has prepared a regulatory impact review of this action, which is available from NMFS (see
An initial regulatory flexibility analysis was not prepared because this proposed rule is not expected to have a significant economic impact on U.S. small entities. Thus, the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have any significant economic impact on a substantial number of small entities.
The regulatory action being considered, and its legal basis, is described in detail earlier in the preamble. Although a new IFTP is proposed to be established for the import, export or re-export of regulated products under the AMLR, HMS ITP and TTVP programs, this new permit generally represents a consolidation of information contained in existing permits and should actually result in fewer reporting or recordkeeping requirements. Data sets to be entered electronically to determine product admissibility are already required to be submitted in paper form under the respective trade programs. Thus, NMFS anticipates that U.S. entities would not be significantly affected by this action because it generally does not pose new or additional burdens with regard to the collection and submission of information necessary to determine product admissibility.
With regard to the possible economic effects of this action, per the response to Question 13 of the supporting statement prepared for the Paperwork Reduction Act analysis (available from
The proposed action would not affect the volume of seafood trade or alter trade flows in the U.S. market. Although the proposed rule would require traders under the TTVP to obtain an IFTP, which they are not currently required to do, NMFS expects that the consolidated IFTP would have no impact on, or would actually reduce, the overall administrative burden on the public; those parties currently required to obtain two separate permits under the AMLR and HMS ITP programs would be required to obtain only one consolidated permit under this proposed rule.
The consolidated permitting and electronic reporting program proposed by this rulemaking would not have significant adverse or long-term economic impacts on small U.S. entities. This proposed rule has also been determined not to duplicate, overlap, or conflict with any other Federal rules. Thus, the requirements and prohibitions in the proposed rule would not have a significant economic impact on a substantial number of small entities. Consequently, an initial regulatory flexibility analysis is not required and none has been prepared.
This proposed rule contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been submitted to OMB for approval. When overall total new burdens for the three requirements proposed under this rule (IFTP, data set submission, and admissibility document(s) submission) are compared to current burdens, the new burdens are estimated to result in an overall net burden decrease of 4,225 hours and $63,650.
Public comment is sought regarding: whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to the Office for International Affairs and Seafood Inspection at the
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.
Administrative practice and procedure, Exports, Marine mammals, Reporting and recordkeeping requirements.
Exports, Fisheries, Fishing, Fishing vessels, Foreign relations, Illegal, unreported or unregulated fishing, Imports, International trade permits, Treaties.
For the reasons set out in the preamble, 50 CFR parts 216 and 300 are proposed to be amended as follows:
16 U.S.C. 1361
(f) * * *
(2)
(i) * * *
(A)
(D)
(ii) * * *
(A)
(D)
(iii) * * *
(A)
(B)
(C)
(3)
(i) A properly completed FCO, and its attached certifications and statements as described in § 216.91(a), must accompany the required CBP entry documents that are filed at the time of, or in advance of, importation.
(ii) FCOs and associated certifications and statements as described in § 216.91(a) must be provided electronically to CBP as indicated in paragraph (f)(2) of this section.
(iii) FCOs that accompany imported shipments of tuna destined for further processing in the United States must be endorsed at each change in ownership and submitted to the Administrator, West Coast Region, by the last endorser when all required endorsements are completed. Such FCOs must be submitted as specified in § 216.93(d)(2).
(f)
(g) * * *
(2)
16 U.S.C. 951
The revision and addition read as follows:
(o) Ship, transport, offer for sale, sell, purchase, import, export, or have custody, control, or possession of, any fish imported, exported or re-exported in violation of this part.
(p) Import, export, or re-export any fish regulated under this part without a valid International Fisheries Trade Permit or applicable shipment documentation.
(b)
(1) Accurately maintain all reports and records required by their IFTP and this subpart;
(3) Within the time specified in the IFTP requirements, submit a copy of such reports and records to NMFS at an address designated by NMFS.
(c) * * *
(6) * * *
(i) * * *
(A) * * *
(
(7) * * *
(i) * * *
(A) * * *
(
The revisions read as follows:
(a) * * *
(1) A dealer importing, or re-exporting AMLR, or a person exporting AMLR, must possess a valid IFTP issued under § 300.322 and file required data sets electronically with CBP at the time of, or in advance of importation or exportation. “Required data set: has the same meaning as § 300.321 (
(2) An AMLR may be imported into the United States if its harvest has been authorized by a U.S.-issued individual permit or its importation has been authorized by an IFTP and, in the case of frozen
(4) An IFTP or preapproval issued under this section does not authorize the harvest or transshipment of any AMLR by or to a vessel of the United States.
(b)
(d)
(e)
(f)
(g)
(2)
(h)
(j)
(b) Import into, or export or re-export from, the United States any AMLRs without applicable catch documentation as required by § 300.107(c), without an IFTP as required by § 300.114 (a)(1), or in violation of the terms and conditions for such import, export or re-export as specified on the IFTP.
(r) Without a valid first receiver permit issued under this subpart, receive AMLRs from a vessel or receive AMLRs from a vessel without a valid harvesting permit issued under this subpart.
(ii) Import into, or export or re-export from, the United States any AMLRs harvest by a vessel of the United States
The additions and revisions read as follows:
An importer, entering for consumption fish or fish products regulated under this subpart from any ocean area into the United States, or an exporter exporting or re-exporting such product, must possess a valid International Fisheries Trade Permit (IFTP) issued under § 300.322.
(a)
(3) A biweekly report is not required for export consignments of bluefin tuna when the information required on the biweekly report has been previously supplied on a biweekly report submitted under § 635.5(b)(2)(i)(B) of this title. The person required to obtain a trade permit under § 300.322 must retain, at his/her principal place of business, a copy of the biweekly report which includes the required information and is submitted under § 635.5(b)(2)(i)(B) of this title, for a period of 2 years from the date on which each report was submitted to NMFS.
(b) Recordkeeping. Any person trading fish and fish products regulated under this subpart and required to submit biweekly reports under paragraph (a) of this section must retain, at his/her principal place of business, a copy of each biweekly report and all supporting records for a period of 2 years from the date on which each report was submitted to NMFS.
(c) Other requirements and recordkeeping requirements. Any person trading fish and fish products regulated under this subpart and required to obtain a trade permit under § 300.322 is also subject to the reporting and recordkeeping requirements identified in § 300.185.
(d) Inspection. Any person authorized to carry out the enforcement activities under the regulations in this subpart (authorized person) has the authority, without warrant or other process, to inspect, at any reasonable time: fish or fish products regulated under this subpart, biweekly reports, statistical documents, catch documents, re-export certificates, relevant sales receipts, import and export documentation, and any other records or reports made, retained, or submitted pursuant to this subpart. A permit holder must allow NMFS or an authorized person to inspect any fish or fish products regulated under this subpart, and inspect and copy any import export, and re-export documentation and any reports required under this subpart, and the records, in any form, on which the completed reports are based, wherever they exist. Any agent of a person trading and required to obtain a trade permit under § 300.322, or anyone responsible for importing, exporting, re-exporting, storing, packing, or selling fish or fish products regulated under this subpart, shall be subject to the inspection provisions of this section.
(e) Applicability of reporting and recordkeeping requirements. Reporting and recordkeeping requirements in this subpart apply to any person engaging in trading regardless of whether a trade permit has been issued to that person.
(a) * * *
(2)
(ii)
(B) Bluefin tuna, imported into the Customs territory of the United States or entered for consumption into the separate customs territory of a U.S. insular possession, from a country requiring a BCD tag on all such bluefin tuna available for sale, must be accompanied by the appropriate BCD tag issued by that country, and said BCD tag must remain on any bluefin tuna until it reaches its final destination. If the final import destination is the United States, which includes U.S. insular possessions, the BCD tag must remain on the bluefin tuna until it is cut into portions. If the bluefin tuna portions are subsequently packaged for domestic commercial use or re-export, the BCD tag number and the issuing country must be written legibly and indelibly on the outside of the package.
(iii)
(B) All other imports that have been previously re-exported from another nation, should have the intermediate importers certification of the original statistical document completed.
(iv) Consignment documents must be validated as specified in § 300.187 by a responsible government official of the flag country whose vessel caught the fish (regardless of where the fish are first landed). Re-export certificates must be validated by a responsible government official of the re-exporting country.
(v) A permit holder may not accept an import without the completed consignment document or re-export certificate as described in paragraphs (a)(2)(i) through (a)(2)(iv) of this section.
(vi) For fish or fish products, except shark fins, regulated under this subpart that are entered for consumption, the permit holder must provide correct and complete information, as requested by NMFS, on the original consignment document that accompanied the consignment.
(b) * * *
(2)
(c) * * *
(2)
(ii) If a consignment of fish or fish products regulated under this subpart, except bluefin tuna or shark fins, that was previously entered for consumption as described in paragraph (c)(1) of this section is not subdivided into sub-consignments or consolidated, for each re-export consignment, a permit holder must complete the intermediate importer's certification on the original statistical document and note the entry number on the top of the statistical document. Such re-exports do not need a re-export certificate and the re-export does not require validation. An electronic image of the statistical document with the completed intermediate importer's certification and the required data set must be filed electronically with CBP via ACE at the time of re-export.
(3)
(a) Falsify information required on an application for a permit submitted under § 300.322.
(b) Import as an entry for consumption, purchase, receive for export, export, or re-export any fish or fish product regulated under this subpart without a valid trade permit issued under § 300.322.
(c) Fail to possess, and make available for inspection, a trade permit at the permit holder's place of business, or alter any such permit as specified in § 300.322.
(m) Fail to electronically file via ACE a validated consignment document and the required data set for imports at time of entry into the Customs territory of the United States of fish or fish products regulated under this subpart except shark fins, regardless of whether the importer, exporter, or re-exporter holds a valid trade permit issued pursuant to § 300.322 or whether the fish products are imported as an entry for consumption.
(n) Import or accept an imported consignment of fish or fish products regulated under this subpart, except shark fins, without an original, complete, accurate, approved, valid and properly validated, species-specific consignment document and re-export certificate (if applicable) with the required information and exporter's certification completed.
The regulations in this subpart are issued under the authority of the Atlantic Tunas Convention Act of 1975 (ATCA), the Magnuson-Stevens Fishery Conservation and Management Act, the Tuna Conventions Act of 1950, and the Antarctic Marine Living Resources Convention Act of 1984. These regulations implement the applicable recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT) for the conservation and management of tuna and tuna-like species in the Atlantic Ocean, the Inter-American Tropical Tuna Commission (IATTC) for the conservation and management of highly migratory fish resources in the eastern Pacific Ocean, and the Commission for the Conservation of Antarctic Marine Living Resources so far as they affect vessels and persons subject to the jurisdiction of the United States. These regulations are also issued under the Marine Mammal Protection Act of 1972, the Dolphin Protection Consumer Information Act and the Security and Accountability For Every Port Act of 2006. The requirements in this subpart may be incorporated by reference in other regulations under this title.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
A person importing for consumption or non-consumption, exporting, or re-exporting fish or fish products regulated under this subpart from any ocean area must file all reports and documentation required under the AMLR trade program, HMS ITP, and TTVP, and under other regulations that incorporate by reference the requirements of this subpart.
In addition to the prohibitions specified in §§ 300.4, 300.117, 300.189, 600.725 and 635.71 of this title, it is unlawful for any person subject to the jurisdiction of the United States to:
(a) violate any provision of this subpart, or any IFTP issued under this subpart,
(b) Import fish or fish products regulated under this subpart without a valid IFTP or without submitting complete and accurate information.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes regulations that would implement Amendment 112 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP) and Amendment 102 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (GOA FMP) and revise regulations for observer coverage requirements for certain small catcher/processors in the Gulf of Alaska (GOA) and Bering Sea and Aleutian Islands Management Area (BSAI). If approved, this proposed rule would modify the criteria for NMFS to place small catcher/processors in the partial observer coverage category under the North Pacific Groundfish and Halibut Observer Program (Observer Program). Under this proposed rule, the owner of a non-trawl catcher/processor could choose to be in the partial observer coverage category, on an annual basis, if the vessel processed less than 79,000 lb (35.8 mt) of groundfish on an average weekly basis in a particular prior year, as specified in this proposed rule. This proposed rule would not alter observer coverage requirements for a catcher/processor using trawl gear or for a catcher/processor when participating in a catch share program; these catcher/processors would continue to be required to be in the full observer coverage category. This proposed rule would provide a relatively limited exception to the general requirement that all catcher/processors are in the full observer coverage category, and maintain the full observer coverage requirement for all trawl catcher/processors and catcher/processors participating in a catch share program that requires full coverage. The net impact of this proposed rule on the information available for fisheries management is expected to be small due, in part, to the small amount of fishing activity that would be impacted. This proposed rule is intended to promote the goals of the BSAI and GOA FMPs, and to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and other applicable laws.
Submit comments on or before January 28, 2016.
You may submit comments on this document, identified by NOAA-NMFS-2015-0114, by any of the following methods:
• Electronic Submission: Submit all electronic public comments via the Federal eRulemaking Portal. Go to
• Mail: Submit written comments to Glenn Merrill, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS, Attn: Ellen Sebastian. Mail comments to P.O. Box 21668, Juneau, AK 99802-1668.
Electronic copies of Amendment 112 to the BSAI FMP and Amendment 102 to the GOA FMP, the Regulatory Impact Review/Initial Regulatory Flexibility Analysis (Analysis), and the Categorical Exclusion prepared for this action are available from
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this rule may be submitted to NMFS at the above address; by email to
Anne Marie Eich, 907-586-7228.
NMFS manages the groundfish fisheries of the GOA under the GOA FMP. NMFS manages the groundfish fisheries of the BSAI under the BSAI FMP. The North Pacific Fishery Management Council (Council) prepared the GOA FMP and the BSAI FMP pursuant to the Magnuson-Stevens Act (16 U.S.C. 1801,
The Council submitted Amendment 112 to the BSAI FMP and Amendment 102 to the GOA FMP (collectively referred to as Amendment 112/102) for review by the Secretary of Commerce, and a notice of availability of Amendment 112/102 was published in the
This proposed rule would modify the criteria used by NMFS to place small catcher/processors in the partial observer coverage category in the Observer Program. Under this proposed rule, the owners of non-trawl catcher/processors could choose to be in the partial observer coverage category for the upcoming fishing year if their vessels processed less than 79,000 lb (35.8 mt) of groundfish on an average weekly basis in a particular prior year, as specified in this rule. This proposed rule does not alter observer coverage requirements for a catcher/processor using trawl gear or for a catcher/processor when participating in a catch share program; these catcher/processors would continue to be required to be in the full observer coverage category. The terms “production” and “processing” are used synonymously in this proposed rule. The following sections describe: (1) The Observer Program, (2) the Need for the Proposed Action, (3) the Rationale for Major Provisions of the Proposed Rule, and (4) the Proposed Rule.
Regulations implementing the Observer Program allow NMFS-certified observers (observers) to obtain information necessary for the conservation and management of the BSAI and GOA groundfish and halibut fisheries. Observers collect biological samples and fishery-dependent information on total catch and fishing vessel interactions with protected species. Managers use data collected by observers to monitor quotas, manage groundfish catch and bycatch, and document and reduce fishery interactions with protected resources. Scientists use observer-collected data for stock assessments and marine ecosystem research.
The Observer Program was implemented in 1990 (55 FR 4839, February 12, 1990). In 2012, NMFS restructured the funding and deployment systems of the Observer Program (77 FR 70062, November 21, 2012). Since implementation of the restructured Observer Program in 2013, vessels, shoreside processors and stationary floating processors participating in the groundfish and halibut fisheries off of Alaska are placed in one of two observer coverage categories: (1) Partial observer coverage category, or (2) full observer coverage category.
An observer must be on board a vessel in the full observer coverage category any time the vessel is harvesting, receiving, or processing groundfish in a federally managed or parallel groundfish fishery, as specified at § 679.51(a)(2)(i). In the full observer coverage category, vessel operators obtain observers by contracting directly with observer providers. Operators of vessels in the full observer coverage category pay the observer provider for each day the observer is on board the vessel, including days that the vessel is travelling to or from the fishing grounds but not fishing.
NMFS deploys observers on vessels in the partial observer coverage category according to a statistical sample design based on an annual deployment plan developed in consultation with the Council. Vessels in the partial observer coverage category are required to carry observers on fishing trips selected at random per the statistical sample design. Instead of paying for each day an observer is on board, NMFS assesses a fee equal to 1.25 percent of the ex-vessel value of the retained groundfish and halibut landed by vessels in the partial observer coverage category. NMFS uses these fees to establish a Federal contract with an observer service provider to deploy observers in the partial observer coverage category. Under this structure, observer coverage funding is based on the number of days a vessel operates (full observer coverage category) or on the ex-vessel value of a vessel's retained catch regardless of the amount of time the vessel is covered by an observer (partial observer coverage category).
Before the Observer Program was restructured, most catcher/processors were required to have one or two observers on board at all times to generate vessel-specific estimates of retained and discarded catch needed to manage catch share programs. Observer coverage requirements on catcher/processors that were not in a catch share program were based on vessel length and gear type and included coverage levels equal to zero or no coverage, 30 percent of fishing trips, and 100 percent of fishing trips or full observer coverage. To monitor catch on unobserved catcher/processors, NMFS used the vessel-reported processed weight to estimate retained catch and data from observed vessels to estimate at-sea discards, including PSC, for each vessel. Under the restructured Observer Program, almost all catcher/processors were assigned to the full observer coverage category to obtain independent estimates of catch, at-sea discards, and PSC to reduce the potential for introducing error into NMFS' catch accounting system (as described in the proposed rule: 77 FR 23326, April 18, 2012).
The restructured Observer Program provided three limited exceptions for catcher/processors to be placed in the partial observer coverage category. The restructured Observer Program provided these exceptions in recognition that the cost of full observer coverage would be disproportionate to total revenues for some small catcher/processors.
First, the restructured Observer Program provided an exception (specified at the current § 679.51(a)(2)(v)) that applies to a hybrid vessel less than 60 feet length overall (LOA) that acted as both a catcher vessel and a catcher/processor in the same year in any year from 2003 through 2009. This exception to the full coverage requirement applies only if the vessel owner elected to participate in the partial observer coverage category at least 30 days prior to the vessel's first trip logged under Observer Declare and Deploy System (ODDS). ODDS is the system for assigning observers to trips by vessels in the partial observer coverage category (§ 679.51(a)(1)(ii)). All but two of the vessels that were eligible
Second, the restructured Observer Program provided an exception from full coverage (specified at the current § 679.5(a)(2)(v)) if a catcher/processor had an average daily production of less than 5,000 lb (2.3 mt) round weight equivalent in its most recent full calendar year of operation from 2003 through 2009. This exception applied only if the owner of a catcher/processor made a one-time election to be placed in the partial observer coverage category before the catcher/processor's first fishing trip logged under ODDS. All but one of the vessels that were eligible for this exception elected to be placed in the partial observer coverage category.
Third, the restructured Observer Program provided an exception from full coverage (specified at § 679.5(a)(2)(iv)(B)) if a catcher/processor did not process more than one metric ton round weight of groundfish on any day in the immediately preceding year. This exception is based on the catcher/processor's production in any year after implementation of the restructured Observer Program (
The first two exceptions are based on a vessel's activity between 2003 and 2009. A vessel that started processing after 2009 could never qualify to be placed in the partial observer coverage category under either of these exceptions. Also, the first two exceptions permanently placed a vessel in the partial observer coverage category. These exceptions have no provision to review the production of a catcher/processor placed in the partial observer coverage category on an ongoing basis and remove them from the partial observer coverage category if their production increases. Out of approximately seventy catcher/processors in the Observer Program, three catcher/processors have qualified for, and elected to be assigned permanently to, the partial observer coverage category under these two exceptions (Section 2.1.1 and Table 2 of the Analysis).
The third exception, the one metric ton exception, is theoretically open to any catcher/processor that began production after 2009. However, in reviewing production data from 2008 through 2014 for this action, NMFS found no active catcher/processor (
Beginning with comments on the proposed rule for the restructured Observer Program, industry participants asked that the final rule for the restructured Observer Program allow NMFS to place catcher/processors with limited production in the partial observer coverage category. In response to these comments, NMFS stated in the final rule for the restructured Observer Program (77 FR 70062, November 21, 2012) that neither the Council nor NMFS had analyzed the situation of small catcher/processors that began production after 2009. NMFS explained that if these industry participants wished to be considered for placement in the partial observer coverage category, the Council and NMFS would need to make these changes through a separate rulemaking process.
Members of industry subsequently sought a change in the rules for placement of catcher/processors in the partial observer coverage category. Members of industry stated that the cost of full observer coverage for vessels that began processing, or wished to begin processing, relatively small amounts of groundfish after 2009, was disproportionate to the revenues they could receive. The Council and NMFS reviewed and developed a series of analyses that resulted in this proposed action. The history of this action is described in detail in Section 1.2 of the Analysis.
Data on past production identified a small number of catcher/processors that processed a small amount of groundfish relative to the rest of the fleet. The Council and NMFS concluded that these vessels were paying, or would pay, a disproportionate amount for full observer coverage relative to the amount these vessels had processed, or would be likely to process. The Council and NMFS concluded that the cost of full observer coverage might be discouraging beneficial activity, such as processing sablefish in remote fishing grounds in the Aleutian Islands or processing by small jig gear vessels.
The Council and NMFS concluded that the placement of catcher/processors in the partial observer coverage category should not be a closed category but should be open to all catcher/processors based on an ongoing measure of their groundfish production in a year, except for catcher/processors where information needs compel full observer coverage regardless of the amount of production. Specifically, this proposed rule would not revise observer coverage requirements for trawl catcher/processors or catcher/processors while they are participating in a catch share program (Section 2.4.1 of the Analysis), even when these catcher/processors meet the production requirement.
The objectives for this proposed rule are to (1) refine the balance between observer data quality from the fishery and cost of observer coverage to catcher/processors with limited groundfish production relative to the rest of the catcher/processor fleet by allowing those catcher/processors with limited production to be placed in the partial observer coverage category based on contemporary groundfish production amounts; and (2) implement this exception without altering the full observer coverage requirements for all trawl catcher/processors and catcher/processors in a catch share program.
This discussion relies on the description provided in Section 2 of the Analysis.
This proposed rule would establish a production threshold for placement in the partial observer coverage category of average weekly groundfish production of 79,000 lb (35.8 mt) or less in a standard basis year or an alternate basis year (as defined below). The Council and NMFS considered five possible measures of groundfish production that could be used to establish the eligibility for catcher/processors to be assigned to the partial observer coverage category: Average daily production; average weekly production; maximum daily production; maximum weekly production; and overall annual production. For each measure of groundfish production, the Council and NMFS examined a range of production amounts and analyzed the effects of those alternatives.
The Council and NMFS selected a weekly production measure because it would include catcher/processors that engage in intense bursts of processing activity during a year but may not process throughout the whole year. A weekly reporting period is the standard measure of production for a trip by a catcher/processor under the current regulation (see definition of “Fishing trip” in § 679.2). Using an average weekly production measure is less sensitive to variations in processing activity that can occur by using an
The Council and NMFS considered a range of average weekly production measures as a threshold for partial coverage. The Council and NMFS considered a lower average weekly production threshold of 42,000 lb (19.1 mt) and a higher average weekly production threshold of 79,000 lb (35.8 mt). The three catcher/processors that are currently eligible for placement in the partial observer coverage category would still be eligible under the higher production threshold considered, and would generally be eligible for placement in the partial observer coverage category at the lower production threshold (see Table 7, Section 3.7.2 of the Analysis). The Council and NMFS selected the higher production standard to ensure that catcher/processors that are currently eligible for placement in the partial observer coverage category would continue to be eligible if these vessels maintain their current levels of production.
The Council and NMFS concluded that this production threshold would maintain a limited exception to the general requirement that catcher/processors are in the full observer coverage category. Based on historical production data, approximately 3 percent of non-trawl catcher/processors have production that would allow them to be eligible for placement in the partial observer coverage category under this proposed rule. Based on historical production data, this would represent less than 1 percent of the aggregate groundfish production in the GOA and the BSAI. The Council does not anticipate that this action would impair data quality because the overwhelming amount of groundfish production would remain subject to full observer coverage (Section 3.6.7 of the Analysis). NMFS expects that up to 11 vessels would be eligible for placement in the partial observer coverage category based on estimated production data of all catcher/processors (Table 17 in Section 3.7.12 of the Analysis). The catcher/processors eligible for partial coverage under this proposed rule are engaged primarily in the hook-and-line and Pacific cod and sablefish fisheries (see Section 3.7.12 of the Analysis).
The Council and NMFS realize that it would be impossible for NMFS to place a catcher/processor in the partial observer coverage category for a fishing year beginning January 1 based on data from the fishing year that had just ended on December 31 (
If a catcher/processor had no production in the standard basis year, (
The Council and NMFS also considered the initial type of observer coverage (
The Council and NMFS recommended placing any new non-trawl catcher/processor without production history in the partial coverage category in its first year of operation. The Council and NMFS selected this option after analyzing the potential impact on data quality and costs of assigning new non-trawl catcher/processors to both the full or partial observer coverage categories. The Council and NMFS realize that the costs of full observer coverage could prevent some non-trawl catcher/processors from starting processing, particularly processing of sablefish in remote fishing grounds in the Aleutian Islands, and processing of Pacific cod by catcher/processors using jig gear. If non-trawl catcher/processors had to operate for their first two years in the full observer coverage category, it might defeat one of the objectives of this action, namely encouraging beneficial activity that is being prevented by the cost of full observer coverage.
The Council and NMFS decided to exclude all trawl catcher/processors, regardless of their amount of production, from eligibility to participate in the partial observer coverage category. The unchanged observer requirements for trawl catcher/processors and catcher/processors that participate in a catch share program section of this preamble provides additional detail on trawl catcher/processor observer coverage requirements. Section 3.7.4 of the Analysis contains additional detail on the rationale for placing catcher/processors with no production in their appropriate observer coverage categories.
The Council and NMFS considered whether the owner of an eligible catcher/processor should have the option to be placed in the partial observer coverage category for the upcoming fishing year, or if NMFS would automatically place the qualifying vessel in the partial observer coverage category for the upcoming fishing year based on production data without any action by the vessel owner. The Council and NMFS decided that providing the vessel owner with the option to remain in the full observer coverage category best met the purposes
This proposed rule would establish two deadlines for a vessel owner to choose placement in the partial observer coverage category. First, NMFS anticipated that this proposed rule could be approved, be published, and become effective in spring of 2016. To achieve the benefits of this proposed rule in a timely manner, NMFS would establish a deadline in 2016 for a vessel owner of an eligible catcher/processor to request placement in the partial observer coverage category within 15 days after the effective date of the final rule, if approved. The effective date of the final rule would be 30 days after its publication in the
This proposed rule would also establish a deadline applicable for the 2017 fishing year, and for all future fishing years. In the Analysis, NMFS stated that a July 1 deadline for choosing to be placed in the partial observer coverage would give vessel owners adequate time to choose partial observer coverage and would give NMFS adequate time to incorporate that information into its development of the Observer Program annual deployment plan for the upcoming fishing year (Section 2.2.4 of the Analysis). For the 2017 fishing year, a vessel owner would have to request placement in the partial observer coverage category by July 1, 2016.
While it is possible that a vessel may meet the production threshold to request to be in the partial observer coverage category, this proposed rule does not alter existing observer coverage requirements for a catcher/processor using trawl gear or a catcher/processor when participating in a catch share program; these catcher/processors would continue to be required to be in the full observer coverage category. The rationale for each is described below.
During the development of this proposed rule, the Council and NMFS consistently stated that this proposed rule would not supersede any requirements for full observer coverage when a catcher/processor is participating in a catch share program (Section 2.4 of the Analysis). The requirements for full, or greater than full, coverage in these programs show a special need for verified individual accounting of catch by the catcher/processors in these programs.
Therefore, the proposed rule would not provide exceptions for a catcher/processor subject to additional observer requirements specified in § 679.51(a)(2)(vi) to be placed in the partial observer coverage category. The existing additional observer requirements would continue to apply to catcher/processors participating in the following catch share programs: Community Development Quota (CDQ) Program (except catcher/processors sablefish CDQ fishing); American Fisheries Act; Aleutian Islands directed pollock fishery; Amendment 80 trawl catcher/processors in the BSAI non-pollock fisheries; catcher/processors in the Central GOA Rockfish Program; and the longline catcher/processor subsector. Section 2.2 of the Analysis describes each of these catch share programs and the catcher/processors fishing under those programs in greater detail.
Trawl catcher/processors, regardless of production level, would continue to be placed in the full observer coverage category. Trawl catcher/processors are subject to multiple bycatch, or prohibited species catch (PSC), limits for salmon, halibut, crab and herring (see § 679.21(d)(3), (e)(1), (f)(2), (h)(2), and (i)(3)). Therefore, NMFS has identified a heightened need for data from these vessels best achieved under full observer coverage. In addition, Section 2.4.1 of the Analysis states that most trawl catcher/processors are currently operating under the provisions of either the Amendment 80 or American Fisheries Act catch share programs and would be ineligible for placement in the partial observer coverage category because of the requirements for additional observer coverage under those catch share programs. Finally, NMFS analyzed production data from trawl catcher/processors relative to the 79,000 lb (35.8 mt) average weekly production threshold. No active trawl catcher/processors met this threshold to be eligible for placement in the partial observer coverage category during the years analyzed (2009 through 2014). Given these factors, and even if a trawl catcher/processor met the production requirement in the future, this proposed rule would not alter the existing requirements that a catcher/processor using trawl gear would continue to be required to be in the full observer coverage category.
The proposed rule would revise regulations at 50 CFR part 679 to modify the criteria for NMFS to place small catcher/processors in the partial observer coverage category in the Observer Program. The primary provision of the proposed rule is to establish a new paragraph in § 679.51, namely § 679.51(a)(3), “Catcher/processor placement in the partial observer coverage category for a year.”
At § 679.51(a)(3)(i), this proposed rule would define the following terms for purposes of the new § 679.51(a)(3): A “fishing year” as the year during which a catcher/processor might be placed in the partial observer coverage category; the “standard basis year” as the fishing year minus two years; and the “alternate basis year” as the most recent year before the standard basis year in which a catcher/processor had any groundfish production but not earlier than 2009.
The proposed rule at § 679.51(a)(3)(i) also defines a vessel's “average weekly groundfish production,” as the annual groundfish round weight production estimate for a catcher/processor, divided by the number of separate weeks during which production occurred, as determined by production reports, but excluding any groundfish that was caught with trawl gear. Thus, if a vessel has groundfish production any day in a week, excluding trawl production, that would be considered as a week of production.
The proposed rule would specify at § 679.51(a)(3)(ii) the annual deadline for requesting placement in the partial observer coverage category as 15 days after the effective date of the final rule in 2016, and July 1 of the year before the year that the vessel owner would like to be placed in the partial observer coverage category, for 2017 and all future years. NMFS will make a determination within 30 days of receipt of the request for placement in the partial observer coverage category.
The proposed rule would specify at § 679.51(a)(3)(iii) the requirements for
To determine eligibility for placement in the partial observer coverage category, NMFS will first examine the catcher/processor's production in the standard basis year, namely two years before the fishing year. If a catcher/processor produced at or below the production threshold (79,000 lb (35.8 mt) average weekly groundfish production) in the standard basis year, but more than zero pounds, the vessel would meet the production threshold for placement in the partial observer coverage category in the upcoming fishing year. If a catcher/processor exceeded that production threshold, the vessel would not be eligible for placement in the partial observer coverage category in the upcoming fishing year.
If a catcher/processor had no production in the standard basis year, NMFS would examine the vessel's production in the alternative basis year, namely the first year that the vessel had any production before the standard basis year not earlier than 2009. If a catcher/processor had average groundfish weekly production of 79,000 lb (35.8 mt) or less in the alternate basis year, the vessel would meet the production threshold requirement for placement in the partial observer coverage category for the upcoming fishing year. If a catcher/processor exceeded the production threshold in the alternate basis year, the vessel would not be eligible for placement in the partial observer coverage category. If a catcher/processor had no production from 2009 through the standard basis year or an alternate basis year, the vessel would meet the production threshold requirement for placement in the partial observer coverage category.
If a catcher/processor meets the production threshold requirement for placement in the partial observer coverage category and is not a vessel using trawl gear or otherwise required to have full observer coverage by participation in a catch share program, the catcher/processor would be placed in partial observer coverage only if the owner of the vessel makes the request by the specified deadline. The proposed rule specifies at § 679.51(a)(3)(iv) how the vessel owner would request placement in the partial observer coverage category. A vessel owner would need to submit a request form to NMFS, which NMFS would make available on the NMFS Alaska Region Web site at
The proposed rule specifies at § 679.51(a)(3)(v) that NMFS will notify a vessel owner in writing if NMFS has placed the vessel in the partial observer coverage category once a request form has been submitted. Until NMFS provides this notice, the catcher/processor would remain in the full observer coverage category.
The proposed rule specifies at § 679.51(a)(3)(vi) that if NMFS denies a request for placement in the partial observer coverage category, NMFS would issue an Initial Administrative Determination, which will explain in writing the reasons for the denial. If the vessel owner wishes to appeal the denial, the proposed rule provides at § 679.51(a)(3)(vii) that the vessel owner would be able to appeal to the National Appeals Office according to the procedures in 15 CFR part 906.
In addition to the proposed new paragraph at § 679.51(a)(3), the proposed rule has several additional provisions. The proposed rule would add regulations at § 679.51(a)(1)(i)(C) to clarify that a catcher/processor placed in the partial observer coverage category under § 679.51(a)(3) is in the partial observer coverage category. The proposed rule would revise § 679.51(a)(2)(i)(A) to clarify that catcher/processors are placed in the full observer coverage category unless they are placed the partial observer coverage category using criteria specified at § 679.51(a)(3). The proposed rule also removes the regulations detailing the current exceptions to the full observer coverage category for catcher/processors at § 679.51(a)(2)(iv)(B).
The proposed rule would add a new category to the definition of fishing trip for purposes of the Observer Program in § 679.2. Section 679.2 currently defines a fishing trip for a catcher vessel delivering to a shoreside or stationary floating processor and for a catcher vessel delivering to a tender vessel. The new definition would define a fishing trip for a catcher/processor in the partial observer coverage category, namely the period of time that begins when the vessel departs a port to harvest fish until the vessel returns to port and offloads all processed product. This definition would be necessary because the current definition of a fishing trip does not accurately apply to a catcher/processor in the partial coverage category.
This proposed rule would add a new requirement at § 679.5(e)(13) for a catcher/processor landing report. The operator of a catcher/processor placed in the partial observer coverage category would be required to submit a catcher/processor landing report by 2400 hours, A.l.t., on the day after the end of the fishing trip. This would be a new reporting requirement created for this program. The landing report would be generated through eLandings or other NMFS-approved software by consolidating the daily production reports for the period the vessel operator defines as the fishing trip for purposes of observer coverage. NMFS would use information from the catcher/processor landing report to link catch data with observer data, to determine how to appropriately assign at-sea discard rates and PSC rates to unobserved catcher/processors in the partial observer coverage category, and to monitor compliance with the requirement for catcher/processors placed in the partial observer coverage category to log all fishing trips in ODDS.
The proposed rule would revise § 679.51(e)(1)(iii)(B) to remove requirements from catcher/processors placed in the partial observer coverage category to provide equipment for the purpose of observer data entry and transmission. Currently, all catcher/processors are required to provide an observer with a computer, NMFS-supplied software, and the ability to transmit data to NMFS using a point-to-point connection from the vessel. Removing this requirement would reduce the financial burden on small catcher/processors placed in the partial observer coverage category, especially for vessels mentioned in Section 3.7.4 of the Analysis that may begin to operate as a catcher/processor (
The proposed rule would revise § 679.55(a) and (c) to clarify that all catcher/processors named on a Federal Fishing Permit (FFP) and not in the full
The proposed rule includes corrections to fix two cross reference errors in § 679.2 and replace language in § 679.5 that refer to old terminology of “100 percent observer coverage”. That terminology would be replaced with “full observer coverage”; this is the terminology used under the restructured Observer Program.
Pursuant to section 304 (b)(1)(A) and 305(d) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with Amendments 112 and 102, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
The objectives for this proposed rule are to (1) refine the balance between observer data quality from the fishery and cost of observer coverage to catcher/processors with limited production relative to the rest of the catcher/processor fleet by allowing those catcher/processors with limited production the opportunity to be placed in the partial observer coverage category based on contemporary groundfish production amounts; and (2) maintain the full observer coverage requirement for all trawl catcher/processors and catcher/processors in a catch share program regardless whether these catcher/processors meet the groundfish production requirement for placement in the partial observer coverage category.
An Initial Regulatory Flexibility Analysis (IRFA) was prepared, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. The IRFA describes the reasons why this action is being proposed; the objectives and legal basis for the proposed rule; the number and description of small entities directly regulated by the proposed action; any projected reporting, recordkeeping, or other compliance requirements of the proposed rule; any overlapping, duplicative, or conflicting Federal rules; impacts of the action on small entities; and any significant alternatives to the proposed rule that would accomplish the stated objectives of the Magnuson-Stevens Act, and any other applicable statutes, and would minimize any significant adverse impacts of the proposed rule on small entities. Descriptions of the proposed action, its purpose, and the legal basis are contained earlier in this preamble and are not repeated here. A summary of the IRFA follows. A copy of the IRFA is available from NMFS (see
The RFA recognizes and defines three kinds of small entities: (1) Small businesses, (2) small non-profit organizations, and (3) small government jurisdictions. The proposed action would directly regulate small businesses.
The Small Business Administration has established size standards for all major industry sectors in the United States. A business primarily involved in finfish harvesting is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual gross receipts not in excess of $20.5 million, for all its affiliated operations worldwide.
Under the preferred alternative that would be implemented by this proposed rule, NMFS expects that up to 11 vessels may qualify for placement in the partial observer coverage category (See Section 3.4 and Section 4.6 of the Analysis for additional detail). NMFS estimates that these 11 vessels may be separated into four groups of entities.
The first group of vessels consists of three catcher/processors that currently qualify for placement in the partial observer coverage category under the existing program rules. These were discussed in detail in Section 3.7.2 of the Analysis. These three vessels are estimated to be small entities based on estimates of their gross revenues, and of their known affiliations.
The second group consists of three catcher/processors that currently operate as catcher/processors and are in the full observer coverage category, but that may be eligible to operate in the partial observer coverage category as a result of this proposed rule. These three catcher/processors are described in Section 3.7.3 of the Analysis. Two of these vessels are estimated to be small entities on the basis of estimates of their gross revenues, and of their known affiliations. One vessel is estimated to be a large entity on the basis of its gross revenue and its known affiliations.
The third group consists of catcher vessels that may begin to operate as catcher/processors if this action is taken. As discussed in Section 3.7.4 of the Analysis, NMFS could not identify vessels in this group on the basis of historical information. However, NMFS noted that at least one jig vessel operator has indicated that he may begin catcher/processor operations using jig gear in Federal waters if that vessel could be eligible for placement in the partial observer coverage category. NMFS estimates that this one known jig vessel would be estimated to be a small entity on the basis of gross revenues and affiliations of all known vessels currently using jig gear.
Finally, the analysis determined that fishing operations using sablefish “A” quota shares in the Aleutian Islands may begin processing at-sea and operating as catcher/processors in the Aleutian Islands if those vessels are eligible for placement in the partial observer coverage category. Section 3.7.5 of the Analysis provides additional detail on these vessels. NMFS identified that up to four vessels could operate as catcher/processors for sablefish. NMFS estimates that, with one exception, these vessels would be estimated to be small entities on the basis of estimates of their gross revenues, and of their known affiliations. Collectively, NMFS estimates that up to 9 of the 11 vessels identified in these four groups would be considered directly regulated small entities.
The proposed action contains one new reporting and recordkeeping requirement that affects the small entities. Vessel owners or operators desiring to be placed in the partial observer coverage category for a fishing year will have to submit a simple form expressing that choice by July 1 (except for the 2016 fishing year, as described previously). This information is needed for preparation of the Observer Program annual deployment plan.
This form will use production data that will be available to the owner or operator on the eLandings Web site. Given the simplicity of the form, and the accessibility of the data needed to complete it, NMFS estimates that it will take no more than 30 minutes to complete and file the form. For Paperwork Reduction Act estimation purposes, NMFS values this type of effort at $37 per hour. Approximately 9 small entities could be affected by this requirement. Thus, the total public time required to complete 9 forms a year x 30 minutes is 4.5 hours. At a cost of $37 per hour, the estimated cost would be about $167.
The RFA requires identification of any significant alternatives to the proposed rule that accomplish the stated objectives of the proposed action, consistent with applicable statutes, and that would minimize any significant economic impact of the proposed rule on small entities. As noted in the IRFA, the proposed action is expected to
The Council and NMFS adopted the average weekly production threshold of 79,000 lb (35.8 mt) as its preferred alternative. This production threshold would allow a catcher/processor to qualify for placement in the partial observer coverage category for a year, if its round weight equivalent of their processed product, two years previous, averaged less than 79,000 lb (35.8 mt) a week. If the vessel had not operated two years previously, NMFS would use its production in the first year with production since 2009, inclusive of 2009. If the vessel has not produced in this period, NMFS would allow the vessel to be placed in the partial observer coverage category in the year in which application is made, unless it is a trawl vessel, in which case it would be in the full observer coverage category.
This action is meant to reduce the relative burden on directly regulated small catcher/processors in comparison with the status quo. For vessels that qualify, this action would allow them to forego full observer coverage and operate with less expensive partial observer coverage, should they choose to do so. There are three catcher/processors that enjoy permanent placement in the partial observer coverage category under the status quo. These vessels would, under the action alternative, now have to qualify for placement in the partial observer coverage category each year. The Council and NMFS chose the 79,000-lb average weekly threshold, rather than an alternative 42,000-lb average weekly threshold, to maximize the potential for these three vessels to qualify for the option to be placed in the partial observer coverage category in future years. Moreover, one of the objectives of this action was to end the permanent placement in the partial observer coverage category for catcher/processor vessels and create a flexible system that could respond if a vessel increased production.
The Council and NMFS considered multiple elements and options under Alternative 2 that would qualify more vessels or fewer vessels for placement in the partial observer coverage category. In addition to the two average weekly production thresholds, a low and a high average daily, maximum daily production, maximum weekly, and annual production measures were considered.
The production thresholds analyzed under Element 1 Option 4B (high maximum weekly production) and Option 5B (high annual production) could have qualified one more small catcher/processor for partial observer coverage than is expected to qualify under the Council's preferred alternative (Option 2B: average weekly production threshold of 79,000 lb). The Council did not select Option 4B because basing a threshold on maximum weekly production could have excluded some catcher/processors that had one week of relatively high production, but had relatively low average production over the remainder of the year. The Council did not select Option 5B because it could allow catcher/processors with relatively high production levels over the course of several weeks or months during the year into the partial observer coverage category. NMFS recommended that catcher/processors with these high intensity production periods during the year should remain in the full observer coverage category so that all of their fishing activity is observed.
The average weekly measure was chosen, because it provided a measure of production intensity, which the annual, maximum daily, and maximum weekly measures, did not provide; it was readily measurable; and it was less prone to manipulation or unusually high levels of production than the other options considered. A week is also the standard measure of production for a catcher/processor trip in current regulation (Section 2.2.1 and Section 4.9 of the Analysis).
No relevant Federal rules have been identified that would duplicate or overlap with the proposed action.
This proposed rule contains collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). These requirements have been submitted to OMB for approval. The information collections are presented by OMB control number.
OMB Control No. 0648-0318
Public reporting burden for Catcher/Processor Observer Partial Coverage Request is estimated to average 30 minutes per response.
