| Page Range | 5573-5880 | |
| FR Document |
| Page and Subject | |
|---|---|
| 81 FR 5879 - National Teen Dating Violence Awareness and Prevention Month, 2016 | |
| 81 FR 5877 - National African American History Month, 2016 | |
| 81 FR 5873 - American Heart Month, 2016 | |
| 81 FR 5703 - Revised Sunshine Act Meeting Notice | |
| 81 FR 5784 - Sunshine Act Meeting | |
| 81 FR 5792 - Exelon Generation Company, LLC, Braidwood Station, Units 1 and 2 | |
| 81 FR 5573 - Kiwifruit Grown in California; Increased Assessment Rate | |
| 81 FR 5707 - Foreign-Trade Zone 279-Terrebonne Parish, Louisiana; Application for Subzone; Thoma-Sea Marine Constructors, LLC, Houma and Lockport, Louisiana | |
| 81 FR 5781 - Proposed Information Collection; Special Park Use Applications | |
| 81 FR 5585 - Amendments to the Rules of Practice and Procedure To Allow Each Signatory Party and the Commission To Administer a Single Process for the Review and Adjudication of Projects | |
| 81 FR 5704 - Foreign-Trade Zone (FTZ) 196-Fort Worth, Texas; Notification of Proposed Production Activity, General Electric Transportation (Locomotives, Drill Equipment, Off-Highway Vehicle Wheels, Inverters and Brake Systems); Fort Worth and Haslet, Texas | |
| 81 FR 5821 - Citizens Coinage Advisory Committee Meeting | |
| 81 FR 5744 - Rocky Mountain Region Transmission, Ancillary Services, and Sale of Surplus Products-Rate Order No. WAPA-174 | |
| 81 FR 5740 - Record of Decision for the Windy Gap Firming Project | |
| 81 FR 5778 - Endangered Species; Receipt of Applications for Permit | |
| 81 FR 5718 - Applications for New Awards; State Personnel Development Grants Program | |
| 81 FR 5712 - Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review | |
| 81 FR 5708 - Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Advance Notification of Sunset Reviews | |
| 81 FR 5709 - Certain Frozen Fish Fillets From the Socialist Republic of Vietnam: Preliminary Results of Antidumping Duty New Shipper Review; 2014-2015 | |
| 81 FR 5710 - Honey From the People's Republic of China: Initiation of Antidumping Duty New Shipper Review; 2014-2015 | |
| 81 FR 5707 - Certain Lined Paper Products From India: Notice of Partial Rescission of Antidumping Duty Administrative Review; 2014-2015 | |
| 81 FR 5711 - Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Initiation of Antidumping Duty New Shipper Review | |
| 81 FR 5715 - Privacy Act of 1974; System of Records | |
| 81 FR 5758 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products | |
| 81 FR 5811 - Defense Trade Advisory Group; Notice of Membership | |
| 81 FR 5812 - Advisory Committee on International Economic Policy; Notice of Open Meeting | |
| 81 FR 5812 - 30-Day Notice of Proposed Information Collection: Special Immigrant Visa Biodata Form | |
| 81 FR 5749 - Farm, Ranch, and Rural Communities Advisory Committee; Notice of Charter Renewal | |
| 81 FR 5749 - Proposed Information Collection Request; Comment Request; Application for Registration and Pesticide Report for Pesticide-Producing and Device-Producing Establishments | |
| 81 FR 5600 - Cyazofamid; Pesticide Tolerances | |
| 81 FR 5627 - Fisheries of the Exclusive Economic Zone off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area | |
| 81 FR 5627 - Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 610 in the Gulf of Alaska | |
| 81 FR 5820 - Open Meeting of the Advisory Committee on Risk-Sharing Mechanisms | |
| 81 FR 5628 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska | |
| 81 FR 5666 - Small Business Investment Company Program-Impact SBICs | |
| 81 FR 5703 - Submission for OMB Review; Comment Request; Correction | |
| 81 FR 5716 - Privacy Act of 1974; System of Records | |
| 81 FR 5715 - Submission for OMB Review; Comment Request | |
| 81 FR 5766 - Public Meeting of the Presidential Commission for the Study of Bioethical Issues | |
| 81 FR 5726 - DOE Response to Recommendation 2015-1 of the Defense Nuclear Facilities Safety Board, Emergency Preparedness and Response at the Pantex Plant | |