OMB Control No. 0648-0515
Public reporting burden for Catcher/Processor Landing Report through eLandings is estimated to average one minute per response.
OMB Control No. 0648-0711
Public reporting burden for submittal of Observer Fee through eFISH is estimated to average 1 minute per response.
Public comment is sought regarding: whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to NMFS at the
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at:
Alaska, Fisheries, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 50 CFR part 679 is proposed to be amended as follows:
16 U.S.C. 773
(3) * * *
(iii) For a catcher/processor in the partial observer coverage category, the period of time that begins when the vessel departs a port to harvest fish until
(e) * * *
(13)
(ii) The vessel operator must log into eLandings or other NMFS-approved software and provide the information required on the computer screen. Additional instructions for submitting a catcher/processor landing report is on the Alaska Region Web site at
(iii) For purposes of this landing report requirement, the end of a fishing trip is defined in § 679.2, paragraph (3)(iii) of the definition of a fishing trip.
(iv) The vessel operator must submit the catcher/processor landing report to NMFS by 2400 hours, A.l.t., on the day after the end of the fishing trip.
(a) * * *
(1) * * *
(i) * * *
(B) A catcher vessel when fishing for halibut with hook-and-line gear and while carrying a person named on a permit issued under § 679.4(d)(1)(i), § 679.4(d)(2)(i), or § 679.4(e)(2), or for sablefish IFQ with hook-and-line or pot gear and while carrying a person named on a permit issued under § 679.4(d)(1)(i) or § 679.4(d)(2)(i); or
(C) A catcher/processor placed in the partial observer coverage category under paragraph (a)(3) of this section.
(2) * * *
(i) * * *
(A) Catcher/processors, except a catcher/processor placed in the partial observer coverage category under paragraph (a)(3) of this section;
(3)
(A)
(B)
(C)
(D)
(ii)
(iii)
(A) An average weekly groundfish production of:
(
(
(
(B) Is not a catcher/processor using trawl gear; and
(C) Is not subject to additional observer coverage requirements in paragraph (a)(2)(vi) of this section.
(iv)
(v)
(vi)
(vii)
(e) * * *
(1) * * *
(iii) * * *
(B)
(a)
(c)
Food Safety and Inspection Service, USDA.
Notice and request for comments.
The Food Safety and Inspection Service (FSIS; also Agency) is clarifying its approach within the National Residue Program's (NRP's) Tier 2 exploratory program when it tests tissue samples collected from livestock and poultry carcasses and detects chemicals that do not have established tolerances or other regulatory levels. This approach applies to potentially hazardous chemicals that are not animal drugs or pesticide chemicals with established tolerances. The Agency also intends to apply this approach to egg products should these products become subject to chemical testing and to products from fish of the order Siluriformes when the final rule to make these species amenable to the Federal Meat Inspection Act (FMIA) is fully implemented. FSIS requests comments on the approach discussed in this document, and on how FSIS can further improve its management of environmental contaminants and other chemical hazards in meat and poultry products.
To receive full consideration, comments must be received on February 29, 2016.
FSIS invites interested persons to submit comments on this notice. Comments may be submitted by one of the following methods:
Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to
Dr. Patty Bennett, Humane Handling Enforcement Coordinator, Office of Field Operations, FSIS, USDA; Telephone (202)720-5397.
To protect consumers and to verify the safety of meat, poultry, and egg products
However, in addition to animal drugs and pesticide chemicals, there are other chemicals, including metals, mycotoxins, dioxins, and other environmental and industrial contaminants, that may on occasion be found in FSIS-regulated products. The NRP systematically addresses animal drugs and pesticide chemicals, but it has not covered other chemicals in a structured manner. The fact that it has not done so led the USDA Office of the Inspector General (OIG) to recommend, in a March 2010 report on FSIS's chemical residue program, that FSIS “establish policies and procedures for handling hazardous substances with no tolerances.”
In this notice, FSIS is announcing that it has taken significant steps to enhance its ability to address all types of chemical hazards and is clarifying its approach within the NRP for addressing hazardous chemicals without established tolerances.
On July 6, 2012, FSIS announced that it was restructuring the NRP with respect to how samples are collected and analyzed for chemical compounds (
The restructured NRP consists of three tiers of sampling. Tier 1 is the scheduled sampling program that functions as an exposure assessment and includes sampling of both domestic and imported product. Production classes representing the majority of the annual volume of animals slaughtered in the United States (
Samples tested under Tier 1 are analyzed for a set of chemicals that currently includes animal drugs and pesticide chemicals. When any level of a chemical subject to Tier 1 testing is detected in a livestock carcass muscle sample, FSIS inspection program personnel are instructed to condemn the carcass and all parts, unless a tolerance level has been set for the chemical in the tissue and production class in question, and the detected level does not exceed this tolerance (
Tier 2 testing encompasses two separate programs. The first, known as the inspector-generated program, is a targeted testing program in which field public health veterinarians (PHVs) decide to perform in-plant screens because they suspect that animals or carcasses contain higher than allowable levels of chemical residues. FSIS inspectors will collect and submit samples for inspector-generated residue testing if a screen test is positive, or if a PHV has reason to believe that a carcass or its parts may contain violative levels of one or more chemical residues, even if the screen test is negative (
The second, Tier 2 testing program, known as the exploratory assessment program, includes sampling plans designed in response to information gained from previous exposure assessments, from the chemical hazard identification process, or from other agencies. Unlike livestock carcasses selected for sampling under Tier 1 or under the inspector-generated program, carcasses selected for sampling under the exploratory assessment program can be released into commerce before exploratory sampling results are available. Essentially the exploratory assessment program is designed to investigate animal populations when the compounds in question have no established tolerances; respond to intelligence regarding use of veterinary drugs, pesticides, and environmental contaminants reported from the field; determine the prevalence and concentration of residues; and evaluate residue trends.
Tier 3 testing occurs in response to indications of chemical exposure to more than a single animal and encompasses targeted testing at the herd or flock level. Events triggering this type of testing are rare and usually involve extensive coordination between federal and state agencies at both the local and headquarters levels.
This notice provides clarification to the Tier 2 exploratory assessment program.
Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
Under the FMIA, “any carcass, part thereof, meat or meat food product” is adulterated “if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in the case the substance is not an added substance, such article shall not be considered adulterated . . . if the quantity of such substance in or on such article does not ordinarily render it injurious to health” (21 U.S.C. 601(m)(1)). Under the FMIA, a product is also adulterated “if it bears or contains by reason of administration of any substance to the live animal or otherwise any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity, (ii) a food additive, or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food” (21 U.S.C. 601(m)(2)(A)). In addition, a product is adulterated under the FMIA if it bears or contains any pesticide chemical, color additives, or food additive that is unsafe within the meaning of the Federal Food, Drug, and Cosmetics Act (FFDCA) (21 U.S.C. 601(m)(2)(B)-(D)). Both the PPIA and EPIA contain similar provisions (21 U.S.C. 453(g)(1)-(2) and 1033(a)(1)-(2)).
As mentioned above, because FSIS has primarily monitored livestock and poultry carcasses for animal drugs and pesticide chemicals, the approach described in this notice is initially intended to apply to livestock and poultry carcasses. FDA and EPA have statutory authority to establish residue tolerances that allow certain chemicals to remain in food products in non-harmful quantities, without causing these products to be adulterated. Under the FFDCA, the FDA may establish tolerances regulatory limits, and other limitations or specifications for animal drugs, approve food additives including conditions under which they may be used, and establish tolerances and regulatory limits for added or naturally occurring poisonous or deleterious substances, and the EPA may establish tolerance levels for registered pesticides. Title 21 of the Code of Federal Regulations (CFR) sets out tolerances and regulatory limits established by FDA, while Title 40 of the CFR sets out the tolerance levels established by EPA. In addition, FDA may also establish non-binding action levels that provide guidance for levels of contamination at which a food may be regarded as adulterated.
Many of the tolerances and regulatory limits applicable to meat, poultry, or egg products have only been established for chemicals that are either animal drugs or pesticide chemicals. Yet other hazardous chemicals exist that do not have established tolerances, regulatory limits, or action levels but that could nonetheless be present in FSIS-regulated products at levels that may cause consumers to exceed a risk level for human consumption.
When a livestock or poultry carcass tested under the Tier 1 or the Tier 2 inspector-generated program is determined to contain a level of an animal drug or pesticide chemical that exceeds the applicable tolerance set by FDA or EPA, the carcass and parts are adulterated under the FMIA or PPIA and as such must be condemned.
In contrast, although FSIS has detected, and continues to detect, environmental contaminants and other potential hazardous chemicals without established tolerances or regulatory levels through its exploratory assessment program, the Agency does not have a consistent and structured procedure for addressing these exploratory assessment results. Therefore, to better address the potential human health risks that may be associated with the presence of environmental contaminants and other potential chemical hazards without tolerances in meat and poultry products, FSIS is providing information regarding its approach to responding to findings from its exploratory sampling program. This information is intended to clarify how the Agency will respond to sampling results that reveal the presence of contaminants and chemicals of this type. FSIS is publishing this
FSIS intends to proceed as follows when chemicals without established tolerances or other applicable regulatory levels are detected in livestock or poultry carcasses. For chemicals designated for testing in the Tier 2 exploratory assessment program, FSIS will derive a
If, based on FSIS testing results, carcasses in Tier 2 testing are found to contain levels of a chemical above the
If the levels of the chemical are found to be above the DML on more than an occasional basis, FSIS will consider adding the chemical to the Tier 1 scheduled sampling program. FSIS will consult with the appropriate federal agency (FDA or EPA) regarding such an action and will issue a notice in the
The
For almost all chemicals being considered for Tier 2 exploratory testing, a health-based guidance value exists, and the DML will be derived as described above. In the extremely rare instance where there is not a health-based guidance value, FSIS will work its federal partners to decide on a course of action to develop one. In other instances however, a DML equivalent, such as a maximum level determination by the Codex Alimentarius, is available for specific chemicals in specific food commodities (
FSIS may identify potential chemicals of concern for testing and the possible presence of chemical hazards in meat and poultry products through scientific literature reviews, expert elicitations, attendance at scientific meetings, collaboration with Federal, State, and international partners, and communication with stakeholders and trade partners. FSIS will also consult with its NRP collaboration body, the interagency Surveillance Advisory Team (SAT),
Moreover, the multi-residue methods recently adopted by FSIS laboratories not only enable the Agency to test for a greater number of animal drug and pesticide chemical residues than in the past but also allow detection of a greater number of other potentially harmful chemicals, most of which do not have regulatory tolerances. As mentioned, FSIS has already been collecting data on certain environmental contaminants, including several metals, through its Tier 2 exploratory sampling.
As a result of these efforts, FSIS may identify a chemical in meat or poultry products that is not being monitored by the Agency, and for which no applicable tolerance exists. In most such cases, FSIS will seek to empirically confirm the chemical's presence in FSIS-regulated product through a Tier 2 exploratory assessment, which may be run for a period of time (
No significant costs to establishments, regardless of size, are expected as a result of the Tier 2 exploratory assessment program. The purpose of this sampling is to determine prevalence and levels of various hazardous chemicals in meat and poultry carcasses. Exploratory testing is being conducted under the NRP at little or no additional cost to the establishment or to the Agency. Once a DML is established, and FSIS is confident that these products are not adulterated based on the results from the exploratory testing, FSIS will then be able to limit the scope of this testing in the future. As mentioned, establishments will receive notification if any results of those tests are above the DML. There is no requirement for establishments to hold carcasses until acceptable results are available (as for Tier 1 and Tier 2 inspector-generated samples) under Tier 2 exploratory sampling, so there is no establishment cost associated with Tier 2 exploratory assessment program.
In most instances, FSIS does not expect establishments to take significant mitigating actions as a result of Tier 2 exploratory sampling since the purpose of this sampling is to inform the Agency on general prevalence, and not the performance of a particular establishment. However, if an establishment has received multiple test results that are above the DML or if it receives a test result well above the DML, FSIS will consult and work with its federal, state and local partners to determine the cause of the positive test results at little or no additional expense to establishments. Once a cause has been discovered, the establishment may receive a letter from FSIS or its partner agencies (which could include any test results, possible leads of sources of contamination to evaluate, and provide opportunities to consult with the appropriate agencies), at which time the establishment may voluntarily choose to incur the additional costs of certain mitigating actions, such as discarding feed or replacing feed troughs. Given its experience under the dioxin survey program and the ongoing Tier 2 exploratory program for veterinary drugs and pesticides, FSIS expects these follow-up letters and mitigating actions to be a rare occurrence while products from an establishment are tested in the Tier 2 exploratory assessment program.
If a chemical is moved into Tier 1 sampling, the Agency will inform the public and will conduct a cost-benefit analysis for the specific chemicals and products involved. The public will then have the opportunity to comment on the cost-benefit analysis.
The approach discussed in this notice is intended to provide more structure and consistency for existing FSIS procedures and practices for addressing chemicals in livestock and poultry carcasses that do not have established tolerances or other regulatory levels. The approach is designed to cover most chemical hazards that do not derive from animal drugs or pesticide chemicals. As part of an integrated chemical hazard identification, prioritization, and management system
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 may be accessed online at:
Send your completed complaint form or letter to USDA by mail, fax, or email:
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).
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,
National Institute of Food and Agriculture, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations that implement the Paperwork Reduction Act of 1995, this notice announces the National Institute of Food and Agriculture's (NIFA) intention to request approval to establish a new information collection and record keeping requirement for the Veterinary Medical Loan Repayment Program (VMLRP).
Written comments on this notice must be received by February 29, 2016, to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Written comments may be submitted by any of the following methods: Email:
Robert Martin, Records Officer; Email:
The VMLRP Program Office proposes a record keeping requirement for VMLRP participants and to collect additional information from current participants, their employers and past participants. The records to be maintained and the information collected will allow for better oversight and assessment of the program. Additionally, to streamline OMB approval processes all currently approved VMLRP information collections (OMB Control Number 0524-0046 and 0524-0047) will be combined into a single package along with the new information proposed. Each new requirement is described in detail below.
Estimate of Burden:
Estimate of Burden:
All responses to this notice will be summarized and included in the request to OMB for approval. All comments will become a matter of public record.
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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
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.
Notice.
The Rural Housing Service (RHS), an Agency within Rural Development, announces that it is soliciting competitive applications under its Housing Preservation Grant (HPG) program. This action is taken to comply with Agency regulations found in 7 CFR part 1944, subpart N, which requires the Agency to announce the opening and closing dates for receipt of pre-applications for HPG funds from eligible applicants.
The closing deadline for receipt of all pre-applications in response to this Notice is 5:00 p.m., local time for each Rural Development State Office on February 12, 2016. Rural Development State Office locations can be found at:
For general information, applicants may contact Jeaneane Shelton, Finance and Loan Analyst, Multi-Family Housing Preservation and Direct Loan Division, USDA Rural Development, STOP 0781, 1400 Independence Avenue SW., Washington, DC 20250-0781, telephone (202) 720-5443 (voice) (this is not a toll free number) or (800) 877-8339 (TDD-Federal Information Relay Service) or via email at,
The reporting requirements contained in this Notice have been approved by the Office of Management and Budget under Control Number 0575-0115.
The HPG program is a grant program, authorized under 42 U.S.C. 1490m and implemented at 7 CFR part 1944, subpart N, which provides qualified public agencies, private non-profit organizations including, but not limited to, faith-based and neighborhood partnerships, and other eligible entities, grant funds to assist low- and very low-income homeowners in repairing and rehabilitating their homes in rural areas. In addition, the HPG program assists rental property owners and cooperative housing complexes in rural areas in repairing and rehabilitating their units if they agree to make such units available to low- and very low-income persons.
The funding instrument for the HPG program will be a grant agreement. The term of the grant can vary from 1 to 2 years, depending on available funds and demand. No maximum or minimum grant levels have been established at the National level. In accordance with 7 CFR 1944.652, coordination and leveraging of funding for repair and rehabilitation activities with housing and community development organizations or activities operating in the same geographic area are expected, but not required. You should contact the Rural Development State Office to determine the allocation. HPG applicants who were previously selected for HPG funds are eligible to submit new applications to apply for Fiscal Year (FY) 2016 HPG program funds. New HPG applications must be submitted for the renewal or supplementation of existing HPG repair and/or rehabilitation projects that will be completed with FY 2016 HPG funds.
For FY 2016, the amount of funding available for the HPG Program can be found at the following link:
The commitment of program dollars will be made to selected applicants that have fulfilled the necessary requirements for obligation.
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All applicants will file an original and two copies of Standard Form (SF) 424, “Application for Federal Assistance,” and supporting information with the appropriate Rural Development State Office. A pre-application package, including SF-424, is available in any Rural Development State Office. All pre-applications shall be accompanied by the following information which Rural Development will use to determine the applicant's eligibility to undertake the HPG program and to evaluate the pre-application under the project selection criteria of 7 CFR 1944.679.
(a) A statement of activities proposed by the applicant for its HPG program as appropriate to the type of assistance the applicant is proposing, including:
(1) A complete discussion of the type of and conditions for financial assistance for housing preservation, including whether the request for assistance is for a homeowner assistance program, a rental property assistance program, or a cooperative assistance program;
(2) The process for selecting recipients for HPG assistance, determining housing preservation needs of the dwelling, performing the necessary work, and monitoring/inspecting work performed;
(3) A description of the process for identifying potential environmental impacts in accordance with 7 CFR 1944.672 and the provisions for compliance with Stipulation I, A-G of the Programmatic Memorandum of Agreement, also known as PMOA, (RD Instruction 2000-FF, available in any Rural Development State Office) in accordance with 7 CFR 1944.673(b);
(4) The development standard(s) the applicant will use for the housing preservation work; and, if not the Rural Development standards for existing dwellings, the evidence of its acceptance by the jurisdiction where the grant will be implemented;
(5) The time schedule for completing the program;
(6) The staffing required to complete the program;
(7) The estimated number of very low- and low-income minority and nonminority persons the grantee will assist with HPG funds; and, if a rental property or cooperative assistance program, the number of units and the term of restrictive covenants on their use for very low- and low-income;
(8) The geographical area(s) to be served by the HPG program;
(9) The annual estimated budget for the program period based on the financial needs to accomplish the objectives outlined in the proposal. The budget should include proposed direct and indirect administrative costs, such as personnel, fringe benefits, travel, equipment, supplies, contracts, and other cost categories, detailing those costs for which the grantee proposes to use the HPG grant separately from non-HPG resources, if any. The applicant budget should also include a schedule (with amounts) of how the applicant proposes to draw HPG grant funds,
(10) A copy of an indirect cost proposal when the applicant has another source of Federal funding in addition to the Rural Development HPG program;
(11) A brief description of the accounting system to be used;
(12) The method of evaluation to be used by the applicant to determine the effectiveness of its program which encompasses the requirements for quarterly reports to Rural Development in accordance with 7 CFR 1944.683(b) and the monitoring plan for rental properties and cooperatives (when applicable) according to 7 CFR 1944.689;
(13) The source and estimated amount of other financial resources to be obtained and used by the applicant for both HPG activities and housing development and/or supporting activities;
(14) The use of program income, if any, and the tracking system used for monitoring same;
(15) The applicant's plan for disposition of any security instruments held by them as a result of its HPG activities in the event of its loss of legal status;
(16) Any other information necessary to explain the proposed HPG program; and
(17) The outreach efforts outlined in 7 CFR 1944.671(b).
(b) Complete information about the applicant's experience and capacity to carry out the objectives of the proposed HPG program.
(c) Evidence of the applicant's legal existence, including, in the case of a private non-profit organization, which may include, but not be limited to, faith-based and community organizations, a copy of, or an accurate reference to, the specific provisions of State law under which the applicant is organized; a certified copy of the applicant's Articles of Incorporation and Bylaws or other evidence of corporate existence; certificate of incorporation for other than public bodies; evidence of good standing from the State when the corporation has been in existence 1 year or more; and the names and addresses of the applicant's members, directors and officers. If other organizations are members of the applicant-organization, or the applicant is a consortium, pre-applications should be accompanied by the names, addresses, and principal purpose of the other organizations. If the applicant is a consortium, documentation showing compliance with paragraph (4)(ii) under the definition of “organization” in 7 CFR 1944.656 must also be included.
(d) For a private non-profit entity, which may include, but not be limited to, faith-based and community organizations, the most recent audited statement and a current financial statement dated and signed by an authorized officer of the entity showing the amounts and specific nature of assets and liabilities together with information on the repayment schedule and status of any debt(s) owed by the applicant.
(e) A brief narrative statement which includes information about the area to be served and the need for improved housing (including both percentage and the actual number of both low-income and low-income minority households and substandard housing), the need for the type of housing preservation assistance being proposed, the anticipated use of HPG resources for historic properties, the method of evaluation to be used by the applicant in determining the effectiveness of its efforts.
(f) A statement containing the component for alleviating any overcrowding as defined by 7 CFR 1944.656.
(g) Applicant must submit an original and one copy of Form RD 1940-20, “
(h) Applicant must also submit a description of its process for:
(1) Identifying and rehabilitating properties listed on or eligible for listing on the National Register of Historic Places;
(2) Identifying properties that are located in a floodplain or wetland;
(3) Identifying properties located within the Coastal Barrier Resources System; and
(4) Coordinating with other public and private organizations and programs that provide assistance in the rehabilitation of historic properties (Stipulation I, D, of the PMOA, RD
(i) The applicant must also submit evidence of the State Historic Preservation Office's, (SHPO), concurrence in the proposal, or in the event of non-concurrence, a copy of SHPO's comments together with evidence that the applicant has received the Advisory Council on Historic Preservation's advice as to how the disagreement might be resolved, and a copy of any advice provided by the Council.
(j) The applicant must submit written statements and related correspondence reflecting compliance with 7 CFR 1944.674(a) and (c) regarding consultation with local government leaders in the preparation of its program and the consultation with local and state government pursuant to the provisions of Executive Order 12372.
(k) The applicant is to make its statement of activities available to the public for comment prior to submission to Rural Development pursuant to 7 CFR 1944.674(b). The application must contain a description of how the comments (if any were received) were addressed.
(1) The applicant must submit an original and one copy of Form RD 400-1, “
Applicants should review 7 CFR part 1944, subpart N for a comprehensive list of all application requirements.
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4. Intergovernmental Review Intergovernmental Review. The HPG program is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.
5. Funding Restrictions. There are no limits on proposed direct and indirect costs. Expenses incurred in developing pre-applications will be at the applicant's risk.
6. Other Submission Requirements. To comply with the President's Management Agenda, the Department of Agriculture is participating as a partner in the Government-wide Grants.gov site. Housing Preservation Grants [Catalog of Federal Domestic Assistance #10.433] is one of the programs included at this Web site. If you are an applicant under the Housing Preservation Grant program, you may submit your pre-application to the Agency in either electronic or paper format. Please be mindful that the pre-application deadline for electronic format differs from the deadline for paper format. The electronic format deadline will be based on Eastern Standard Time. The paper format deadline is local time for each Rural Development State Office.
Users of Grants.gov will be able to download a copy of the pre- application package, complete it off line, and then upload and submit the application via the Grants.gov site. You may not email an electronic copy of a grant pre-application to USDA Rural Development; however, the Agency encourages your participation in Grants.gov.
The following are useful tips and instructions on how to use the Web site:
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site as well as the hours of operation. USDA Rural Development strongly recommends that you do not wait until the application deadline date to begin the application process through Grants.gov. To use Grants.gov, applicants must have a DUNS number.
• You may submit all documents electronically through the Web site, including all information typically included on the Application for Rural Housing Preservation Grants, and all necessary assurances and certifications.
• After you electronically submit your application through the Web site, you will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number.
• RHS may request that you provide original signatures on forms at a later date.
• If you experience technical difficulties on the closing date and are unable to meet the 5:00 p.m. (Eastern Standard Time) deadline, print out your application and submit it to your State Office, you must meet the closing date and local time deadline.
• Please note that you must locate the downloadable application package for this program by the CFDA Number or FedGrants Funding Opportunity Number, which can be found at
In addition to the electronic pre- application at the
Applicants are encouraged but not required, to also provide an electronic copy of all hard copy forms and documents submitted in the pre-application/application package as requested by this Notice. The forms and documents must be submitted as read-only Adobe Acrobat PDF files on an electronic media such as CDs, DVDs or USB drives. For each electronic device that you submit, you must include a Table of Contents listing all of the documents and forms on that device. The electronic medium must be submitted to the local Rural Development State Office where the project will be located.
If you receive a loan or grant award under this Notice, USDA reserves the right to post all information that is not protected by the Privacy Act submitted as part of the pre-application/application package on a public Web site with free and open access to any member of the public.
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(a) Providing a financially feasible program of housing preservation assistance. “Financially feasible” is defined as proposed assistance which will be affordable to the intended recipient or result in affordable housing for very low- and low-income persons.
(b) Serving eligible rural areas with a concentration of substandard housing for households with very low- and low-income.
(c) Being an eligible applicant as defined in 7 CFR 1944.658.
(d) Meeting the requirements of consultation and public comment in accordance with 7 CFR 1944.674.
(e) Submitting a complete pre-application as outlined in 7 CFR 1944.676.
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(a) Points are awarded based on the percentage of very low-income persons that the applicant proposes to assist, using the following scale:
(b) The applicant's proposal may be expected to result in the following percentage of HPG fund use (excluding administrative costs) to total cost of unit preservation. This percentage reflects maximum repair or rehabilitation with the least possible HPG funds due to leveraging, innovative financial assistance, owner's contribution or other specified approaches. Points are awarded based on the following percentage of HPG funds (excluding administrative costs) to total funds:
(c) The applicant has demonstrated its administrative capacity in assisting very low- and low-income persons to obtain adequate housing based on the following:
(1) The organization or a member of its staff has at least one or more years experience successfully managing and operating a rehabilitation or weatherization type program: 10 points.
(2) The organization or a member of its staff has at least one or more years experience successfully managing and operating a program assisting very low- and low-income persons obtain housing assistance: 10 points.
(3) If the organization has administered grant programs, there are no outstanding or unresolved audit or investigative findings which might impair carrying out the proposal: 10 points.
(d) The proposed program will be undertaken entirely in rural areas outside Metropolitan Statistical Areas, also known as MSAs, identified by Rural Development as having populations below 10,000 or in remote parts of other rural areas (
(e) The program will use less than 20 percent of HPG funds for administration purposes:
(f) The proposed program contains a component for alleviating overcrowding as defined in 7 CFR 1944.656: 5 points.
In the event more than one pre-application receives the same amount of points, those pre-applications will then be ranked based on the actual percentage figure used for determining the points. Further, in the event that pre-applications are still tied, then those pre-applications still tied will be ranked based on the percentage for HPG fund use (low to high). Further, for applications where assistance to rental properties or cooperatives is proposed, those still tied will be further ranked based on the number of years the units are available for occupancy under the program (a minimum of 5 years is required). For this part, ranking will be based from most to least number of years.
Finally, if there is still a tie, then a lottery system will be used. After the award selections are made, all applicants will be notified of the status of their applications by mail.
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The U.S. Department of Agriculture (USDA) prohibits discrimination against its customers, employees, and applicants for employment on the basis of race, color, national origin, age, disability, sex, gender identity, religion, reprisal and where applicable, political beliefs, marital status, familial or parental status, religion, sexual orientation, or all or part of an individual's income is derived from any public assistance program, or protected genetic information in employment or in any program or activity conducted or funded by the Department. (Not all prohibited bases will apply to all programs and/or employment activities.)
If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form (PDF), found online at
Individuals who are deaf, hard of hearing or have speech disabilities and you wish to file either an EEO or program complaint please contact USDA through the Federal Relay Service at (800) 877-8339 or (800) 845-6136 (in Spanish).
Persons with disabilities, who wish to file a program complaint, please see information above on how to contact us by mail directly or by email. If you require alternative means of communication for program information (
Applicants are encouraged, but not required, to submit this pre-application form electronically by accessing the Web site:
Supporting documentation required by this pre-application may be attached to the email generated when you click the Send Form button to submit the form. However if the attachments are too numerous or large in size, the email box will not be able to accept them. In that case, submit the supporting documentation for this pre-application to the State Office with your complete application package under item IX.
Documents Submitted, indicate the supporting documents that you are submitting either with the pre-application or to the State Office.
Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Wyoming Advisory Committee to the Commission will convene at 1:00 p.m. (MST) on Thursday, January 14, 2016, via teleconference. The purpose of the planning meeting is for the Advisory Committee to continue their discussion and plans to identify specific issues for future study.
Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1-888-364-3109; Conference ID: 480871. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free phone number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1-800-977-8339 and provide the FRS operator with the Conference Call Toll-Free Number: 1-888-364-3109, Conference ID: 480871. Members of the public are invited to submit written comments; the comments must be received in the regional office by Tuesday, February 16, 2016. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Thursday, January 14, 2016, at 1:00 p.m. (MST).
To be held via teleconference:
Conference Call Toll-Free Number: 1-888-364-3109, Conference ID: 480871.
TDD: Dial Federal Relay Service 1-800-977-8339 and give the operator the above conference call number and conference ID.
Malee V. Craft, Regional Director,
On October 14, 2015, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the South Jersey Port Corporation, grantee of FTZ 142, requesting subzone status subject to the existing activation limit of FTZ 142, on behalf of Nine West Holdings, Inc. in West Deptford, New Jersey.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 142D is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 142's 249-acre activation limit.
Samsung Austin Semiconductor, L.L.C. (Samsung), operator of Subzone 183B, submitted a notification of proposed production activity to the FTZ Board for its facility in Austin, Texas. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on December 14, 2015.
Samsung already has authority to produce semiconductor memory devices for export. The current request would add foreign-status hexamethyldisilazane to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status material described in the submitted notification and subsequently authorized by the FTZ Board.
Export production under FTZ procedures could exempt Samsung from customs duty payments on the foreign-status hexamethyldisilazane (3.7% duty rate) and the materials and components in the existing scope of authority. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is February 8, 2016.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
For further information, contact Diane Finver at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Groundfish Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Thursday, January 14, 2016 at 9 a.m.
The meeting will be held at the DoubleTree by Hilton, 50 Ferncroft Road, Danvers, MA 01950; phone: (978) 777-2500; fax: (978) 750-7911.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The committee will receive an update from the Plan Development Team on witch flounder analysis for Framework Adjustment 55, for informational purposes only. The committee will also discuss and plan for 2016 Council priorities for groundfish. They will review and potentially provide input on draft guidance prepared by NMFS related to the evaluation of catch share programs. The committee will also review and discuss potential 5-year research priorities for groundfish. Other business will be discussed as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; intent to prepare an environmental impact statement and initiate scoping process; request for comments; extension of comment period and announcement of additional public hearing.
In the Notice of Intent (NOI) that published on Monday, November 23, 2015, the Council and NMFS announced the intention to prepare an environmental impact statement in accordance with the National Environmental Policy Act. This notice is to alert the interested public of an additional public hearing and to extend the written comment period from January 7, 2016, to January 20, 2016, to ensure adequate time for the public to comment on the NOI.
The deadline for written and electronic scoping comments on the NOI published on November 23, 2015 (80 FR 72951) is extended to January 20, 2016, by 5 p.m., local time.
Written scoping comments on Amendment 22 may be sent by any of the following methods:
• Email to the following address:
• Mail to Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950; or
• Fax to (978) 465-3116.
Requests for copies of the Amendment 22 scoping document and other information should be directed to Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950, telephone (978) 465-0492. The scoping document is accessible electronically via the Internet at
Thomas Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
On November 23, 2015, NMFS published an NOI (80 FR 72951) with a comment period ending on January 7, 2016. The comment period is being extended to January 20, 2016, to allow the public additional time to comment.
The Council will take and discuss scoping comments on this amendment at an additional public meeting:
1. Wednesday, January 20, 2016, at 6:00 p.m. Hampton Inn, 2100 Post Road, Warwick, RI 02886; (401) 739-8888.
This meeting is accessible to people with physical disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies (see
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Wednesday, January 13, 2016 at 9:30 a.m.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Committee plans to receive a Herring Advisory Panel report. The committee will also review Amendment 8 to the Atlantic Herring Fishery Management Plan. They will also review information and analyses which addresses concerns related to the Acceptable Biological Catch control rule, and localized depletion in inshore waters. The committee plans to discuss the potential for using state port-side monitoring data to monitor the River herring/Shad catch caps. The committee will also discuss 5-year research priorities for Atlantic herring (2017-22). They also will discuss a future action to consider revising the haddock catch cap accountability measure. Other business will be discussed as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
The next meeting of the U.S. Commission of Fine Arts is scheduled for 21 January 2016, at 9:00 a.m. in the Commission offices at the National Building Museum, Suite 312, Judiciary Square, 401 F Street NW., Washington, DC 20001-2728. Items of discussion may include buildings, parks and memorials.
Draft agendas and additional information regarding the Commission are available on our Web site:
Office of the Secretary, Department of Defense, DoD.
Notice of DRG revised rates.
This notice describes the changes made to the TRICARE DRG-based payment system in order to conform to changes made to the Medicare Prospective Payment System (PPS).
It also provides the updated fixed loss cost outlier threshold, cost-to-charge ratios, and the data necessary to update the FY 2016 rates.
Defense Health Agency, TRICARE, Medical Benefits and Reimbursement Section, 16401 East Centretech Parkway, Aurora, CO 80011-9066.
Sharon L. Seelmeyer, Medical Benefits and Reimbursement Section, TRICARE, telephone (303) 676-3690. Questions regarding payment of specific claims under the TRICARE DRG-based payment system should be addressed to the appropriate contractor.
The final rule published on September 1, 1987 (52 FR 32992) set forth the basic procedures used under the CHAMPUS DRG-based payment system. This was subsequently amended by final rules published August 31, 1988 (53 FR 33461); October 21, 1988 (53 FR 41331); December 16, 1988 (53 FR 50515); May 30, 1990 (55 FR 21863); October 22, 1990 (55 FR 42560); and September 10, 1998 (63 FR 48439).
An explicit tenet of these final rules, and one based on the statute authorizing the use of DRGs by TRICARE, is that the TRICARE DRG-based payment system is modeled on the Medicare PPS, and that, whenever practicable, the TRICARE system will follow the same rules that apply to the Medicare PPS. The Centers for Medicare and Medicaid Services (CMS) publishes these changes annually in the
In addition, this notice updates the rates and weights in accordance with our previous final rules. The actual changes we are making, along with a description of their relationship to the Medicare PPS, are detailed in this notice.
Following is a discussion of the changes CMS has made to the Medicare PPS that affect the TRICARE DRG-based payment system.
Under both the Medicare PPS and the TRICARE DRG-based payment system, cases are classified into the appropriate DRG by a Grouper program. The Grouper classifies each case into a DRG on the basis of the diagnosis and procedure codes and demographic information (that is, sex, age, and discharge status). The Grouper used for the TRICARE DRG-based payment system is the same as the current Medicare Grouper with certain modifications. For FY 2008, Medicare implemented their Medicare-Severity DRG (MS-DRG) based payment system. TRICARE, however, continued with the Centers for Medicare and Medicaid Services DRG-based (CMS-DRG) payment system for FY 2008. For FY 2009, the TRICARE/CHAMPUS DRG-based payment system shall be modeled on the MS-DRG system, with the following modifications.
The MS-DRG system consolidated the 43 pediatric CMS DRGs that were defined based on age less than or equal to 17 into the most clinically similar MS-DRGs. In their Inpatient Prospective Payment System final rule for MS-DRGs, Medicare stated for their population these pediatric CMS DRGs contained a very low volume of Medicare patients. At the same time, Medicare encouraged private insurers and other non-Medicare payers to make refinements to MS-DRGs to better suit the needs of the patients they serve. Consequently, TRICARE finds it appropriate to retain the pediatric CMS-DRGs for our population. TRICARE is also retaining the TRICARE-specific DRGs for neonates and substance use.
For FY09, TRICARE will use the MS-DRG v26.0 pre-MDC hierarchy, with the exception that MDC 15 is applied after DRG 011-012 and before MDC 24.
For FY10, there are no additional or deleted DRGs.
For FY 11, the added DRGs and deleted DRGs are the same as those included in CMS' final rule published on August 16, 2010. That is, DRG 009 is deleted; DRGs 014 and 015 are being added.
For FY 12, the added DRGs and deleted DRGs are the same as those included in CMS' final rule published on August 18, 2011 (76 FR 51476-51846). That is, DRG 015 is deleted; DRGs 016 and 017 are being added.
For FY 2013 there are no new, revised, or deleted DRGs.
For FY 2014 there are no new, revised, or deleted DRGs.
For FY 2015 the added, deleted, and revised DRGs are the same as those included in the CMS' final rule published on August 22, 2014 (79 FR 49880) with the exception of endovascular cardiac valve replacement for which CMS added DRGs 266/267 and TRICARE added DRGs 317/318 because the TRICARE Grouper already has DRGs 266/267 assigned to pediatric procedures.
For FY2016 the added, deleted, and revised DRGs are the same as those
TRICARE will continue to use the same wage index amounts used for the Medicare PPS. TRICARE will also duplicate all changes with regard to the wage index for specific hospitals that are redesignated by the Medicare Geographic Classification Review Board. In addition, TRICARE will continue to utilize the out-commuting wage index adjustment.
TRICARE is adopting CMS' percentage of labor related share of the standardized amount. For wage index values greater than 1.0, the labor related portion of the Adjusted Standardized Amount (ASA) shall continue to equal 69.6 percent. For wage index values less than or equal to 1.0 the labor related portion of the ASA shall continue to equal 62 percent.
TRICARE will update the adjusted standardized amounts according to the final updated hospital market basket used for the Medicare PPS for all hospitals subject to the TRICARE DRG-based payment system according to CMS' August 17, 2015, final rule. For FY 2016, the market basket is 2.4 percent. Note: Medicare's FY 2016 market basket index adjusts according to hospitals' compliance with quality data and electronic health record meaningful use submissions. These adjustments do not apply to the TRICARE Program.
Since TRICARE does not include capital payments in our DRG-based payments (TRICARE reimburses hospitals for their capital costs as reported annually to the contractor on a pass through basis), we will use the fixed loss cost outlier threshold calculated by CMS for paying cost outliers in the absence of capital prospective payments. For FY 2016, the TRICARE fixed loss cost outlier threshold is based on the sum of the applicable DRG-based payment rate plus any amounts payable for Indirect Medical Education (IDME) plus a fixed dollar amount. Thus, for FY 2016, in order for a case to qualify for cost outlier payments, the costs must exceed the TRICARE DRG base payment rate (wage adjusted) for the DRG plus the IDME payment (if applicable) plus $20,758 (wage adjusted). The marginal cost factor for cost outliers continues to be 80 percent.
The FY 2016 TRICARE National Operating Standard Cost as a Share of Total Costs (NOSCASTC) used in calculating the cost outlier threshold is 0.921. TRICARE uses the same methodology as CMS for calculating the NOSCASTC; however, the variables are different because TRICARE uses national cost-to-charge ratios while CMS uses hospital specific cost-to-charge ratios.
Passage of the Medical Modernization Act of 2003 modified the formula multipliers to be used in the calculation of IDME adjustment factor. Since the IDME formula used by TRICARE does not include disproportionate share hospitals (DSHs), the variables in the formula are different than Medicare's, however; the percentage reductions that will be applied to Medicare's formula will also be applied to the TRICARE IDME formula. The multiplier for the IDME adjustment factor for TRICARE for FY 2016 is 1.02.
TRICARE uses a national Medicare cost-to-charge ratio (CCR). For FY 2016, the Medicare CCR used for the TRICARE DRG-based payment system for acute care hospitals and neonates will be 0.2631. This is based on a weighted average of the hospital-specific Medicare CCRs (weighted by the number of Medicare discharges) after excluding hospitals not subject to the TRICARE DRG system (Sole Community Hospitals, Indian Health Service hospitals, and hospitals in Maryland). The Medicare CCR is used to calculate cost outlier payments, except for children's hospitals. The Medicare CCR has been increased by a factor of 1.0065 to include an additional allowance for bad debt. The 1.0065 factor reflects the provisions of the Middle Class Tax Relief and Job Creation Act of 2012. For children's hospital cost outliers, the CCR used is 0.2840.
The final rule published on May 21, 2014 (79 FR 29085) set forth all final claims with discharge dates of October 1, 2014, or later and reimbursed under the TRICARE DRG-Based payment system, are to be priced using the rules, weights, and rates in effect as of the date of discharge. Prior to this, all final claims were priced using the rules, weights, and rates in effect as of the date of admission.
The updated rates and weights are accessible through the Internet at
Deputy Chief Management Officer, Department of Defense (DoD).
Notice of Federal Advisory Committee Meeting.
The DoD is publishing this notice to announce a meeting of the National Commission on the Future of the Army (“the Commission”). The meeting will be closed to the public.
Date of the Closed Meeting: Wednesday, January 13, 2016, from 8:00 a.m. to 5:00 p.m.
Address of Closed Meeting, January 13, 2016: Rm 12110, 12th Floor, Zachary Taylor Building, 2530 Crystal Dr., Arlington, VA 22202.
Mr. Don Tison, Designated Federal Officer, National Commission on the Future of the Army, 700 Army Pentagon, Room 3E406, Washington, DC 20310-0700, Email:
This meeting will be held under the provisions of the Federal Advisory Committee Act (FACA) 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.
During the closed meeting on Wednesday, January 13, 2016, the
January 13, 2016—Closed Meeting: The Commission will hold a closed meeting to review the Commission's report for content after recommend edits from the OSD security review. All presentations and resulting discussion are classified.
In accordance with applicable law, 5 U.S.C. 552b(c) and 41 CFR 102-3.155, the DoD has determined that the meeting scheduled for January 13, 2016 will be closed to the public. Specifically, the Assistant Deputy Chief Management Officer, with the coordination of the DoD FACA Attorney, has determined in writing that this meeting will be closed to the public because it will discuss matters covered by 5 U.S.C. 552b(c)(1).
Pursuant to section 10(a)(3) of the FACA and 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written comments to the Commission in response to the stated agenda of the closed meeting or the Commission's mission. The Designated Federal Officer (DFO) will review all submitted written statements. Written comments should be submitted to Mr. Donald Tison, DFO, via facsimile or electronic mail, the preferred modes of submission. Each page of the comment must include the author's name, title or affiliation, address, and daytime phone number. All comments received before Tuesday, January 12, 2016, will be provided to the Commission before the January 13, 2016, meeting. All contact information may be found in the
The DoD sponsor for the Commission is the Deputy Chief Management Officer. The Commission is tasked to submit a report, containing a comprehensive study and recommendations, by February 1, 2016 to the President of the United States and the Congressional defense committees. The report will contain a detailed statement of the findings and conclusions of the Commission, together with its recommendations for such legislation and administrative actions it may consider appropriate in light of the results of the study. The comprehensive study of the structure of the Army will determine whether, and how, the structure should be modified to best fulfill current and anticipated mission requirements for the Army in a manner consistent with available resources.
Department of Defense.
Renewal of Federal Advisory Committee.
The Department of Defense is publishing this notice to announce that it is renewing the charter for the Secretary of the Navy Advisory Panel (“the Panel”).
Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.
This committee's charter is being renewed in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d).
The Panel is a discretionary Federal advisory committee that provides the Secretary of Defense and the Deputy Secretary of Defense, through the Secretary of the Navy, independent advice and recommendations on critical matters concerning the Department of the Navy.
The Panel's focus will include Department of the Navy administration and management, recruitment and training, equipment acquisition and maintenance, military and civilian manpower systems, basing and support infrastructure, and logistical support. The Panel will also focus on research and development matters confronting the U.S. Navy and the U.S. Marine Corps and on matters pertaining to preserving the history and heritage of the Naval Services.
The Panel shall be composed of no more than 15 members. The members will be eminent authorities in the fields of science, research, finance, history, engineering, business, and industry.
The appointment of Panel members will be authorized by the Secretary of Defense or the Deputy Secretary of Defense, and administratively certified by the Secretary of the Navy, for a term of service of one-to-four years, and their appointments will be renewed on an annual basis in accordance with DoD policies and procedures. Members of the Panel who are not full-time or permanent part-time Federal officers or employees will be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as special government employee (SGE) members. Panel members who are full-time or permanent part-time Federal officers or employees will serve as regular government employee (RGE) members. No member, unless authorized by the Secretary of Defense, may serve more than two consecutive terms of service on the Panel, to include its subcommittees, or serve on more than two DoD federal advisory committees at one time.
All members of the Panel are appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest.
Except for reimbursement of official Panel-related travel and per diem, Panel members serve without compensation.
The Secretary of the Navy has the delegated authority to appoint the Panel's Chair from among the membership previously authorized by the Secretary of Defense or Deputy Secretary of Defense.
The DoD, as necessary and consistent with the Panel's mission and DoD policies and procedures, may establish subcommittees, task forces, or working groups to support the Panel.
Establishment of subcommittees will be based upon a written determination, to include terms of reference, by the Secretary of Defense, the Deputy Secretary of Defense, or the Secretary of the Navy, as the DoD Sponsor.
Such subcommittees shall not work independently of the Panel and shall report all their recommendations and advice solely to the Panel for full deliberation and discussion. Subcommittees, task forces, or working groups have no authority to make decisions and recommendations, verbally or in writing, on behalf of the Panel. No subcommittee or any of its members can update or report, verbally or in writing, directly to the DoD or any Federal officers or employees. If a majority of Panel members are appointed to a particular subcommittee, then that subcommittee may be required to operate pursuant to the same notice and openness requirements of FACA which govern the Panel's operations.
Pursuant to Secretary of Defense policy, the Secretary of the Navy is authorized to administratively certify the appointment of subcommittee members if the Secretary of Defense or
Subcommittee members, with the approval of the Secretary of Defense, will be appointed for a term of service of one-to-four years, subject to annual renewals; however, no member shall serve more than two consecutive terms of service on the subcommittee. Subcommittee members, if not full-time or part-time Federal officers or employees, will be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as SGE members. Subcommittee members who are full-time or permanent part-time Federal officers or employees will serve as RGE members. With the exception of reimbursement for travel and per diem as it pertains to official travel related to the Panel or its subcommittees, Panel subcommittee members shall serve without compensation.
The Secretary of Defense authorizes the Secretary of the Navy to appoint the chair and vice chair of any appropriately approved subcommittees from among the subcommittee membership previously authorized by the Secretary of Defense or Deputy Secretary of Defense.
Each subcommittee member is appointed to provide advice on behalf of the Government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest.
All subcommittees operate under the provisions of the FACA, the Sunshine Act, governing Federal statutes and regulations, and established DoD policies and procedures.
Currently, DoD has approved the following two permanent subcommittees to the Panel:
(a) The Naval Research Advisory Committee shall be composed of not more than seven members and shall provide independent advice and recommendations on scientific, technical, research, and development matters confronting the U.S. Navy and the U.S. Marine Corps. Pursuant to 10 U.S.C. 5024(a), the subcommittee shall consist of civilians preeminent in the fields of science, research, and development work, and one member must be from the field of medicine. The estimated number of meetings is four per year.
(b) The Secretary of the Navy's Advisory Subcommittee on Naval History shall be composed of not more than 15 members and shall provide independent advice and recommendations on matters pertaining to preserving the heritage and legacy of the Naval Services and disseminating their rich history to the Service and the American public. Advisory topics may include professional standards, methods, program priorities, cooperative relationships in Marine Corps and Navy's historical research and publication programs, museums, archives, archeology, libraries, manuscript collections, rare book collections, art collections, preservation, and curatorial activities. The subcommittee shall consist of civilians who have broad managerial experience, vision, and understanding in one or more of the following areas: Military and maritime history, archives, museology, art, library science, and information technology. The estimated number of meetings is one per year.
The Panel's Designated Federal Officer (DFO), pursuant to DoD policy, shall be a full-time or permanent part-time DoD employee, and will be appointed in accordance with established DoD policies and procedures.
The Panel's DFO is required to be in attendance at all Panel and subcommittee meetings for the duration of each and every meeting. However, in the absence of the Panel's DFO, a properly approved Alternate DFO, duly appointed to the Panel according to DoD policies and procedures, will attend the entire duration of all of the Panel or subcommittee meeting.
The DFO, or the Alternate DFO, will call all of the Panel and its subcommittee meetings; prepare and approve all meeting agendas; adjourn any meeting, when the DFO, or the Alternate DFO, determines adjournment to be in the public interest or required by governing regulations or DoD policies and procedures; and chair meetings when directed to do so by the official to whom the Panel reports.
Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to Panel membership about the Panel's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Panel.
All written statements shall be submitted to the DFO for the Panel, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Panel's DFO can be obtained from the GSA's FACA Database—
The DFO, pursuant to 41 CFR 102-3.150, will announce planned meetings of the Panel. The DFO, at that time, may provide additional guidance on the submission of written statements that are in response to the stated agenda for the planned meeting in question.
DoD.
Meeting notice.
The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Vietnam War Commemoration Advisory Committee. This meeting is open to the public.
The public meeting of the Vietnam War Commemoration Advisory Committee (hereafter referred to as “the Committee”) will be held on Friday, January 15, 2016. The meeting will begin at 8:30 a.m. and end at 12:30 p.m.
1331 F Street NW., Suite 1000, Washington, DC 20004.
Committee's Designated Federal Officer: The committee's Designated Federal Officer is Mr. Michael Gable, Vietnam War Commemoration Advisory Committee, 1101 Wilson Blvd., Suite 810, Arlington, VA 22209,
This meeting is being held under the provisions of the Federal Advisory
Purpose of the Meeting: At this meeting, the Committee will convene and receive a series of updates on the Vietnam War Commemoration. The mission of the Committee is to provide the Secretary of Defense, through the Director of Administration and Management (DA&M), independent advice and recommendations regarding major events and priority of efforts during the commemorative program for the 50th Anniversary of the Vietnam War, in order to achieve the objectives for the Commemorative Program.
Availability of Materials for the Meeting: A copy of the agenda for the Committee may be obtained from the Commemoration's Web site at
Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. All members of the public who wish to attend the public meeting must contact Mr. Michael Gable, Mr. Mark Franklin or Ms. Scherry Chewning at the number listed in the
Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact Mr. Mark Franklin or Ms. Scherry Chewning at least five (5) business days prior to the meeting so that appropriate arrangements can be made.
Pursuant to 41 CFR 102-3.105(j) and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written comments to the Commemoration about its mission and topics pertaining to this public meeting.
Written comments should be received by the DFO at least five (5) business days prior to the meeting date so that the comments may be made available to the Commemoration for their consideration prior to the meeting. Written comments should be submitted via email to the address for the DFO given in the
Institute of Education Sciences (IES), 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 February 29, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Yumiko Sekino, (202) 219-2046.
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.
• To what extent do youth with disabilities who receive special education services under IDEA make progress through high school compared with other youth, including those identified for services under Section 504 of the Rehabilitation Act? For students with disabilities, has high school course taking and completion rates changed over the past few decades?
• Are youth with disabilities achieving the post-high school outcomes envisioned by IDEA, and how do their college, training, and employment rates compare with those of other youth?
• How do these high school and postsecondary experiences and outcomes vary by student characteristics, including their disability category, age, sex, race/ethnicity, English Learner status, income status, and type of high school attended (including regular public school, charter school, career/technical school, special education school, or other State or Federally-operated institution)?
Office of Fossil Energy, Department of Energy.
Notice of availability of the 2014 EIA LNG Export Study and the 2015 LNG Export Study, and request for comments.
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of the availability of two studies examining the cumulative impacts of liquefied natural gas (LNG) exports in the above-referenced proceedings and invites the submission of comments regarding those studies. DOE commissioned the studies to inform DOE's decisions on applications seeking authorization to export LNG from the lower-48 states to non-free trade agreement countries.
Comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, February 12, 2016. DOE will not accept reply comments.
Pursuant to section 3 of the Natural Gas Act, 15 U.S.C. 717b, exports of natural gas, including LNG, must be authorized by DOE/FE.
Previously, in August 2012, DOE/FE had authorized one non-FTA LNG export authorization—to Sabine Pass Liquefaction, LLC, for a volume of LNG equivalent to 2.2 Bcf/d of natural gas—and had several other non-FTA export applications pending before it.
• An analysis performed by the Energy Information Administration (EIA) and originally published in January 2012, entitled
• An evaluation performed by NERA Economic Consulting (NERA), a private contractor retained by DOE, entitled
DOE/FE invited public comment on the 2012 LNG Export Study, and received comments representing a diverse range of interests and perspectives.
To date, DOE/FE has issued 12 final long-term authorizations, in response to 14 applications, granting long-term authority to export LNG and compressed natural gas (CNG) to non-FTA countries in a cumulative volume of exports totaling 10.008 Bcf/d of natural gas.
The 29 proceedings identified above involve applications submitted by the named parties seeking authorization to export LNG from the lower-48 states to non-FTA countries. In light of the volume of long-term LNG and CNG exports to non-FTA countries authorized to date, DOE/FE determined that a study of the economic impacts of LNG exports is again warranted. Therefore, on May 29, 2014, DOE announced plans to undertake economic studies in order to gain a better understanding of how potentially higher levels of U.S. LNG exports—between 12
Specifically, for the 2014 EIA LNG Export Study, DOE/FE asked EIA to evaluate the impact of increased natural gas demand, reflecting possible exports of U.S. natural gas, on domestic energy markets using the modeling analysis presented in the
The purpose of this Notice is to enter the 2014 EIA LNG Export Study and the 2015 LNG Export Study in the administrative record of the 29 listed non-FTA export proceedings and to invite comments on these two studies, as applied to each proceeding. The 2014 EIA LNG Export Study, the 2015 LNG Export Study, and the comments that DOE/FE receives in response to this Notice will help to inform DOE's determination of the public interest in each case.
EIA prepared a report entitled
The Center for Energy Studies at Rice University's Baker Institute and Oxford Economics were jointly commissioned to undertake a scenario-based assessment of the macroeconomic impact of alternative levels of U.S. LNG exports under a range of assumptions concerning U.S. resource endowment (natural gas supply), U.S. natural gas demand, and the international market environment.
A comprehensive set of scenarios was prepared to understand the economic impact of higher U.S. LNG exports under a range of circumstances for domestic and international gas markets. This scenario approach was chosen to enable conclusions that are independent of any particular set of starting conditions for the U.S. or international natural gas markets, and to highlight the impact of increasing U.S. LNG exports under alternative domestic and international conditions. The authors considered sets of circumstances that would result in different international demand pull for U.S. sourced LNG. The variants considered were international conditions sufficient to support 12 Bcf/d and 20 Bcf/d of U.S. LNG exports.
DOE invites comments on the 2014 EIA LNG Export Study and/or the 2015 LNG Export Study to help inform DOE in its public interest determinations of the authorizations sought in the 29 non-FTA export applications identified above. Comments must be limited to the methodology, results, and conclusions of these studies on the factors evaluated. These factors include the potential impact of LNG exports on domestic energy consumption, production, and prices; the macroeconomic factors identified in the two studies, including Gross Domestic Product, consumption, U.S. economic sector analysis, and U.S. LNG export feasibility analysis; and any other factors included in the analyses. In addition, comments may be directed toward the feasibility of various scenarios used in both analyses. While this invitation to comment covers a broad range of issues, the Department may disregard comments that are not germane to the present inquiry. Due to the complexity of the issues raised in these studies, interested parties will be provided 45 days from the date of publication of this Notice in which to submit their comments.
DOE is not establishing a new proceeding or docket by today's issuance, and the submission of comments in response to this Notice will not make commenters parties to any of the 29 listed LNG export proceedings. Persons with an interest in the outcome of one or more of those proceedings have been given an opportunity to intervene in and/or protest those applications by complying with the procedures established in the respective notices of application published in the
Comments may be submitted using one of the following supplemental methods:
(1) Submitting the comments using the online form at
(2) Mailing an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in
(3) Hand delivering an original and three paper copies of the filing to the Office of Regulation and International
For administrative efficiency, DOE/FE prefers comments to be filed electronically using the online form (method 1). However, for those commenters lacking access to the Internet, comments may be filed in hard copy using one of the other two methods identified above. All comments must include a reference to the “2014 EIA LNG Export Study” and/or “2015 LNG Export Study” in the title line.
The 2014 EIA LNG Export Study and 2015 LNG Export Study are available for inspection and copying in the Division of Natural Gas Regulation docket room, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. The two studies and any comments filed in response to this Notice will be available electronically at the following DOE/FE Web site:
U.S. Energy Information Administration (EIA), Department of Energy (DOE).
Agency Information Collection Activities: Information Collection Extension With Changes; Notice and Request for Comments.
The EIA, pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years with the Office of Management and Budget (OMB), Form FE-746R, “Natural Gas Imports and Exports.” 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, including the validity of the methodology and assumptions used; (c) ways to enhance 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.
Comments regarding this proposed information collection must be received on or before February 29, 2016. If you anticipate difficulty in submitting comments within that period, contact the person listed in
Send comments to Benjamin Nussdorf. To ensure receipt of the comments by the due date, submission by email (
Requests for additional information or copies of the information collection instrument and instructions should be directed to Benjamin Nussdorf at the contact information given above. Forms and instructions are also available on the Internet at:
This information collection request contains:
(1)
(2)
(3)
(4)
The EIA, as part of its effort to comply with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), provides the general public and other Federal agencies with opportunities to comment on collections of energy information conducted by or in conjunction with the EIA. Also, the EIA will later seek approval by the Office of Management and Budget (OMB) under Section 3507(a) of the Paperwork Reduction Act of 1995.
DOE's Office of Fossil Energy (FE) is delegated the authority to regulate natural gas imports and exports under section 3 of the Natural Gas Act of 1938, 15 U.S.C. 717b. In order to carry out its delegated responsibility, FE requires those persons seeking to import or export natural gas to file an application providing basic information on the scope and nature of the proposed import/export activity. Once an importer or exporter receives authorization from FE, they are required to submit monthly reports of all import and export transactions. Form FE-746R collects critical information on U.S. natural gas trade including: Name of importer/exporter; country of origin/destination; international point of entry/exit; name of supplier; volume; price; transporter; geographic market served; and duration of supply contract on a monthly basis. The data, published in
(4a)
FE proposes to add the following reporting sections for the collection and identification of new types of natural gas transactions related to:
(a) Exports/imports of compressed natural gas by vessel;
(b) Exports/imports of compressed natural gas by rail;
(c) Exports/imports of compressed natural gas by waterborne transport;
(d) Exports/imports of liquefied natural gas by rail;
(e) Exports/imports of liquefied natural gas by waterborne transport;
(f) Other exports and imports of natural gas by rail, truck, vessel, and waterborne transport;
(g) Re-export of liquefied natural gas by vessel; and
(h) Exports/Imports of liquefied natural gas by vessel in International Standards Organization (ISO) containers;
(5)
(6)
(7)
(8)
Section 13(b) of the Federal Energy Administration Act of 1974, Public Law 93-275, codified at 15 U.S.C. 772(b) and Section 3 of the Natural Gas Act of 1938, codified at 15 U.S.C. 717b.
Take notice that on December 21, 2015, Will Zapalac submitted for filing, an application for authority to hold interlocking positions, pursuant to section 305(b) of the Federal Power Act (FPA)
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on December 22, 2015, pursuant to Rule 206
Complainant certifies that copies of the complaint were served on the contacts for Respondent as listed on the Commission's list of Corporate Officials. In addition, Complainant also served all parties listed on the service list in Docket No. ER16-308-000.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. The application is not ready for environmental analysis at this time.
n.
o. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
p.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that on December 18, 2015, First ECA Midstream LLC (FECAM), filed an application pursuant to section 7(c) of the Natural Gas Act (NGA), and Parts 157 and 284 of the Commission's Regulations, for a certificate of public convenience and necessity to own, operate as an interstate pipeline, and maintain an existing approximately 16 mile, 4-16 inch diameter natural gas pipeline located in Clearfield and Elk Counties, Pennsylvania. Also, FECAM requests Blanket Certificates and Waivers of the tariff requirements, related accounting, and other regulatory requirements. The filing may also be viewed on the Web at
Any questions regarding this application should be directed to Benjamin M. Sullivan, First ECA Midstream LLC, 500 Corporate Landing, Charleston, West Virginia 25311, telephone (304) 925-6100, fax (304) 925-3285, email:
The existing pipeline currently is used solely for the gathering of natural gas for delivery to the interstate pipeline system of Dominion Transmission, Inc. (DTI) and National Fuel Gas Supply Corporation (NFG). FECAM requests Commission's approval of using the pipeline for the purpose of transporting natural gas in interstate commerce. The existing pipeline not only will continue to deliver natural gas to DTI and NFG, but also will receive natural gas from DTI. The existing pipeline will transport certain of natural gas received from DTI to a power plant operated by NRG REMA LLC (REMA), in Shawville, Pennsylvania. FECAM will construct measurement and regulating facilities to receive gas from DTI and a tap for delivery gas to the power plant's line pursuant to the blanket certificate. FECAM, REMA, and their affiliates have entered into an agreement for the firm
Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
Motions to intervene, protests and comments may be filed electronically via the Internet in lieu of paper; see, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. The application is not ready for environmental analysis at this time.
n.
o. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
p.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities 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,
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. This application is not ready for environmental analysis (EA) at this time.
k.
White Pine Hydro operates the project in a run-of-river mode, in accordance with the 1997 Saco River Instream Flow Agreement, which provides that outflow approximate inflow from the upstream Bonny Eagle Project No. 2529 and act to minimize impoundment level fluctuations. White Pine Hydro also operates the project with a minimum outflow of 768 cfs, or inflow, whichever is less, in accordance with the project's current water quality certificate. The project generates an annual average of 34,007 MWh.
l. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
m. Procedural Schedule: The application will be processed according to the following preliminary Hydro Licensing Schedule. Revisions to the schedule will be made as appropriate.
o. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
On December 3, 2015, the Commission issued an order denying a complaint filed by Sage Grouse Energy Project, LLC (Sage Grouse) against PacifiCorp under Rule 206(a) of the Commission's Rules of Practice and Procedure.
Pursuant to section 313(a) of the Federal Power Act,
Take notice that the Federal Energy Regulatory Commission (Commission) will hold a Commission staff-led technical conference on Reliability Standard for Transmission System Planned Performance for Geomagnetic Disturbance (GMD) Events on issues identified in the Notice of Proposed Rulemaking (NOPR) and subsequent public comments in the above-captioned docket on March 1, 2016. The conference will begin at 9:00 a.m. and end at approximately 5:00 p.m. (Eastern Time). The conference will be held at the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The technical conference will facilitate a structured dialogue on GMD-related topics, including but not limited to: (1) The benchmark GMD event(s); (2) vulnerability assessments; and (3) monitoring of related parameters. The technical conference will be led by Commission staff, with prepared remarks to be presented by invited panelists, which must be submitted to the Commission in advance of the conference. A subsequent notice providing an agenda and details on the topics for discussion will be issued in advance of the conference. Commissioners may attend and participate.
There is no fee for attendance. However, members of the public are encouraged to preregister online at:
Those wishing to participate in panel discussions should submit nominations no later than close of business on Wednesday, January 6, 2016 online at:
This event will be webcast and transcribed. Transcripts of the conference will be available for a fee from Ace-Federal Reporters, Inc. (202-347-3700).
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to
For more information about the technical conference, please contact: Sarah McKinley, Office of External Affairs, 202-502-8368
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric reliability 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:
Western Area Power Administration, DOE.
Notice of final transmission service formula rates.
The Deputy Secretary of Energy confirmed and approved Rate Order No. WAPA-172 and Rate Schedules CAP-FT3, CAP-NFT3, and CAP-NITS3, placing transmission service formula rates for the Central Arizona Project (CAP) of the Western Area Power Administration (Western) into effect on an interim basis. The provisional rates will be in effect until the Federal Energy Regulatory Commission (FERC) confirms, approves, and places them into effect on a final basis, or until they are replaced by other rates. The provisional rates will provide sufficient revenue to pay all annual costs, including interest expense, and repay required investment within the allowable periods.
Rate Schedules CAP-FT3, CAP-NFT3, and CAP-NITS3 are effective on the first day of the first full billing period beginning on or after January 1, 2016, and will be in effect until FERC confirms, approves, and places the rate schedules in effect on a final basis through December 31, 2020, or until the rate schedules are superseded.
Mr. Jack Murray, Vice President of Power Marketing, Desert Southwest Customer Service Regional Office, Western Area Power Administration, P.O. Box 6457, Phoenix, AZ 85005-6457, (602) 605-2555, email
An FRN was published on July 24, 2015 (80 FR 44100) announcing the proposed rates for transmission service and initiating a public consultation and comment period. On July 29, 2015, Western notified all CAP customers and interested parties of the rate adjustment and provided a copy of the published FRN. On August 27, 2015, Western held a public information forum in Phoenix, Arizona, explained the proposed rates and potential changes to the proposed rates, answered questions, and provided handouts. On September 24, 2015, Western held a public comment forum in Phoenix, Arizona, to give the public an opportunity to comment for the record. No comments were received at the forum.
Previous Rate Schedules CAP-FT2, CAP-NFT2, and CAP-NITS2 for Rate Order No. WAPA-124
By Delegation Order No. 00-037.00A, effective October 25, 2013, the Secretary of Energy delegated: (1) The authority to develop power and transmission rates to Western's Administrator, (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy, and
Under Delegation Order Nos. 00-037.00A and 00-001.00F, and in compliance with 10 CFR part 903 and 18 CFR part 300, I hereby confirm, approve, and place provisional rates for transmission service under Rate Order No. WAPA-172 into effect on an interim basis. New Rate Schedules CAP-FT3, CAP-NFT3, and CAP-NITS3 will be submitted promptly to FERC for confirmation and approval on a final basis.
In the matter of: Western Area Power Administration Rate Adjustment for the Central Arizona Project
These rates were established in accordance with section 302 of the Department of Energy (DOE) Organization Act (42 U.S.C. 7152). This Act transferred to and vested in the Secretary of Energy the power marketing functions of the Secretary of the Department of the Interior and the Bureau of Reclamation under the Reclamation Act of 1902 (ch. 1093, 32 Stat. 388), as amended and supplemented by subsequent laws, particularly section 9(c) of the Reclamation Project Act of 1939 (43 U.S.C. 485h(c)), and other Acts that specifically apply to the project involved.
By Delegation Order No. 00-037.00A, effective October 25, 2013, the Secretary of Energy delegated: (1) The authority to develop power and transmission rates to Western Area Power Administration's (Western) Administrator, (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy, and (3) the authority to confirm, approve, and place into effect on a final basis, to remand, or to disapprove such rates to the Federal Energy Regulatory Commission. Existing DOE procedures for public participation in power rate adjustments (10 CFR part 903) were published on September 18, 1985.
As used in this Rate Order, the following acronyms and definitions apply:
The new provisional rates will take effect on the first day of the first full billing period beginning on or after January 1, 2016, and will remain in effect until FERC confirms, approves, and places the rate schedules in effect on a final basis through December 31, 2020, or until the rate schedules are superseded.
Western followed the Procedures for Public Participation in Power and Transmission Rate Adjustments and Extensions, 10 CFR part 903, in developing these rates. The steps Western took to involve interested parties in the rate process were:
1. An FRN was published on July 24, 2015 (80 FR 44100) announcing the proposed rates for transmission service, initiating a public consultation and comment period, and setting forth the dates and locations of public information and public comment forums.
2. On July 29, 2015, Western notified all CAP customers and interested parties of the rate adjustment and provided a copy of the published FRN.
3. On August 27, 2015, Western held a public information forum in Phoenix, Arizona. Western explained the proposed rates and potential changes to the proposed rates, answered questions, and provided handouts.
4. On September 24, 2015, Western held a public comment forum in Phoenix, Arizona, to give the public an opportunity to comment for the record. There were no comments received at this forum.
5. Western created a CAP rate adjustment Web site to provide interested parties with information about this rate adjustment process. The Web site is located at
6. On October 6, 2015, Western provided answers to a list of questions concerning the proposed rates and posted the answers on the CAP rate adjustment Web site.
The CAP is one of three related water development projects that make up the Colorado River Basin Project. The others are the Dixie and the Upper Basin projects. The CAP was developed for Arizona and western New Mexico; the Dixie Project for southeastern Utah; and the Upper Basin Project for Colorado and New Mexico.
Congress authorized the Colorado River Basin Project in 1968 to improve water resources in the Colorado River Basin. Segments of the 1968 authorization allowed Federal participation in the Navajo Generating Station (Navajo), which has three coal-fired steam electric generating units with a combined capacity of 2,250 MW. Construction of the plant, located near Lake Powell at Page, Arizona, began in 1970 and generation began in 1976.
The 24.3 percent Federal Share of Navajo, or 546,750 kW, is used to power the pumps that move Colorado River water through CAP canals. Surplus generation is currently marketed under the Navajo Power Marketing Plan adopted on Dec. 1, 1987. Surplus Navajo short-term firm and non-firm transmission service will be marketed at the CAP 115/230-kV transmission rate during the term of the rate schedules.
The existing rates for point-to-point transmission service consist of a firm rate and a non-firm rate. The existing rate for firm point-to-point transmission service under Rate Schedule CAP-FT2 is $13.56/kW-year. The existing rate for non-firm point-to-point transmission service under Rate Schedule CAP-NFT2 is 1.55 mills/kWh. The existing rates under Rate Schedules CAP-FT2, CAP-NFT2, and CAP-NITS2 expire December 31, 2015.
The provisional rates will supersede the existing rates and become effective on an interim basis on the first day of the first full billing period beginning on or after January 1, 2016. The provisional rate for firm point-to-point transmission service under Rate Schedule CAP-FT3 is $14.88/kW-year. The provisional rate for non-firm point-to-point transmission service under Rate Schedule CAP-NFT3 is 1.70 mills/kWh. The provisional rates will result in a rate increase of 10 percent when compared to the existing rates. A comparison of the existing and provisional rates for transmission service follows:
Western's Administrator certified that the provisional rates for CAP transmission service under Rate Schedules CAP-FT3, CAP-NFT3, and CAP-NITS3 are the lowest possible rates consistent with sound business principles. The provisional rates were developed following administrative policies and applicable laws.
According to Reclamation law, Western must establish rates which provide sufficient revenue to recover annual O&M, purchase power, transmission service and other costs, interest expense, and repay investments. Western calculates the rates each year to determine if the existing rates will provide adequate revenue to repay all power system costs within the required time. Repayment criteria are based on existing law and applicable policies, including DOE Order RA 6120.2. To meet the cost recovery criteria outlined in DOE Order RA 6120.2, a rate calculation was completed to demonstrate that sufficient revenues will be collected under the provisional rates to meet future obligations.
The existing rates are insufficient and do not provide adequate revenue to cover costs due primarily to the replacement of the aging ED2-Saguaro line. Construction of this line started in 2015, and the costs will be spread over a 5-year period.
A secondary factor for the rate increase is a decrease in projected sales of long-term firm point-to-point transmission service. The provisional rates include the reduction in the sales forecast for 115/230-kV transmission service over the 5-year cost evaluation period.
All brochures, studies, comments, letters, memorandums, and other documents that Western used to develop the provisional rates are available for inspection and copying at the Desert Southwest Customer Service Regional Office, Western Area Power Administration, 615 South 43rd Avenue, Phoenix, AZ 85009-5313. Many of these documents and supporting information are available on Western's Web site at
In compliance with the National Environmental Policy Act (NEPA) of 1969, (42 U.S.C. 4321,
Western has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.
The interim rates confirmed, approved, and placed into effect herein, together with supporting documents, will be submitted to FERC for confirmation and final approval.
In view of the foregoing and under the authority delegated to me, I confirm and approve on an interim basis Rate Schedules CAP-FT3, CAP-NFT3, and CAP-NITS3 to become effective on the first day of the first full-billing period beginning on or after January 1, 2016, and to remain in effect until FERC confirms, approves, and places the rate schedules in effect on a final basis through December 31, 2020, or until the rate schedules are superseded.
The first day of the first full billing period beginning on or after January 1,
2016, through December 31, 2020, or until superseded by another rate schedule, whichever occurs earlier.
The transmission customer will compensate the Central Arizona Project (CAP) each month for Reserved Capacity under the applicable Firm Point-To-Point Transmission Service Agreement and the formula rate described herein.
A recalculated rate will go into effect every January 1 based on the above formula and updated financial and operational data. Western will notify the transmission customer annually of the recalculated rate on or before December 1. Discounts may be offered from time-to-time in accordance with Western's Open Access Transmission Tariff.
Alternating current at 60 Hertz, three-phase, delivered and metered at the voltages and points of delivery established by contract or service agreement over the CAP 115/230-kV transmission system.
There shall be no entitlement to transfer of reactive kilovolt amperes at delivery points, except when such transfers may be mutually agreed upon by the parties and contracting officer or their authorized representatives.
Billing determinants for the formula rate above will be as specified in the contract or service agreement. Billing will occur monthly under the formula rate.
Losses incurred for service under this rate schedule will be accounted for as agreed to by the parties in accordance with the contract or service agreement. If losses are not fully provided by a Transmission Customer, charges for financial compensation may apply.
Western will assess a charge for any unreserved use of the transmission system. Unreserved use occurs when a customer uses transmission service that it has not reserved or uses transmission service in excess of its reserved capacity. Unreserved use may also include a customer's failure to curtail transmission when requested.
The charge assessed for unreserved use is two times the maximum allowable rate for the service at issue as follows: The penalty for a single hour of unreserved use is based on the daily short-term rate. The penalty for more than one assessment of unreserved use for any given duration (
A customer that exceeds its reserved capacity at any point of receipt or point of delivery, or a customer that uses transmission service at a point of receipt or point of delivery that it has not reserved, is required to pay for all ancillary services provided by the Western Area Lower Colorado (WALC) Balancing Authority and associated with the unreserved use. The customer will pay for ancillary services based on the amount of transmission service used and not reserved.
The first day of the first full billing period beginning on or after January 1, 2016, through December 31, 2020, or until superseded by another rate schedule, whichever occurs earlier.
The transmission customer will compensate the Central Arizona Project (CAP) each month for Non-Firm Point-To-Point Transmission Service under the applicable agreement and the formula rate described herein.
Alternating current at 60 Hertz, three-phase, delivered and metered at the voltages and points of delivery established by contract or service agreement over the CAP 115/230-kV transmission system.
There shall be no entitlement to transfer of reactive kilovolt amperes at delivery points, except when such transfers may be mutually agreed upon by the parties and contracting officer or their authorized representatives.
Billing determinants for the formula rate above will be as specified in the service agreement. Billing will occur monthly under the formula rate.
Losses incurred for service under this rate schedule will be accounted for as agreed to by the parties in accordance with the contract or service agreement. If losses are not fully provided by a transmission customer, charges for financial compensation may apply.
Western will market excess transmission service from the Navajo (500-kV) portion of the CAP on a short-term basis at the formula rate described herein.
The first day of the first full billing period beginning on or after January 1, 2016, through December 31, 2020, or until superseded by another rate schedule, whichever occurs earlier.
The transmission customer will compensate the Central Arizona Project (CAP) each month for Network Integration Transmission Service (NITS) under the applicable agreement and the formula rate described herein.
Billing determinants for the formula rate above will be as specified in the service agreement. Billing will occur monthly under the formula rate.
Losses incurred for service under this rate schedule will be accounted for as agreed to by the parties in accordance with the contract or service agreement. If losses are not fully provided by a transmission customer, charges for financial compensation may apply.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NESHAP for Hydrochloric Acid Production (40 CFR part 63, subpart NNNNN) (Renewal)” (EPA ICR No. 2032.08, OMB Control No. 2060-0529) 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 January 28, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2011-0275, 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)
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 Aluminum, Copper and Other Non-ferrous Metals Foundries (40 CFR part 63, subpart ZZZZZZ) (Renewal)” (EPA ICR No. 2332.04, OMB Control No. 2060-0630) 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 January 28, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2011-0526, 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 Pulp and Paper Production (40 CFR part 63, subpart S) (Renewal)” (EPA ICR No. 2452.03, OMB Control No. 2060-0681) 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 January 28, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2011-00208, 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 the Wood Building Products Surface Coating Industry (40 CFR part 63, subpart QQQQ) (Renewal)” (EPA ICR No. 2034.06, OMB Control No. 2060-0510) 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 January 28, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OCEA-2011-0274, 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.
This notice announces the availability of EPA's proposed interim registration review decision for alpha-chlorohydrin and opens a public comment period on this proposed interim decision. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, that the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.
Comments must be received on or before February 29, 2016.
Submit your comments, identified by the docket identification (ID) number for the specific pesticide of interest provided in the Table by one of the following methods:
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This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager for the pesticide of interest identified in the Table.
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Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's proposed interim registration review decision for the pesticide shown in the following table, and opens a 60-day public comment period on this proposed interim decision.
Alpha-chlorohydrin (Proposed Interim Decision). The registration review docket for alpha-chlorohydrin (EPA-HQ-OPP-2015-0726) is opening in December 2015. The only registered use for alpha-chlorohydrin is as a tamper-proof bait station/bait application delivery system for elimination of Norway rats. Alpha-chlorohydrin is approved for use in and around the indoors of commercial/industrial facilities and sanitary sewers. The label states not to use the product in any facility where children may be present, and there are no outdoor uses permitted. EPA is also publishing a draft human health risk assessment and a draft ecological problem formulation at the time of the docket opening for a 60-day public comment period. In this alpha-chlorohydrin proposed interim decision, the Agency has determined that no additional data are required and no changes to the affected registration or its labeling are currently required. At this time, EPA is making no human health or environmental safety findings associated with the Endocrine Disruptor Screening Program (EDSP) screening of alpha-chlorohydrin, nor is it making an endangered species finding. EPA's registration review decision for alpha-chlorohydrin will depend upon the result of an EDSP Federal Food, Drug and Cosmetic Act (FFDCA) section 408(p) determination, and Endangered Species Assessment (ESA) determination.
The registration review docket for a pesticide generally includes earlier documents related to the registration review of the case. In the case of alpha-chlorohydrin the Agency expedited the registration review and is opening the docket with the proposed interim decision and supporting documents.
The registration review program is being conducted under congressionally mandated time frames, and EPA recognizes the need both to make timely decision and to involve the public. Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a(g)) required EPA to establish by regulation procedures for reviewing pesticide registrations, originally with a goal of reviewing each pesticide's registration every 15 years to ensure that a pesticide continues to meet the FIFRA standard for registration. The Agency's final rule to implement this program was issued in August 2006 and became effective in October 2006, and appears at 40 CFR part 155, subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA) was amended and extended in September 2007. FIFRA, as amended by PRIA in 2007, requires EPA to complete registration review decisions by October 1, 2022, for all pesticides registered as of October 1, 2007.
The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed interim registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed interim decisions. All comments should be submitted using the methods in
The Agency will carefully consider all comments received by the closing date and will provide a “Response to Comments Memorandum” in the docket. The interim registration review decision will explain the effect that any comments had on the interim decision and provide the Agency's response to significant comments.
Background on the registration review program is provided at:
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Synthetic Fiber Production Facilities (40 CFR part 60, subpart HHH) (Renewal)” (EPA ICR No. 1156.13, OMB Control No. 2060-0059) 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 January 28, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2012-0528, 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 Secondary Aluminum Production (40 CFR part 63, subpart RRR) (Renewal)” (EPA ICR No. 1894.08, OMB Control No. 2060-0433) 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 January 28, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2012-0505, 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
Note this ICR merges the burden from EPA ICR Number 2453.01, the ICR for the 2015 final rule. Therefore, this ICR reflects additional burden items not present in the previous renewal. In addition, this ICR revises bag leak detector costs per comments received from the Aluminum Association. These changes result in an overall increase in the capital and O&M costs.
Environmental Protection Agency (EPA).
Notice.
EPA has received an application to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on this application.
Comments must be received on or before January 28, 2016.
Submit your comments, identified by docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:
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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).
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EPA has received an application to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on this application. Notice of receipt of this application does not imply a decision by the Agency on this application.
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Petroleum Refineries for which Construction, Reconstruction, or Modification Commenced after May 14, 2007 (40 CFR part 60, subpart Ja) (Renewal)” (EPA ICR No. 2263.05, OMB Control No. 2060-0602) 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 January 28, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2011-0228, 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
There is an increase in the respondent labor hours since we assumed all respondents are now required to comply with the flare ongoing rule requirements each year compared to one third per year in the active ICR. In addition, the labor burden calculation in the renewal includes additional hours associated with managerial and clerical work since the active ICR did not break down these types of labor costs, which also contribute to labor burden increase.
Environmental Protection Agency (EPA).
Notice.
The EPA Science Advisory Board (SAB) Staff Office announces four public teleconferences of the SAB Hydraulic Fracturing Research Advisory Panel as part of the peer review of the EPA draft report,
The public teleconferences will be held on the following dates: Monday, February 1, 2016 from 11:00 a.m. to 6:00
The teleconferences will be conducted by telephone only.
Members of the public who wish to obtain further information regarding these public teleconferences may contact Edward Hanlon, Designated Federal Officer, by telephone: (202) 564-2134 or email at
The EPA's Office of Research and Development (ORD) has developed a draft assessment report concerning the relationship between hydraulic fracturing and drinking water in the United States. The purpose of the report,
The purpose of the February 1, 2016, public teleconference is for the SAB Hydraulic Fracturing Research Advisory Panel to discuss its draft report regarding its peer review of the agency's draft report. If the SAB Staff Office determines that there will be insufficient time during the February 1, 2016, teleconference for the Panel to complete discussion on its draft report or to accommodate the members of the public who registered in advance to provide oral public comments, the teleconference on February 2, 2016, will be held to provide additional time for the Panel's discussions or for oral public comments. The purpose of the March 7, 2016, teleconference is for the SAB Hydraulic Fracturing Research Advisory Panel to further discuss its draft report regarding its peer review of the agency's draft report. If the SAB Staff Office determines that there will be insufficient time during the March 7, 2016, teleconference for the Panel to complete discussion on its draft report or to accommodate the members of the public who registered in advance to provide oral public comments, the teleconference on March 10, 2016, will be held to provide additional time for the Panel's discussions or for oral public comments.
Availability of Meeting Materials: Additional background on this SAB activity, the teleconference agendas, draft panel report, and other materials for the teleconferences will be posted on the SAB Web site at
Procedures for Providing Public Input: Federal advisory committees and panels, including scientific advisory committees, provide independent advice to the EPA. Interested members of the public may submit relevant information on the topic of this advisory activity, and/or the group conducting the activity, for the SAB to consider during the advisory process. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for SAB committees and panels to consider or if it relates to the clarity or accuracy of the technical information.
Throughout the Panel review process, there will be opportunities for the public to provide comments. For example, the public was invited to provide comments to the Docket on the EPA's charge questions to the SAB and the draft EPA report and provide oral statements to the Panel during the Panel teleconferences and meeting, and will have opportunity to provide comments to the Docket on the draft EPA report and the SAB Panel's draft report, provide oral statements to the Panel during upcoming Panel teleconferences, and provide oral and written comments in preparation for quality review of the SAB Panel's draft report by the Chartered SAB. Members of the public wishing to provide written comments may submit them to the EPA Docket electronically via
Written statements should be identified by Docket ID No. EPA-HQ-OA-2015-0245 and submitted to the Docket at
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Public comments submitted after January 21, 2016 for the February 1, 2016, teleconference will be marked late, and should be submitted to the Docket by email, mail, hand delivery or fax (see detailed instructions above). Public comments submitted after February 22, 2016 for the March 7, 2016, teleconference will be marked late, and should be submitted to the Docket by email, mail, hand delivery or fax (see detailed instructions above). Consistent with SAB Staff Office general practice, comments received after January 21, 2016 for the February 1, 2016, teleconference, and after February 22, 2016 for the March 7, 2016, teleconference, will be made available to the SAB Panel as soon as practicable.
It is EPA's policy to include all comments received in the public docket without change and to make the comments available on-line at
Documents in the docket are listed in the
Accessibility: For information on access or services for individuals with disabilities, please contact Mr. Edward Hanlon at the phone number or email address noted above, preferably at least ten days prior to the meeting to give EPA as much time as possible to process your request.
Export-Import Bank of the U.S.
Submission for OMB Review and Comments Request.
The Export-Import Bank of the United States (Ex-Im Bank), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. This collection of information is necessary, pursuant to 12 U.S.C. Sec. 635(a)(1), to determine where insurance proceeds should be sent and to determine which exporters require lender financing of their insured receivables.
Ex-Im Bank's exporter policy holders, along with the financial institution providing it with financing, provide this form to Ex-Im Bank. The form transfers the duties and obligations of the insured exporter to the financial institution. It also provides certifications to the financial institution and Ex-Im Bank that the financed export transaction results in a valid, enforceable, and performing debt obligation. Exporter policy holders need this form to obtain financing for their medium term export sales.
The form can be viewed at
Comments should be received on or before January 28, 2016 to be assured of consideration.
Comments may be submitted electronically on
Export-Import Bank of the U.S.
Submission for OMB review and comments request.
Form Title: EIB 99-14 Export-Import Bank Trade Reference form.
The Export-Import Bank of the United States (Ex-Im Bank), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. This collection of information is necessary, pursuant to 12 U.S.C. Sec. 635 (a) (1), to determine whether or not a company has a good payment history.
This form will enable Ex-Im Bank to make a credit decision on a foreign buyer credit limit request submitted by a new or existing policy holder. Additionally, this form is used by those Ex-Im Bank policy holders granted delegated authority to commit the Bank to a foreign buyer credit limit.
The form can be viewed at
Comments should be received on or before January 28, 2016 to be assured of consideration.
Comments may be submitted electronically on
Board of Governors of the Federal Reserve System.
Notice is hereby given of the final approval of proposed information collections by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.
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Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before January 20, 2016.
Interested parties may file a comment at
Andrea Arias (202) 326-2715 or Jacqueline Conner (202) 326-2844, Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for December 21, 2015), on the World Wide Web at:
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before January 20, 2016. Write “In the Matter of Oracle Corporation,—Consent Agreement; File No. 132 3115” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “In the Matter of Oracle
Visit the Commission Web site at
The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order applicable to Oracle Corporation (“Oracle”).
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.
Oracle is a Delaware corporation that, among other things, develops the Java computing platform, which is used to power applications that, for example, allow consumers to play online games, chat with people online, calculate mortgage interest, and view images in 3D. Consumers primarily use the Java Platform, Standard Edition (“Java SE”). When an update to Java SE was available, a consumer would typically receive a prompt to update the software. When the consumer proceeded to install the update, the consumer would encounter a series of installation screens, which stated that “Java provides safe and secure access to the world of amazing Java content,” and that Java SE updates and a consumer's “system” would have “the latest . . . security improvements.” During the Java SE update process, however, Oracle did not inform consumers that Java SE updates automatically removed only the most recent prior iteration of Java SE installed on the consumer's computer, even if the consumer had multiple iterations of Java SE installed, and that the update would not remove any iteration released prior to Java SE iteration 6 update 10. As such, after the update process, consumers could still have additional older, insecure iterations of Java SE installed on their computers, which attackers targeted to obtain consumers' personal information through malware designed to exploit vulnerabilities (“exploit kits”).