| 81 FR 5658 - Appliance Standards and Rulemaking Federal Advisory Committee: Notice of Intent To Establish a Working Group for Circulator Pumps To Negotiate a Notice of Proposed Rulemaking for Energy Conservation Standards | |
| 81 FR 5727 - Appliance Standards and Rulemaking Federal Advisory Committee: Notice of Open Meetings | |
| 81 FR 5741 - Desert Southwest Customer Service Region Network Integration Transmission Service and Ancillary Services-Rate Order No. WAPA-175 | |
| 81 FR 5750 - Agency Information Collection Activities; Submission for OMB Review; Comment Request | |
| 81 FR 5756 - Availability of Draft Toxicological Profile; Glutaraldehyde | |
| 81 FR 5748 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Recordkeeping for Institutional Dual Use Research of Concern (iDURC) Policy Compliance | |
| 81 FR 5813 - Notice of Statute of Limitations on Claims; Notice of Final Federal Agency Actions on Proposed Highway in California | |
| 81 FR 5814 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System | |
| 81 FR 5815 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System | |
| 81 FR 5814 - Petition for Waiver of Compliance | |
| 81 FR 5813 - Notice of Final Federal Agency Actions on Proposed Highway in California; Statute of Limitations on Claims | |
| 81 FR 5780 - Notice of Public Meeting, Resource Advisory Council to the Boise District, Bureau of Land Management, U.S. Department of the Interior | |
| 81 FR 5781 - Notice of Public Meeting, BLM Alaska Resource Advisory Council | |
| 81 FR 5782 - Certain Computing or Graphics Systems, Components Thereof, and Vehicles Containing Same; Institution of Investigation | |
| 81 FR 5809 - Submission for OMB Review; Comment Request | |
| 81 FR 5738 - Whitewater Creek Hydroelectric Project; Notice of Cultural Resource Meeting | |
| 81 FR 5739 - Advantage Investment Group, LLC, Spencer Mountain Hydropower, LLC; Notice of Application for Transfer of License and Soliciting Comments, Motions To Intervene, and Protests | |
| 81 FR 5731 - South Carolina Electric & Gas Company; South Carolina Parr Hydroelectric Project; Notice of Proposed Revised Restricted Service List for a Programmatic Agreement | |
| 81 FR 5735 - PJM Interconnection, LLC; Supplemental Notice of Technical Conference | |
| 81 FR 5730 - 3 Phases Renewables, Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 5729 - Electric Power Supply Association, Retail Energy Supply Association, Dynegy Inc., Eastern Generation, LLC, NRG Power Marketing LLC and GenOn Energy Management, LLC v. FirstEnergy Solutions Corporation, Ohio Edison Company, The Cleveland Electric Illuminating Company and The Toledo Edison Company; Notice of Complaint | |
| 81 FR 5730 - Electric Power Supply Association, Retail Energy Supply Association, Dynegy Inc., Eastern Generation, LLC, NRG Power Marketing LLC, GenOn Energy Management, LLC v. AEP Generation Resources, Inc., Ohio Power Company; Notice of Complaint | |
| 81 FR 5728 - Columbia Gas Transmission, LLC; Notice of Availability of the Environmental Assessment for the Proposed Line Wb2va Integrity Project | |
| 81 FR 5728 - Combined Notice of Filings #2 | |
| 81 FR 5732 - Combined Notice of Filings #1 | |
| 81 FR 5596 - Update to Product Lists | |
| 81 FR 5752 - General Motors, LLC; Analysis of Proposed Consent Order To Aid Public Comment | |
| 81 FR 5751 - Jim Koons Management Company; Analysis of Proposed Consent Order To Aid Public Comment | |
| 81 FR 5754 - Lithia Motors, Inc.; Analysis of Proposed Consent Order To Aid Public Comment | |
| 81 FR 5717 - Invitation to Unmanned Aircraft Industry for Review and Comment Period on Edition 1 of NATO Standardization Agreement (STANAG) 4703 Light Unmanned Aircraft Systems (UAS) Airworthiness Requirements (AEP-83) | |
| 81 FR 5816 - Notice of Request for Comments on Update to the Uniform System of Accounts (USOA) and Changes to the National Transit Database (NTD) Reporting Requirements | |
| 81 FR 5779 - Agency Information Collection Activities: Request for Comments | |