The Commission's complaint alleges that Oracle violated Section 5(a) of the FTC Act by failing to disclose that, in numerous instances, updating Java SE would not delete or replace all older iterations of Java SE on a consumer's computer, and as a result, a consumer's computer could still have iterations of Java SE installed that are vulnerable to security risks. This fact would be material to consumers' decisions whether to take further action after “updating” Java SE to protect their computers, in light of Oracle's representations to consumers that by updating Java SE, users would ensure that Java SE on their computers had the latest security improvements.
The complaint further alleges that, by failing to inform consumers that the Java SE update process did not remove all prior iterations of the software, Oracle left some consumers vulnerable to a serious, well-known, and reasonably foreseeable security risk that attackers would target these computers through exploit kits, resulting in the theft of personal information. Consumers with insecure iterations of Java SE on their computers were vulnerable to exploit kits targeting Java SE vulnerabilities while browsing infected Web sites or clicking on nefarious links. Attackers used exploit kits targeting Java SE vulnerabilities to install key loggers that captured consumers' usernames and passwords, which could be used to log into a consumer's PayPal, bank, and credit card accounts. Other Java SE exploit kits may have resulted in the unauthorized acquisition and transmission of sensitive personal information for the purpose of targeted spear-phishing campaigns.
The proposed order contains provisions designed to prevent Oracle from engaging in the future in practices similar to those alleged in the complaint.
Part I of the proposed order prohibits Oracle from misrepresenting (1) the privacy or security of the covered software on a consumer's computer, including but not limited to the effect on privacy or security of any installation or update of the covered software; and (2) how to uninstall older iterations of the covered software.
Part II of the proposed order requires Oracle to ensure that during any installation or update of any iteration of Java SE released after the date of service of the order, Oracle:
(1) clearly and conspicuously discloses to the consumer all iterations of Java SE 1.4.2 or later, other than any iteration(s) released within the last quarter, currently installed on the consumer's computer;
(2) clearly and conspicuously explains that there may be risks to the security of the consumer's computer if the consumer chooses not to remove any iterations of Java SE older than the iteration(s) released within the last quarter currently installed on the consumer's computer; and
(3) clearly and conspicuously discloses which iterations of Java SE 1.4.2 or later, other than any iteration(s) released within the last quarter, that remain installed following installation or update of Java SE, and clearly and conspicuously provides instructions describing how consumers can effectively uninstall these iterations.
Part III of the proposed order requires Oracle to notify consumers who downloaded, installed, or updated Java SE that, in some instances, they may have older, insecure iterations of Java SE on their computers; and provide instructions to such consumers on how to remove these older iterations. In addition, for three (3) years, Oracle must provide an uninstall tool that allows consumers to uninstall iterations of Java SE 1.4.2 or later; a page on their primary Web site that explains how to uninstall older, insecure iterations of Java SE; and free support through an electronic form to help consumers with their update and/or uninstall issues.
Parts IV through VIII of the proposed order are standard reporting and compliance provisions. Part IV requires Oracle to retain documents relating to its compliance with the order for a five-year period. Part V requires dissemination of the order now and in the future to all current and future principals, officers, directors, and managers, and to persons with managerial or supervisory responsibilities relating to Parts I-III of the order. Part VI ensures notification to the FTC of changes in corporate status. Part VII mandates that Oracle submit a
The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed complaint or order or to modify the order's terms in any way.
By direction of the Commission.
Office of Government-Wide Policy (OGP), General Services Administration (GSA).
Notice of FTR Bulletin 16-02, Calendar Year (CY) 2016 Privately Owned Vehicle (POV) Mileage Reimbursement Rates and Standard Mileage Rate for Moving Purposes (Relocation Allowances).
The General Services Administration (GSA) uses the single standard mileage rate established by the Internal Revenue Service (IRS) as the mileage rate for privately owned automobiles (POA). In addition, the IRS' mileage rate for medical or moving purposes is used to determine the POA rate when a Government-furnished automobile is authorized. This IRS rate also establishes the standard mileage rate for moving purposes as it pertains to official relocation. Finally, GSA's annual privately owned airplane and motorcycle mileage reimbursement rate reviews have resulted in new CY 2016 rates. GSA conducts independent airplane and motorcycle studies that evaluate various factors, such as the cost of fuel, the depreciation of the original vehicles costs, maintenance and insurance, and/or by applying consumer price index data. FTR Bulletin 16-02 establishes the new CY 2016 POV mileage reimbursement rates for official temporary duty and relocation travel ($0.54 for POAs, $0.19 for POAs when a Government furnished automobile is authorized, $1.17 for privately owned airplanes, $0.51 for privately owned motorcycles, and $0.19 for moving purposes), pursuant to the process discussed above. This notice of subject bulletin is the only notification to agencies of revisions to the POV mileage rates for official travel and relocation other than the changes posted on GSA's Web site.
For clarification of content, please contact Mr. Cy Greenidge, Office of Government-wide Policy, Office of Asset and Transportation Management, at 202-219-2349, or by email at
GSA posts the POV mileage reimbursement rates, formerly published in 41 CFR Chapter 301, solely on the internet at
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding a new OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement concerning High Global Warming Potential Hydrofluorocarbons. A notice was published in the
Submit comments on or before January 28, 2016.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
• Regulations.gov:
• Mail: General Services Administration, Regulatory Secretariat Division (MVCB), ATTN: Ms. Flowers, 1800 F Street NW., Washington, DC 20405.
Mr. Charles Gray, Procurement Analyst, Federal Acquisition Policy Division, at 703-795-6328 or email
DoD, GSA, and NASA published a proposed rule at 80 FR 26883 on May 11, 2015, to implement Executive branch policy in the President's Climate Action Plan to procure, when feasible, alternatives to high GWP HFCs. FAR Case 2014-026, High Global Warming Potential Hydrofluorocarbons, proposed to modify FAR provision 52.223-11, Ozone-Depleting Substances, and 52.223-12, Refrigeration Equipment and Air Conditioners, to address high global warming potential (GWP) hydrofluorocarbons (HFCs).
For equipment and appliances that normally contain 50 or more pounds of HFCs or HFC blends, the clauses will now include requirements to track by type, equipment/application, contract, agency, and location, the amount in pounds of HFCs or HFC blends contained in such equipment and appliances delivered to the Government; or added or taken out of such equipment and appliances that will be maintained, repaired, or disposed under the contract. The contractor is required to report the information annually to a centralized Government Web site.
To estimate the number of respondents affected by the reporting requirement in FAR 52.223-11 and 52.223-12, the Government reviewed the number of contracts awarded or orders issued for the Federal Supply Code Categories that would most commonly be used for the bulk materials, products used for maintenance, and equipment containing HFCs:
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Office of Child Support Enforcement, ACF, HHS
Notice of the award of a single-source expansion supplement grant to the Wisconsin Department of Children and Families to support the evaluation of the Child Support Noncustodial Parent Employment Demonstration.
The Administration for Children and Families (ACF), Office of Child Support Enforcement, Division of Program Innovation announces the award of a cooperative agreement in the amount of $700,000 to the Wisconsin Department for Children and Families in Madison, WI to support the evaluation of the Child Support Noncustodial Parent Employment Demonstration.
In FY 2012, the Office of Child Support Enforcement (OCSE) competitively awarded a cooperative agreement to the Wisconsin Department of Children and Families to conduct a 5-year evaluation of OCSE's national demonstration called Child Support Noncustodial Parent Employment Demonstration (CSPED) under Funding Opportunity Announcement (FOA) number HHS-2012-ACF-OCSE-FD-0537. Under this FOA, a total of $4.5 million of 1115 funds were made available to the Wisconsin Department of Children and Families to conduct this evaluation.
The award of $700,000 the Wisconsin Department of Children and Families is required to cover the unanticipated costs of conducting the CSPED evaluation. The CSPED evaluation includes an impact evaluation using random assignment, an implementation study and a benefit-cost analysis. The evaluator is also providing evaluation-related technical assistance to the grantees implementing CSPED. A baseline and 12 month follow-up survey are being conducted. Administrative data from multiple sources are also being collected and evaluated. A grants management information system was developed for grantees to use to conduct random assignment, enroll individuals into the project, and document service delivery.
The period of support for this supplement is September 30, 2015 through September 29, 2016.
Elaine Sorensen, Office of Child Support Enforcement, 330 C Street SW., Washington, DC 20201. Telephone: 202-401-5099; Email:
OCSE originally anticipated that there would be eight implementation sites in the CSPED demonstration and developed the Funding Opportunity Announcement for the evaluation of this demonstration accordingly. However, 8 grantees with 25 implementation sites were approved and awarded funding by OCSE to be part of CSPED under a separate funding announcement (HHS-2012-ACF-OCSE-FD-0297). This expansion of the number of implementation sites in CSPED has increased the costs of conducting the CSPED evaluation. Furthermore, random assignment was delayed in some sites and enrollment has been slower than expected in other sites. These delays have also increased the costs of the CSPED evaluation. Another
As a consequences of these unanticipated costs, the $700,000 supplemental grant will be used for the following activities: (1) Conduct the day-to-day operation of the evaluation, including all costs involved in ensuring continued compliance with human subject research requirements; (2) conduct research and analyze information from the multiple implementation sites; (3) conduct the baseline and follow-up surveys; (4) maintain and provide evaluation-related technical assistance to OCSE and the grantees for the grants management information system; and (5) complete an internal memo describing interim impact findings.
Section 1115 of the Social Security Act authorizes funds for experimental, pilot, or demonstration projects that are likely to assist in promoting the objectives of Part D of Title IV.
Administration for Community Living, HHS.
Notice.
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit written comments on the collection of information by January 28, 2016.
Submit written comments on the collection of information by email to
Clare Barnett, Administration for Community Living, Administration on Intellectual and Developmental Disabilities, Office of Program Support, One Massachusetts Avenue NW., Room 4204, Washington, DC 20201, 202-357-3426.
Federal statute and regulation require each State Protection and Advocacy (P&A) System annually prepare for public comment a Statement of Goals and Priorities (SGP) for the P&A for Developmental Disabilities (PADD) program for each coming fiscal year. Following the required public input for the coming fiscal year, the P&A is required by Federal statute and regulation to submit the final version of the SGP to the Administration on Intellectual and Developmental Disabilities (AIDD). AIDD reviews the SGP for compliance and will aggregate the information in the SGPs into a national profile of programmatic emphasis for P&A Systems in the coming year to provide an overview of program direction, and permit AIDD to track accomplishments against goals and formulate areas of technical assistance and compliance with Federal requirements.
ACL estimates the burden of this collection of information as follows:
Estimated Total Annual Burden Hours: 2,508
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff.” The purpose of this guidance is to make recommendations for 510(k) submissions and complying with special controls being proposed to support reclassification of ECT Devices into Class II (special controls) for severe major depressive episode (MDE) associated with Major Depressive Disorder (MDD) or Bipolar Disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. 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 March 28, 2016.
An electronic copy of the guidance document is available for download from the Internet. See the
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Peter G. Como, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G242, Silver Spring, MD 20993-0002, 301-796-6919.
This draft guidance document provides draft recommendations for 510(k) submissions and complying with special controls being proposed to support reclassification of ECT Devices into Class II (special controls) for severe MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. An ECT device is an electrical device used for treating severe psychiatric disturbances by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head. This draft guidance is being issued in conjunction with a
FDA is issuing a proposed administrative order to reclassify ECT devices for the treatment of severe MDE associated with MDD or BPD in patients 18 years of age or older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which are currently Class III devices, into Class II (special controls) subject to premarket notification. FDA is proposing this reclassification under the Federal Food, Drug and Cosmetic Act (FD&C Act) based on new information pertaining to the device. This guidance is intended to provide recommendations on how to comply with the special controls proposed in 21 CFR 876.5540(b)(1) and indicate what information is suggested for submission to FDA in a 510(k) to demonstrate that the special controls have been met.
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 ECT devices for Class II intended uses. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An
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 (44 U.S.C. 3501-3520). The collection of information in 21 CFR part 807 subpart E have been approved under OMB control number 0910-0120; the collection of information in 21 CFR 801 has been approved under OMB control number 0910-0485; and the collection of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by February 29, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520) Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Positron emission tomography is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug product. FDA's CGMP regulations at 21 CFR part 212 are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding safety, identity, strength, quality, and purity. The CGMP requirements for PET drugs are issued under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). These CGMP requirements are designed to take into account the unique characteristics of PET drugs, including their short half-lives and the fact that most PET drugs are produced at locations that are very close to the patients to whom the drugs are administered.
The CGMP regulations are intended to ensure that approved PET drugs meet the requirements of the FD&C Act as to safety, identity, strength, quality, and purity. The regulations address the following matters: Personnel and resources; quality assurance; facilities and equipment; control of components, in-process materials, and finished products; production and process controls; laboratory controls; acceptance criteria; labeling and packaging controls; distribution controls; complaint handling; and recordkeeping.
The CGMP regulations establish several recordkeeping requirements and a third-party disclosure requirement for the production of PET drugs. In making our estimates of the time spent in complying with these information collection requirements, we relied on communications we have had with PET producers, visits by our staff to PET facilities, and our familiarity with both PET and general pharmaceutical manufacturing practices. The estimated annual recordkeeping and third-party disclosure burden is based on there being approximately 129 PET drug production facilities.
As explained in this document, Table 1 provides an estimate of the annual recordkeeping burdens and Table 2 provides an estimate of the annual third-party disclosure burdens associated with this collection.
Section 212.5(b)(2) provides that for investigational PET drugs produced under an investigational new drug (IND) and research PET drugs produced with approval of a Radioactive Drug Research Committee (RDRC), the requirement under the FD&C Act to follow current good manufacturing practice is met by complying with the regulations in part 212 or with USP 32 Chapter 823. We believe that PET production facilities producing drugs under INDs and RDRCs are currently substantially complying with the recordkeeping requirements of USP 32 Chapter 823 (see section 121(b) of the Modernization Act), and accordingly, we do not estimate any recordkeeping burden for this provision.
Sections 212.20(c) through (e), 212.50(a) through (c), and 212.80(c) set forth requirements for batch and production records as well as written control records. We estimate that it would take approximately 20 hours annually for each PET production facility to prepare and maintain written production and control procedures and to create and maintain master batch records for each PET drug produced. We also estimate that there will be a total of approximately 221 PET drugs produced, with a total recordkeeping burden of approximately 4,420 hours. We estimate that it would take a PET production facility an average of 30 minutes to complete a batch record for each of approximately 501 batches. Our estimated burden for completing batch records is approximately 32,320 hours.
Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) contain requirements for records dealing with equipment and physical facilities. We estimate that it would take approximately 1 hour to establish and maintain these records for each piece of equipment in each PET production facility. We estimate that the total burden for establishing procedures for these records would be approximately 1,939 hours. We estimate that recording maintenance and cleaning information would take approximately 5 minutes a day for each piece of equipment, with a total recordkeeping burden of approximately 40,238 hours.
Sections 212.20(c) and 212.40(a), (b), and (e) contain requirements on records regarding receiving and testing of components, containers, and closures. We estimate that the annual burden for establishing these records would be approximately 259 hours. We estimate that each facility would receive approximately 36 shipments annually and would spend approximately 10 minutes per shipment entering records. The annual burden for maintaining these records would be approximately 773 hours.
Section 212.50(f)(2) requires that any process verification activities and results be recorded. Because process verification is only required when results of the production of an entire batch are not fully verified through finished-product testing, we believe that process verification will be a very rare
Sections 212.20(c), 212.60(a), (b), and (g), 212.61(a) through (b), and 212.70(a), (b), and (d) set out requirements for documenting laboratory testing and specifications referred to in laboratory testing, including final release testing and stability testing. Each PET drug production facility will need to establish procedures and create forms for the different tests for each product they produce. We estimate that it will take each facility an average of 1 hour to establish procedures and create forms for one test. The estimated annual burden for establishing procedures and creating forms for these records is approximately 3,232 hours, and the annual burden for recording laboratory test results is approximately 10,730 hours.
Section 212.70(e) requires PET drug producers to notify all receiving facilities if a batch fails sterility tests. We believe that sterility test failures might occur in only 0.05 percent of the batches of PET drugs produced each year. Therefore, we have estimated in Table 2 that each PET drug producer will need to provide approximately 0.25 sterility test failure notice per year to receiving facilities. The notice would be provided using email or facsimile transmission and should take no more than 1 hour.
Section 212.70(f) requires PET drug producers to document any conditional final releases of a product. We believe that conditional final releases will be fairly uncommon, but for purposes of the PRA, we estimated that each PET production facility would have one conditional final release a year and would spend approximately 1 hour documenting the release and notifying receiving facilities. The estimate of one conditional final release per year per facility is an appropriate average number because many facilities may have no conditional final releases while others might have only a few.
Sections 212.20(c) and 212.71(a) and (b) require PET drug producers to establish procedures for investigating products that do not conform to specifications and conduct these investigations as needed. We estimate that it will take approximately 1 hour annually to record and update these procedures for each PET production facility. We also estimate, for purposes of the PRA, that 36 out-of-specification investigations would be conducted at each facility each year and that it would take approximately 1 hour to document the investigation, which results in an annual burden of 4,654 hours.
Sections 212.20(c) and 212.71(d) require PET drug producers to establish and document procedures for reprocessing PET drugs. We estimate that it will take approximately 1 hour a year to document these procedures for each PET production facility. We do not estimate a separate burden for recording the actual reprocessing, both because we believe it would be an uncommon event and because the recordkeeping burden has been included in our estimate for batch production and control records.
Sections 212.20(c) and 212.90(a) require that written procedures regarding distribution of PET drug products be established and maintained. We estimate that it will take approximately 1 hour annually to establish and maintain records of these procedures for each PET production facility. Section 212.90(b) requires that distribution records be maintained. We estimate that it will take approximately 15 minutes to create an actual distribution record for each batch of PET drug products, with a total burden of approximately 16,160 hours for all PET producers.
Sections 212.20(c) and 212.100 require that PET drug producers establish written procedures for dealing with complaints, as well as document how each complaint is handled. We estimate that establishing and maintaining written procedures for complaints will take approximately 1 hour annually for each PET production facility and that each facility will receive approximately one complaint a year and will spend approximately 30 minutes recording how the complaint was dealt with.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in Fiscal Year (FY) 2016. In addition, FDA has established a docket, where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide early input to support guidances that will be developed.
Although you can comment on any guidance at any time, submit either electronic or written comments by February 29, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The
Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 66, rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.
During negotiations on the Medical Device User Fee Amendments of 2012 (MDUFA III), Title II, Food and Drug Administration Safety and Innovation Act (Pub. L. 112-114), FDA agreed to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. Among these commitments included:
• Annually posting a list of priority medical device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year (the “A-list”) and
• annually posting a list of device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit each fiscal year (the “B-list”).
FDA invites interested persons to submit comments on any or all of the guidance documents on the lists as explained in 21 CFR 10.115(f)(5). FDA has established the docket number (FDA-2012-N-1021) where comments on the FY 2016 lists, draft language for guidance documents on those topics, suggestions for new or different guidances, and relative priority of guidance documents may be submitted and shared with the public (see
In addition to posting the lists of prioritized device guidance documents, FDA has committed to updating its Web site in a timely manner to reflect the Agency's review of previously published guidance documents; including, the deletion of guidance documents that no longer represent the Agency's interpretation of or policy on a regulatory issue and notation of guidance documents that are under review by the Agency.
Fulfillment of these commitments will be reflected through the issuance of updated guidance on existing topics, removal of guidances that that no longer reflect FDA's current thinking on a particular topic, and annual updates to the A-list and B-list announced in this notice.
On June 5, 2014, CDRH held a public workshop to provide stakeholders (
At the 2014 workshop, stakeholders requested that draft guidance documents be more clearly identified as “draft” to indicate to CDRH stakeholders and staff that they are not for implementation. CDRH revised its templates for new draft guidance documents by adding the watermark “DRAFT” to all pages in order to more conspicuously mark the guidance as not for implementation. CDRH implemented the use of the new templates effective August 6, 2014, and continues to use these templates.
Stakeholders also recommended that CDRH's guidance documents Web page (
CDRH is aware of draft guidance documents yet to be finalized. Therefore, in order to assure the timely completion or re-issuance of draft guidances in FY 2015, CDRH committed to performance goals for current and future draft guidance documents. For draft guidance documents issued after October 1, 2014, CDRH committed to finalize, withdraw, reopen the comment period or issue another draft guidance on the topic for 80 percent of the documents within 2 years of the close of the comment period and for the remaining 20 percent, within 5 years. In FY 2015, CDRH has withdrawn 14 of 20 draft guidances issued prior to October 1, 2009, and has been continuing to work towards finalizing the remaining draft guidances. Furthermore, in FY 2016, CDRH will finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2010, CDRH expects to renew or modify, as appropriate, these performance goals in FY 2017 and subsequent years.
At the 2014 workshop, stakeholders also expressed a desire to be involved earlier in the guidance development process. CDRH representatives discussed various ways in which the Center currently encourages participation by external stakeholders in the guidance development process. In the case of emerging technologies, CDRH uses “leapfrog” guidances to provide initial recommendations regarding the type of information that would be appropriate in the review of these emerging technologies. Input from external stakeholders help CDRH
Additionally, in FY 2015, in anticipation of guidance documents expected to be developed, CDRH sought stakeholder input regarding Patient Matched Instrumentation for Orthopedics, Medical Devices Intended for Aesthetic Use, and Dual 510(k) and Clinical Laboratory Improvement Amendments Act (CLIA) Waiver by Application. The feedback received has been considered in the development of these guidances and CDRH has included the Dual 510(k) and CLIA Waiver by Application guidance and Patient Matched Instrumentation for Orthopedics on the FY2016 B-List.
CDRH is posing the following questions to interested persons for consideration and comment, so that relevant future draft guidances on these technologies can be as complete and useful as possible. We will carefully consider the comments received in the development of new guidance documents and incorporate the information where appropriate. CDRH believes that public input during guidance development and after a draft guidance is issued on the topic will lead to a comprehensive and informed final guidance on the Agency's policy for the technologies and processes in the following list:
EMC assessment is a vital part of ensuring that risks associated with performance degradation of electrically-powered medical devices associated with electromagnetic interference are adequately addressed. CDRH recently published a short draft guidance entitled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” (Ref. 6) to provide a framework for promoting consistent submission and review of EMC information in premarket submissions. In addition, CDRH plans to also draft a more detailed guidance on this topic guidance to provide more comprehensive information and transparency to stakeholders regarding the information necessary to support an EMC claim. FDA invites comments on the following questions:
a. There has been increasing use of electromagnetic emitters (
b. Given that basic safety, as defined in the IEC 60601-1 family of standards, does not include effectiveness, how is device performance evaluated differently than device safety for EMC? Specifically, are pass/fail criteria chosen such that they will address both performance and safety for each EMC test? Alternatively, are safety and performance tested separately?
c. When networks (wired or wireless) are determined to be necessary for device performance, how are they included as a system when tested for EMC?
d. The use of “third party” components can significantly affect the EMC of the medical device system. How are device systems evaluated for EMC when off-the-shelf components such as smartphones, tablets, or PCs are intended to be used in the device system?
e. Medical devices, like most electronic products, go through various design changes that can affect the EMC of the device system. The changes or modifications can occur after initial EMC testing. What factors and methods are used to determine how device changes or modifications (
f. The use of magnetic resonance (MR) imaging technology on medical device users and patients is increasing. MR imaging incorporates very strong magnetic and electric fields that can have very significant effects on the safety and effectiveness of medical devices, especially electrically active devices. How is MR safety and compatibility addressed for electrically active medical devices intended for use in the MR environment? How is MR safety addressed (
g. Several medical device EMC consensus standards specify the information to be conveyed to the user regarding device EMC. Is this information sufficient? If not, what additional type of information is typically provided to help the user manage the risks associated with medical device EMC and how is this information conveyed?
While the national transplant waiting list continues to grow, rates of donation and transplant remain stagnant. On average, 22 people die each day waiting for a transplant. The dire deficit in organ transplants has propelled a new wave of innovation in perfusion-based organ preservation technologies. With such innovation also comes the challenge of demonstrating that these new technologies, when evaluated in animal models, are sufficiently safe for early clinical experience.
After animal organs undergo preservation using a new organ transport device or solution, there are generally two models to assess post-reperfusion injury: (1) An in vivo model in which the organ is transplanted into a surrogate recipient animal and (2) an ex vivo model in which the organ is reperfused under simulated transplant conditions. FDA intends to develop guidance to provide recommendations for utilizing both in vivo and ex vivo models to evaluate emerging organ preservation technologies. Prior to drafting our recommendations in a future guidance document, FDA invites comments on the following questions:
a. What are the potential limitations of an ex vivo model in assessing reperfusion injury, and how can these limitations be mitigated? In addition to markers for cell injury and function, histology, and the use of allogeneic blood during reperfusion, what measures can be taken to improve the data generated in an ex vivo model?
b. In an in vivo model, what are strategies to limit confounding factors, such as immunological responses and hemodynamic instability, from affecting the assessment of device-related reperfusion injury?
c. Is there a perceived hierarchy of evidence regarding data obtained from an ex vivo model and those obtained from an in vivo model? Or rather, is it
d. What role does the risk of the device play in the utilization of in vivo and ex vivo models? Regarding specific experimental parameters (
e. What are the organ-specific challenges in developing in vivo and ex vivo models to assess reperfusion injury?
f. What approaches would improve the in vivo and ex vivo study designs to ensure the generation of sufficient, meaningful data while limiting the number of animals used in such studies?
In addition, to enhance the CDRH guidance program, CDRH invites interested persons to comment on the following questions:
a. The cover page of each guidance document includes contact information for questions regarding the guidance, and a list of CDRH Offices that have generally contributed to the drafting of the guidance. Is the list of CDRH Offices involved in the drafting of the guidance informative? What other administrative information should be included on the cover page?
b. CDRH is committed to the continual improvement of the quality of guidance documents and we are seeking to identify examples of quality guidance documents. Are there specific guidance documents published in the past 5 years that were particularly informative and helpful that could serve as models for future guidance documents? Please provide the title of the guidance documents and briefly describe what specific aspects were informative and helpful?
c. Has the enhanced Guidance Document Search feature on the FDA Web site (
CDRH has issued over 1,000 guidance documents to provide stakeholders with the Agency's thinking on numerous topics. Each guidance reflected the Agency's current position at the time that it was issued. However, the guidance program has issued these guidances over a period greater than 20 years, raising the question of how current do previously issued final guidances remain? CDRH has resolved to address this concern through a staged review of previously issued final guidances in collaboration with stakeholders.
At the Web site where CDRH has posted the “A-list” and “B-list” for FY 2016, CDRH has also posted a list of final guidance documents that issued in 2006, 1996, 1986, and 1976.
The Center is interested in external feedback on whether any of these final guidances should be revised or withdrawn. In addition, for guidances that are recommended for revision, information explaining the need for revision, such as, the impact and risk to public health associated with not revising the guidance, would also be helpful as the Center considers potential action with respect to these guidances. CDRH intends to provide these lists of previously-issued final guidances annually through FY 2025 so that by 2025, FDA and stakeholders will have assessed the applicability of all guidances older than 10 years. For instance, in the annual notice for FY 2017, CDRH expects to provide a list of the final guidance documents that issued in 2007, 1997, 1987, and 1977; the annual notice for FY 2018 is expected to provide a list of the final guidance documents that issued in 2008, 1998, 1988, and 1978, and so on. CDRH will consider the comments received from this retrospective review when determining priorities for updating guidance documents, and will revise these as resources permit. During FY 2015, CDRH received comments regarding guidances issued in 2005, 1995, and 1985, and is considering further actions on specific guidances in response to comments received.
Under the Good Guidance Practices regulation at § 10.115(f)(4), the public may, at any time, suggest that CDRH revise or withdraw an already existing guidance document. The suggestion should clearly explain why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. Interested persons are requested to examine the list of previously issued final guidances provided by CDRH on the annual agenda Web site but feedback on any guidance is appreciated.
This notice announces the Web site location of the document that provides the A and B lists of guidance documents, which CDRH is intending to publish during FY 2016. To access these two lists, visit FDA's Web site at
FDA and CDRH priorities are subject to change at any time. Topics on this and past guidance priority lists may be removed or modified based on current priorities. CDRH's experience in guidance development has shown that there are many reasons that CDRH staff may not complete the entire agenda of guidances it undertakes. Staff is frequently diverted from guidance development to other priority activities. In addition, at any time new issues may arise to be addressed in guidance that could not have been anticipated at the time the annual list is generated. These may involve newly identified public health issues.
The following references are on display in the Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on paliperidone palmitate extended-release injectable suspension entitled “Draft Guidance on Paliperidone Palmitate.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release injectable suspension.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 29, 2016.
You may submit comments as follows:
Submit electronic submissions in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions: To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.
In the
As described in that guidance, FDA adopted this process to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of draft BE recommendations for paliperidone palmitate extended-release injectable suspension. FDA initially approved new drug application 022264 for INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable suspension. There are no approved ANDAs for this product. In August 2011, we issued a draft guidance for industry on BE recommendations for paliperidone palmitate extended-release injectable suspension, which we subsequently revised in December 2013. We are now issuing a further revised draft guidance for industry on BE recommendations for generic paliperidone palmitate extended-release injectable suspension (“Draft Guidance on Paliperidone Palmitate”).
In May 2013, Janssen Research and Development, LLC, manufacturer of the reference listed drug, INVEGA SUSTENNA, submitted a citizen petition requesting that FDA require that any ANDA referencing INVEGA SUSTENNA extended-release injectable suspension meet certain conditions related to demonstrating BE (Docket No. FDA-2013-P-0608). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the Draft Guidance on Paliperidone Palmitate in responding to the petition.
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 the design of BE studies to support ANDAs for paliperidone palmitate extended-release injectable suspension. It does not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the document at either
Food and Drug Administration, HHS.
Notice; establishment of docket; request for comments.
The Food and Drug Administration (FDA) is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, regarding clinical trial designs.
Submit either electronic or written comments on the collection of information by January 28, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA held a workshop on “Clinical Trial Designs in Emerging Infectious Diseases” in partnership with the National Institute of Allergy and Infectious Diseases, the HHS Office of the Assistant Secretary for Preparedness and Response, and the Centers for Disease Control and Prevention as a step in collecting information. The objectives of the workshop were to: (1) Discuss the deployment of investigational products in the context of emerging infectious diseases, drawing on the lessons learned in the Ebola virus epidemic; (2) explore the strengths and weaknesses of different clinical trial designs for establishing the safety and efficacy of investigational products for the treatment and/or prevention of life-threatening emerging infectious diseases (EID) in resource-limited settings from scientific, ethical, and operational perspectives; (3) identify areas of consensus and areas needing further discussion, with the goal of formulating acceptable options for the deployment of investigational products in clinical trials for future EIDs; and (4) discuss planning and other factors that can impact on the ability to establish clinical trials in a timely fashion to evaluate investigational therapies. The meeting agenda, transcripts, and web cast recordings are available on the FDA Web site at
FDA is opening this docket to provide an avenue for the public to submit additional information that may be relevant to the design and conduct of clinical trials for establishing the safety and efficacy of investigational products for the treatment and/or prevention of life-threatening emerging infectious diseases. Individuals submitting comments are specifically invited to address the scientific, ethical, and practical considerations that should be taken into account when designing and implementing clinical trials for future emerging infectious diseases in resource-limited settings.
This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 80 FR 66545-66546 dated October 29, 2015).
This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Bureau of Health Workforce (RQ). Specifically, this notice: (1) Abolishes the Office of Workforce Development and Analysis (RQA); (2) abolishes the Office of Health Careers (RQB); and (3) updates the functional statement for the Bureau of Health Workforce (RQ).
Delete the organizational structure for the Bureau of Health Workforce (RQ) and replace in its entirety.
The Bureau of Health Workforce is headed by the Associate Administrator, who reports directly to the Administrator, Health Resources and Services Administration.
1. Office of the Associate Administrator (RQ);
2. Division of Policy and Shortage Designation (RQ1);
3. Division of Business Operations (RQ2);
4. Division of External Affairs (RQ3);
5. National Center for Health Workforce Analysis (RQ4);
6. Division of Medicine and Dentistry (RQ5);
7. Division of Nursing and Public Health (RQ6);
8. Division of Practitioner Data Bank (RQ7);
9. Division of Participant Support and Compliance (RQ8);
10. Division of Health Careers and Financial Support (RQ9);
11. Division of National Health Service Corps (RQC); and
12. Division of Regional Operations (RQD).
Delete the functional statement for the Bureau of Health Workforce (RQ) and replace in its entirety.
This notice reflects organizational changes in Bureau of Health Workforce (RQ). Specifically, this notice: (1) Abolish the Office of Workforce Development and Analysis; (RQA); (2) abolishes the Office of Health Careers (RQB); and (3) updates the functional statement for the Bureau of Health Workforce (RQ).
The Bureau of Health Workforce (BHW) improves the health of the nation's underserved communities and vulnerable populations by developing, implementing, evaluating, and refining programs that strengthen the nation's health care workforce. BHW programs support a diverse, culturally competent workforce by addressing components including: Education and training; recruitment and retention; financial support for students, faculty, and practitioners; supporting institutions; data analysis; and evaluation and coordination of health workforce activities. These efforts support development of a skilled health workforce serving in areas of the nation with the greatest need.
The Office of the Associate Administrator provides overall leadership, direction, coordination, and planning in support of the BHW's programs designed to help meet the health professions workforce needs of the nation and improve the health of the nation's underserved communities and vulnerable populations. The office guides and directs the bureau's workforce analysis efforts and provides guidance and support for advisory councils. Additionally, the office provides direction by coordinating the recruitment, education, training, and retention of diverse health professionals in the healthcare system and supporting communities' efforts to build more integrated and sustainable systems of care. Specifically: (1) Directs and provides policy guidance for workforce recruitment, student and faculty assistance, training, and placement of health professionals to serve in underserved areas; (2) directs the bureau's health professions workforce data collection and analysis efforts in support of BHW's programs, and provides oversight for the evaluation of grantee performance and program outcomes; (3) guides and supports work
The Executive Office collaborates with BHW leadership to plan, coordinate, and direct bureau-wide administrative management activities. Specifically: (1) Executes the bureau's budget; (2) provides human resource services regarding all aspects of personnel management, workforce planning, and the allocation and utilization of personnel resources; (3) coordinates the business management functions for the bureau's grants programs; (4) plans, directs, and coordinates bureau-wide administrative management activities,
The Division of Policy and Shortage Designation serves as the focal point for the development of the BHW programs and policies. Specifically: (1) Leads and coordinates the analysis, development, and drafting of policies impacting bureau programs; (2) coordinates program planning, and tracking of legislation and other information related to BHW's programs; (3) directly supports national efforts to analyze and address equitable distribution of health professionals for access to health care for underserved populations; (4) reviews requests for and designates health professional shortage areas and medically-underserved areas and populations; (5) finalizes designation policies and procedures for both current and proposed designation criteria; (6) oversees grants to state primary care offices and conducts all business management aspects of the review, negotiation, award, and administration of these grants; (7) provides oversight, processing, and coordination for the HHS sponsored J1-visa program; (8) works collaboratively with other components within HRSA and HHS, and with other federal agencies, state, and local governments, and other public and private organizations on issues affecting BHW's programs and policies; (9) performs environmental scanning on issues that affect BHW's programs and assesses the impact of programs on underserved communities; (10) monitors BHW's activities in relation to HRSA's strategic plan; (11) develops budget projections and justifications; and (12) serves as the bureau's focal point for program information.
The Division of Business Operations serves as the focal point for the bureau's data management systems, reports, data analysis, and automation of business processes to support the administration of BHW programs. Specifically: (1) Provides leadership for implementing BHW's systems development, enhancement, and administration; (2) designs and implements data systems to assess and improve program performance; (3) provides user support and training to facilitate the effectiveness of the bureau's information systems and deliver excellent customer service to internal and external stake holders; and (4) ensures that data management systems and other tools continue to evolve to support changes to program policy, process, and data throughout the bureau.
The Division of External Affairs provides communication and public affairs expertise to the bureau and serves as the focal point for the development of all external communication as well as dissemination of public information and promotional materials in support of the bureau's programs and activities. Specifically the division: (1) Leads, coordinates, and conducts outreach and engagement strategies for various audiences including students, clinicians, health care sites, and critical shortage facilities, as well as workforce grantees and applicants; (2) coordinates and conducts the bureau's virtual events for clinicians, grantees, sites, and applicants; (3) establishes and manages partner collaborations with national organizations and academic institutions; (4) develops and implements communication initiatives to promote the bureau's programs to target audiences; and (5) maintains responsibility for all targeted communication initiatives.
The National Center for Health Workforce Analysis is the focal point for the coordination and management of the bureau's health professions workforce data collection, analysis, and evaluation efforts. The National Center for Health Workforce Analysis leads and monitors the development of workforce projections relating to BHW programs and acts as a national resource for such information and data.
The Division of Medicine and Dentistry serves as the bureau's lead for the program administration and oversight of medical and dental programs. Specifically: (1) Administers grants to educational institutions and other eligible organizations for the development, improvement, and operation of educational programs for primary care physicians (pre-doctoral, residency), physician assistants, dentists and dental hygienists, including support for community-based training and funding for faculty development to teach in primary care specialties training; (2) provides technical assistance and consultation to grantee institutions and other governmental and private organizations on the operation of these educational programs; (3) evaluates programmatic data and promotes the dissemination and application of findings arising from
The Division of Nursing and Public Health serves as the bureau's lead for the administration and oversight of nursing, behavioral and public health programs. Specifically: (1) Administers grants and provides technical assistance to educational institutions and other eligible entities in support of nursing education, practice, retention, diversity, and faculty development; (2) administers grants and provides technical assistance to educational institutions and other eligible entities in support of behavioral and public health education and practice; (3) addresses nursing workforce shortages through projects that focus on expanding enrollment in baccalaureate programs, and develops internships, residency programs, and other training mechanisms to improve the preparation of nurses, and behavioral and public health professionals, providing care for underserved populations; (4) collaborates within the bureau to identify and support analytical studies to determine the present and future supply and requirements for nurses, and behavioral and public health professionals; (5) evaluates programmatic data and promotes the dissemination and application of findings arising from supported programs; (6) provides staff support, and the Director, on behalf of the Secretary, serves as the Chair of the National Advisory Council on Nurse Education and Practice; and (7) represents the bureau, agency, and federal government, as designated, on national committees maintaining effective relationships within HRSA and with other federal and non-federal agencies, state and local governments, and other public and private organizations concerned with health personnel development, and improving access to health care for the nation's underserved.
The Division of Practitioner Data Bank coordinates with the department and other federal entities, state licensing boards, national, state, and local professional organizations, to promote quality assurance efforts and deter fraud and abuse by administering the National Practitioner Data Bank (NPDB). Specifically, the division: (1) Monitors adverse licensure information on all licensed health care practitioners and health care entities; (2) develops, proposes, and monitors efforts for (a) credentialing assessment, granting of privileges, monitoring and evaluating programs for physicians, dentists, other health care professionals, (b) professional peer review to promote an evaluation of the competence, professional conduct, or the quality and appropriateness of patient care provided by health care practitioners, and (c) risk management and utilization reviews; (3) encourages and supports evaluation and demonstration projects and research using NPDB data on medical malpractice payments and adverse actions taken against practitioners' licenses, clinical privileges, professional society memberships, and eligibility to participate in Medicare/Medicaid; (4) ensures integrity of data collection, follows all disclosure procedures without fail; (5) conducts and supports research based on the NPDB data; (6) maintains active consultative relations with professional organizations, societies, and federal agencies involved with the NPDB; (7) works with the Secretary's office to provide technical assistance to states undertaking malpractice reform; and (8) maintains effective relations with the Office of the General Counsel, the Office of the Inspector General, and HHS concerning practitioner licensing and data bank issues.
The Division of Participant Support and Compliance serves as the organizational focal point for the bureau's centralized, comprehensive customer service function to support individual program participants. The Division provides regular and ongoing communication, technical assistance, and support to program participants through the period of obligated service and closeout. Specifically: (1) Manages the staff and daily operations of the bureau's centralized customer service function; (2) initiates contact with and monitors program participants throughout their service; (3) manages clinician support, employment verification, site status changes/transfers, in-service reviews; (4) provides oversight and approval of the default, suspension, and waiver processes; (5) oversees the approval process and response for exception requests and congressional inquiries; (6) manages the 6-month verification process; (7) conducts closeout activities for each program participant and issues completion certificates; (8) manages the monthly payroll for NURSE Corps Loan Repayment Program participants; and (9) maintains program participants' case files in the bureau's management information system.
The Division of Health Careers and Financial Support serves as the point of contact for responding to inquiries; disseminating program information; providing technical assistance; administering grants, developing appropriate policies and procedures; and processing applications and awards pertaining to health workforce scholarship, loan, loan repayment, and pipeline development programs. Specifically: (1) Reviews, ranks, and selects participants and grantees for NURSE Corps, Faculty Loan Repayment Program, Native Hawaiian Health Scholarship Program, and other discretionary grant programs that provide scholarships, loans, and loan repayment to students, health professionals and faculty; (2) verifies and processes loan and lender related payments in prescribed manner and maintains current information on NURSE Corps and other scholarship, loan, and loan repayment applications and awards through automated BHW information systems; (3) manages NURSE Corps scholar in-school activities; (4) facilitates NURSE Corps scholar placement; and (5) administers grants and provides technical assistance to educational institutions and other eligible entities for the development of a diverse and culturally competent health workforce.
The Division of National Health Service Corps serves as the point of contact for responding to inquiries, disseminating program information, providing technical assistance, and processing applications and awards pertaining to the NHSC scholarship and loan repayment programs. Specifically: (1) Reviews, ranks, and selects participants for the scholarship and loan repayment programs; (2) verifies and processes loan and lender related payments in prescribed manner and maintains current information on scholarship and loan repayment applications and awards through automated BHW information systems; (3) manages scholar in-school and post-graduate training activities; (4) administers the NHSC State Loan Repayment Program; and (5) provides leadership and staff support for the NHSC National Advisory Committee.
The Division of Regional Operations serves as the regional component of BHW, cutting across divisions and working with the bureau programs that fund participants to serve in Health Professions Shortage Areas. Specifically, the Regional Offices support the bureau by: (1) Providing support for the recruitment and retention of primary health care providers in Health Professions Shortage Areas; (2) coordinating with state and regional level partners and stakeholders, and health professions schools in support of the BHW programs and initiatives; (3) reviewing and approving/disapproving NHSC site applications and recertification's; (4) completing NHSC site visits and providing technical assistance to sites; and (5) managing the scholar placement process.
All delegations of authority and re-delegations of authority made to HRSA officials that were in effect immediately prior to this reorganization, and that are consistent with this reorganization, shall continue in effect pending further re-delegation.
This reorganization is effective upon date of signature.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant and contract 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 and contract applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following 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.
National Institutes of Health (NIH) .
Notice of proposed actions under the
The NIH is considering a proposal to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to
To ensure consideration, comments must be submitted in writing by January 28, 2016.
Comments may be submitted by email at
If you have questions, or require additional background information about this proposed action, please contact the NIH and by email at
The NIH has received a request to consider experiments that involve the deliberate transfer of a drug resistance trait to a microorganism such that the acquisition could compromise the use of the drug to control disease in humans, veterinary medicine, or agriculture. This type of research falls under Section III-A-1-a of the
The proposed experiment entails transferring chloramphenicol resistance to
The proposal to transfer chloramphenicol resistance to
Office of the Assistant Secretary for Fair Housing and Equal Opportunity, the Department of Housing and Urban Development, HUD.
Announcement of funding awards.
In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department under the Notice of Funding Availability (NOFA) for the Fair Housing Initiatives Program (FHIP) for Fiscal Year (FY) 2015. This announcement contains the names and addresses of those award recipients
Myron Newry, Director, FHIP Division, Office of Programs, Office of Fair Housing and Equal Opportunity, Department of Housing and Urban Development, 451 Seventh Street SW., Room 5230,Washington, DC 20410. Telephone number (202) 402-7095 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.
Title VIII of the Civil Rights Act of 1968, as amended, 42 U.S.C. 3601-19 (the Fair Housing Act) provides the Secretary of Housing and Urban Development with responsibility to accept and investigate complaints alleging discrimination based on race, color, religion, sex, handicap, familial status or national origin in the sale, rental, or financing of most housing. In addition, the Fair Housing Act directs the Secretary to coordinate with State and local agencies administering fair housing laws and to cooperate with and render technical assistance to public or private entities carrying out programs to prevent and eliminate discriminatory housing practices.
Section 561 of the Housing and Community Development Act of 1987, 42 U.S.C. 3616, established FHIP to strengthen the Department's enforcement of the Fair Housing Act and to further fair housing. This program assists projects and activities designed to enhance compliance with the Fair Housing Act and substantially equivalent State and local fair housing laws. Implementing regulations are found at 24 CFR part 125.
On July 22, 2015, the Department published its FY 2015 NOFA, which announced the availability of approximately $39,200,000 to be utilized for FHIP projects and activities. Funding availability for discretionary grants for the FHIP NOFA included: The Private Enforcement Initiative (PEI) ($29,275,000), the Education and Outreach Initiative (EOI) ($3,500,000), and the Fair Housing Organizations Initiative (FHOI) ($6,425,000). This Notice thereby announces grant awards for the FY 2015 FHIP NOFA.
For the FY 2015, the Department reviewed, evaluated and scored the applications received based on the criteria in the FY 2015 NOFA. As a result, HUD has funded the applications announced in Appendix A, and in accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989 (103 Stat. 1987, 42 U.S.C. 3545). The Department is hereby publishing details concerning the recipients of funding awards in Appendix A of this document.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Development (HUD).
Notice of a Federal Advisory Committee Meeting: Manufactured Housing Consensus Committee (MHCC).
This notice sets forth the schedule and proposed agenda for a meeting of the MHCC. The meeting is open to the public and the site is accessible to individuals with disabilities. The agenda provides an opportunity for citizens to comment on the business before the MHCC.
The meeting will be held on January 19 through January 21, 2016, from 9:00 a.m. to 5:00 p.m. Eastern Standard Time (EST).
The meeting will be held at the Kentucky Exposition Center, 937 Phillips Lane, Louisville, Kentucky 40209.
Pamela Beck Danner, Administrator, Department of Housing and Urban Development, Office of Manufactured Housing Programs, 451 7th Street SW., Room 9168, Washington, DC 20410, telephone (202) 708-6423 (this is not a toll-free number). Persons who have difficulty hearing or speaking may access this number via TTY by calling the toll-free Federal Information Relay Service at 800-877-8339.
Notice of this meeting provided in accordance with the Federal Advisory Committee Act, 5. U.S.C. App. 10(a)(2) through implementing regulations at 41 CFR 102-3.150. The MHCC was established by the National Manufactured Housing Construction and Safety Standards Act of 1974, 42 U.S.C. 5403 (a)(3), as amended by the Manufactured Housing Improvement Act of 2000, (Pub. L. 106-569). According to 42 U.S.C. 5403, as amended, the purposes of the MHCC are to:
• Provide periodic recommendations to the Secretary to adopt, revise, and interpret the Federal manufactured housing construction and safety standards in accordance with this subsection;
• Provide periodic recommendations to the Secretary to adopt, revise, and interpret the procedural and enforcement regulations, including regulation specifying the permissible scope and conduct of monitoring in accordance with subsection (b);
• Be organized and carry out its business in a manner that guarantees a fair opportunity for the expression and consideration of various positions and for public participation.
The MHCC is deemed an advisory committee not composed of Federal employees.
*Log items cited in this agenda can be reviewed at
Bureau of Indian Affairs, Interior.
Notice.
The Pueblo of Nambe and State of New Mexico entered into a Tribal-State compact governing Class III gaming; this notice announces that the compact is taking effect.
The compact if effective on December 29, 2015.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the
Bureau of Indian Affairs, Interior.
Notice of Availability.
This notice advises the public that the Bureau of Indian Affairs (BIA) as lead agency, with the Wilton Rancheria (Tribe), City of Galt (City), Sacramento County (County), and the United States Environmental Protection Agency (EPA) serving as cooperating agencies, intends to file a Draft Environmental Impact Statement (DEIS) with the EPA for the Wilton Rancheria fee-to-trust and casino project, Sacramento County, California. This notice announces that the DEIS is now available for public review and that a public hearing will be held to receive comments on the DEIS.
Comments on the DEIS must arrive by February 12, 2016. The date of the public hearing will be announced at least 15 days in advance through a notice to be published in local newspapers (Galt Herald and Sacramento Bee) and online at
The DEIS is available for public review at the Galt Branch of the Sacramento Public Library, 1000 Caroline Ave., Galt, California 95632. You may mail or hand-deliver written comments to Ms. Amy Dutschke, Pacific Regional Director, Bureau of Indian Affairs, 2800 Cottage Way, Sacramento, California 95825. You may also submit comments through email to Mr. John Rydzik, Chief, Division of Environmental, Cultural Resource Management and Safety, Bureau of Indian Affairs, at
The location of the public hearing will be announced at least 15 days in advance through a notice to be published in local newspapers (Galt Herald and Sacramento Bee) and online at
Ms. John Rydzik, Bureau of Indian Affairs, Pacific Regional Office, 2800 Cottage Way, Sacramento, California 95825, (916) 978-6051,
Public review of the DEIS is part of the administrative process for the evaluation of the Tribe's application to BIA for the Federal trust acquisition of approximately 282 acres in Sacramento County, California. The Tribe proposes to construct a casino/hotel/resort on the property. A Notice of Intent (NOI) was published in the Sacramento Bee, the Galt Herald, and
The Tribe has requested that BIA take into trust 282 acres of land (known as the Twin Cities site) currently held in fee, on which the Tribe proposed to construct a casino, hotel, parking area, and other ancillary facilities (Proposed Project). The proposed fee-to-trust property is located within the City of Galt Sphere of Influence Area in unincorporated Sacramento County, California, north of Twin Cities Road between State Highway 99 and the Union Pacific Railroad tracks. The Proposed Project would contain 110,260 square-feet (sf) of gaming floor area, a 12-story hotel with 302 guest rooms, a 360-seat buffet, 60-seat pool grill, other food and beverage providers, a 2,600 sf retail area, a fitness center, spa, and an approximately 48,000 sf convention center. Access to the Twin Cities site would be provided via an improved Mingo Road interchange on Highway 99. The following alternatives are considered in the DEIS:
Environmental issues addressed in the DEIS include geology and soils, water resources, air quality, biological resources, cultural and paleontological resources, socioeconomic conditions (including environmental justice), transportation and circulation, land use, public services, noise, hazardous
Directions for Submitting Comments: Please include your name, return address, and the caption: “DEIS Comments, Wilton Rancheria Fee-to-Trust and Casino Project,” on the first page of your written comments. If emailing comments, please use “DEIS Comments, Wilton Rancheria Fee-to-Trust and Casino Project” as the subject of your email.
Locations where the DEIS is Available for Review: The DEIS is available for review during regular business hours at the BIA Pacific Regional Office and the Galt Branch of the Sacramento Public Library at the addresses noted above in the
Public Comment Availability: Comments, including names and addresses of respondents, will be available for public review during regular business hours at the BIA mailing address shown in the
This notice is published pursuant to Sec. 1503.1 of the Council of Environmental Quality Regulations (40 CFR parts 1500 through 1508) and Sec. 46.305 of the Department of the Interior Regulations (43 CFR part 46), implementing the procedural requirements of the NEPA of l969, as amended (42 U.S.C. 4371,
Bureau of Indian Affairs, Interior.
Notice of reservation proclamation.
This notice informs the public that the Assistant Secretary—Indian Affairs proclaimed approximately 292.77 acres, more or less, an addition to the reservation of the Tonto Apache Indian Tribe of Arizona on December 21, 2015.
Sharlene Round Face, Bureau of Indian Affairs, Division of Real Estate Services, 1849 C Street NW., MS-4642-MIB, Washington, DC 20240, telephone (202) 208-3615.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by part 209 of the Departmental Manual.
A proclamation was issued according to the Act of June 18, 1934 (48 Stat. 984; 25 U.S.C. 467), for the land described below. The land was proclaimed to be part of the Tonto Apache Indian Reservation of the Tonto Apache Tribe, Town of Payson, Gila County and State of Arizona.
Government Lots 4 and 6 and the Southeast quarter of the Southeast quarter of the Southwest quarter of Section 9; the Southwest quarter and the West half of the Southeast quarter of Section 10, all in Township 10 North, Range 10 East of the Gila and Salt River Base and Meridian, Gila County, Arizona, consisting of 272.77 acres, more or less;
A parcel of land being the East half of the Northwest quarter of the Southeast quarter of Section 9, Township 10 North, Range 10 East of the Gila and Salt River Base and Meridian, Gila County, Arizona, more particularly described as follows:
Beginning at the Northeast corner of the Northwest quarter of the Southeast quarter being identical to A.P. No. 2 of Tract 37 of said Section 9;
Thence South 00°02′36″ West, 1,323.57 feet to the Southeast corner of the Northwest quarter of the Southeast quarter being identical to A.P. No. 3 of Tract 37 of said Section 9;
Thence North 89°50′15″ West, 659.35 feet to the Southwest corner of the East half of the Northwest quarter of the Southeast quarter of said Section 9;
Thence North 00°04′46″ West, 1,323.05 feet to the Northwest corner of the East half of the Northwest quarter of the Southeast quarter of said Section 9;
Thence South 89°53′00″ East, 658.51 feet to the true point of beginning, consisting of 20 acres, more or less.
The above described lands contain a total of 292.77 acres, more or less, which are subject to all valid rights, reservations, rights-of-way, and easements of record.
This proclamation does not affect title to the lands described above, nor does it affect any valid existing easements for public roads, highways, public utilities, railroads, and pipelines or any other valid easements or rights-of-way or reservations of record.
Office of the Secretary, Land Buy-Back Program for Tribal Nations, Interior.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Land Buy-Back Program for Tribal Nations (Buy-Back Program), Office of the Secretary, Department of the Interior announces the proposed extension of a public information collection and seeks public comments on the provisions thereof.
Consideration will be given to all comments received by
Send your written comments to Michael Estes, Land Buy-Back Program for Tribal Nations, U.S. Department of the Interior, 1849 C Street NW., MS 5552-MIB, Washington, DC 20240, fax 202-208-3009, or by electronic mail to
To request a copy of the information collection request, any explanatory information and related forms, see the contact information provided in the
This notice is for renewal of information collection.
The Office of Management and Budget (“OMB”) regulations at 5 CFR part 1320, which implement the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
The Secretary of the Interior established the Land Buy-Back Program for Tribal Nations (“the Program”) to implement the land consolidation provisions of the
The Department of the Interior works cooperatively with tribal leaders and individual landowners to reduce the number of fractional interests through voluntary land sales. The Program allows interested individual owners to receive payments for voluntarily selling their land. All lands sold will immediately be held in trust for the tribe with jurisdiction. Tribal leadership, participation, and facilitation are crucial to the success of the Program.
The Program is carrying out its work in accordance with the Claims Resolution Act of 2010 (Pub. L. 111-291, § 101). The Act requires that “[t]he Secretary shall consult with Indian tribes to identify fractional interests within the respective jurisdictions of the Indian tribes for purchase in a manner that is consistent with the priorities of the Secretary.” Moreover, the obligation to engage in meaningful consultations with Federally-recognized tribes is rooted in the United States Constitution and Federal treaties, statutes, executive orders and policies. Federal agencies are required to consult on actions that will have substantial, direct effect or implications for tribal nations, including regulations, rulemakings, policy, guidance, legislative proposals, grant formula changes, and operational activities.
There are about 245,000 owners of nearly three million fractional interests across Indian Country who are eligible to participate in the Program. Informed by early planning activities, the Program identified 42 locations where land consolidation activities—such as planning, outreach, mapping, mineral evaluations, appraisals or acquisitions—have either already occurred or are expected to take place through the middle of 2017. These locations represented 83 percent of all outstanding fractional interests across Indian Country.
The Program has launched a two-part Planning Initiative to help determine its next implementation schedule for 2017 and beyond. Eligible tribal governments not already scheduled for implementation are invited to formally indicate their interest in participating in the Program. More information, including the deadline for tribal expressions of interest, is available to tribal leaders at:
In light of the Program's duty to consult with tribes, we are conducting this information collection request to obtain information from the remaining eligible tribal governments regarding their interest in implementing the Program at their locations and their readiness to do so. The Program will evaluate the expressions of interest provided by tribal governments, among other factors, as it develops its next implementation schedule.
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The Department invites comments on:
(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 the burden of the collection of information and the validity of the methodology and assumptions used;
(c) Ways to enhance 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 appropriate automated, electronic, mechanical, or other collection techniques or other forms of information technology.
“Burden” means the total time, effort, and 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 use technology and systems for the purposes 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, and to complete and review the collection of information; and to transmit or otherwise disclose the information.
It is our policy to make all comments available to the public for review. Before including Personally Identifiable Information (“PII”), such as your address, phone number, email address, or other personal information in your comment(s), you should be aware that your entire comment (including PII) may be made available to the public at any time. While you may ask us in your comment to withhold PII from public view, we cannot guarantee that we will be able to do so. If you wish to view any comments received, you may do so by scheduling an appointment using the
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection renewal; they also will become a matter of public record.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
National Park Service, Interior.
Notice of meetings.
In accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16), notice is hereby given of the 2016 meeting schedule of the Gateway National Recreation Area Fort Hancock 21st Century Federal Advisory Committee.
The meetings will take place on the following dates and at the following locations:
John Harlan Warren, External Affairs Officer, Gateway National Recreation Area, Sandy Hook Unit, 26 Hudson Road, Highlands, New Jersey 07732, (732) 872-5910, email
Under section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16), the purpose of the Committee is to provide advice to the Secretary of the Interior, through the Director of the National Park Service, on the development of a reuse plan and on matters relating to future uses of certain buildings at the Fort Hancock and Sandy Hook Proving Ground National Historic Landmark which lie within Gateway National Recreation Area.
The Committee Web site,
All comments will be made part of the public record and will be electronically distributed to all Committee members. Before including your address, telephone number, email address, or other personal identifying information in your written comments, you should be aware that your entire comment including your personal identifying information will be publicly available. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Park Service, Interior.
Request for nominations.
The National Park Service (NPS), U.S. Department of the Interior, proposes to appoint new members to the Cedar Creek and Belle Grove National Historical Park Advisory Commission (Commission). The NPS is requesting nominations for qualified persons to serve as members of the Commission.
Written nominations must be received by February 29, 2016.
Nominations or requests for further information should be sent to Karen Beck-Herzog, Acting Site Manager, Cedar Creek and Belle Grove National Historical Park, 8693 Valley Pike, P.O. Box 700, Middletown, Virginia 22645, telephone (540) 868-9176.
Karen Beck-Herzog, Acting Site Manager, Cedar Creek and Belle Grove National Historical Park, 8693 Valley Pike, P.O. Box 700, Middletown, Virginia 22645, telephone (540) 868-9176, email
Public Law 107-373 established the Cedar Creek and Belle Grove National Historical Park. Section 9(a) of that law established the Advisory Commission. The Commission was designated by Congress to provide advice to the Secretary of the Interior on the preparation and implementation of the park's general management plan and to advise on land protection.
The Commission consists of 15 members appointed by the Secretary, as follows: (a) 1 representative from the Commonwealth of Virginia; (b) 1 representative each from the local governments of Strasburg, Middletown, Frederick County, Shenandoah County, and Warren County; (c) 2 representatives of private landowners within the Park; (d) 1 representative from a citizen interest group; (e) 1 representative from the Cedar Creek Battlefield Foundation; (f) 1 representative from the Belle Grove, Incorporated; (g) 1 representative from the National Trust for Historic Preservation; (h) 1 representative from the Shenandoah Valley Battlefields
Each member shall be appointed for a term of three years and may be reappointed for not more than two successive terms. A member may serve after the expiration of that member's term until a successor has taken office. The Chairperson of the Commission shall be elected by the members to serve a term of one year renewable for one additional year.
We are currently seeking members to represent the Town of Strasburg, Shenandoah County, the Commonwealth of Virginia, and private landowners within the Park.
Nominations should be typed and should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Commission and permit the Department of the Interior to contact a potential member.
Members of the Commission serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Commission as approved by the Designated Federal Officer, members may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under Section 5703 of Title 5 of the United States Code.
Individuals who are Federally registered lobbyists are ineligible to serve on all FACA and non-FACA boards, committees, or councils in an individual capacity. The term “individual capacity” refers to individuals who are appointed to exercise their own individual best judgment on behalf of the government, such as when they are designated Special Government Employees, rather than being appointed to represent a particular interest.
All nominations must be compiled and submitted in one complete package. Incomplete submissions (missing one or more of the items described above) will not be considered.
Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. 16(b)-(h), that a proposed Final Judgment, Stipulation, and Competitive Impact Statement have been filed with the United States District Court for the District of Columbia in
Copies of the Complaint, proposed Final Judgment, and Competitive Impact Statement are available for inspection on the Antitrust Division's Web site at
Public comment is invited within 60 days of the date of this notice. Such comments, including the name of the submitter, and responses thereto, will be posted on the Antitrust Division's Web site, filed with the Court, and, under certain circumstances, published in the
The United States of America, acting under the direction of the Attorney General of the United States brings this civil action to enjoin the acquisition by Gray Television, Inc. (“Gray”) of Schurz Communications, Inc. (“Schurz”) and to obtain other equitable relief.
1. Gray and Schurz own and operate broadcast television stations in multiple Designated Market Areas (“DMAs”) in the United States.
2. Gray's and Schurz's television stations compete head to head for the business of local and national companies that seek to advertise on broadcast television stations in the South Bend, Indiana DMA, and the Wichita, Kansas DMA.
3. In the South Bend, Indiana DMA, the two broadcast television stations that Gray and Schurz operate account for approximately 67 percent of all broadcast television station gross revenues in that DMA.
4. In the Wichita, Kansas DMA, the three stations that Gray and Schurz operate account for approximately 57 percent of all broadcast television station gross advertising revenues in that DMA.
5. Pursuant to an Asset Purchase Agreement dated September 14, 2015, Gray agreed to acquire Schurz for approximately $440 million.
6. If consummated, the proposed acquisition would eliminate the substantial head-to-head competition between Gray and Schurz in the South Bend, Indiana DMA, and the Wichita, Kansas DMA (collectively “the DMA Markets”). Unless enjoined, the proposed transaction is likely to lead to higher prices and substantially lessen competition for broadcast television spot advertising in each of the DMA Markets in violation of Section 7 of the Clayton Act, 15 U.S.C. 18.
7. The United States brings this action pursuant to Section 15 of the Clayton Act, as amended, 15 U.S.C. 25, to prevent and restrain Gray and Schurz from violating Section 7 of the Clayton Act, 15 U.S.C. 18.
8. The Court has subject-matter jurisdiction over this action pursuant to Section 15 of the Clayton Act, 15 U.S.C. 25, and 28 U.S.C. 1331, 1337(a), and 1345.
9. Gray and Schurz are engaged in interstate commerce and in activities substantially affecting interstate commerce. They each own and operate broadcast television stations in various locations throughout the United States and sell television advertising for those stations. Their television advertising sales have had a substantial effect upon interstate commerce.
10. Defendants have consented to venue and personal jurisdiction in this District. Therefore, venue is proper in this District under Section 12 of the Clayton Act, 15 U.S.C. 22, and 28 U.S.C. 1391(c).
11. Gray is incorporated in the state of Georgia, with its headquarters in Atlanta, Georgia. Gray reported operating revenues of over $508 million for the year ended December 31, 2014. As of February 1, 2015, Gray owned and operated broadcast television stations in 44 geographic markets. It owns and operates broadcast television stations in each of the DMA Markets.
12. Schurz is a privately owned radio, television, cable TV and newspaper company, with its headquarters in Mishawaka, Indiana. Schurz owns and operates 10 broadcast television stations in 7 markets. It also owns and operates broadcast television stations in each of the DMA Markets.
13. The relevant market for Section 7 of the Clayton Act is the sale of television spot advertising to advertisers targeting viewers in each of the DMA Markets.
14. A DMA is a geographical unit for which A.C. Nielsen Company, a firm that surveys television viewers, furnishes broadcast television stations, advertisers, and advertising agencies in a particular area with data to aid in evaluating audience size and composition. DMAs are widely accepted by television stations, advertisers, and advertising agencies as the standard geographic area to use in evaluating television audience size and demographic composition.
15. Gray and Schurz sell television advertising to local and national advertisers in each of the DMA Markets. Gray and Schurz television stations in each of the DMA Markets generate almost all of their revenues by selling advertising to local and national advertisers who want to reach viewers in those markets. Spot advertising placed on television stations in a DMA is aimed at reaching viewing audiences in that DMA, and television stations broadcasting outside that DMA do not provide effective access to those audiences.
16. Spot advertising differs from network and syndicated television advertising. In contrast to spot advertising sales, television networks and producers of syndicated programs sell network and syndicated television advertising on a nationwide basis for broadcast in every market where the network or syndicated program is aired.
17. Broadcast television stations attract viewers through their programming, which is delivered for free over the air or retransmitted to viewers, primarily through wired cable or other terrestrial television systems and through satellite television systems. Broadcast television stations then sell advertising to businesses that want to advertise their products to television viewers. A television station's advertising rates typically are based on the station's ability, relative to competing television stations, to attract viewing audiences that have certain demographic characteristics that advertisers want to reach.
18. Broadcast television spot advertising possesses a unique combination of attributes that set it apart from advertising using other types of media. Television combines sight, sound, and motion, thereby creating a more memorable advertisement. Moreover, of all media, broadcast television spot advertising generally reaches the largest percentage of all potential customers in a particular target geographic area and is therefore especially effective in introducing, establishing, and maintaining the image of a product. For a significant number of advertisers, broadcast television spot advertising, because of its unique combination of attributes, is an advertising medium for which there is no close substitute. Other media, such as radio, newspapers, or outdoor billboards, are not desirable substitutes for broadcast television advertising. None of these media can provide the important combination of sight, sound, and motion that makes television unique and impactful as a medium for advertising.
19. Like broadcast television, subscription television channels such as those carried over cable or satellite television combine elements of sight, sound, and motion, but they are not a desirable substitute for broadcast television spot advertising for two important reasons. First, broadcast television can reach well over 90 percent of homes in a DMA, while satellite, cable and other subscription services often reach many fewer homes. Even when several subscription television companies within a DMA jointly offer cable television spot advertising through a consortium called an interconnect, cable spot advertising does not match the reach of broadcast television spot advertising. As a result, an advertiser can achieve greater audience penetration through broadcast television spot advertising than through advertising on a subscription television channel. Second, because subscription services may offer more than 100 channels, they fragment the audience into small demographic segments. Because broadcast television programming typically has higher rating points than subscription television programming, broadcast television provides a much easier and more efficient means for an advertiser to reach a high proportion of its target demographic.
20. While media buyers often buy advertising on subscription television channels, they do so not as a substitute for broadcast television spot advertising, but rather as a supplement, in order to reach a narrow demographic (
21. Internet-based media is not currently a substitute for broadcast television spot advertising. Although Online Video Distributors (“OVDs”) such as Netflix and Hulu are important sources of video programming, as with cable television advertising, the local video advertising of OVDs lacks the reach of broadcast television spot advertising. Non-video Internet advertising,
22. In addition, broadcast television stations negotiate prices individually with advertisers; consequently, television stations can charge different advertisers different prices. Broadcast television stations generally can identify advertisers with strong preferences to advertise on broadcast television stations in their DMAs. Because of this ability to price discriminate among
23. Broadcast television station ownership in each of the DMA Markets is already significantly concentrated. In each of these markets, four stations, each affiliated with a major network, had more than 90 percent of gross advertising revenues in 2014. In the South Bend, Indiana DMA the two stations that Gray and Schurz operate have approximately 67 percent of all television station gross advertising revenues in that DMA. In the Wichita, Kansas DMA the three stations that Gray and Schurz operate have approximately 57 percent of all television station gross advertising revenues in that DMA.
24. Market concentration is often one useful indicator of the likely competitive effects of a merger. Concentration in each of the DMA Markets would increase significantly as a result of the proposed acquisition.
25. As articulated in the Horizontal Merger Guidelines issued by the Department of Justice and the Federal Trade Commission, the Herfindahl-Hirschman Index (“HHI”) is a measure of market concentration. The more concentrated a market, and the more a transaction would increase concentration in a market, the more likely it is that a transaction would result in a meaningful reduction in competition harming consumers. Mergers resulting in highly concentrated markets (with an HHI in excess of 2,500) that involve an increase in the HHI of more than 200 points are presumed to be likely to enhance market power under the merger guidelines.
26. The post-acquisition HHI in each of the DMA Markets would be over 2,500. In the South Bend, Indiana DMA, the post-acquisition HHI would be approximately 4,800. In the Wichita, Kansas DMA, the post-acquisition HHI would be approximately 4,200. Those HHIs are well above the 2,500 threshold at which the Department normally considers a market to be highly concentrated. In addition, Gray's proposed acquisition of Schurz would result in a substantial increase in the HHIs set forth above in excess of the 200 points presumed to be anticompetitive under the merger guidelines.
27. In addition to increasing concentration in the DMA Markets, the proposed transaction combines stations that are close substitutes and vigorous competitors in markets with limited alternatives. In each of the DMA Markets, Defendants each have broadcast television stations that are affiliated with the major national television networks, ABC, CBS, NBC and FOX. In the South Bend, Indiana DMA, Schurz owns and operates WSBT-TV, a CBS affiliate; and Gray owns and operates WNDU-TV, an NBC affiliate. In the Wichita, Kansas DMA, Schurz owns and operates KWCH-DT, a CBS affiliate; and Gray owns and operates KAKE-TV, an ABC affiliate. Their respective affiliations with those networks, and their local news operations, provide the Defendants' stations with a variety of competing programming options that are often each other's next-best or second-best substitutes for many viewers and advertisers.
28. Advertisers benefit from Defendants' head-to-head competition in the sale of broadcast television spot advertising in the South Bend, Indiana DMA and the Wichita, Kansas DMA. Advertisers purposefully spread their advertising dollars across numerous spot advertising suppliers to reach their marketing goals most efficiently. After the proposed acquisition, advertisers in each of the DMA Markets would likely find it more difficult to “buy around” the Defendants' combined stations in response to higher advertising rates, than to “buy around” Gray's stations or Schurz's stations, as separate entities, as they could have done before the proposed acquisition. Because a significant number of advertisers would likely be unable to reach their desired audiences as effectively unless they advertise on at least one station that Gray would control after the proposed acquisition, those advertisers' bargaining positions would be weaker, and the advertising rates they pay would likely increase.
29. De novo entry into the South Bend, Indiana DMA and the Wichita, Kansas DMA is unlikely. The FCC regulates entry through the issuance of broadcast television licenses, which are difficult to obtain because the availability of spectrum is limited and the regulatory process associated with obtaining a license is lengthy. Even if a new signal became available, commercial success would come, at best, over a period of many years. Thus, entry into each DMA Market's broadcast television spot advertising market would not be timely, likely, or sufficient to deter Gray from engaging in anticompetitive price increases or other anticompetitive conduct after the proposed acquisition occurs.
30. Other broadcast television stations in the South Bend, Indiana DMA and the Wichita, Kansas DMA likely would not increase their advertising capacity in response to a price increase by Gray. The number of 30-second spots in a DMA is largely fixed by programming and time constraints. This fact makes the pricing of spot advertising responsive to changes in demand. Adjusting programming in response to a pricing change is risky, difficult, and time-consuming. Network affiliates are often committed to the programming provided by the network with which they are affiliated, and it often takes years for a station to build its audience. Programming schedules are complex and carefully constructed, taking many factors into account, such as audience flow, station identity, and program popularity. In addition, stations typically have multi-year contractual commitments for individual shows. Accordingly, a television station is unlikely to change its programming sufficiently or with sufficient rapidity to overcome a small but significant price increase imposed by Gray.
31. Although Defendants assert that the proposed acquisition would produce efficiencies, they cannot demonstrate acquisition-specific and cognizable efficiencies that would be sufficient to offset the proposed acquisition's anticompetitive effects.
32. The effect of the proposed acquisition of Schurz by Gray would be to substantially lessen competition in interstate trade and commerce in violation of Section 7 of the Clayton Act.
33. The United States hereby repeats and realleges the allegations of paragraphs 1 through 32 as if fully set forth herein.
34. Gray's proposed acquisition of Schurz likely would substantially lessen competition in interstate trade and commerce, in violation of Section 7 of the Clayton Act, 15 U.S.C. 18. The proposed acquisition likely would have the following effects, among others:
a. Competition in the sale of broadcast television spot advertising in each of the DMA Markets would be substantially lessened;
b. Actual and potential competition among Gray and Schurz in the sale of broadcast television spot advertising in
c. Prices for spot advertising on broadcast television stations in each of the DMA Markets would likely increase, and the quality of services would likely decline.
The United States requests:
d. That the Court adjudge the proposed acquisition to violate Section 7 of the Clayton Act, 15 U.S.C. 18;
e. That the Court permanently enjoin and restrain Defendants from carrying out the transaction, or entering into any other agreement, understanding, or plan by which Gray would acquire Schurz;
f. That the Court award the United States the costs of this action; and
g. That the Court award such other relief to the United States as the Court may deem just and proper.
Pursuant to Section 2(b) of the Antitrust Procedures and Penalties Act (“APPA” or “Tunney Act”), 15 U.S.C. 16(b)-(h), plaintiff United States of America (“United States”) files this Competitive Impact Statement relating to the proposed Final Judgment submitted for entry in this civil antitrust proceeding.
Defendants Gray Television, Inc. (“Gray”) and Schurz Communications, Inc. (“Schurz”) entered into an Asset Purchase Agreement, dated September 14, 2015, pursuant to which Gray would acquire Schurz for approximately $440 million. Defendants compete head-to-head in the sale of broadcast television spot advertising in the following Designated Market Areas (“DMAs”): South Bend, Indiana; and Wichita, Kansas (collectively “the DMA Markets”).
The United States filed a civil antitrust Complaint on December 22, 2015, seeking to enjoin the proposed acquisition. The Complaint alleges that the acquisition's likely effect would be to increase broadcast television spot advertising prices in each of the DMA Markets in violation of Section 7 of the Clayton Act, 15 U.S.C. 18.
At the same time the Complaint was filed, the United States also filed a Hold Separate Stipulation and Order (“Hold Separate”) and proposed Final Judgment, which are designed to eliminate the anticompetitive effects of the acquisition. The proposed Final Judgment, which is explained more fully below, requires Defendants to divest the following broadcast television stations (the “Divestiture Stations”) to Acquirers approved by the United States in a manner that preserves competition in each of the DMA Markets: WSBT-TV, located in the South Bend, Indiana DMA; and KAKE-TV, located in the Wichita, Kansas DMA. The Hold Separate requires Defendants to take certain steps to ensure that the Divestiture Stations are operated as competitively independent, economically viable, and ongoing business concerns, uninfluenced by the consummation of the acquisition so that competition is maintained until the required divestitures occur.
The United States and Defendants have stipulated that the proposed Final Judgment may be entered after compliance with the APPA. Entry of the proposed Final Judgment would terminate this action, except that the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgment and to punish violations thereof.
Gray is incorporated in the state of Georgia, with its headquarters in Atlanta, Georgia. Gray owns and operates broadcast television stations in 44 metropolitan areas. It owns and operates broadcast television stations in each of the DMA Markets.
Schurz is an Indiana corporation, with its headquarters in Mishawaka, Indiana. Schurz owns and operates 10 broadcast television stations in 7 metropolitan areas. It also owns and operates, or provides programming, operating, or sales services to broadcast television stations in each of the DMA Markets.
Pursuant to an Asset Purchase Agreement dated September 14, 2015, Gray agreed to acquire Schurz for approximately $440 million.
Gray and Schurz compete head to head against one another for the business of local and national advertisers that seek to purchase television advertising time in each of the DMA Markets.
The Complaint alleges that the sale of broadcast television spot advertising to advertisers targeting viewers located in each of the DMA Markets constitutes a relevant product market for analyzing this acquisition under Section 7 of the Clayton Act. Gray and Schurz sell television advertising to local and national advertisers that seek to target viewers in each of the DMA Markets. A DMA is a geographical unit designated by the A.C. Nielsen Company, a company that surveys television viewers and furnishes broadcast television stations, advertisers, and advertising agencies in a particular area with data to aid in evaluating television audiences. DMAs are widely accepted by television stations, advertisers, and advertising agencies as the standard geographic area to use in evaluating television audience size and demographic composition. A television station's advertising rates typically are based on the station's ability, relative to competing television stations, to attract viewing audiences that have certain demographic characteristics that advertisers are seeking to reach.
Gray's and Schurz's broadcast television stations in the DMA Markets generate almost all of their revenues by selling advertising to local and national
Broadcast television spot advertising possesses a unique combination of attributes that sets it apart from advertising using other types of media. Because of this unique combination of attributes, broadcast television spot advertising has no close substitute for a significant number of advertisers.
Television combines sight, sound, and motion, thereby creating a more memorable advertisement when compared to other types of advertising. For example, radio spots lack the visual impact of television advertising; and newspaper and billboard ads lack sound and motion, as do many internet search engine and Web site banner ads.
Broadcast television spot advertising also generally reaches the largest percentage of potential customers in a targeted geographic area and is therefore especially effective in introducing, establishing, and maintaining a product's image.
Spot advertising differs from network and syndicated television advertising, which are sold on a nationwide basis by major television networks and by producers of syndicated programs and are broadcast in every market area in which the network or syndicated program is aired. Spot advertising on subscription television channels and internet-based video advertising also lacks the same reach as broadcast television spot advertising.
In addition, through information provided during individualized price negotiations, broadcast television stations can identify advertisers with strong preferences for using broadcast television spot advertising and charge different prices to those advertisers. Consequently, if there were a small but significant and non-transitory increase in the price (“SSNIP”) of broadcast television spot advertising on broadcast television stations in the DMA Markets, advertisers would not reduce their purchases sufficiently to render the price increase unprofitable. Advertisers would not switch enough purchases of advertising time to television stations outside the DMA Markets, or to other media to render the price increase unprofitable.
The Complaint alleges that the proposed acquisition likely would substantially lessen competition in interstate trade and commerce, in violation of Section 7 of the Clayton Act, 15 U.S.C. 18, and likely would have the following effects, among others:
a) competition in the sale of broadcast television spot advertising in each of the DMA Markets would be substantially lessened;
b) competition between Gray broadcast television stations and Schurz broadcast television stations in the sale of broadcast television spot advertising in each of the DMA markets would be eliminated; and
c) the prices for spot advertising on broadcast television stations in each of the DMA Markets likely would increase.
The acquisition, by eliminating Schurz as a separate competitor and combining its operations with Gray's, would allow the combined entity to increase its market share of broadcast television spot advertising and revenues in each of the DMA Markets. In the South Bend, Indiana DMA, combining the two stations that Defendants operate would give Gray approximately 67 percent of all television station gross advertising revenues in that DMA. In the Wichita, Kansas DMA, combining the three stations that Defendants operate would give Gray approximately 57 percent of all television station gross advertising revenues in that DMA.
Gray's acquisition of Schurz would further concentrate the already highly concentrated broadcast television market in each of the DMA Markets. Using the Herfindahl-Hirschman Index (“HHI”), a standard measure of market, the post-acquisition HHI in each of the DMA Markets would be over 2,500. Gray's acquisition of Schurz would result in a substantial increase in the HHI set forth above for each DMA Market in excess of the 200 points presumed likely to enhance market power under the Horizontal Merger Guidelines issued by the Department of Justice and Federal Trade Commission.
Moreover, the acquisition combines stations that are close substitutes and vigorous competitors in a product market with limited alternatives. In each of the DMA Markets, Defendants have broadcast stations that are affiliated with the major national television networks, ABC, CBS, NBC, and FOX. Their respective affiliations with those networks, and their local news operations, provide Defendants' stations with a variety of competing programming options that are often each other's next-best or second-best substitutes for viewers and advertisers.
Finally, the Complaint alleges that entry or expansion in broadcast television spot advertising each of the DMA Markets would not be timely, likely, or sufficient to prevent any anticompetitive effects. New entry is unlikely because any new station would require an FCC license, which is difficult to obtain. Even if a new station became operational, commercial success would come over a period of many years. The number of 30-second spots available at a station is generally fixed. Accordingly, other television stations in each of the DMA Markets could not readily increase their advertising capacity in response to a small but significant price increase by Gray.
In summary, for all these reasons, the Complaint alleges that Gray's proposed acquisition of Schurz would substantially lessen competition in the sale of television spot advertising time to advertisers targeting viewers in each of the DMA Markets, eliminate head-to-head competition between Gray and Schurz television stations in those markets, and result in increased prices and reduced quality of service for television advertisers in each of those markets, all in violation of Section 7 of the Clayton Act.
The divestiture requirement of the proposed Final Judgment will eliminate the anticompetitive effects of the acquisition in each of the DMA Markets by maintaining the Divestiture Stations as independent, economically viable competitors. The proposed Final Judgment requires Gray to divest WSBT-TV, located in South Bend, Indiana to Sinclair Broadcast Group; and KAKE-TV, located in Wichita, Kansas to Lockwood Broadcast Group. The United States has approved each of these divestiture buyers. The United States required Gray to identify each Acquirer of a Divestiture Station in order to provide greater certainty and efficiency in the divestiture process.
The “Divestiture Assets” are defined in Paragraph II. I of the proposed Final Judgment to include all assets, tangible or intangible, principally devoted to or necessary for the operation of the Divestiture Stations as viable, ongoing commercial broadcast television stations. With respect to each Divestiture Station, the divestiture will include assets sufficient to satisfy the United States, in its sole discretion, that such assets can and will be used to operate each station as a viable, ongoing, commercial television business.
To ensure that the Divestiture Stations are operated independently from Gray after the divestitures, Sections IV and XI of the proposed Final Judgment prohibit
Defendants are required to take all steps reasonably necessary to accomplish the divestitures quickly and to cooperate with prospective purchasers. Because transferring the broadcast license for each of the Divestiture Stations requires FCC approval, Defendants are specifically required to use their best efforts to obtain all necessary FCC approvals as expeditiously as possible. The divestiture of each of the Divestiture Stations must occur within 90 calendar days after the filing of the Complaint in this matter. If applications have been filed with the FCC within the period permitted for divestiture seeking approval to assign or transfer licenses to the Acquirers of the Divestiture Assets, but an order or other dispositive action by the FCC on such applications has not been issued before the end of the period permitted for divestiture, the period shall be extended with respect to divestiture of the Divestiture Assets for which no FCC order has issued until 5 calendar days after such order is issued. The United States, in its sole discretion, may agree to one or more extensions of this time period not to exceed 90 calendar days in total, and shall notify the Court in such circumstances.
In the event that Defendants do not accomplish the divestitures within the periods prescribed in the proposed Final Judgment, the proposed Final Judgment provides that the Court, upon application of the United States, will appoint a trustee selected by the United States to effect the divestitures. If a trustee is appointed, the proposed Final Judgment provides that Gray will pay all costs and expenses of the trustee. The trustee's commission will be structured to provide an incentive for the trustee based on the price obtained and the speed with which the divestitures are accomplished. After his or her appointment becomes effective, the trustee will file monthly reports with the Court and the United States describing his or her efforts to accomplish the divestiture of any remaining stations. If the divestiture has not been accomplished after 6 months, the trustee and the United States will make recommendations to the Court, which shall enter such orders as appropriate, to carry out the purpose of the trust, including extending the trust or the term of the trustee's appointment.
Section 4 of the Clayton Act, 15 U.S.C. 15, provides that any person who has been injured as a result of conduct prohibited by the antitrust laws may bring suit in federal court to recover three times the damages the person has suffered, as well as costs and reasonable attorneys' fees. Entry of the proposed Final Judgment will neither impair nor assist the bringing of any private antitrust damage action. Under the provisions of Section 5(a) of the Clayton Act, 15 U.S.C. 16(a), the proposed Final Judgment has no prima facie effect in any subsequent private lawsuit that may be brought against Defendants.
The United States and Defendants have stipulated that the proposed Final Judgment may be entered by the Court after compliance with the provisions of the APPA, provided that the United States has not withdrawn its consent. The APPA conditions entry upon the Court's determination that the proposed Final Judgment is in the public interest.
The APPA provides a period of at least sixty (60) days preceding the effective date of the proposed Final Judgment within which any person may submit to the United States written comments regarding the proposed Final Judgment. Any person who wishes to comment should do so within sixty (60) days of the date of publication of this Competitive Impact Statement in the
Written comments should be submitted to: David C. Kully, Chief, Litigation III Section, Antitrust Division, United States Department of Justice, 450 5th Street NW., Suite 4000, Washington, DC 20530.
The proposed Final Judgment provides that the Court retains jurisdiction over this action, and Defendants may apply to the Court for any order necessary or appropriate for the modification, interpretation, or enforcement of the Final Judgment.
The United States considered, as an alternative to the proposed Final Judgment, a full trial on the merits against Defendants. The United States could have continued the litigation and sought preliminary and permanent injunctions against Gray's acquisition of Schurz. The United States is satisfied, however, that the divestiture of assets described in the proposed Final Judgment will preserve competition for the sale of broadcast television spot advertising in each of the DMA Markets. Thus, the proposed Final Judgment would achieve all or substantially all of the relief the United States would have obtained through litigation, but avoids the time, expense, and uncertainty of a full trial on the merits of the Complaint.
The Clayton Act, as amended by the APPA, requires that proposed consent judgments in antitrust cases brought by the United States be subject to a sixty-day comment period, after which the Court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. 16(e)(1). In
(A) the competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and
(B) the impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial.
As the United States Court of Appeals for the District of Columbia Circuit has held, under the APPA a court considers, among other things, the relationship between the remedy secured and the specific allegations set forth in the government's complaint, whether the decree is sufficiently clear, whether enforcement mechanisms are sufficient, and whether the decree may positively harm third parties.
[t]he balancing of competing social and political interests affected by a proposed antitrust consent decree must be left, in the first instance, to the discretion of the Attorney General. The court's role in protecting the public interest is one of insuring that the government has not breached its duty to the public in consenting to the decree. The court is required to determine not whether a particular decree is the one that will best serve society, but whether the settlement is “
Courts have greater flexibility in approving proposed consent decrees than in crafting their own decrees following a finding of liability in a litigated matter. “[A] proposed decree must be approved even if it falls short of the remedy the court would impose on its own, as long as it falls within the range of acceptability or is `within the reaches of public interest.' ”
Moreover, the Court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its Complaint, and does not authorize the Court to “construct [its] own hypothetical case and then evaluate the decree against that case.”
In its 2004 amendments, Congress made clear its intent to preserve the practical benefits of utilizing consent decrees in antitrust enforcement, adding
There are no determinative materials or documents within the meaning of the APPA that were considered by the United States in formulating the proposed Final Judgment.
WHEREAS, Plaintiff, the United States of America, filed its Complaint on December 22, 2015, and Defendant Gray Television, Inc. (“Gray”) and Defendant Schurz Communications, Inc. (“Schurz”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law, and without this Final Judgment constituting any evidence against or admission by any party regarding any issue of fact or law;
AND WHEREAS, Defendants agree to be bound by the provisions of this Final Judgment pending its approval by the Court;
AND WHEREAS, the essence of this Final Judgment is the prompt and certain divestiture of certain rights or assets by the Defendants to assure that competition is not substantially lessened;
AND WHEREAS, the United States requires Defendants to make certain divestitures for the purpose of remedying the loss of competition alleged in the Complaint;
AND WHEREAS, Defendants have represented to the United States that the divestitures required below can and will be made and that Defendants will later raise no claim of hardship or difficulty as grounds for asking the Court to modify any of the divestiture provisions contained below;
NOW THEREFORE, before any testimony is taken, without trial or adjudication of any issue of fact or law, and upon consent of the parties, it is ORDERED, ADJUDGED, AND DECREED:
This Court has jurisdiction over the subject matter and each of the parties to this action. The Complaint states a claim upon which relief may be granted against Defendants under Section 7 of the Clayton Act, as amended, 15 U.S.C. 18.
As used in this Final Judgment:
A. “Gray” means Defendant Gray Television, Inc., a Georgia corporation headquartered in Atlanta, Georgia, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships, and joint ventures, and their directors, officers, managers, agents, and employees.
B. “Schurz” means Defendant Schurz Communications, Inc., a Indiana corporation headquartered in Mishawaka, Indiana, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships, and joint ventures, and their directors, officers, managers, agents, and employees.
C. “Sinclair” means Sinclair Broadcast Group, Inc., a Maryland corporation headquartered in Hunt Valley, Maryland, its successor and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships, and joint ventures, and their directors, officers, managers, agents, and employees.
D. “Lockwood” means Lockwood Broadcast Group, a Virginia corporation headquartered in Hampton, Virginia, its successor and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships, and joint ventures, and their directors, officers, managers, agents, and employees.
E. “Acquirer” means Sinclair, Lockwood, or another entity to which Defendants divest any of the Divestiture Assets.
F. “DMA” means Designated Market Area as defined by A.C. Nielsen Company based upon viewing patterns and used by the
G. “WSBT-TV” means the CBS-affiliated broadcast television station located in the South Bend, Indiana DMA owned by Defendant Schurz.
H. “KAKE-TV” means the ABC-affiliated broadcast television station located in the Wichita, Kansas DMA owned by Defendant Gray.
I. “Divestiture Assets” means the WSBT-TV and KAKE-TV broadcast television stations and all assets, tangible or intangible, principally devoted to or necessary for the operations of the stations as viable, ongoing commercial broadcast television stations, including, but not limited to, all real property (owned or leased), all broadcast equipment, office equipment, office furniture, fixtures, materials, supplies, and other tangible property; all licenses, permits, authorizations, and applications therefore issued by the Federal Communications Commission (“FCC”)
A. This Final Judgment applies to Defendants, and all other persons in active concert or participation with any of them who receive actual notice of this Final Judgment by personal service or otherwise.
B. If, prior to complying with Sections IV and V of this Final Judgment, Defendants sell or otherwise dispose of all or substantially all of their assets or of lesser business units that include the Defendants' Divestiture Assets, they shall require the purchaser to be bound by the provisions of this Final Judgment. Defendants need not obtain such an agreement from the Acquirers of the assets divested pursuant to this Final Judgment.
A. Defendants are ordered and directed, within ninety (90) calendar days after the filing of the Complaint in this matter, or five (5) calendar days after notice of entry of this Final Judgment by the Court, whichever is later, to divest the Divestiture Assets in a manner consistent with this Final Judgment to one or more Acquirers acceptable to the United States, in its sole discretion. The United States, in its sole discretion, may agree to one or more extensions of this time period not to exceed ninety (90) calendar days in total, and shall notify the Court in such circumstances. With respect to divestiture of the Divestiture Assets by Defendants or a trustee appointed pursuant to Section V of this Final Judgment, if applications have been filed with the FCC within the period permitted for divestiture seeking approval to assign or transfer licenses to the Acquirers of the Divestiture Assets, but an order or other dispositive action by the FCC on such applications has not been issued before the end of the period permitted for divestiture, the period shall be extended with respect to divestiture of the Divestiture Assets for which no FCC order has issued until five (5) days after such order is issued. Defendants agree to use their best efforts to divest the Divestiture Assets as expeditiously as possible, including using their best efforts to obtain all necessary FCC approvals as expeditiously as possible. This Final Judgment does not limit the FCC's exercise of its regulatory powers and process with respect to the Divestiture Assets. Authorization by the FCC to conduct the divestiture of a Divestiture Asset in a particular manner will not modify any of the requirements of this Final Judgment.
B. In the event that Defendants are attempting to divest assets related to WSBT-TV to an Acquirer other than Sinclair, or assets related to KAKE-TV to an Acquirer other than Lockwood:
(1) Defendants, in accomplishing the divestitures ordered by this Final Judgment, promptly shall make known, by usual and customary means, the availability of the Divestiture Assets not yet divested;
(2) Defendants shall inform any person making an inquiry regarding a possible purchase of the applicable Divestiture Assets that they are being divested pursuant to this Final Judgment and provide that person with a copy of this Final Judgment;
(3) Defendants shall offer to furnish to all prospective Acquirers, subject to customary confidentiality assurances, all information and documents relating to the applicable Divestiture Assets customarily provided in a due diligence process except such information or documents subject to the attorney-client privilege or work-product doctrine; and
(4) Defendants shall make available such information to the United States at the same time that such information is made available to any other person.
C. Defendants shall provide the Acquirers and the United States information relating to the personnel involved in the operation and management of the applicable Divestiture Assets to enable the Acquirers to make offers of employment. Defendants shall not interfere with any negotiations by the Acquirers to employ or contract with any employee of any Defendant whose primary responsibility relates to the operation or management of the applicable Divestiture Assets.
D. Defendants shall permit the prospective Acquirers of the Divestiture Assets to have reasonable access to personnel and to make inspections of the physical facilities of the applicable stations; access to any and all environmental, zoning, and other permit documents and information; and access to any and all financial, operational, or other documents and information customarily provided as part of a due diligence process.
E. Defendants shall warrant to the Acquirers that each Divestiture Asset will be operational on the date of sale.
F. Defendants shall not take any action that will impede in any way the permitting, operation, or divestiture of the Divestiture Assets.
G. At the option of the Acquirer(s), Defendants shall enter into a transition services agreement with the Acquirer(s) for a period of up to six (6) months to facilitate the continuous operations of the Divestiture Assets until the Acquirer can provide such capabilities independently. The terms and conditions of any contractual arrangement intended to satisfy this provision must be reasonably related to market conditions and shall be subject to the approval of the United States, in its sole discretion. Additionally, the United States in its sole discretion may approve one or more extensions of this agreement for a total of up to an additional six (6) months.
H. Defendants shall warrant to the Acquirers that there are no material defects in the environmental, zoning, or other permits pertaining to the operation of each asset, and that, following the sale of the Divestiture Assets, Defendants will not undertake, directly or indirectly, any challenges to the environmental, zoning, or other permits relating to the operation of the Divestiture Assets.
I. Unless the United States otherwise consents in writing, the divestitures pursuant to Section IV, or by trustee appointed pursuant to Section V of this Final Judgment, shall include the entire Divestiture Assets and be accomplished in such a way as to satisfy the United States, in its sole discretion, that the Divestiture Assets can and will be used by the Acquirers as part of a viable, ongoing commercial television broadcasting business. Divestiture of the Divestiture Assets may be made to one or more Acquirers, provided that in each instance it is demonstrated to the sole satisfaction of the United States that the Divestiture Assets will remain viable, and the divestiture of such assets will achieve the purposes of this Final Judgment and remedy the competitive harm alleged in the Complaint. The divestitures, whether pursuant to Section IV or Section V of this Final Judgment:
(1) shall be made to Acquirers that, in the United States' sole judgment, have the intent and capability (including the necessary managerial, operational, technical, and financial capability) of competing effectively in the commercial television broadcasting business; and
(2) shall be accomplished so as to satisfy the United States, in its sole discretion, that none of the terms of any agreement between Acquirers and Defendants gives Defendants the ability unreasonably to raise any of the Acquirers' costs, to lower any of the Acquirers' efficiency, or otherwise to interfere in the ability of any of the Acquirers to compete effectively.
A. If Defendants have not divested the Divestiture Assets within the time period specified in Section IV(A), Defendants shall notify the United States of that fact in writing, specifically identifying the Divestiture Assets that have not been divested. Upon application of the United States, the Court shall appoint a trustee selected by the United States and approved by the Court to effect the divestiture of the Divestiture Assets that have not yet been divested.
B. After the appointment of a trustee becomes effective, only the trustee shall have the right to sell the applicable Divestiture Assets. The trustee shall have the power and authority to accomplish the divestiture to an Acquirer acceptable to the United States at such price and on such terms as are then obtainable upon reasonable effort by the trustee, subject to the provisions of Sections IV, V, and VI of this Final Judgment, and shall have such other powers as this Court deems appropriate. Subject to Section V(D) of this Final Judgment, the trustee may hire at the cost and expense of Defendants any investment bankers, attorneys, or other agents, who shall be solely accountable to the trustee, reasonably necessary in the trustee's judgment to assist in the divestiture. Any such investment bankers, attorneys, or other agents shall serve on such terms and conditions as the United States approves, including confidentiality requirements and conflict of interest certifications.
C. Defendants shall not object to a sale by the trustee on any ground other than the trustee's malfeasance. Any such objections by Defendants must be conveyed in writing to the United States and the trustee within ten (10) calendar days after the trustee has provided the notice required under Section VI.
D. The trustee shall serve at the cost and expense of Defendants pursuant to a written agreement, on such terms and conditions as the United States approves, including confidentiality requirements and conflict of interest certifications. The trustee shall account for all monies derived from the sale of the applicable Divestiture Assets and all costs and expenses so incurred. After approval by the Court of the trustee's accounting, including fees for its services yet unpaid and those of any professionals and agents retained by the trustee, all remaining money shall be paid to Defendants and the trust shall then be terminated. The compensation of the trustee and any professionals and agents retained by the trustee shall be reasonable in light of the value of the Divestiture Assets subject to sale by the trustee and based on a fee arrangement providing the trustee with an incentive based on the price and terms of the divestiture and the speed with which it is accomplished, but timeliness is paramount. If the trustee and Defendants are unable to reach agreement on the trustee's or any agents' or consultants' compensation or other terms and conditions of engagement within 14 calendar days of appointment of the trustee, the United States may, in its sole discretion, take appropriate action, including making a recommendation to the Court. The trustee shall, within three (3) business days of hiring any other professionals or agents, provide written notice of such hiring and the rate of compensation to Defendants and the United States.
E. Defendants shall use their best efforts to assist the trustee in accomplishing the required divestiture. The trustee and any consultants, accountants, attorneys, and other agents retained by the trustee shall have full and complete access to the personnel, books, records, and facilities of the business to be divested, and Defendants shall develop financial and other information relevant to such business as the trustee may reasonably request, subject to reasonable protection for trade secret or other confidential research, development, or commercial information or any applicable privileges. Defendants shall take no action to interfere with or to impede the trustee's accomplishment of the divestiture.
F. After its appointment, the trustee shall file monthly reports with the United States and, as appropriate, the Court setting forth the trustee's efforts to accomplish the applicable divestiture ordered under this Final Judgment. To the extent such reports contain information that the trustee deems confidential, such report shall not be filed in the public docket of the Court. Such report shall include the name, address, and telephone number of each person who, during the preceding month, made an offer to acquire, expressed an interest in acquiring, entered into negotiations to acquire, or was contacted or made an inquiry about acquiring, any interest in the Divestiture Assets, and shall describe in detail each contact with any such person. The trustee shall maintain full records of all efforts made to divest the applicable Divestiture Assets.
G. If the trustee has not accomplished any applicable divestiture ordered under this Final Judgment within six (6) months after its appointment, the trustee shall promptly file with the Court a report setting forth (1) the trustee's efforts to accomplish the required divestiture, (2) the reasons, in the trustee's judgment, why the required divestiture has not been accomplished, and (3) the trustee's recommendations. To the extent such report contains information that the trustee deems confidential, such report shall not be filed in the public docket of the Court. The trustee shall at the same time furnish such report to the United States which shall have the right to make additional recommendations consistent with the purpose of the trust. The Court thereafter shall enter such orders as it shall deem appropriate to carry out the purpose of the Final Judgment, which may, if necessary, include extending the trust and the term of the trustee's appointment by a period requested by the United States.
H. If the United States determines that the trustee has ceased to act or failed to act diligently or in a reasonably cost-effective manner, it may recommend the Court appoint a substitute trustee.
A. Within two (2) business days following execution of a definitive divestiture agreement, Defendants or the trustee, whichever is then responsible for effecting the divestitures required herein, shall notify the United States of any proposed divestiture required by Section IV or V of this Final Judgment. If the trustee is responsible, it shall similarly notify Defendants. The notice shall set forth the details of the proposed divestiture and list the name, address, and telephone number of each person not previously identified who offered or expressed an interest in or desire to acquire any ownership interest in the Divestiture Assets, together with full details of the same.
B. Within fifteen (15) calendar days of receipt by the United States of such notice, the United States may request from Defendants, the proposed Acquirer, any other third party, or the trustee, if applicable, additional information concerning the proposed divestiture, the proposed Acquirer, and any other potential Acquirers. Defendants and the trustee shall furnish any additional information requested
C. Within thirty (30) calendar days after receipt of the notice or within twenty (20) calendar days after the United States has been provided the additional information requested from Defendants, the proposed Acquirer, any third party, and the trustee, whichever is later, the United States shall provide written notice to Defendants and the trustee, if there is one, stating whether or not it objects to the proposed divestiture. If the United States provides written notice that it does not object, the divestiture may be consummated, subject only to Defendants' limited right to object to the sale under Section V(C) of this Final Judgment. Absent written notice that the United States does not object to the proposed Acquirer or upon objection by the United States, a divestiture proposed under Section IV or Section V shall not be consummated. Upon objection by Defendants under Section V(C), a divestiture proposed under Section V shall not be consummated unless approved by the Court.
Defendants shall not finance all or any part of any purchase made pursuant to Section IV or V of this Final Judgment.
Until the divestitures required by this Final Judgment has been accomplished, Defendants shall take all steps necessary to comply with the Hold Separate Stipulation and Order entered by this Court. Defendants shall take no action that would jeopardize the divestiture ordered by this Court.
A. Within twenty (20) calendar days of the filing of the Complaint in this matter, and every thirty (30) calendar days thereafter until the divestiture has been completed under Section IV or V of this Final Judgment, Defendants shall deliver to the United States an affidavit as to the fact and manner of their compliance with Section IV or V of this Final Judgment. Each such affidavit shall include the name, address, and telephone number of each person who, during the preceding thirty (30) calendar days, made an offer to acquire, expressed an interest in acquiring, entered into negotiations to acquire, or was contacted or made an inquiry about acquiring, any interest in the Divestiture Assets, and shall describe in detail each contact with any such person during that period. Each such affidavit shall also include a description of the efforts Defendants have taken to solicit buyers for and complete the sale of the Divestiture Assets, including efforts to secure FCC or other regulatory approvals, and to provide required information to prospective Acquirers, including the limitations, if any, on such information. Assuming the information set forth in the affidavit is true and complete, any objection by the United States to information provided by Defendants, including limitations on information, shall be made within fourteen (14) calendar days of receipt of such affidavit.
B. Within twenty (20) calendar days of the filing of the Complaint in this matter, Defendants shall deliver to the United States an affidavit that describes in reasonable detail all actions Defendants have taken and all steps Defendants have implemented on an ongoing basis to comply with Section VIII of this Final Judgment. Each such affidavit shall also include a description of the efforts Defendants have taken to complete the sale of the Divestiture Assets, including efforts to secure FCC or other regulatory approvals. Defendants shall deliver to the United States an affidavit describing any changes to the efforts and actions outlined in Defendants' earlier affidavits filed pursuant to this section within fifteen (15) calendar days after the change is implemented.
C. Defendants shall keep all records of all efforts made to preserve and divest the Divestiture Assets until one year after such divestiture has been completed.
A. For the purposes of determining or securing compliance with this Final Judgment, or of any related orders such as any Hold Separate Stipulation and Order, or of determining whether the Final Judgment should be modified or vacated, and subject to any legally recognized privilege, from time to time authorized representatives of the United States Department of Justice, including consultants and other persons retained by the United States, shall, upon written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division, and on reasonable notice to Defendants, be permitted:
(1) access during Defendants' office hours to inspect and copy, or at the option of the United States, to require Defendants to provide hard copies or electronic copy of, all books, ledgers, accounts, records, data, and documents in the possession, custody, or control of Defendants, relating to any matters contained in this Final Judgment; and
(2) to interview, either informally or on the record, Defendants' officers, employees, or agents, who may have their individual counsel present, regarding such matters. The interviews shall be subject to the reasonable convenience of the interviewee and without restraint or interference by Defendants.
B. Upon the written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division, Defendants shall submit written reports or responses to written interrogatories, under oath if requested, relating to any of the matters contained in this Final Judgment as may be requested.
C. No information or documents obtained by the means provided in this section shall be divulged by the United States to any person other than an authorized representative of the executive branch of the United States, except in the course of legal proceedings to which the United States is a party (including grand jury proceedings), or for the purpose of securing compliance with this Final Judgment, or as otherwise required by law.
D. If at the time information or documents are furnished by Defendants to the United States, Defendants represent and identify in writing the material in any such information or documents to which a claim of protection may be asserted under Rule 26(c)(1)(g) of the Federal Rules of Civil Procedure, and Defendants mark each pertinent page of such material, “Subject to claim of protection under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure,” then the United States shall give Defendants ten (10) calendar days notice prior to divulging such material in any legal proceeding (other than a grand jury proceeding).
Defendants may not (1) reacquire any part of the Divestiture Assets, (2) acquire any option to reacquire any part of the Divestiture Assets or to assign the Divestiture Assets to any other person, (3) enter into any local marketing agreement, joint sales agreement, other cooperative selling arrangement, or shared services agreement, or conduct other business negotiations jointly with the Acquirers with respect to the Divestiture Assets, or (4) provide financing or guarantees of financing with respect to the Divestiture Assets, during the term of this Final Judgment. The shared services prohibition does not preclude Defendants from
This Court retains jurisdiction to enable any party to this Final Judgment to apply to this Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify any of its provisions, to enforce compliance, and to punish violations of its provisions.
Unless this Court grants an extension, this Final Judgment shall expire ten years from the date of its entry.
Entry of this Final Judgment is in the public interest. The parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, and any comments thereon, and the United States' responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and response to comments filed with the Court, entry of this Final Judgment is in the public interest.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before January 28, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on September 3, 2015, Johnson Matthey, Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import thebaine derivatives and fentanyl as reference standards.
The company plans to import the remaining listed controlled substances as raw materials, to be used in the manufacture of bulk controlled substances, for distribution to its customers. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C, 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
On December 21, 2015, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Northern District of Indiana in the lawsuit entitled
The United States and the State filed the lawsuit under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The Complaint names seven parties as Defendants: Anderson Products Inc., doing business in Indiana as Anco Products, Inc.; B-D Industries; Elkhart Plating Corp.; FFP Holdings, LLC, formerly known as Flexible Foam Products, Inc.; Gaska Tape Inc.; Holland Metal Fab, Inc.; and Walerko Tool and Engineering Corp. The Complaint seeks recovery of certain costs that the United States and the State incurred and/or will incur in responding to releases of hazardous substances at the Lusher Street Groundwater Contamination Superfund Site located in the City of Elkhart, Elkhart County, Indiana. This includes the State's past costs of $26,436.38. The Consent Decree requires Defendants to reimburse those State costs and perform injunctive relief related to groundwater contamination and associated soil vapor for Operable Unit 1 at the Site. In return, the United States and the State agree not to pursue the Defendants under Sections 106 and 107 of CERCLA for the matters addressed in the Consent Decree.
The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and
During the public comment period, the proposed Consent Decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $42.00 (25 cents per page reproduction cost) payable to the United States Treasury.
Bureau of Labor Statistics (BLS).
Request for nominations to the BLS Technical Advisory Committee.
The BLS is soliciting new members for the Technical Advisory Committee (TAC). Five current membership terms expire on April 11, 2016. The TAC provides advice and makes recommendations to the Bureau of Labor Statistics on technical aspects of data collection and the formulation of economic measures. On some technical issues there are differing views, and receiving feedback at public meetings provides BLS with the opportunity to consider all viewpoints. The Committee will consist of 16 members and will be chosen from a cross-section of economists, statisticians, and behavioral scientists who represent a balance of expertise. The economists will have research experience with technical issues related to BLS data and will be familiar with employment and unemployment statistics, price index numbers, compensation measures, productivity measures, occupational and health statistics, or other topics relevant to BLS data series. The statisticians will be familiar with sample design, data analysis, computationally intensive statistical methods, non-sampling errors or other areas which are relevant to BLS work. The behavioral scientists will be familiar with questionnaire design, usability or other areas of survey development. BLS invites persons interested in serving on the TAC to submit their names for consideration for committee membership.
Nominations for the TAC membership should be postmarked by January 13, 2016.
Nominations for the TAC membership should be sent to: Commissioner Erica Groshen, U.S. Bureau of Labor Statistics, 2 Massachusetts Avenue NE., Room 4040, Washington, DC 20212.
Jay Stewart, Division Chief, U.S. Bureau of Labor Statistics, 2 Massachusetts Avenue NE., Office of Productivity and Technology, Room 2180. Washington, DC 20212. Telephone: 202-691-7376. This is not a toll free number.
BLS intends to renew memberships in the TAC for another three years. The Bureau often faces highly technical issues while developing and maintaining the accuracy and relevancy of its data on employment and unemployment, prices, productivity, and compensation and working conditions. These issues range from how to develop new measures to how to make sure that existing measures account for the ever changing economy. The BLS presents issues and then draws on the specialized expertise of Committee members representing specialized fields within the academic disciplines of economics, statistics and survey design. Committee members are also invited to bring to the attention of BLS issues that have been identified in the academic literature or in their own research.
The TAC was established to provide advice to the Commissioner of Labor Statistics on technical topics selected by the BLS. Responsibilities include, but are not limited to providing comments on papers and presentations developed by BLS research and program staff, conducting research on issues identified by BLS on which an objective technical opinion or recommendation from outside of BLS would be valuable, recommending BLS conduct internal research projects to address technical problems with BLS statistics that have been identified in the academic literature, participating in discussions of areas where the types or coverage of economic statistics could be expanded or improved and areas where statistics are no longer relevant, and establishing working relationships with professional associations with an interest in BLS statistics, such as the American Statistical Association and the American Economic Association.
Nominations: BLS is looking for committed TAC members who have a strong interest in, and familiarity with, BLS data. The Agency is looking for nominees who use and have a comprehensive understanding of economic statistics. The U.S. Bureau of Labor Statistics is committed to bringing greater diversity of thought, perspective, and experience to its advisory committees. Nominees from all races, gender, age, and disabilities are encouraged to apply. Interested persons may nominate themselves or may submit the name of another person who they believe to be interested in and qualified to serve on the TAC. Nominations may also be submitted by organizations. Nominations should include the name, address, and telephone number of the candidate. Each nomination should include a summary of the candidate's training or experience relating to BLS data specifically, or economic statistics more generally. BLS will conduct a basic background check of candidates before their appointment to the TAC. The background check will involve accessing publicly available, Internet-based sources.
U.S. Copyright Office, Library of Congress.
Notice of inquiry.
The United States Copyright Office is undertaking a public study to assess the operation of section 1201 of Title 17, including the triennial rulemaking process established under the DMCA to adopt exemptions to the prohibition against circumvention of technological measures that control access to copyrighted works. To aid this effort, and to ensure thorough assistance to Congress, the Office is seeking public input on a number of key questions.
Written comments must be received no later than 11:59 p.m. Eastern Time on February 25, 2016. Written reply comments must be received no later than 11:59 p.m. Eastern Time on March 25, 2016. The Office will be announcing one or more public meetings, to take place after written comments are received, by separate notice in the future.
All comments must be submitted electronically. Specific instructions for submitting comments will be posted on the Copyright Office Web site at
Regan A. Smith, Associate General Counsel, by email at
The Digital Millennium Copyright Act (“DMCA”) has played a pivotal role in the development of the modern digital economy. Enacted in 1998 to implement the United States' obligations under two international treaties,
Section 1201 prohibits the circumvention of technological measures employed by or on behalf of copyright owners to control access to their works (also known as “access controls”), as well as the trafficking in technologies or services that facilitate such circumvention.
Section 1201 includes a triennial rulemaking process through which the Librarian of Congress, following a public proceeding conducted by the Register of Copyrights in consultation with the National Telecommunications and Information Administration of the Department of Commerce (“NTIA”), may grant limited exceptions to section 1201(a)(1)'s bar on the circumvention of access controls. By statute, the triennial rulemaking process addresses only the prohibition on the act of circumvention itself; section 1201 does not provide a mechanism to grant exceptions to the anti-trafficking provisions of sections 1201(a)(2) or 1201(b).
Those seeking an exemption from the prohibition on circumvention must establish that “persons who are users of a copyrighted work are, or are likely to be in the succeeding 3-year period, adversely affected by the prohibition . . . in their ability to make noninfringing uses under this title of a particular class of copyrighted works.”
In considering a proposed exemption, the Librarian—and hence the Register—must also weigh the statutory factors listed in section 1201(a)(1)(C), namely: “(i) the availability for use of copyrighted works; (ii) the availability for use of works for nonprofit archival, preservation, and educational purposes; (iii) the impact that the prohibition on the circumvention of technological measures applied to copyrighted works has on criticism, comment, news reporting, teaching, scholarship, or research; (iv) the effect of circumvention of technological measures on the market for or value of copyrighted works; and (v) such other factors as the Librarian considers appropriate.”
In addition, section 1201(a)(1) specifies that exemptions adopted through the triennial rulemaking must be defined based on “a particular
Exemptions adopted via the rulemaking process are to remain in effect for three years. Congress made clear that the basis for an exemption must be established
In addition to the temporary exemptions adopted pursuant to the triennial rulemaking process, section 1201 provides eight permanent exemptions to the prohibition on circumvention, namely for certain activities of nonprofit libraries, archives, and educational institutions (section 1201(d)) and law enforcement (section 1201(e)); for reverse engineering (section 1201(f)); encryption research (section 1201(g)); the protection of personally identifying information (section 1201(i)); security testing (section 1201(j)); the prevention of access by minors to the internet (section 1201(h)); and relating to certain analog devices such as VHS and Beta format cassettes (section 1201(k)). Separately, section 112 includes a limited permanent exception to section 1201 for purposes of making ephemeral recordings.
In 2014, Congress addressed certain issues relating to section 1201 by passing the Unlocking Consumer Choice and Wireless Competition Act (“Unlocking Act”), which primarily concerned the circumvention of technological measures that control access to computer programs that enable wireless telephone handsets to connect to wireless communication networks (“cellphone unlocking”).
The Unlocking Act also permanently established that circumvention under any exemption to permit a wireless telephone handset or other wireless device to connect to a different telecommunications network may be initiated by the owner of the handset or device, by another person at the direction of the owner, or by a provider of commercial mobile radio or data service, so long as the purpose is to enable the owner or a family member to connect to a wireless network in an authorized manner.
As the number of participants in the triennial rulemaking has expanded with each successive cycle, the Office has done what it can within the existing statutory framework to streamline the proceedings. For the recent sixth triennial rulemaking proceeding, the Register (in consultation with NTIA and past proceeding participants) adjusted the administrative procedures to make the process more accessible and understandable; facilitate participation, coordination, and the development of the factual record; and reduce administrative burdens on both the participants and the Copyright Office.
Even with these improvements, however, the rulemaking procedure, as enacted by Congress, is resource-intensive for both participants and the Office. An area of particular concern is the requirement that previously granted exemptions be reviewed anew. During the most recent rulemaking, a number of petitions essentially sought renewal of existing exemptions—for example, unlocking of cellphones and jailbreaking of smartphones. Some of these petitions—including a petition to permit circumvention so that literary works distributed electronically could continue to be accessed by persons who are blind, visually impaired, or print disabled—were unopposed.
Since the enactment of section 1201, the use of technological measures has been useful in expanding consumer choice and the avenues for dissemination of creative works, for example, movies and video games.
These concerns were highlighted throughout the recently completed sixth triennial proceeding. In the 2015 rulemaking, some of the proposed exemptions concerned the ability to access and make noninfringing uses of expressive copyrighted works, such as motion pictures, video games, and e-books, which Congress undoubtedly had in mind when it created the triennial review process. But others concerned the ability to circumvent access controls on copyrighted computer code in consumer devices. Proponents of these latter classes sought to access the computer code not for its creative content, but rather to enable greater functionality and interoperability of devices ranging from cellphones, tablets, and smart TVs to 3-D printers, automobiles, tractors, and pacemakers.
A related issue is whether section 1201 should be clarified to ensure that intended beneficiaries of exemptions are able to engage in the permitted circumvention activities.
Another concern is that section 1201's permanent exemptions have failed to keep up with changing technologies. In testimony, the Register has identified the limited nature of the existing security testing exemptions and supported congressional review of this problem.
As noted above, section 1201 was adopted in 1998 to implement the United States' obligations under two international treaties.
The scope of this study is limited to the operation and effectiveness of section 1201. It is not intended to focus on broader issues concerning the role of copyright with respect to software embedded in everyday products. Those issues are the subject of a separate and concurrent Copyright Office study.
The Office invites written comments on the specific subjects below. A party choosing to respond to this Notice of Inquiry need not address every subject, but the Office requests that responding parties clearly identify and separately address each subject for which a response is submitted.
1. Please provide any insights or observations regarding the role and effectiveness of the prohibition on circumvention of technological measures in section 1201(a).
2. How should section 1201 accommodate interests that are outside of core copyright concerns, for example, in cases where circumvention of access controls protecting computer programs implicates issues of product interoperability or public safety?
3. Should section 1201 be adjusted to provide for presumptive renewal of previously granted exemptions—for example, when there is no meaningful opposition to renewal—or otherwise be modified to streamline the process of continuing an existing exemption? If so, how?
4. Please assess the current legal requirements that proponents of an exemption must satisfy to demonstrate entitlement to an exemption. Should they be altered? If so, how? In responding, please comment on the relationship to traditional principles of administrative law.
5. Please provide additional suggestions to improve the rulemaking process.
6. Please assess the role of the anti-trafficking provisions of sections 1201(a)(2) and 1201(b) in deterring copyright infringement, and address whether any amendments may be advisable.
7. Should section 1201 be amended to allow the adoption of exemptions to the prohibition on circumvention that can extend to exemptions to the anti-trafficking prohibitions, and if so, in what way? For example, should the Register be able to recommend, and the Librarian able to adopt, exemptions that permit third-party assistance when justified by the record?
8. Please assess whether the existing categories of permanent exemptions are necessary, relevant, and/or sufficient. How do the permanent exemptions affect the current state of reverse engineering, encryption research, and security testing? How do the permanent exemptions affect the activities of libraries, archives, and educational institutions? How might the existing permanent exemptions be amended to better facilitate such activities?
9. Please assess whether there are other permanent exemption categories that Congress should consider establishing—for example, to facilitate access to literary works by print-disabled persons?
10. To what extent and how might any proposed amendments to section 1201 implicate the United States' trade and treaty obligations?
11. Please identify any pertinent issues not referenced above that the Copyright Office should consider in conducting its study.
National Aeronautics and Space Administration (NASA).
Notice of proposed revisions to existing Privacy Act systems of records.
Pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), the National Aeronautics and Space Administration is issuing public notice its proposal to modify a previously noticed system of records and rescind another previously noticed system. This notice publishes details of the proposed updates as set forth below under the caption
Submit comments within 30 calendar days from the date of this publication. The changes will take effect at the end of that period, if no adverse comments are received.
Patti F. Stockman, Privacy Act Officer, Office of the Chief Information Officer, National Aeronautics and Space Administration Headquarters, Washington, DC 20546-0001, (202) 358-4787,
NASA Privacy Act Officer, Patti F. Stockman, (202) 358-4787,
Pursuant to the provisions of the Privacy Act of 1974, 5 U.S.C. 552a, and as part of its biennial System of Records review, NASA is making the following minor modifications of its system of records Exchange Records on Individuals/NASA 10XROI: Inclusion of a statement of purpose for the system of records; updates of system and subsystem managers; clarification of routine uses; and correction of previous typographical errors. Further, NASA
Exchange Records on Individuals.
None.
Locations 1-9, 11, 12, 18, and 19, as set forth in Appendix A.
This system maintains information on present and former employees of, and applicants for employment with, NASA Exchanges, recreational associations, and employees' clubs at NASA Centers; and civil servants and contractors, and their dependents, who are members of or participants in NASA Exchange programs, activities, clubs and/or recreational associations. Finally, the system maintains information on children, and their parents or guardians, who participate in Exchange-operated child care and educational development programs.
For present and former employees of NASA Exchange entities including child care and educational development center programs, records in the system relate to personnel actions and determinations during their application to and employment by the NASA Exchange. Records contain information about individuals and their employment such as name, birth date, Social Security Number, home contact information, marital status, references, veteran preference, tenure, disabilities, position description, unemployment claims; salary, leave and payroll deduction information; and job performance and personnel actions.
For civil servants, contractors, and others who apply for and participate in Exchange-sponsored programs, activities, clubs and/or recreational associations, records include employee or contractor identification number, organization, location, telephone number, and other information directly related to status or interest in participation in such activities.
For civil servant or contractor dependents who apply for Exchange scholarships, records in the system include information such as parents' home and work address and telephone numbers, income, and financial assistance they will provide the student; the student's high school and colleges applied to, high school graduation date, class ranking, and transcripts; and student community activities and personal goals.
For current or former participants in Exchange-operated child care and development centers, records in the system include identification and other information facilitating enrollment in the entity and proper care of the children. Specific records include information such as home and work addresses, email addresses, and telephone numbers; financial payment information; emergency contact names, addresses and telephone numbers; children's names and pictures as well as their health care and insurance providers; medical histories; physical, emotional, or other special care requirements; and child care and educational development center correspondence with parents/guardians such as authorizations to release the child to another person or field trip permission slips.
51 U.S.C. 20113(a)
Records in this system are used to facilitate individuals' participation in and use of NASA Exchange programs and fitness and childcare facilities; for application evaluation and award of Exchange higher education scholarships; and to execute personnel actions and determinations for applicants to, and employees of, the Exchange entities at NASA Centers.
Any disclosures of information will be compatible with the purpose for which the Agency collected the information. The following are routine uses: (1) To provide information to insurance carriers with regard to worker's compensation, health and accident, and retirement insurance coverages; (2) to provide employment or credit information to third parties as requested by a current or former Exchange employee to whom the records pertain; (3) to provide various Federal, State, and local taxing authorities itemized listing of withholdings for individual income taxes; (4) to respond to State employment compensation requests for wage and separation data on former employees; (5) to report previous job injuries to worker's compensation organizations; (6) for person to notify in an emergency; (7) to report unemployment records to appropriate State and local authorities; and (8) NASA standard routine uses as set forth in Appendix B.
Records in this system are maintained on electronic media and/or as hard-copy documents.
All records are retrieved from the system by the individual's name. For children or parents/guardians associated with child care facilities, records may be retrieved by either the child's or parent's/guardian's name.
Electronic records are maintained on secure NASA servers and protected in accordance with all Federal standards and those established in NASA regulations at 14 CFR 1212.605. Additionally, server and data management environments employ infrastructure encryption technologies both in data transmission and at rest on servers. Approved security plans are in place for information systems containing the records in accordance with the Federal Information Security Management Act of 2002 (FISMA) and OMB Circular A-130, Management of Federal Information Resources. Only authorized personnel requiring information in the official discharge of their duties are authorized access to records through approved access or authentication methods. Access to electronic records is achieved only from workstations within the NASA Intranet or via a secure Virtual Private Network (VPN) connection that requires two-factor hardware token authentication or via employee PIV badge authentication from NASA-issued computers. Non-electronic records are secured in locked rooms or files.
Records are maintained in Agency files and destroyed in accordance with NASA Records Retention Schedules, Schedule 9 Item 6/D.
Contractor Industrial Relations Officer, Location 1.
Subsystem Managers: Exchange Store Operations Manager, Location 1; Exchange Council Chair, Location 2, Exchange Operations Manager, Locations 3-5; Chairperson, Exchange Council, Location 6 and 7; Treasurer, NASA Exchange, Location 8; Exchange Operations Manager, Locations 9, 12, and 19; President, NASA Exchange, Location 11; and NSSC Exchange Counsel, Location 18. Locations are as set forth in Appendix A.
Individuals may obtain information from the cognizant subsystem managers listed above.
Information on oneself or one's child may be obtained by submitting a written request to the appropriate system or subsystem manager listed above.
The NASA rules for access to records and for contesting contents and appealing initial determinations by the individual concerned appear in the NASA rules at 14 CFR part 1212.
Information is obtained directly from the individual on whom the record is maintained and the individual's supervisor, or from parents/guardians of children enrolled in the child care and educational development centers.
National Science Foundation.
Submission for OMB Review; Comment Request.
The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. This is the second notice for public comment; the first was published in the
Suzanne H. Plimpton at (703) 292-7556 or send email to
NSF 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 second use of the information is program evaluation. The Directorate is committed to investing in a range of substantive areas. With data from this collection, the Directorate can calculate submission rates and funding rates in specific areas of research. Similarly, the information can be used to identify emerging areas of research, evaluate changing infrastructure needs in the research community, and track the amount of international research. As the National Science Foundation is
The Directorate of Biological Sciences has a continuing commitment to monitor its information collection in order to preserve its applicability and necessity. Through periodic updates and revisions, the Directorate ensures that only useful, non-redundant information is collected. These efforts will reduce excessive reporting burdens
December 28, 2015, January 4, 11, 18, 25, February 1, 2016.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of December 28, 2015.
There are no meetings scheduled for the week of January 4, 2016.
There are no meetings scheduled for the week of January 11, 2016.
There are no meetings scheduled for the week of January 18, 2016.
There are no meetings scheduled for the week of January 25, 2016.
There are no meetings scheduled for the week of February 1, 2016.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Nuclear Regulatory Commission.
Draft regulatory guide; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG) DG-5043, “Training and Qualification of Security Personnel at Nuclear Power Reactor Facilities.” The proposed revision to the regulatory guide (RG) updates training and qualification guidance that incorporates lessons learned since the original publication of the guide.
Submit comments by February 29, 2016. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date. Although a time limit is given, comments and suggestions in connection with items for inclusion in guides currently being developed or improvements in all published guides are encouraged at any time.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specified subject):
•
•
James Vaughn, Office of Nuclear Security and Incident Response, telephone: 301-287-3586, email:
Please refer to Docket ID NRC-2015-0287 when contacting the NRC about the availability of information regarding this document. You may obtain publically-available information related to this document, by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0287 in your comment submission. The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The NRC is issuing for public comment a DG in the NRC's “Regulatory Guide” series. This series was developed to describe and make available to the public information regarding methods that are acceptable to the NRC staff for implementing specific parts of the NRC's regulations, techniques that the staff uses in evaluating specific issues or postulated events, and data that the staff needs in its review of applications for permits and licenses.
The DG, entitled, “Training and Qualification of Security Personnel at Nuclear Power Reactor Facilities,” is a proposed revision guide temporarily identified by its task number, DG-5043. DG-5043 is proposed revision 1 of RG 5.75, “Training and Qualification of Security Personnel at Nuclear Power Reactor Facilities.” The guide proposes revised guidance for methodologies that licensees and applicants should use to select, train, equip, test, qualify, and re-qualify armed and unarmed security personnel, watchpersons, and members of the licensee staff that support the licensee's security organization, to ensure that these individuals possess and maintain the knowledge, skills, and abilities required to carry out their assigned duties and responsibilities effectively.
DG-5043 describes a method that the NRC staff considers acceptable for use by nuclear power plant licensees in meeting the requirements for training and qualification of security personnel as set forth in Section VI of Appendix B to title 10 of the
This DG may be applied to applications for operating licenses and combined licenses docketed by the NRC as of the date of issuance of the final regulatory guide, as well as future applications submitted after the issuance of the regulatory guide. Such action would not constitute backfitting as defined in the Backfit Rule or be otherwise inconsistent with the applicable issue finality provision in 10 CFR part 52, inasmuch as such applicants or potential applicants are not within the scope of entities protected by the Backfit Rule or the relevant issue finality provisions in part 52. Neither section 50.109 nor the issue finality provisions under 10 CFR part 52—with certain exceptions—were intended to apply to every NRC action that substantially changes the expectations of current and future applicants. The exceptions to the general principle are whenever an applicant references a part 52 license (
Therefore, no applicant referencing an early site permit, design certification rule, or standard design approval would be protected by relevant issue finality provisions with respect to the security matters addressed in this draft regulatory guide.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Draft supplemental environmental impact statement; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft supplement to Supplement 38 to the Generic Environmental Impact Statement for License Renewal of Nuclear Power Plants (GEIS), NUREG-1437, regarding the renewal of operating licenses DPR-26 and DPR-64, held by Entergy Nuclear Operations, Inc. (Entergy), for the operation of Indian Point Nuclear Generating Unit Nos. 2 and 3 (IP2 and IP3), for an additional 20 years of operation. Units IP2 and IP3 are located in Westchester County in the Village of Buchanan, New York, approximately 24 miles north of New York City.
Submit comments by March 4, 2016. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Michael Wentzel, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-6459, email:
Please refer to Docket ID NRC-2008-0672 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2008-0672 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
The NRC is issuing for public comment a draft supplement to Supplement 38 to the GEIS, NUREG-1437 (ADAMS No. ML15351A422), regarding the renewal of operating licenses DPR-26 and DPR-64, held by Entergy for the operation of IP2 and IP3, for an additional 20 years of operation. Units IP2 and IP3 are located in Westchester County in the Village of Buchanan, New York, approximately 24 miles north of New York City. The NRC staff published final plant-specific Supplement 38 to NUREG-1437 (final supplemental environmental impact statement (FSEIS)), Volumes 1-3 (ADAMS No. ML103360205), in December 2010 (75 FR 77920). The FSEIS documented the NRC staff's findings relative to the environmental impacts of the license renewal of IP2 and IP3. In June 2013 (78 FR 39018), the NRC staff published a final supplement to 2010 FSEIS as NUREG-1437, Supplement 38, Volume 4 (ADAMS No. ML13170A028). The June 2013 supplement updated the NRC staff's final analysis to include corrections to impingement and entrainment data presented in the FSEIS; revised conclusions on thermal impacts based on newly available thermal plume studies; and provided an update of the status of the NRC's consultation, under section 7 of the Endangered Species Act of 1973, as amended, with the National Marine Fisheries Service regarding the shortnose sturgeon and Atlantic sturgeon.
On September 2, 2014 (79 FR 52059), the NRC notified the public of its intent to prepare a second supplement to the FSEIS to evaluate new information identified subsequent to the publication of the June 2013 supplement, including new aquatic impact data, refined cost estimates associated with the licensee's severe accident mitigation alternatives analysis, and other matters. This draft supplement, published as Volume 5 of the FSEIS, documents the NRC staff's evaluation of the new information.
Documents related to this notice are available on the NRC's Plant Application for License Renewal Web site at
For the Nuclear Regulatory Commission.
Pension Benefit Guaranty Corporation.
Notice of request for OMB approval of revised collection of information.
The Pension Benefit Guaranty Corporation (PBGC) is modifying its collection of information on Locating and Paying Participants (OMB control number 1212-0055; expires December 31, 2015) and is requesting that the Office of Management and Budget approve the revised collection of information under the Paperwork
Comments must be submitted by January 28, 2016.
Comments should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Pension Benefit Guaranty Corporation, via electronic mail at
Jo Amato Burns, Attorney, or Catherine B. Klion, Assistant General Counsel, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005-4026, 202-326-4400, ext. 3072 (Burns) or 3041 (Klion). (For TTY/ASCII users, call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4400.)
PBGC is requesting that OMB approve modifications to an information collection needed to locate and pay participants and beneficiaries who may be entitled to pension benefits under a defined benefit plan that has terminated. The collection consists of information that participants and beneficiaries are asked to provide when applying for benefits. In addition, in some instances, as part of a search for participants and beneficiaries who may be entitled to benefits, PBGC requests individuals to provide identifying information that the individual would provide as part of an initial contact with PBGC. The information collection also includes My Pension Benefit Account (My PBA), an application on PBGC's Web site,
PBGC will add one new form to the information collection, Form 717, Benefit Inquiry Questionnaire. PBGC will send this form to individuals who contact PBGC to inquire whether PBGC is holding any benefits to which they are entitled. The questionnaire will request information that PBGC needs to determine whether the individual is owed benefits and, if so, the benefit amount.
In addition, PBGC is making clarifying, simplifying, editorial, and other changes to the information collection.
The collection of information has been approved by OMB under control number 1212-0055 (expires December 31, 2015). PBGC is requesting that OMB extend its approval (with modifications) for three years from its approval date. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
PBGC estimates that the average annual burden associated with this collection of information will be 126,090 hours and $1,360 for the next three years. The burden estimate includes 124,410 hours and $1,330 for participants in plans covered by the PBGC insurance program. The remaining burden is attributable to participants expected to be covered by the expanded Missing Participants program under Pension Protection Act of 2006 amendments to ERISA, once that program is in effect.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 171 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. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-48 and CP2016-63 to consider the Request pertaining to the proposed Priority Mail Contract 171 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 January 4, 2016. The public portions of these filings can be
The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-48 and CP2016-63 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 January 4, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning a Type 2 rate adjustment and the filing of a related negotiated service agreement with Canada Post. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On December 17, 2015, the Postal Service filed a notice, pursuant to 39 CFR 3010.40
The Postal Service's filing consists of the Notice, two attachments, and redacted and unredacted versions of an Excel file with supporting financial workpapers. Notice at 2. Attachment 1 is an application for non-public treatment of materials filed under seal with the Commission.
The Agreement is the successor agreement to one previously found to be functionally equivalent to the baseline agreement in the Inbound Market Dominant Multi-Service Agreement with Foreign Postal Operators 1 (MC2010-35) product.
The Postal Service asserts that it is providing at least the 45 days advance notice required under 39 CFR 3010.41; and identifies the parties to the Agreement as the United States Postal Service and Canada Post, the designated postal operator for handling letter-post originating in Canada. Notice at 3, 6. The Postal Service further asserts that the Agreement is intended to remain in effect until December 31, 2017.
The Postal Service states that the Agreement includes negotiated pricing and settlement for various inbound letter-post products, including registered mail, small packets with delivery confirmation, and International Business Reply Service (IBRS).
The Commission, in conformance with rule 3010.44, establishes Docket No. R2016-4 to consider issues raised in the Notice. The Commission invites comments from interested persons on whether the Agreement is consistent with 39 U.S.C. 3622 and the requirements of 39 CFR part 3010. Comments are due no later than January 5, 2016. The public portions of this filing can be accessed via the Commission's Web site (
The Commission appoints Nina Yeh to represent the interests of the general public (Public Representative) in this docket.
1. The Commission establishes Docket No. R2016-4 for consideration of matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Nina Yeh is appointed to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
3. Comments by interested persons in this proceeding are due no later than January 5, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 170 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. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-47 and CP2016-62 to consider the Request pertaining to the proposed Priority Mail Contract 170 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 January 4, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-47 and CP2016-62 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than January 4, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections.
Under Section 9 of the Railroad Retirement Act (RRA), and Section 6 of the Railroad Unemployment Insurance Act (RUIA), railroad employers are required to submit reports of employee service and compensation to the RRB as needed for administering the RRA and RUIA. To pay benefits due on a
In addition, 20 CFR 209.12(b) requires all railroad employers to furnish the RRB with the home addresses of all employees hired within the last year (new-hires). Form BA-6a,
Completion of the forms is mandatory. Multiple responses may be filed by respondent.
Under Section 1(b)(1) of the Railroad Retirement Act (RRA), the term “employee” includes an individual who is an employee representative. As defined in Section 1(c) of the RRA, an employee representative is an officer or official representative of a railway labor organization other than a labor organization included in the term “employer,” as defined in the RRA, who before or after August 29, 1935, was in the service of an employer under the RRA and who is duly authorized and designated to represent employees in accordance with the Railway Labor Act, or, any individual who is regularly assigned to or regularly employed by such officer or official representative in connection with the duties of his or her office. The requirements relating to the application for employee representative status and the periodic reporting of the compensation resulting from such status is contained in 20 CFR 209.10.
The RRB utilizes Forms DC-2a,
Under Section 6 of the Railroad Retirement Act (RRA), benefits that may be due on the death of a railroad employee
When the RRB receives notification of the death of a railroad employee or survivor annuitant, an RRB field office utilizes Form RL-94-F, Survivor Questionnaire, to secure additional information from surviving relatives needed to determine if any further benefits are payable under the RRA. Completion is voluntary. One response is requested of each respondent. The RRB proposes the following changes to Form RL-94-F:
• Add new Item 8d, Divorced Spouse's Date of Divorce from Employee;
• Renumber current Item 8d to 8e, and
• Change “Address” to “Mailing Address” in Items 6, 7, 8a, 10, 11, 12, 14.b.2, 15b, and 16 for those applicants who live outside the country.
The RRB utilizes Form GL-99, Employer's Deemed Service Months Questionnaire, to obtain service and compensation information from railroad employers to determine if an employee can be credited with additional deemed months of railroad service.
The RRB proposes non-burden impacting editorial changes to Form GL-99. Completion is mandatory. One response is required for each RRB inquiry.
On October 20, 2015, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19b(1) of the Securities Exchange Act of 1934 (“Act”)
ICC has proposed reorganizing the RMF in response to a recommendation from the CFTC regarding improvements to the governance of ICC's risk management documentation. Specifically, ICC has proposed organizational and clarifying edits to the RMF and the Treasury Operations Policies and Procedures, and has proposed adopting a new Risk Management Model Description Document. ICC has represented that these revisions do not require any changes to the ICC Clearing Rules (“Rules”).
ICC will move the Collateral Assets Risk Management Framework appendix from the RMF to the Treasury Operations Policies and Procedures. Accordingly, ICC will update references throughout the RMF to the Collateral Assets Risk Management Framework appendix to refer instead to the Treasury Operations Policies and Procedures. ICC will move appendices containing technical risk management information (formerly, RMF Appendices 3-5) to the new ICC Risk Management Model Description Document. Accordingly, ICC will update references throughout the RMF to these appendices to refer to the Risk Management Model Description Document.
ICC will also make general updates and edits throughout the RMF for clarity and consistency. Such edits will include correcting verb tenses, adopting consistent abbreviations, and adjusting sentence order to assure logical presentation and word flow, and using more succinct language. ICC has represented that the edits are not substantive and do not affect the nature of ICC's risk management program.
Within the Overview section of the RMF, ICC will refine the Business Overview details to more accurately describe the business operations of Intercontinental Exchange, Inc. and ICC.
ICC will edit the Governance and Organization section of the RMF to more fully describe which topics the Risk Committee is responsible to advise the Board. The list of documents reviewed by the Risk Committee on at least an annual basis will be revised to include the ICC Risk Management Model Description Document, the ICC Treasury Operations Policies and Procedures, and the ICC Liquidity Risk Management Framework. The Risk Working Group (“RWG”) description will be updated to note that the group consists of risk personnel from ICC Clearing Participants (“CPs”), and to clarify that the RWG is responsible for reviewing ICC's risk philosophy and recommending changes to ICC's RMF. The validation function of the risk philosophy and tolerance will be removed from the list of RWG responsibilities as, according to ICC, such functions are the ultimate responsibility of the Board. The Advisory Committee description will be updated to note that the committee is comprised of representatives of up to twelve clients/customers of ICC CPs (ICC has represented that currently there are twelve client/customer members). The CDS Default Committee description will be updated to note that the committee is comprised of representatives from ICC CPs on a rotating basis and to remove reference to a duty to provide feedback on ICC's RMF and parameters because the CDS Default Committee is only convened upon the declaration of a default. The committee description will be enhanced to note that, as the CDS Default Committee assists ICC in determining and managing Minimum Target Prices for auctioned portfolios related to a default, the committee oversees necessary auction(s) as well as the process to re-establish a matched book. The Risk Management Organization section will be updated to remove outdated language stating that the Risk Management Department conducts an annual review of ICC's Risk Management Framework Policy Statement and submits proposed changes to the RWG, Risk Committee, and Board. Further, the section will be updated to remove reference to the Risk Management Department being responsible for ICC's intellectual capital and personnel, while creating, implementing and maintaining ICC's risk management policies.
ICC will make edits to the Product Summary section of the RMF. ICC will clarify language to refer to Index CDS Instruments (as opposed to Index Products), Single Name CDS Instruments (as opposed to Single Name CDS), and reference entities (as opposed to companies). The Index CDS instruments section will be revised to remove reference to the International Index Company. The Single Name CDS Instruments section will be modified to refine language concerning what constitutes a credit event. The list of attributes defining a CDS contract will be enhanced to include Maturity, as well as reference Notional Amount, as opposed to Notional Principal. Reference to the terms of the contracts being prescribed by the ICC Rules and Participant Agreement will be removed. The Risk Factors, Risk Sub-Factors and Instruments section will be revised to enhance the definition of Risk Sub-Factor to refer to a specific single name reference obligation seniority and doc clause combination.
ICC will make edits to the Systemic Risk Management Approach section of the RMF, which includes Waterfall Levels 1 through 5. ICC will revise Waterfall Level 1: Membership Criteria to remove reference, within the Operational Criteria, to employee participation on industry committees (
ICC will revise the Waterfall Level 2: Initial Margin description to clarify that ICC's IM requirements consist of a set of individual components that account for various risks and that the methodology includes consideration of hypothetical scenarios for those components. ICC will add language to the Spread Response Requirements section to note that the hypothetical prices used in calculating the instrument spread response risk IM requirement reflect the time-to-maturity horizon reduced by one day. ICC will revise the distributions and related parameters subsection to refer to the more specific feature Mean Absolute Deviation (“MAD”) as opposed to the more general term “scale.” ICC will remove reference to a set Exponentially Weighted Moving Average decay factor, as ICC asserts the factor is dynamic, subject to review and changed by the Risk Department in consultation with the Risk Committee. ICC will also remove outdated language regarding the initial setting of Auto Regressive process for first order parameters.
ICC will revise the description of the considered scenarios to provide a mathematical description of how the considered scenarios are constructed based on statistical analysis of historical time series. The term structure scenario construction will now be clearly defined in terms of 99% Value-at-Risk equivalent risk measures for different tenors, and the cross-tenor correlation structure will be estimated from time series analysis. ICC will revise the term “contracting” to “tightening” in the context of spread behavior to, according to ICC, provide conformity to more commonly used credit market terminology.
Within the Recovery Rate (“RR”) Sensitivity Requirements subsection, ICC will clarify that two additional single name-specific stress-test RRs are considered in determining the requirements.
ICC will revise Waterfall Level 3: Mark-to-Market Margin description. Specifically, ICC will revise the methodology section to remove specific calculations regarding the methodology and instead refer to the ICC EOD Price Discovery Policies and Procedures, which ICC asserts contain a more fulsome methodology description.
ICC will revise Waterfall Level 4: Intra-day Risk Monitoring/Special Margin Call Execution to clarify language describing the calculation of prices to determine the adequacy of collected IM intraday. Specifically, as part of the calculation, ICC will utilize bid-offer quotes which will be automatically fed into the ICC risk management intraday monitoring system.
ICC will revise Waterfall Level 5: Guaranty Fund description. The ICC GF is designed to provide adequate funds to cover losses associated with the default of the two CPs, as well as any affiliated CPs (
ICC will add language to the Guaranty Fund Allocation subsection of the RMF to state that the CP's total uncollateralized GF stress loss is the difference between the sum of the stress loss given default, GF stress spread response, GF stress basis risk and interest rate losses and the sum of the IM idiosyncratic jump-to-default requirements, IM spread response requirement, IM basis and interest risk requirement.
ICC will revise the General Wrong Way Risk and Contagion Measures subsection to remove technical information that was moved to the Risk Management Model Description Document.
ICC will revise the Position Concentration Limits subsection of the Risk Limits and Controls section to clarify that ICC's concentration charge is designed to increase a CP's IM requirement toward the risk of maximum loss and ultimately, at the extreme, toward the full expected notional amount of liability of the sold protection or the present value of the amount of coupon payments for bought protection. ICC will summarize language referring to the notional liability of the protection sold or the full value of coupon payments to refer more generally to loss associated with the portfolio. ICC will revise the Model Time Horizon subsection to note that the standard risk horizon can be increased by the ICC Risk Management Department during banking holiday periods to reflect ICC's limited ability to execute margin calls without Risk Committee consultation. ICC will further revise the Position Concentration Thresholds subsection to clarify that, if at any point, either the margin requirements or concentration charges grow to be a concern, ICC has the authority to execute special or intraday margin calls, and/or to increase the rate at which the concentration charges grow.
ICC will revise the Stress Testing subsection of the Back Testing and Stress Testing section to remove specific assumptions associated with the various stress scenarios used in the daily risk management process. For proprietary reasons, these specific assumptions will now be included in ICC's Stress Testing Framework. ICC will also clarify that the Risk Management Department presents stress results at the monthly Risk Committee meetings, as well as recommendations about next steps and recommendations to add or retire stress tests.
ICC will make edits to the Default Treatment section to remove outdated language stating that ICC seconds
ICC will revise the Cash Settlement subsection of the Settlement section to remove outdated language stating that ICC will evaluate a transition to a central bank model for U.S. cash if available.
ICC will make edits to the Market Investment Risk Management section of the RMF. Specifically, ICC will delete redundant language regarding ICC's investment policy that can be found in the ICC Treasury Operations Policies and Procedures.
ICC will enhance the ICC Clearing Participant Risk Management Questionnaire appendix to add more specific details that better capture the intent of the questions contained within.
ICC will revise the Overview section of the Clearing Participant Default Management Procedures appendix to refer more generally to ICC's default management procedures, as opposed to offering specific details provided elsewhere within the appendix. ICC will also revise the CDS Default Committee subsection to remove language stating that the CDS Default Committee Members are responsible for determining and adjusting minimum target prices for auctions. ICC will add language to the Hedging and Liquidation subsection to note that the CDS Default Committee is responsible for assisting ICC with respect to liquidating and hedging positions with the Non-Defaulting CPs, in consultation with the Chief Risk Officer. ICC will clarify the Auction Procedures/Competitive Bidding section to state that the auction bidding process will be open for an ICC specified minute window, as opposed to a specific 15-minute window.
ICC will remove the Collateral Assets Risk Management Framework Appendix 7 from the RMF and add it as an appendix to the ICC Treasury Operations Policies and Procedures. Accordingly, references within the Treasury Operations Policies and Procedures to the RMF will be updated. Additionally, ICC will update its list of banking relationships contained within the document. ICC will also make conforming and non-material edits to the document.
Finally, ICC will create the Risk Management Model Description Document, which includes the technical risk information previously included in Appendices 3 to 5 of the RMF as well as information previously included in explanatory risk documents. Technical risk information, previously included in explanatory risk documents, will be incorporated consistently throughout the new Risk Management Model Description Document. The inclusion of such information does not constitute a substantive change to the RMF, as it serves to enhance the transparency of the technical details of the current implementation described in the previous RMF. In the Risk Management Model Description Document, ICC will provide additional technical information to improve the understanding and/or replication of the models. ICC will also provide improved logical connections among all model components, which, ICC asserts, should contribute to developing a general intuition for ICC's risk approach.
ICC represents that material changes to the Risk Management Model Description Document will be approved by ICC's Board of Managers and submitted, in the appropriate form to regulators consistent with other documents constituting ICC's RMF. The Risk Management Model Description Document will include a technical description of ICC's Initial Margin methodology (Recovery Rate Sensitivity Risk Analysis; Loss Given Default Risk Analysis; Liquidity Risk Analysis; Large Position Risk Analysis; Jump-To-Default Risk Analysis; Interest Rate Sensitivity Risk Analysis; Basic Risk Analysis; Spread Risk Analysis; Multi-Currency Portfolio Treatment; and Portfolio Loss Boundary Condition) and ICC's Guaranty Fund methodology (Guaranty Fund Size Estimation; Guaranty Fund Requirements and Periodic Adjustments; and General Wrong Way Risk and Contagion Stress Tests). Within the Spread Risk Analysis section, where ICC previously had listed explicit risk factors within the RMF, ICC will replace such explicit risk factors with the underlying formulas used in deriving such factors.
Section 19(b)(2)(C) of the Act
The Commission finds that the proposed rule change is consistent with the requirements of Section 17A of the Act
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 Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
NASDAQ proposes to modify the NASDAQ Level 2 Professional subscriber (“Subscriber”) fee. While the changes proposed herein are effective upon filing, the Exchange has designated that the amendments be operative on January 4, 2016.
The text of the proposed rule change is below. Proposed new language is italicized; proposed deletions are bracketed.
(a) No change.
(b) Subscriber Fees.
(1) NASDAQ Level 2
(A) Non-Professional Subscribers pay a monthly fee of $9 each;
(B) Professional Subscribers pay a monthly fee of $
(C)-(E) No Change.
(2)-(4) No change.
(c)-(f) No change.
In its filing with the Commission, NASDAQ 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. NASDAQ 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 increase the NASDAQ Level 2 Professional Subscriber fee (“Level 2 fee”). Specifically, the Exchange proposes to increase the Level 2 fee by $10 from $50 to $60 for display usage based upon direct or indirect access, or for non-display usage based upon indirect access only. This proposed rule change will not affect the pricing of the NASDAQ OpenView Non-Professional and Professional Subscriber fees.
The NASDAQ Level 2 product is optional. NASDAQ has enhanced this product through capacity upgrades and regulatory data sets over the life of the product. The network capacity for NASDAQ Level 2 has also increased from a 56 Kb feed to the current 33 Mb feed. Additionally, since NASDAQ Level 2 is also used for market making functions, NASDAQ has invested over the years to add regulatory data sets, such as Market Maker Mode, Trading Action status, Limit Up—Limit Down, Market Wide Circuit Breaker (MWCB) messaging and Short Sale Threshold Indicator.
Moreover, NASDAQ also increased the infrastructure resiliency with the migration of the entire Exchange's Disaster Recovery facility to Chicago, Illinois, which further reduces proximity risk. The costs associated with this migration are being apportioned among data products across multiple asset classes and, as a result, some of this cost is being allocated to NASDAQ Level 2.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
In adopting Regulation NMS, the Commission granted self-regulatory organizations and broker-dealers increased authority and flexibility to offer new and unique market data to the public.
The Commission concluded that Regulation NMS—by deregulating the market in proprietary data—would itself further the Act's goals of facilitating efficiency and competition:
[E]fficiency is promoted when broker-dealers who do not need the data beyond the prices, sizes, market center identifications of the NBBO and consolidated last sale information are not required to receive (and pay for) such data. The Commission also believes that efficiency is promoted when broker-dealers may choose to receive (and pay for) additional market data based on their own internal analysis of the need for such data.
By removing “unnecessary regulatory restrictions” on the ability of exchanges to sell their own data, Regulation NMS advanced the goals of the Act and the principles reflected in its legislative history. If the free market should determine whether proprietary data is sold to broker-dealers at all, it follows that the price at which such data is sold should be set by the market as well. The Exchange considers Level 2 to be the sort of market data product that the Commission envisioned when it adopted Regulation NMS.
The decision of the United States Court of Appeals for the District of Columbia Circuit in
The Court in
NASDAQ believes that the allocation of the proposed fee is fair and equitable in accordance with Section 6(b)(4) of the Act, and not unreasonably discriminatory in accordance with Section 6(b)(5) of the Act. As described above, the proposed fee is based on pricing conventions and distinctions that exist in NASDAQ's current fee schedule. These distinctions are each based on principles of fairness and equity that have helped for many years to maintain fair, equitable, and not unreasonably discriminatory fees, and that apply with equal or greater force to the current proposal.
As described in greater detail below, if NASDAQ has calculated improperly and the market deems the proposed fees to be unfair, inequitable, or unreasonably discriminatory, firms can discontinue the use of their data because the proposed product is optional to all parties. Firms are not required to purchase data and NASDAQ is not required to make data available or to offer specific pricing alternatives for potential purchases. NASDAQ can discontinue offering a pricing alternative (as it has in the past) and firms can discontinue their use at any time and for any reason (as they often do), including due to their assessment of the reasonableness of fees charged. NASDAQ continues to establish and revise pricing policies aimed at increasing fairness and equitable allocation of fees among Subscribers.
NASDAQ believes that periodically it must adjust the Subscriber fees to reflect market forces. NASDAQ believes it is an appropriate time to adjust this fee to more accurately reflect the investments made to enhance this product through capacity upgrades and regulatory data sets added. This also reflects that the market for this information is highly competitive and continually evolves as products develop and change.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Notwithstanding its determination that the Commission may rely upon competition to establish fair and equitably allocated fees for market data, the
There is intense competition between trading platforms that provide transaction execution and routing services and proprietary data products. Transaction execution and proprietary data products are complementary in that market data is both an input and a byproduct of the execution service. In fact, market data and trade execution are a paradigmatic example of joint products with joint costs. Data products are valuable to many end Subscribers only insofar as they provide information that end Subscribers expect will assist them or their customers in making trading decisions.
The costs of producing market data include not only the costs of the data distribution infrastructure, but also the costs of designing, maintaining, and operating the exchange's transaction execution platform and the cost of regulating the exchange to ensure its fair operation and maintain investor confidence. The total return that a trading platform earns reflects the revenues it receives from both products and the joint costs it incurs. Moreover, an exchange's customers view the costs of transaction executions and of data as a unified cost of doing business with the exchange. A broker-dealer will direct orders to a particular exchange only if the expected revenues from executing trades on the exchange exceed net transaction execution costs and the cost of data that the broker-dealer chooses to buy to support its trading decisions (or those of its customers). The choice of data products is, in turn, a product of the value of the products in making profitable trading decisions. If the cost of the product exceeds its expected value, the broker-dealer will choose not to buy it. Moreover, as a broker-dealer chooses to direct fewer orders to a particular exchange, the value of the product to that broker-dealer decreases, for two reasons. First, the product will contain less information, because executions of the broker-dealer's orders will not be reflected in it. Second, and perhaps more important, the product will be less valuable to that broker-dealer because it does not provide information about the venue to which it is directing its orders. Data from the competing venue to which the broker-dealer is directing orders will become correspondingly more valuable.
Thus, an increase in the fees charged for either transactions or data has the potential to impair revenues from both products. “No one disputes that competition for order flow is `fierce'.”
Analyzing the cost of market data distribution in isolation from the cost of all of the inputs supporting the creation of market data will inevitably underestimate the cost of the data. Thus, because it is impossible to create data without a fast, technologically robust, and well-regulated execution system, system costs and regulatory costs affect the price of market data. It would be equally misleading, however, to attribute all of the exchange's costs to the market data portion of an exchange's joint product. Rather, all of the exchange's costs are incurred for the unified purposes of attracting order flow, executing and/or routing orders, and generating and selling data about market activity. The total return that an exchange earns reflects the revenues it receives from the joint products and the total costs of the joint products.
Competition among trading platforms can be expected to constrain the aggregate return each platform earns from the sale of its joint products, but different platforms may choose from a range of possible, and equally reasonable, pricing strategies as the means of recovering total costs. NASDAQ pays rebates to attract orders, charges relatively low prices for market information and charges relatively high prices for accessing posted liquidity. Other platforms may choose a strategy of paying lower liquidity rebates to attract orders, setting relatively low prices for accessing posted liquidity, and setting relatively high prices for market information. Still others may provide most data free of charge and rely exclusively on transaction fees to recover their costs. Finally, some platforms may incentivize use by providing opportunities for equity ownership, which may allow them to charge lower direct fees for executions and data.
In this environment, there is no economic basis for regulating maximum prices for one of the joint products in an industry in which suppliers face competitive constraints with regard to the joint offering. Such regulation is unnecessary because an “excessive” price for one of the joint products will ultimately have to be reflected in lower prices for other products sold by the firm, or otherwise the firm will experience a loss in the volume of its sales that will be adverse to its overall profitability. In other words, an increase in the price of data will ultimately have to be accompanied by a decrease in the cost of executions, or the volume of both data and executions will fall.
The level of competition and contestability
The large number of SROs, TRFs, BDs, and ATSs that currently produce proprietary data or are currently capable of producing it provides further pricing discipline for proprietary data products. Each SRO, TRF, ATS, and BD is currently permitted to produce proprietary data products, and many currently do so or have announced plans to do so, including NASDAQ, New York Stock Exchange LLC, NYSE MKT LLC, NYSE Arca, and BATS Exchange (“BATS”)/Direct Edge.
Any ATS or BD can combine with any other ATS, BD, or multiple ATSs or BDs to produce joint proprietary data products. Additionally, order routers and market data vendors can facilitate single or multiple BDs' production of proprietary data products. The potential sources of proprietary products are virtually limitless. Notably, the potential sources of data include the BDs that submit trade reports to TRFs and that have the ability to consolidate and distribute their data without the involvement of FINRA or an exchange-operated TRF.
The fact that proprietary data from ATSs, BDs, and vendors can by-pass SROs is significant in two respects. First, non-SROs can compete directly with SROs for the production and sale of proprietary data products, as BATS and NYSE Arca did before registering as exchanges by publishing proprietary book data on the internet. Second, because a single order or transaction report can appear in a core data product, an SRO proprietary product, and/or a non-SRO proprietary product, the data available in proprietary products is exponentially greater than the actual number of orders and transaction reports that exist in the marketplace.
In addition to the competition and price discipline described above, the market for proprietary data products is also highly contestable because market entry is rapid, inexpensive and, based on Nasdaq's experience, profitable. The history of electronic trading is replete with examples of entrants that swiftly grew into some of the largest electronic trading platforms and proprietary data producers: Archipelago, Bloomberg Tradebook, Island, RediBook, Attain, TracECN, BATS Trading and BATS/Direct Edge. A proliferation of dark pools and other ATSs operate profitably with fragmentary shares of consolidated market volume.
Regulation NMS, by deregulating the market for proprietary data, has increased the competition of that market. While BDs have previously published their proprietary data individually, Regulation NMS encourages market data vendors and BDs to produce proprietary products cooperatively in a manner never before possible. Multiple market data vendors already have the capability to aggregate data and disseminate it on a profitable scale, including Bloomberg and Thomson Reuters. In Europe, Cinnober aggregates and disseminates data from over 40 brokers and multilateral trading facilities.
In the case of TRFs, the rapid entry of several exchanges into this space in 2006-2007 following the development and Commission approval of the TRF structure demonstrates the contestability of this aspect of the market.
Moreover, consolidated data provides two additional measures of pricing discipline for proprietary data products that are a subset of the consolidated data stream. First, the consolidated data is widely available in real-time at $1 per month for non-professional users. Second, consolidated data is also available at no cost with a 15- or 20-minute delay. Because consolidated data contains marketwide information, it effectively places a cap on the fees assessed for proprietary data (such as last sale data) that is simply a subset of the consolidated data. The mere availability of low-cost or free consolidated data provides a powerful form of pricing discipline for proprietary data products that contain data elements that are a subset of the consolidated data, by highlighting the optional nature of proprietary products.
In this environment, an unjustified price increase in the fees charged for either transactions or data has the potential to impair revenues from both products. “No one disputes that competition for order flow is `fierce'.”
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend BOX Rule 2020 (Participant Eligibility and Registration) to replace the Limited
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 amend BOX Rule 2020 (Participant Eligibility and Registration) to replace the Limited Representative—Proprietary Trader and Limited Principal—Proprietary Trader registration categories and establish the Securities Trader and Securities Trader Principal registration categories. The Exchange is also amending its rules to establish the Series 57 examination as the appropriate qualification examination for Securities Traders and eliminating the reference to the S501 continuing education program currently applicable to Proprietary Traders.
BOX currently uses the Series 56 qualification examination for the Limited Representative—Proprietary Trader registration category referenced in BOX Rule 2020(b)(2).
BOX notes that the proposed rule change does not impose any additional examination burdens on persons who are already registered on BOX. A person registered as a Limited Representative—Proprietary Trader and Limited Principal—Proprietary Trader on the effective date of the proposed rule change will be grandfathered in as a Securities Trader or Securities Trader Principal, respectively, without having to take additional examinations or any other actions. In addition, individuals who were registered as either a Limited Representative—Proprietary Trader or Limited Principal—Proprietary Trader prior to the effective date of the proposed rule change will be eligible to register as a Securities Trader or Securities Trader Principal without having to take any additional examinations, provided no more than two years have passed between the date they were last registered as a representative and the date they register as a Securities Trader or Securities Trader Principal.
On January 22, 2015, FINRA entered into a Termination Agreement with the national securities exchanges that set forth the terms and conditions that will govern the winding down of the Series 56 examination in advance of its replacement by the Series 57 examination and the integration of the S501 Program into the S101 Regulatory Element Continuing Education Program. The Series 57 qualification examination will be recognized by FINRA and the other national securities exchanges on January 4, 2016.
FINRA has developed the Series 57 qualification examination and has filed the qualification examination with the Commission as part of a separate proposed rule change.
BOX current registration rules require a person seeking to register as a Limited Principal—Proprietary Trader to have passed the underlying qualification examination Series 56 and be registered pursuant to Exchange Rules as a Limited Representative—Proprietary Trader, and
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
BOX 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.
BOX's proposed rule change to replace the Limited Representative—Proprietary Trader registration category and qualification examination Series 56 with the Securities Trader registration category and Series 57 qualification examination will reduce the burden on associated persons currently required to be registered as proprietary traders by harmonizing the registration requirements for representatives engaged in securities trading activities across different markets. Under the proposed rule change, associated persons would be eligible to engage in securities trading activities by registering as Securities Traders and passing a single comprehensive Securities Trader qualification examination which is consistent with the other national securities exchanges.
BOX believes that the proposed rule change relating to Securities Trader Principals will harmonize the registration and qualification requirements for principals that supervise securities trading activities across different markets.
Further, the proposed rule change does not impose any additional examination burdens on persons who are already registered. There is no obligation to take the proposed Series 57 examination in order to continue in their present duties, so the proposed rule change is not expected to disadvantage current registered persons relative to new entrants in this regard.
The Exchange has neither solicited nor received comments on the proposed rule change.
(a) This proposed rule change is filed pursuant to paragraph (A) of section 19(b)(3) of the Exchange Act
(b) This proposed rule change does not significantly affect the protection of investors or the public interest, does not impose any significant burden on competition, and, by its terms, does not become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest. The Exchange has requested that the Commission waive the 30-day operative delay period for “non-controversial” proposals and make the proposed rule change effective and operative upon filing
The Commission believes that waiving the thirty-day operative delay is consistent with the protection of investors and the public interest, because waiving the operative delay will enable BOX to have registration and qualification requirements that are consistent with those of the other national securities exchanges and FINRA. Therefore, the Commission hereby waives the thirty-day operative delay and designates the proposal operative as of January 4, 2016.
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.
The Commission will post all comments on the Commission's Internet
All submissions should refer to File Number SR-BOX-2015-38 and should be submitted on or before January 19, 2016.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On June 5, 2015, NASDAQ OMX PHLX LLC (“Exchange” or “Phlx”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Phlx proposes to amend and correct inconsistencies in several provisions of Phlx Rule 1080.07, which governs the handling of Complex Orders submitted to the System. The System currently includes a Complex Order Opening Process (“COOP”); the Complex Order Live Auction (“COLA”), an automated auction for seeking liquidity and price improvement for Complex Orders; and a Complex Limit Order Book (“CBOOK”). In addition, the proposal revises Phlx Rule 1080.07 to describe the acceptance and treatment of all-or-none Complex Orders.
The Phlx proposes several changes to Phlx Rule 1080.07(d) to accurately describe the operation of the COOP for Complex Order Strategies and to provide additional details regarding the COOP.
Phlx Rule 1080.07(d)(ii), as amended, provides that the Phlx will conduct a COOP for any Complex Order Strategy for which the Phlx has received an order prior to the opening, unless the Complex Order Strategy is already open as a result of another electronic auction process or another electronic auction involving the same Complex Order Strategy is in progress.
The COOP is comprised of two phases, the COOP Timer and the COOP Evaluation.
New subparagraphs (1), (2), and (3), of Phlx Rule 1080.07(d)(ii)(B) describe the manner in which market participants may respond to a Complex Order Opening Auction Notification. Phlx XL participants
In addition to submitting Complex Order Responses, Phlx XL market makers
COOP Sweeps and Complex Order Responses will not be visible to any participant and will not be disseminated by the Exchange.
Upon expiration of the COOP Timer, the COOP Evaluation begins.
If the System determines at the end of the COOP Timer that no trade is possible (
The proposal revises the rules describing the operation of the COLA to indicate that the System uses the process set forth in Phlx Rule 1080.07(d)(ii)(C)(2) not only to determine executions at the conclusion of the COOP, but also to determine executions against a COLA-eligible order at the conclusion of the COLA.
The proposal revises the Phlx's rules to describe the handling of IOC and DNA Orders at the opening. Complex Orders marked as IOC or DNA that are received before the COOP is initiated will be cancelled and will not participate in the COOP, although a COOP will occur in that Complex Order Strategy.
IOC Complex Orders received during a COOP will join the COOP and will be treated like any other Complex Order, except that they will be cancelled at the end of the COOP Timer if they are not executed.
The proposal also revises Phlx Rule 1080.07(b)(iii) to state that Floor Brokers using the Options Floor Broker Management System may enter Complex Orders as IOC only on behalf of “SQTs, RSQTs, non-SQT ROTs, specialists, non-Phlx market makers on another exchange, and Firms,” rather than on behalf of “broker-dealers or affiliates of broker-dealers.” The Phlx states that this revision merely replaces vague terms (broker-dealers or affiliates of broker-dealers) with more precise terms that are linked to definitions in the rule.
The proposal makes several changes to the rules governing the operation of the COLA. First, the proposal amends and corrects Phlx Rule 1080.07(e)(iv) to add a definition of COLA Sweep and to indicate that only Phlx XL market makers, rather than Phlx XL participants, may submit COLA
Second, the proposal revises the specialist allocation provisions in Phlx Rule 1080.07(e)(vi)(C). Phlx Rule 1080.07(e)(vi)(C) currently provides that, after customer marketable Complex Orders have been executed against a COLA-eligible order, a specialist that submits a COLA Sweep for the same price as other COLA Sweeps that are eligible for execution against the COLA-eligible order will be entitled to receive the greater of: (1) The proportion of the aggregate size at the cPBBO associated with such specialist's COLA Sweep, SQT and RSQT COLA Sweeps, and non-SQT ROT Complex Orders on the CBOOK; (2) the Enhanced Specialist Participation as described in Phlx Rule 1014(g)(ii) (which provides a specialist with an enhanced participation of 30% of the remainder of an order under certain circumstances); or (3) 40% of the remainder of the order. The proposal eliminates Phlx Rule 1080.07(e)(vi)(C)(3), which would provide the specialist with 40% of the remainder of a COLA-eligible order.
Third, the proposal revises Phlx Rule 1080.07(e)(vii) to indicate that COLA Sweeps that exceed the size of a COLA-eligible order are eligible to trade with other incoming COLA-eligible orders, COLA Sweeps, and any other interest received during the COLA Timer after the initial COLA-eligible order has been executed “to the fullest extent possible,” rather than “in its entirety.”
Fourth, the proposal deletes from Phlx Rule 1080.07(e)(vi)(B) a provision stating that, for allocation purposes, the size of a COLA Sweep or responsive Complex Order received during the COLA Timer will be limited to the size of the COLA-eligible order.
The proposal adds a new defined term, “Firm,” that will distinguish Firms from other non-market maker off-floor broker-dealers.
(a) If such incoming non-customer Complex Order is a limit order at the same price as the best priced Complex Order or COLA Sweep, the incoming non-customer Complex Order will be executed at such price, subject to the provisions set forth sub-paragraph (e) above.
(b) If such incoming non-customer Complex Order is a limit order that improved the best priced Complex Order or COLA Sweep, the incoming non-customer Complex Order will be executed at the limit order price.
(c) If such incoming non-customer Complex Order is a market order or a limit order that crosses the cPBBO, the incoming non-customer Complex Order will be executed at a price of $0.01 better than the cPBBO on the same side of the market as the COLA-eligible order.
According to the Phlx, the trading style and needs of Firms are more like market makers.
Third, the proposal amends Phlx Rule 1080.07(e)(viii)(C)(1) to indicate that orders from non-market maker off-floor broker-dealers that are not Firms will be treated like non-broker-dealer customer orders for purposes of determining the execution price their orders will receive when executing against a COLA-eligible order.
(a) If such incoming customer Complex Order is a limit order at the same price as the best priced Complex Order or COLA Sweep, the incoming Complex Order will be executed at such price.
(b) If such incoming Complex Order is a limit order that improved the best priced Complex Order or COLA Sweep, the incoming customer Complex Order will be executed at the mid-point of the best priced Complex Order or COLA Sweep and the limit order price, rounded, if necessary, to the closest minimum trading increment to the benefit of the COLA-eligible order.
(c) If such incoming customer Complex Order is a market order or a limit order that crosses the cPBBO, the incoming Complex Order will be executed at the mid-point of the cPBBO on the same side of the market as the COLA-eligible order and the best priced Complex Order or COLA Sweep, rounded, if necessary, to the closest minimum trading increment to the benefit of the COLA-eligible order.
Phlx Rule 1080.07(f)(i)(F) currently provides that a Complex Order received during the final 10 seconds of the trading session is placed on the CBOOK.
In addition, the proposal revises Phlx Rule 1080.07(f)(ii) to indicate that Phlx XL market makers may submit one or more CBOOK Sweeps to execute against Complex Order interest on the CBOOK.
In the current proposal, the Phlx proposes to accept all-or-none Complex Orders and specify how they are handled.
The Phlx notes that all-or-none orders are commonly available for non-Complex Orders, and that this order type would allow market participants to obtain a certain minimum size.
The proposal revises the Phlx Rule 1080.07(c)(iii) to make clear that a Complex Order has priority over established bids or offers in the marketplace for the individual legs that comprise the Complex Order unless the established bid or offer for at least one leg of the Complex Order is a non-broker-dealer customer order.
(B) Where a Complex Order in a conforming ratio consists of the underlying security (stock or ETF) and one options leg has priority over bids or offers established in the marketplace, except over bids or offers established by non-broker-dealer customer orders. However, where a Complex Order in a conforming ratio consists of the underlying stock or ETF and more than one options leg, the options legs have priority over bids and offers established in the marketplace, including non-broker-dealer customer orders, if at least one options leg improves the existing market for that option.
In Amendment No.1, the Phlx proposes to further clarify or add detail to several rules, provide additional rationale for certain proposed changes, and specify the time when the Phlx plans to begin accepting all-or-none Complex Orders. Specifically, Amendment No. 1 revises Phlx Rule 1080.07(d)(ii)(C) to indicate that all-or-none Complex Orders received during the COOP will be executed if possible,
Amendment No. 1 revises Phlx Rule 1080.07(e)(viii)(C)(1) to clarify that, for purposes of that rule, the term “incoming customer orders” refers to orders from non-broker-dealer customers and non-market maker off-floor broker-dealers other than Firms. The Phlx notes that it is necessary to exclude from this definition Firms, which otherwise would fall within the definition of non-market maker off-floor broker-dealers. Amendment No. 1 also provides additional analysis to support the statutory basis for this proposed change, stating that it is consistent with just and equitable principles of trade to treat both non-broker-dealer customers and non-market-maker, non-Firm off-floor broker-dealers as “customers” for purposes of determining the execution price of their orders when executing against a COLA-eligible order because both non-broker-dealer customers and non-market maker, non-Firm off-floor broker-dealers seek liquidity in the marketplace.
Amendment No. 1 revises Phlx Rule 1080.07(e)(viii)(C)(2) to specify that “non-customer orders” for purposes of that rule, refers to orders from Phlx market makers, Firms, and non-Phlx market makers.
Amendment No. 1 revises the text of Phlx Rule 1080.07(c)(iii), the Phlx's spread priority rule, to make clear that a Complex Order has priority over established bids or offers in the marketplace for the individual legs of the order unless the established bid or offer for at least one leg is a non-broker-dealer customer order. In addition, Amendment No. 1 explains that if the established bid or offer for at least one leg of the order is a non-broker-dealer customer order, then at least one leg of the Complex Order must be executed at a better price than the established bid or offer for that leg. Thus, a Complex Order cannot be executed at the cPBBO if there is non-broker-dealer customer interest at the cPBBO. For example, with respect to a Complex Order with four legs, if the established best bid or offer in the individual leg market for one component of the Complex Order is a non-broker-dealer customer order, and the best bids or offers in the individual leg market for the remaining three component legs of the Complex Order are market maker quotes, the Complex Order would be required to trade at a price that is better than the cPBBO.
Amendment No. 1 deletes the provision in Phlx Rule 1080.07(c)(ii)(D) indicating that Complex Orders will not trade on Phlx XL when the Phlx's automated execution system is disengaged for any options component of a Complex Order. As noted above and in Amendment No. 1, the Phlx cannot disengage its automatic execution system.
Amendment No. 1 revises Phlx Rule 1080.07(f)(ii) to provide for the submission of CBOOK Sweeps. Specifically, Amendment No. 1 revises the rule to indicate that Phlx XL market makers may submit one or more CBOOK Sweeps to execute against Complex Order interest on the CBOOK. A CBOOK Sweep, which is similar to a COOP Sweep or a COLA Sweep, will expire if it is not executed immediately. The Phlx notes that a non-Phlx XL market maker participant that wanted to submit interest that would expire if it is not executed immediately would be able to submit an IOC order.
Finally, Amendment No. 1 provides additional rationale for the proposal to prevent Firm orders from triggering a COLA. Specifically, Amendment No. 1 states that the Phlx believes that if Firm orders were able to start a COLA, this could impede the ability of other Complex Orders to start a COLA. In addition, the Phlx believes that it could impede the submission of competitive responses and/or quoting if market makers are hesitant to provide an aggressive price for COLAs that may have been initiated by Firms.
The Phlx believes that it would be consistent with the Act to approve Amendment No. 1 on an accelerated basis because the changes proposed in Amendment No. 1 provide additional details or clarifications to the proposal, without adding new requirements, or provide additional rationale or analysis to support the proposed changes. As noted above, Amendment No. 1 also specifies that the Phlx proposes to begin accepting all-or-none Complex Orders within 60 days after approval of the proposal.
Amendment No. 2 revises Phlx Rule 1080.07(e)(iv) to indicate that Phlx XL participants may bid and or offer on either or both side(s) of the market during a COLA Timer by submitting one or more Complex Orders in $0.01 increments. Amendment No. 2 further provides that a Complex Order marked as a response will expire if it is unexecuted at the end of the COLA Timer. A Complex Order not marked as a response will be placed on the CBOOK if it is not executed during the COLA, unless the order is marked IOC. Amendment No. 2 indicates that Complex Orders marked as a response will not be visible to any participant and will not be disseminated by the Phlx. The Phlx believes that these changes should be approved on an accelerated basis because they provide additional detail to the rule and clarify the responsive process for a COLA. The Phlx also notes that these COLA provisions parallel the provisions in Phlx Rule 1080.07(d)(ii)(B) related to the COOP.
In addition, Amendment No. 2 revises Phlx Rule 1080.07(d)(ii)(B) to indicate that Phlx XL participants may respond to a Complex Order Opening Auction Notification by submitting Complex Orders in increments of $0.01. Amendment No. 2 also indicates that a Complex Order that is not marked as a response to a Complex Order Opening Auction Notification will be placed on the CBOOK if it is not executed during the opening. The Phlx believes that these changes should be approved on an accelerated basis because they provide additional detail to the rule.
The Commission finds that the proposed rule change, as modified by Amendment Nos. 1 and 2, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission believes that the COOP rules, as amended, are designed to facilitate an orderly opening for Complex Orders, or an orderly re-opening following a trading halt. The Phlx states that the COOP, which operates in a manner similar to an opening process for single leg orders, is designed to facilitate price discovery and to execute as much trading interest as possible at the best possible price(s).
At the conclusion of the COOP Timer, the System conducts a COOP Evaluation to determine the maximum number of contracts that can trade, taking into account Complex Orders marked all-or-none (which will be executed if possible), unless the maximum number of contracts can only trade without including all-or-none orders.
The Phlx states that the opening price logic in Phlx Rule 1080.07(d)(ii)(C), as amended, which determines the execution price of crossing interest in the COOP, maximizes the number of contracts executed during the opening process and ensures that residual contracts of partially executed orders or quotes are at a price equal to or inferior to the opening price.
In addition to submitting Complex Orders to respond to a Complex Order Opening Auction Notification, Phlx XL market makers may respond by submitting one or more COOP Sweeps.
As discussed above, the proposal also describes the handling of IOC and DNA orders during the opening process.
Under the proposal, orders from Firms are treated like orders from market makers for purposes of triggering a COLA and for purposes of determining the execution price that their orders will receive when trading against a COLA-eligible order. Specifically, under Phlx Rule 1080.07(e)(i)(B)(1), as amended, proprietary orders from Firms, like orders from market makers, will not be COLA-eligible and therefore will not trigger a COLA. In contrast, orders from non-market maker off-floor broker-dealers that are not Firms will be COLA-eligible.
Phlx Rule 1080.07(e)(viii)(C)(2), as amended, treats Firm orders like market maker orders for purposes of determining the execution price that their orders will receive when executing against a COLA-eligible order.
The proposal revises Phlx Rule 1080.07(f)(i)(F) to indicate that a Complex Order received during the final configurable number of seconds of the trading session, rather than during the final 10 seconds of the trading session, will be placed on the CBOOK after any marketable portion of the Complex Order is executed. The Phlx states that a COLA auction may be triggered and completed in less than 10 seconds, and thus that the 10-second time period is too long and could prevent executions from occurring.
The Commission believes that the proposed changes to the spread priority provisions in Phlx Rule 1080.07(c)(iii) will benefit market participants by clarifying the operation of the rule. Among other things, the proposed changes make clear that a Complex Order may not be executed at the cPBBO if there is non-broker-dealer customer interest at the cPBBO and that, if any of the bids or offers established in the marketplace consist of a non-broker-dealer customer order, than at least one leg of the Complex Order must be executed at a price better than the established price for that leg by the minimum trading increment.
The Commission believes that the proposal to revise Phlx Rule 1080.07(b)(iii) to state that Floor Brokers using the Options Floor Broker Management System may enter Complex Orders as IOC only on behalf of “SQTs, RSQTs, non-SQT ROTs, specialists, non-Phlx market makers on another exchange, and Firms,” rather than on behalf of “broker-dealers or affiliates of broker-dealers” will clarify the rule by using more precise terms that are defined in Phlx Rule 1080.07.
The proposal also deletes two provisions that refer, incorrectly, to the disengagement of the Phlx's automated execution system.
Finally, the proposal establishes rules governing the trading of all-or-none Complex Orders, including provisions that describe the treatment of all-or-none Complex Orders at the opening and indicate that all-or-none Complex Orders will not execute against interest in the individual leg market.
The Commission finds good cause to approve the proposed rule change, as modified by Amendment Nos. 1 and 2, prior to the 30th day after the date of publication of notice of Amendment Nos. 1 and 2 in the
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether Amendment Nos. 1 and 2 to the proposed rule change are 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 is proposing to adopt a new Fee and Rebate Schedule (the “Fee Schedule”) pursuant to Exchange Rule 16.1 that the Exchange will use upon the resumption of trading on the Exchange.
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 parts of such statements.
The Exchange proposes to implement a new Fee Schedule pursuant to NSX Rule 16.1, with the goal of maximizing the effectiveness of its business model and providing Equity Trading Permit (“ETP”) Holders
For all securities priced $1.00 and above, the Exchange is proposing competitively priced fees that apply to all ETP Holders uniformly. For all orders that remove liquidity from the NSX Book
The Exchange notes that the fee that the Exchange will charge for taking liquidity from the Exchange in securities priced $1.00 or above, while $0.0002 higher than the fee that the Exchange used prior to ceasing trading operations of the close of business on May 30, 2014, is the lowest standard liquidity removing fee of any stock exchange in the National Market System that does not use the inverse pricing model. In light of these minimal taker fees, the fee structure does not provide for rebates to ETP Holders posting liquidity. While ETP Holders will not receive rebates for posting liquidity, ETP Holders will, nonetheless, not have to pay a fee for posting liquidity on the NSX Book (referred to as “maker” orders) for all order types. This pricing structure for securities priced $1.00 or more will make for a cost-effective execution venue for ETP Holders and their customers. Furthermore, the fees will not provide an advantage to any ETP Holder or investor over another. Lastly, in order to further incentivize posting and removing liquidity, the Exchange will no longer charge an increased fee for either adding liquidity using a Zero Display Reserve Order (
For executions in all securities priced under $1.00, the Exchange is proposing to implement a Fee Schedule that is nearly identical to the maker-taker model that the Exchange used prior to the cessation of the Exchange's trading operations. For orders that remove liquidity or are routed, the Exchange proposes to assess a fee of 0.30% of the executed trade value.
The Exchange also proposes to assess ETP Holders with regulatory, market data, and connectivity fees. The Exchange proposes to assess a regulatory fee of $500 per calendar month for each ETP Holder. This amount is the same amount that the Exchange charged prior to ceasing trading operations. The regulatory fee is designed to assure that ETP Holders share in the cost of adequately funding the regulatory function for the NSX marketplace.
The Exchange will offer its proprietary market data to ETP Holders and other authorized recipients through the NSX Depth of Book Feed
To provide a more accessible and competitive marketplace, the Exchange is proposing to remove several fees that the Exchange assessed prior to ceasing its trading operations. The proposed Fee Schedule does not provide for the one-time onboarding fee of $5,000 that the Exchange previously assessed applicant ETP Holders applying to become order delivery users. Prior to December 14, 2015, the Exchange offered order delivery as a mode of order interaction with the Exchange's trading system, as provided in Rule 11.13(b) and Interpretations and Policies .01 thereunder. The Exchange has amended
The Exchange is also proposing to remove language regarding the assessing of “Pass Through Fees.” These fees, which are incurred from the ETP Holder's use of directed orders, will be factored into the cost of sending a directed order, as described above. Also, as described above, the Exchange will no longer assess a greater fee for adding liquidity using a Zero Display Reserve Order or removing a Zero Display Reserve Order from the NSX Book. The Exchange also proposes to remove from the Fee Schedule reference to fees assessed for using a “Double Play Order,” because the Exchange no longer offers the Double Play Order functionality.
Pursuant to Exchange Rule 16.1(c), the Exchange will “provide ETP Holders with notice of all relevant dues, fees, assessments and charges of the Exchange” through the issuance of an Information Circular and will post the Fee Schedule and the instant rule filing on the Exchange's Web site,
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6(b) of the Act,
The Exchange submits that the proposed Fee Schedule equitably allocates fees and that the fees contained therein are reasonable, as required by Section 6(b)(4) of the Act. The Exchange is proposing to adopt a model whereby an ETP Holder adding liquidity to the Exchange in securities priced at $1.00 or greater will pay
Further, for securities priced below $1.00, the Exchange is proposing to maintain a maker-taker fee structure, as it did as of May 30, 2014, with the exception of charging a higher fee for directed orders that is based on the higher cost associated with routing such orders.
In addition to being reasonable, all of the proposed execution fees are equitably allocated in that they will apply uniformly to all ETP Holders accessing the System. Each ETP Holder will have the ability to determine the extent to which the Exchange's proposed structure will provide it with an economic incentive to use the System, and model its business accordingly. Thus, the Fee Schedule provides for a low-cost, simple, and streamlined approach which will benefit both ETP Holders and the Exchange in determining revenues and expenses, as well as maximizing the Exchange's competitive position.
The Exchange also submits that its proposed regulatory, market data, and connectivity fees are consistent with Section 6(b)(4) of the Act. The fees are competitively and reasonably priced
The Exchange further submits that the proposed execution fees satisfy the requirements of Section 6(b)(5) of the Act in that they do not permit unfair discrimination between customers, issuers, brokers, or dealers, and are designed to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system. Under the proposed changes to the Fee Schedule, all ETP Holders executing orders on the Exchange will be subject to one fee and/or rebate structure, and such changes are thereby designed to meet the requirements of the Section 6(b)(5) that the rules of the Exchange not permit unfair discrimination among ETP Holders and their customers. The Exchange submits that the proposal will promote just and equitable principles of trade by providing a streamlined Fee Schedule that will reduce the administrative burdens and expenses incurred by ETP Holders in determining the revenues and costs associated with its activity on the Exchange. Moreover, the Exchange believes that offering low execution fees will incentivize market participants to post and to access the liquidity on the NSX Book, which would inure to the benefit of all market participants seeking greater and better execution opportunities. In this regard, the proposed Fee Schedule will promote just and equitable principles of trade and operate to remove impediments to and perfect the mechanism of a free and open market and a national market system under Section 6(b)(5).
The Exchange's market data, regulatory, and connectivity fees are also consistent with Section 6(b)(5) of the Act. These fees will be uniformly applied to all ETP Holders, with the sole variable being the connectivity fee that is derived from the number of connections that the ETP Holder maintains with NSX (
Further, eliminating the Exchange's former fee for adding liquidity by using a Zero Display Reserve Order or removing liquidity provided by a Zero Display Reserve Order from the NSX
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 Exchange Act. The proposed rule change seeks to adopt a Fee Schedule that will apply uniformly to all ETP Holders accessing the Exchange. The Exchange further submits that its proposed execution, regulatory, market data, and connectivity fees have been reasonably calibrated such that they should impose no burden on competition. Moreover, the proposed fees and rebates will enhance rather than burden competition by operating to increase liquidity and improve execution quality on the Exchange through reasonable and equitably allocated economic incentives.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The proposed rule change has taken effect upon filing pursuant to Section 19(b)(3)(A)(ii) of the Act
At any time within 60 days of the filing of such 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.
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 delete Rule 1068, Execution of Multi-Part Orders, as described further below.
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 purpose of the filing is to update the Exchange's rulebook by deleting Rule 1068, Execution of Multi-Part Orders.
PBOT has long been replaced by successive futures exchanges (NASDAQ Futures Exchange, Inc. and, most recently, NASDAQ Futures, Inc. (collectively “NFX”)). NFX operates as an all-electronic futures exchange, such that no trading floor exists
Rule 1068 inadvertently remained in the rulebook after NFX no longer operated with a trading floor, and is now proposed to be deleted.
The Exchange believes that its proposal 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 not necessary or appropriate in furtherance of the purposes of the Act. There are no market participants impacted by the deletion of this rule. This rule was specifically intended to permit NFX members to transact business on a trading floor, which no longer exists. Further, the Exchange does not list these products and therefore no market participant may transact foreign currency futures. Those Phlx members desiring to transact foreign currency options may continue to trade those securities on Phlx. Accordingly, there is no impact on intra-market competition. Market participants who seek to trade in foreign currency options along with foreign currency futures can do so by submitting separate orders to various securities and futures exchanges.
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)(iii) 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 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 amend Chapter XV, entitled “Options Pricing,” at Section 2, which governs pricing for Exchange members using the NASDAQ Options Market (“NOM”), the Exchange's facility for executing and routing standardized equity and index options.
The Exchange purposes [sic] to remove specific rule text added in SR-NASDAQ-2015-149,
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 Chapter XV, Section 2, entitled “NASDAQ Options Market—Fees and Rebates” to amend Tier 8 of the Customer and Professional Penny Pilot Options
Today, the Exchange offers Participants tiered Customer and Professional rebates based on various criteria, with rebates ranging from $0.20 to $0.48 per contract.
The Exchange proposes to amend Tier 8 of the Customer and Professional Penny Pilot Options Rebate to Add Liquidity, which states “Participant adds Customer, Professional, Firm, Non-NOM Market Maker, and/or Broker-
The Exchange believes the Tier 8 Customer and Professional Penny Pilot Option Rebate to Add Liquidity will continue to incentivize market participants to send order flow to NOM, the resulting liquidity will benefit all market participants.
The Exchange believes that the proposed rule change is consistent with Section 6 of the Act,
The Exchange's proposal to amend Tier 8 of the Customer and Professional Penny Pilot Options Rebate to Add Liquidity to remove the December 2, 2015 to December 31, 2015 date range is reasonable because the Exchange seeks to continue to incentivize Participants to send order flow to NOM. The Exchange believes that the heightened volume requirement to qualify for Tier 8, as compared with other tier volume requirements, combined with the requirement to continue to certify for the Investor Support Program will continue to incentivize Participants to transact an even greater number of qualifying Customer and/or Professional volume, which liquidity will benefit other market participants by providing them the opportunity to interact with that liquidity. The Exchange notes that incentivizing Participants to add options liquidity through the payment of an additional rebate is not novel as, today, Tier 8 permits the additional [sic] of equity volume to qualify for this rebate. The concept of participating in the equities market as a means to qualify for an options rebate exists today. This participation benefits the Nasdaq Market Center as well as the NOM market by incentivizing order flow to these markets. This rebate recognizes the prevalence of trading in which members simultaneously trade different asset classes within the same strategy. Participants will continue to be required to add liquidity to both the options and equities requirement if they qualify for the Tier 8 rebate utilizing the second method.
The Exchange's proposal to amend Tier 8 of the Customer and Professional Penny Pilot Options Rebate to Add Liquidity to remove the December 2, 2015 to December 31, 2015 date range is equitable and not unfairly discriminatory because all Participants may continue to qualify for Tier 8. Qualifying Participants will continue to be uniformly paid a $0.48 per contract rebate.
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's proposal to amend Tier 8 of the Customer and Professional Penny Pilot Options Rebate to Add Liquidity to remove the December 2, 2015 to December 31, 2015 date range does not impose an undue burden on intra-market competition because all Participants are eligible to qualify for the Tier 8 Customer or Professional Rebate to Add Liquidity, provided they meet the qualifications. Also, the Tier 8 rebate will be uniformly paid to those Participants that are eligible for the rebate.
As noted above, continuing to incentivize Participants to add not only options but equities volume does not impose an undue burden on intra-market competition because cash equities and options markets are linked, with liquidity and trading patterns on one market affecting those on the other; the Exchange believes that pricing incentives that encourage market
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) 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 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.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
I. The information collection below is pending at SSA. SSA will submit it to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than February 29, 2016. Individuals can obtain copies of the collection instrument by writing to the above email address.
SSA uses Form SSA-8202-BK to conduct low-and middle-error-profile telephone or face-to-face redetermination interviews with Supplemental Security Income (SSI) recipients and representative payees. The information SSA collects during the interview is necessary to determine whether SSI recipients met and continue to meet all statutory and regulatory requirements for SSI eligibility, and whether they received, and still receive the correct payment amount.
II. SSA submitted the information collection below to OMB for clearance. Your comments regarding the information collection would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than January 28, 2016. Individuals can obtain copies of the OMB clearance package by writing to
The Promoting Readiness of Minors in SSI (PROMISE) demonstration pursues positive outcomes for children with disabilities who receive SSI and their families by reducing dependency on SSI. The Department of Education (ED) awarded six cooperative agreements to states to improve the provision and coordination of services and support for children with disabilities who receive SSI and their families to achieve improved education and employment outcomes. ED awarded PROMISE funds to five single-state projects, and to one six-state consortium.
ED, SSA, DOL, and HHS intend the PROMISE projects to address key limitations in the existing service system for youth with disabilities. By intervening early in the lives of these young people, at ages 14-16, the projects engage the youth and their families well before critical decisions regarding the age 18 redetermination are upon them. We expect the required partnerships among the various state and Federal agencies that serve youth with disabilities to result in improved integration of services and fewer dropped handoffs as youth move from one agency to another. By requiring the programs to engage and serve families and provide youth with paid work experiences, the initiative is mandating the adoption of critical best practices in promoting the independence of youth with disabilities.
SSA is requesting clearance for the collection of data needed to implement and evaluate PROMISE. The evaluation provides empirical evidence on the impact of the intervention for youth and their families in several critical areas, including: (1) Improved educational attainment; (2) increased employment skills, experience, and earnings; and (3) long-term reduction in use of public benefits. We base the PROMISE evaluation on a rigorous design that entails the random assignment of approximately 2,000 youth in each of the six projects to treatment or control groups (12,000 total). The PROMISE projects provide enhanced services for youth in the treatment groups; whereas youth in the control groups are eligible only for those services already available in their communities independent of the interventions.
The evaluation assesses the effect of PROMISE services on educational attainment, employment, earnings, and reduced receipt of disability payments. The three components of this evaluation include:
• The process analysis, which documents program models, assesses the relationships among the partner organizations, documents whether the grantees implemented the programs as planned, identifies features of the programs that may account for their impacts on youth and families, and identifies lessons for future programs with similar objectives.
• The impact analysis, which determines whether youth and families in the treatment groups receive more services than their counterparts in the control groups. It also determines whether treatment group members have better results than control group members with respect to the targeted outcomes noted above.
• The cost-benefit analysis, which assesses whether the benefits of PROMISE, including increases in employment and reductions in benefit receipt, are large enough to justify its costs. We conduct this assessment from a range of perspectives, including those of the participants, state and Federal governments, SSA, and society as a whole.
SSA planned several data collection efforts for the evaluation. These include: (1) Follow-up interviews with youth and their parent or guardian 18 months and 5 years after enrollment; (2) phone and in-person interviews with local program administrators, program supervisors, and service delivery staff at two points in time over the course of the demonstration; (3) two rounds of focus groups with participating youth in the treatment group; (4) two rounds of focus groups with parents or guardians of participating youth; (5) staff activity logs which provide data on aspects of service delivery; and (6) collection of administrative data. At this time, SSA requests clearance for the staff activity logs. SSA will request clearance for the 5-year survey interviews in a future submission. The respondents are the administrative and direct service staff, as well as some subcontractors whose primary roles with their organizations involve PROMISE service delivery.
The Department of State will conduct an open meeting at 10:30 a.m. on Monday, January 25, 2016, at the headquarters of the Radio Technical Commission for Maritime Services (RTCM) in Suite 605, 1611 N. Kent Street, Arlington, Virginia 22209. The primary purpose of the meeting is to prepare for the fortieth Session of the International Maritime Organization's (IMO) Facilitation Committee to be held at the IMO Headquarters, United Kingdom, April 4-8, 2016. This meeting is the first of two public meetings and is being held to solicit public comment on the cyber-related agenda items.
The agenda items to be considered include:
To better understand all aspects of the maritime industry's use of cyber systems, we are seeking specific input on the following questions:
Members of the public may attend this meeting up to the seating capacity of the room. To facilitate the building security process, and to request reasonable accommodation, those who plan to attend should contact the meeting coordinator, Mr. David Du Pont, by email at
Federal Aviation Administration (FAA), DOT.
Notice of a request for a change in designation of on-airport property purchased with AIP funding from aeronautical to non-aeronautical use.
The FAA is requesting public comment on the Lancaster Airport Authority's proposal to change 6.191 acres of airport property at Lancaster Airport, Lititz, Pennsylvania from aeronautical to non-aeronautical use. This acreage was purchased with federal financial assistance through the Airport Improvement Program under Grant Agreements 3-42-0049-13-95, 3-42-0049-16-98, and 3-42-0049-19-01 under 49 U.S.C. 47107(c). In accordance with 49 U.S.C. 47107(h), this notice is required to be published in the
Comments must be received on or before January 28, 2016.
Comments on this application may be mailed or delivered to the following address: David Eberly, Manager, Lancaster Airport, 500 Airport Road, Suite G, Lititz, PA 17543-9340, 717-569-1221 and at the FAA Harrisburg Airports District Office: Lori K. Pagnanelli, Manager, Harrisburg Airports District Office, 3905 Hartzdale Dr., Suite 508, Camp Hill, PA 17011, (717) 730-2830.
Charles Sacavage, Project Manager, Harrisburg Airports District Office, location listed above.
The request for change in designation of on-airport property may be reviewed in person at this same location.
The following is a brief overview of the request:
The Lancaster Airport Authority requests to change the designation of 6.191 acres of on-airport property from aeronautical to non-aeronautical use. No land shall be sold as part of this land request. The property is situated on the northwest corner of the intersection of Stauffer Road and Millport Road in Warwick Township. The 6.191 acres are part of a 29.855 acre parcel that was purchased on June 27, 1997 to protect the Runway 26 Runway Protection Zone (RPZ) from incompatible development. The subject area itself, however, is located outside the designated RPZ. The 6.191 acre area requested to be designated as non-aeronautical is unable to be utilized for aviation purposes because it is located across a public road (Millport Road) from the air operations area and is inaccessible by aircraft. The subject acreage is currently being used as a yard waste reclamation collection center. The purpose of this request is to permanently change the designation of the property given there is no potential for future aviation use, as demonstrated by the Airport Layout Plan. Subsequent to the implementation of the proposed redesignation, rents received by the airport from this property must be used in accordance with FAA's Policy and Procedures Concerning the Use of Airport Revenue, published in the
Any person may inspect the request by appointment at the FAA office address listed above. Interested persons are invited to comment. All comments will be considered by the FAA to the extent practicable.
Federal Highway Administration (FHWA), U.S. DOT.
Notice of Limitation on Claims for Judicial Review of Actions by TxDOT and Federal Agencies.
This notice announces actions taken by Texas Department of Transportation (TxDOT) and Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, SH 365 from FM 1016/Conway Avenue to US 281/Military Highway in Hidalgo County in the State of Texas. Those actions grant licenses, permits, and approvals for the project.
By this notice, TxDOT is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before May 27, 2016. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Mr. Carlos Swonke, P.G., Environmental Affairs Division, Texas Department of Transportation, 125 East 11th Street, Austin, Texas 78701; telephone: (512) 416-2734; email:
Notice is hereby given that TxDOT and Federal agencies have taken final agency actions by issuing licenses, permits, and approvals for the following highway project in the State of Texas: The SH 365 project would initially be developed as a four-lane divided controlled access toll facility divided by a grassy median with Rights-of-Way (ROW) reserved for future widening for the ultimate facility when necessary. The ultimate facility
The actions by TxDOT and the Federal agencies, and the laws under which such actions were taken, are described in the final Environmental Assessment (EA) issued in June, 2015 for the project, for which a Finding of No Significant Impact (FONSI) was issued on July 2, 2015, and in other documents in the TxDOT administrative record. The EA, FONSI, and other documents in the administrative record file are available by contacting TxDOT at the address provided above. The FONSI may also be viewed and downloaded from the project sponsor Web site at
This notice applies to all TxDOT decisions and Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. General: National Environmental Policy Act (NEPA) [42 U.S.C. 4321-4351]; Federal-Aid Highway Act [23 U.S.C. 109].
2. Air: Clean Air Act [42 U.S.C. 7401-7671(q)].
3. Land: Section 4(f) of the Department of Transportation Act of 1966 [49 U.S.C. 303]; Landscaping and Scenic Enhancement (Wildflowers), 23 U.S.C. 319.
4. Wildlife: Endangered Species Act [16 U.S.C. 1531-1544 and Section 1536]; Fish and Wildlife Coordination Act [16 U.S.C. 661-667(d)]; Migratory Bird Treaty Act [16 U.S.C. 703-712].
5. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended [16 U.S.C. 470(f)
6. Social and Economic: Civil Rights Act of 1964 [42 U.S.C. 2000(d)-2000(d)(1)]; American Indian Religious Freedom Act [42 U.S.C. 1996]; Farmland Protection Policy Act (FPPA) [7 U.S.C. 4201-4209].
7. Wetlands and Water Resources: Clean Water Act [33 U.S.C. 1251-1377]; Land and Water Conservation Fund (LWCF) [16 U.S.C. 4601-4604]; Safe Drinking Water Act (SDWA) [42 U.S.C. 300(f)-300(j)(6)]; Rivers and Harbors Act of 1899 [33 U.S.C. 401-406]; Wild and Scenic Rivers Act [16 U.S.C. 1271-1287]; Emergency Wetlands Resources Act [16 U.S.C. 3921, 3931]; TEA-21 Wetlands Mitigation [23 U.S.C. 103(b)(6)(m), 133(b)(11)]; Flood Disaster Protection Act [42 U.S.C. 4001-4128].
8. Executive Orders: E.O. 11990, Protection of Wetlands; E.O. 11988, Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 11593, Protection and Enhancement of Cultural Resources; E.O. 13007, Indian Sacred Sites; E.O. 13287, Preserve America; E.O. 13175, Consultation and Coordination with Indian Tribal Governments; E.O. 11514, Protection and Enhancement of Environmental Quality; E.O. 13112, Invasive Species; E.O. 12372, Intergovernmental Review of Federal Programs.
The environmental review, consultation, and other actions required by applicable Federal environmental laws for this project are being, or have been, carried-out by TxDOT pursuant to 23 U.S.C. 327 and a Memorandum of Understanding dated December 16, 2014, and executed by FHWA and TxDOT.
23 U.S.C. 139(l)(1).
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of Limitation on Claims for Judicial Review of Actions by FHWA.
This notice announces actions taken by the FHWA that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, Trunk Highway (TH) 1/169 in the vicinity of Eagles Nest Lake from approximately 0.1 miles west of Sixmile Road to approximately 0.1 mile east of Bradach Road in the County of St. Louis, Minnesota. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before May 27, 2016. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
For FHWA: William Lohr, FHWA Minnesota Division Office, 380 Jackson Street, Suite 500, Saint Paul, MN 55101, telephone at 651-291-6100, or via email at
Notice is hereby given that FHWA has taken final agency actions subject to 23 U.S.C. 139(l)(1) by issuing licenses, permits, and approvals for the following highway project in the State of Minnesota: The proposed project will address deteriorating pavement conditions and provide safety improvements to a 5.7-mile long segment of TH 1/169 in the vicinity of Eagles Nest lake from approximately 0.1 mile west of Sixmile Road to approximately 0.1 mile east of Bradach Road in rural Saint Louis County, Minnesota. Approximately 3.5
The actions by the agencies, and the laws under which such actions were taken, are described in the Environmental Assessment (EA) for the project, approved on December 11, 2014, in the FHWA Finding of No Significant Impact (FONSI) issued on November 3, 2015, and in other documents in the project records. The EA, FONSI, and other project records are available by contacting FHWA or the MnDOT at the addresses provided above. The Environmental Assessment (EA) can be viewed and downloaded from the project Web site at
This notice applies to all Federal agency decisions that are final as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. General: National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4351); Federal-Aid Highway Act (23 U.S.C. 109 and 128).
2. Air: Clean Air Act (42 U.S.C. 7401-7671q).
3. Wildlife: Endangered Species Act (16 U.S.C. 1531-1544).
4. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended (16 U.S.C. 470f); Archeological Resources Protection Act of 1977 (16 U.S.C. 470aa-470mm).
5. Wetlands and Water Resources: Clean Water Act (Sections 319, 401, and 404 (33 U.S.C. 1251-1387); Rivers and Harbors Act of 1899 (33 U.S.C. 401-406); Wetlands Mitigation (23 U.S.C. 119(g) and 133(b)(14)).
6. Executive Orders (E.O.): E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13007 Indian Sacred Sites; E.O. 13287 Preserve America; E.O. 13175 Consultation and Coordination with Indian Tribal Governments; E.O. 11514 Protection and Enhancement of Environmental Quality; and E.O. 13112 Invasive Species.
23 U.S.C. 139 (l)(1)
Federal Motor Carrier Safety Administration (FMCSA).
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 55 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate CMVs in interstate commerce.
Comments must be received on or before January 28, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2015-0340 using any of the following methods:
•
•
•
•
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. The 55 individuals listed in this notice have recently requested such an exemption from the diabetes prohibition in 49 CFR 391.41(b) (3), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.
Mr. Adams, 63, has had ITDM since 2015. His endocrinologist examined him
Mr. Barrall, 44, has had ITDM since 2008. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Barrall understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Barrall meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Delaware.
Mr. Bland, 59, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Bland understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bland meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Missouri.
Mr. Bostwick, 47, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Bostwick understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bostwick meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Massachusetts.
Mr. Bracken, 53, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Bracken understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bracken meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Pennsylvania.
Mr. Callahan, 41, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Callahan understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Callahan meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Kentucky.
Mr. Carlson, 60, has had ITDM since 1981. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Carlson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Carlson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Michigan.
Mr. Clark, 43, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Clark understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Clark meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Texas.
Mr. Clark, 44, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Clark understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Clark meets the requirements
Mr. Craig, 55, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Craig understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Craig meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from North Carolina.
Mr. Dean, 43, has had ITDM since 2011. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Dean understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Dean meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from New Jersey.
Ms. Dillon, 30, has had ITDM since 1995. Her endocrinologist examined her in 2015 and certified that she has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. Her endocrinologist certifies that Ms. Dillon understands diabetes management and monitoring has stable control of her diabetes using insulin, and is able to drive a CMV safely. Ms. Dillon meets the requirements of the vision standard at 49 CFR 391.41(b)(10). Her ophthalmologist examined her in 2015 and certified that she has stable nonproliferative diabetic retinopathy. She holds an operator's license from Pennsylvania.
Mr. Dirl, 60, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Dirl understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Dirl meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Dykes, 40, has had ITDM since 2009. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Dykes understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Dykes meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Massachusetts.
Mr. Engle, 55, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Engle understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Engle meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Kentucky.
Mr. Frank, 21, has had ITDM since 2006. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Frank understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Frank meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from New York.
Mr. Fry, 46, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Fry understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Fry meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Kansas.
Mr. Glover, 69, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in
Mr. Goacher, 75, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Goacher understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Goacher meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from North Carolina.
Mr. Gonzalez, 32, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Gonzalez understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gonzalez meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Oregon.
Mr. Hamilton, 30, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hamilton understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hamilton meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Texas.
Mr. Henry, 66, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Henry understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Henry meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Ohio.
Mr. Hensley, 56, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hensley understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hensley meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Missouri.
Mr. Hicks, 57, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hicks understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hicks meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Hoffman, 55, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hoffman understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hoffman meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Huffman, 65, has had ITDM since 2006. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Huffman understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Huffman meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from North Carolina.
Mr. Jones, 56, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Jones understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Jones meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Maryland.
Mr. Krueger, 51, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Krueger understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Krueger meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Nebraska.
Mr. Kuck, 43, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Kuck understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Kuck meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Alaska.
Mr. Lenhart, 59, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Lenhart understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Lenhart meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Ohio.
Mr. Leonard, 56, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Leonard understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Leonard meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from New Hampshire.
Mr. McAlister, 56, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. McAlister understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. McAlister meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from New Hampshire.
Mr. Moorhead, 70, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Moorhead understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Moorhead meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Kentucky.
Ms. Moultrie, 60, has had ITDM since 2012. Her endocrinologist examined her in 2015 and certified that she has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. Her endocrinologist certifies that Ms. Moultrie understands diabetes management and monitoring has stable control of her diabetes using insulin, and is able to drive a CMV safely. Ms. Moultrie meets the requirements of the vision standard at 49 CFR 391.41(b)(10). Her ophthalmologist examined her in 2015 and certified that she does not have diabetic retinopathy. She holds a Class B CDL from Georgia.
Mr. Olmstead, 52, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Olmstead understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Olmstead meets the requirements of the vision standard at
Mr. Parker, 34, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Parker understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Parker meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Vermont.
Mr. Patch, 62, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Patch understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Patch meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from New York.
Mr. Peacock, 64, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Peacock understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Peacock meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Kansas.
Mr. Piekenbrock, 59, has had ITDM since 2007. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Piekenbrock understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Piekenbrock meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Pittman, 52, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Pittman understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Pittman meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Indiana.
Mr. Raben, 23, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Raben understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Raben meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Georgia.
Mr. Richardson, 54, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Richardson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Richardson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from New York.
Mr. Rosencrans, 61, has had ITDM since 2008. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Rosencrans understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Rosencrans meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Russo, 44, has had ITDM since 2005. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or
Mr. Schumann, 62, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Schumann understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Schumann meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from New Jersey.
Mr. Smith, 45, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Smith understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Smith meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class B CDL from Massachusetts.
Mr. Sunnarborg, 39, has had ITDM since 1982. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Sunnarborg understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Sunnarborg meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Minnesota.
Mr. Swain, 46, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Swain understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Swain meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Pennsylvania.
Mr. Toro, 50, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Toro understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Toro meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from New York.
Mr. Wacker, 53, has had ITDM since 2009. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Wacker understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Wacker meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Ward, 45, has had ITDM since 1978. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Ward understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ward meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative and stable proliferative diabetic retinopathy. He holds an operator's license from Wisconsin.
Mr. Wheat, 59, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Wheat understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV
Mr. White, 62, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. White understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. White meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Michigan.
Mr. Worsfold, 58, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Worsfold understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Worsfold meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Nebraska.
Mr. Zagorski, 36, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Zagorski understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Zagorski meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from North Carolina.
In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated in the date section of the notice.
FMCSA notes that section 4129 of the Safe, Accountable, Flexible and Efficient Transportation Equity Act: A Legacy for Users requires the Secretary to revise its diabetes exemption program established on September 3, 2003 (68 FR 52441).
Section 4129 requires: (1) Elimination of the requirement for 3 years of experience operating CMVs while being treated with insulin; and (2) establishment of a specified minimum period of insulin use to demonstrate stable control of diabetes before being allowed to operate a CMV.
In response to section 4129, FMCSA made immediate revisions to the diabetes exemption program established by the September 3, 2003 notice. FMCSA discontinued use of the 3-year driving experience and fulfilled the requirements of section 4129 while continuing to ensure that operation of CMVs by drivers with ITDM will achieve the requisite level of safety required of all exemptions granted under 49 U.S.C. 31136(e).
Section 4129(d) also directed FMCSA to ensure that drivers of CMVs with ITDM are not held to a higher standard than other drivers, with the exception of limited operating, monitoring and medical requirements that are deemed medically necessary.
The FMCSA concluded that all of the operating, monitoring and medical requirements set out in the September 3, 2003 notice, except as modified, were in compliance with section 4129(d). Therefore, all of the requirements set out in the September 3, 2003 notice, except as modified by the notice in the
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
We will consider all comments and material received during the comment period and may change this proposed rule based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble, To submit your comment online, go to
Federal Railroad Administration (FRA), Department of Transportation.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and its implementing regulations, the Federal Railroad Administration (FRA) hereby announces that it is seeking renewal of the following currently approved information collection activities. Before submitting these information collection requests (ICRs) for clearance by the Office of Management and Budget (OMB), FRA is soliciting public comment on specific aspects of the activities identified below.
Comments must be received no later than February 29, 2016.
Submit written comments on any or all of the following proposed activities by mail to either: Mr. Robert Brogan, Information Collection Clearance Officer Office of Safety, Regulatory Safety Analysis Division, RRS-21, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 25, Washington, DC 20590, or Ms. Kimberly Toone, Information Collection Clearance Officer, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 35, Washington, DC 20590. Commenters requesting FRA to acknowledge receipt of their respective comments must include a self-addressed stamped postcard stating, “Comments on OMB control number 2130-__.” Alternatively, comments may be transmitted via facsimile to (202) 493-6216 or (202) 493-6497, or via email to Mr. Brogan at
Mr. Robert Brogan, Information Collection Clearance Officer, Regulatory Safety Analysis Division, RRS-21, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 25, Washington, DC 20590 (telephone: (202) 493-6292) or Ms. Kimberly Toone, Information Collection Clearance Officer, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-6132). (These telephone numbers are not toll-free.)
The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, sec. 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to provide 60-days notice to the public for comment on information collection activities before seeking approval for reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA invites interested respondents to comment on the following summary of proposed information collection activities regarding (i) whether the information collection activities are necessary for FRA to properly execute its functions, including whether the activities will have practical utility; (ii) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (iii) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (iv) ways for FRA to minimize the burden of information collection activities on the public by automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
Below is a brief summary of the currently approved ICRs that FRA will submit for clearance by OMB as required under the PRA:
FRA research indicates that prescription and OTC drug use has become prevalent among railroad employees. For this reason, FRA has added certain non-controlled substances to its routine post-accident testing program, which currently routinely tests only for alcohol and controlled substances. At this time, FRA is adding two types of non-controlled substances, tramadol (a synthetic opioid) and sedating antihistamines. Publication of the PATT Final Rule, however, in no way limits FRA's post-accident testing to the identified substances or in any way restricts FRA's ability to make routine amendments to its standard post-accident testing panel without prior notice. Furthermore, in addition to its standard post-accident testing panel, FRA always has the ability to test for “other impairing substances specified by FRA as necessary to the particular accident investigation.”
FRA uses the additional information collected for research and accident investigation purposes. The addition of non-controlled substances to the post-accident testing panel helps inform FRA about a broader range of potentially impairing prescription and OTC drugs that may be currently contributing to the cause or severity of train accidents/incidents. Research generated by these data will inform future agency policy decisions regarding these non-controlled substances.
Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b), 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501-3520.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0143. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel U TURN is:
The complete application is given in DOT docket MARAD-2015-0143 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0148. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel NEUVA OLA is:
The complete application is given in DOT docket MARAD-2015-0148 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0147. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel CARPE VITA is:
The complete application is given in DOT docket MARAD-2015-0147 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0141. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel THE DUCHESS is:
The complete application is given in DOT docket MARAD-2015-0141 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration (MARAD), Department of Transportation.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before January 28, 2016.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW., Washington, DC 20503. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; the accuracy of the Department's estimate of the burden of the proposed information collection; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
Jan Downing, 202-366-0783, Office of Cargo and Commercial Sealift, Maritime Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590.
The Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended; and 49 CFR 1.93.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0146. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel SHERYL ANN is:
The complete application is given in DOT docket MARAD-2015-0146 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0142. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel LOWCOUNTRY NATIVE is:
The complete application is given in DOT docket MARAD-2015-0142 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0144. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel CALYPSO is:
The complete application is given in DOT docket MARAD-2015-0144 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0145. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel ISLAND FLYER is:
The complete application is given in DOT docket MARAD-2015-0145 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0138. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel EROS is:
The complete application is given in DOT docket MARAD-2015-0138 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before January 28, 2016.
Comments should refer to docket number MARAD-2015-0139. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel THE GOLDFISCH is:
The complete application is given in DOT docket MARAD-2015-0139 at
Anyone is able to search the electronic form of all 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 DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of application for modification of special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the applications described herein. This notice is abbreviated to expedite docketing and public notice. Because the sections affected, modes of transportation, and the nature of application have been shown in earlier
Comments must be received on or before January 13, 2016.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC or at
This notice of receipt of applications for modification of special permit is published in accordance with Part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of actions on special permit applications.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given of the actions on special permits applications in (October to October 2014). The mode of transportation involved are identified by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft. Application numbers prefixed by the letters EE represent applications for Emergency Special Permits. It should be noted that some of the sections cited were those in effect at the time certain special permits were issued.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of Applications for Special Permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before January 28, 2016.
Send comments to Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hanrdous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC or at
This notice of receipt of applications for special permit is published in accordance with Part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of application delayed more than 180 days.
In accordance with the requirements of 49 U.S.C. 5117(c), PHMSA is publishing the following list of special permit applications that have been in process for 180 days or more. The reason(s) for delay and the expected completion date for action on each application is provided in association with each identified application.
Ryan Paquet, Director, Office of Hazardous Materials Special Permits and Approvals, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
1. Awaiting additional information from applicant.
2. Extensive public comment under review.
3. Application is technically complex and is of significant impact or precedent-setting and requires extensive analysis.
4. Staff review delayed by other priority issues or volume of special permit applications.
N—New application.
M—Modification request.
R—Renewal Request.
P—Party To Exemption Request.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Regulations Governing U.S. Treasury Securities—State and Local Government Series.
Written comments should be received on or before February 29, 2016 to be assured of consideration.
Direct all written comments and requests for further information to Bureau of the Fiscal Service, Bruce A. Sharp, 200 Third Street A4-A, Parkersburg, WV 26106-1328, or
Requests for additional information or copies of the form(s) and instructions should be directed to Dwayne Boothe, Branch Manager, Special Investments Branch; 200 Third Street Room 119, Parkersburg, WV 26106-1328, or
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Claim for United States Savings Bonds Not Received.
Written comments should be received on or before February 29, 2016 to be assured of consideration.
Direct all written comments and requests for further information to Bureau of the Fiscal Service, Bruce A. Sharp, 200 Third Street, A4-A, Parkersburg, WV 26106-1328, or
Requests for additional information or copies of the form(s) and instructions should be directed to Ron Lewis; 200 Third Street, Room 515, Parkersburg, WV 26106-1328, or
Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection 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.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Regulations Governing Book-Entry Treasury Bonds, Notes, and Bills.
Written comments should be received on or before February 29, 2016 to be assured of consideration.
Direct all written comments and requests for further information to Bureau of the Fiscal Service, Bruce A. Sharp, 200 Third Street A4-A, Parkersburg, WV 26106-1328, or
Requests for additional information or copies of the form(s) and instructions should be directed to Ron Lewis; 200 Third Street Room 515, Parkersburg, WV 26106-1328, or
Current Actions: Extension of a previously approved collection.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Request by Owner or Person Entitled to Payment or Reissue of United States Savings Bonds/Notes Deposited in Safekeeping When Original Custody Receipts Are Not Available.
Written comments should be received on or before February 29, 2016 to be assured of consideration.
Direct all written comments and requests for further information to Bureau of the Fiscal Service, Bruce A.
Requests for additional information or copies of the form(s) and instructions should be directed to Ron Lewis; 200 Third Street, Room 515, Parkersburg, WV 26106-1328, or
Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection 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.
Departmental Offices, Department of the Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). The Treasury is soliciting comments concerning a proposed information collection under a Treasury Financial Empowerment Innovation Fund project to assess the effectiveness of financial decision-making components of near-peer counseling for high school and college students.
Written comments must be submitted on or before February 29, 2016 to be assure of consideration.
Comments regarding this information collection should be addressed to the Treasury Office of Consumer Policy contact listed below. All responses to this notice will be included in the request for OMB's approval. All comments will also become a matter of public record.
Requests for additional information or copies of the information collection instrument and instructions should be directed to James Gatz, Senior Policy Analyst, Office of Consumer Policy, Room 1426, Department of the Treasury, 1500 Pennsylvania Avenue NW., Washington, DC 20220, by telephone on 202-622-3946, or by email at
(1) In order to reduce the applied tariff rates of the United States to the level agreed upon by APEC leaders, the HTS is modified as set forth in the Annex to this proclamation.
(2) The modifications to the HTS set forth in the Annex to this proclamation shall be effective with respect to goods entered, or withdrawn from warehouse for consumption, on or after December 31, 2015.
| 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 |