| 81 FR 5766 - Meeting of the Presidential Advisory Council on HIV/AIDS; Correction | |
| 81 FR 5661 - Regulatory Capital Rules: The Federal Reserve Board's Framework for Implementing the U.S. Basel III Countercyclical Capital Buffer | |
| 81 FR 5717 - Agency Information Collection Activities; Comment Request; 2016-17 Baccalaureate and Beyond Longitudinal Study (B&B:16/17) Field Test Data Collection | |
| 81 FR 5803 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change Amending the NYSE MKT Company Guide To Create a New Section 146 Under Which a Certain Category of Newly Listed Issuers Would Be Entitled To Receive Complimentary Products and Services From the Exchange | |
| 81 FR 5795 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Options Regulatory Fee | |
| 81 FR 5809 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Change To Provide for Price Collar Thresholds for Trading Halt Auctions | |
| 81 FR 5800 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Options Regulatory Fee | |
| 81 FR 5802 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Change Modifying the NYSE Amex Options Fee Schedule To Add an Early Adopter Specialist Credit | |
| 81 FR 5806 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Schedule of Fees | |
| 81 FR 5811 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Make Permanent the Pilot Program Eliminating Minimum Value Sizes for Opening Transactions in New Series of FLEX Options | |
| 81 FR 5796 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Make Minor Changes to Rule 1064, Crossing, Facilitation and Solicited Orders | |
| 81 FR 5807 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule Change Deleting Rule 410B Governing Reporting Requirements for Off-Exchange Transactions | |
| 81 FR 5793 - Self-Regulatory Organizations; NYSE MKT LLC; Order Approving a Proposed Rule Change Deleting Rule 410B-Equities Governing Reporting Requirements for Off-Exchange Transactions | |
| 81 FR 5798 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Reflect Changes to the Investment Strategy for the PowerShares S&P 500® Downside Hedged Portfolio | |
| 81 FR 5677 - Strengthening Oversight of Over-Income Tenancy in Public Housing; Advance Notice of Proposed Rulemaking | |
| 81 FR 5778 - Final Fair Market Rents for the Housing Choice Voucher Program and Moderate Rehabilitation Single Room Occupancy Program Fiscal Year 2016; Revised | |
| 81 FR 5777 - 60 Day Notice of Proposed Information Collection: Indian Community Capital Initiative: Withdrawal Notice | |
| 81 FR 5735 - Transcontinental Gas Pipe Line Company, LLC; Supplemental Notice of Intent for the Proposed Dalton Expansion Project, Request for Comments on Environmental Issues Related to New Route Modifications Under Consideration | |
| 81 FR 5733 - Combined Notice of Filings #1 | |
| 81 FR 5734 - Records Governing Off-the-Record Communications; Public Notice | |
| 81 FR 5739 - Texas Gas Transmission, LLC; Notice of Availability of the Environmental Assessment for the Proposed Northern Supply Access Project | |
| 81 FR 5737 - Combined Notice of Filings #3 | |
| 81 FR 5730 - Combined Notice of Filings #2 | |
| 81 FR 5767 - National Institute of Nursing Research; Notice of Closed Meetings | |
| 81 FR 5771 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 5772 - National Institute of Diabetes and Digestive Kidney Diseases; Notice of Closed Meetings | |
| 81 FR 5767 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 5770 - Center for Scientific Review; Notice of Closed Meeting | |
| 81 FR 5770 - National Institute of Environmental Health Sciences; Notice of Closed Meeting | |
| 81 FR 5769 - National Institute of Mental Health; Notice of Closed Meeting | |
| 81 FR 5771 - National Center for Advancing Translational Sciences; Notice of Closed Meeting | |
| 81 FR 5773 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 81 FR 5770 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings | |
| 81 FR 5771 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 81 FR 5784 - Polyethylene Terephthalate (PET) Resin From Canada, China, India, and Oman; Revised Schedule for Hearing in Final Investigations | |
| 81 FR 5791 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Guard Youth ChalleNGe Job ChalleNGe Evaluation; Correction | |
| 81 FR 5791 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Placement Verification and Follow Up of Job Corps Participants; Correction | |
| 81 FR 5791 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Institutional Analysis of American Job Centers Study; Correction | |
| 81 FR 5679 - Drawbridge Operation Regulation; Broad Creek, Laurel, DE | |
| 81 FR 5774 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0001 | |
| 81 FR 5773 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0112 | |
| 81 FR 5776 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0016 | |
| 81 FR 5575 - Hispanic-Serving Agricultural Colleges and Universities (HSACU) | |
| 81 FR 5760 - Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments | |
| 81 FR 5619 - Pacific Island Pelagic Fisheries; Exemption for Large U.S. Longline Vessels To Fish in Portions of the American Samoa Large Vessel Prohibited Area | |
| 81 FR 5681 - Fisheries of the Exclusive Economic Zone Off Alaska; Bycatch Management in the Bering Sea Pollock Fishery | |
| 81 FR 5756 - List of Highest Priority Devices for Human Factors Review; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 5764 - Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 5762 - Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 5764 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application | |
| 81 FR 5764 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Postmarketing Adverse Drug Experience Reporting | |
| 81 FR 5763 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792 | |
| 81 FR 5792 - Arts Advisory Panel Meetings | |
| 81 FR 5676 - Proposed Establishment of Class E Airspace; Moriarty, NM | |
| 81 FR 5784 - Agency Information Collection Activities; Proposed eCollection; eComments Requested; Renewal of a Currently Approved Collection: Office of Justice Programs' Community Partnership Grants Management System (GMS) | |
| 81 FR 5792 - Advisory Committee for Environmental Research and Education; Notice of Meeting | |
| 81 FR 5785 - Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance | |
| 81 FR 5789 - Investigations Regarding Eligibility To Apply for Worker Adjustment Assistance | |
| 81 FR 5579 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 81 FR 5584 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 81 FR 5577 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 81 FR 5581 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 81 FR 5629 - Animal Welfare; Marine Mammals | |
| 81 FR 5819 - Notice of Request for Clearance of a Revision of a Currently Approved Information Collection: National Census of Ferry Operators | |
| 81 FR 5589 - Center for Food Safety and Applied Nutrition Library Address; Technical Amendments | |
| 81 FR 5823 - Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations | |
| 81 FR 5605 - Pole Attachment Rates |
Agricultural Marketing Service
Animal and Plant Health Inspection Service
National Institute of Food and Agriculture
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Western Area Power Administration
Agency for Toxic Substances and Disease Registry
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Geological Survey
Land Management Bureau
National Park Service
Foreign Claims Settlement Commission
Employment and Training Administration
National Endowment for the Arts
Federal Aviation Administration
Federal Highway Administration
Federal Railroad Administration
Federal Transit Administration
United States Mint
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Agricultural Marketing Service, USDA.
Final rule.
This rule implements a recommendation from the Kiwifruit Administrative Committee (Committee) for an increase of the assessment rate established for the 2015-16 and subsequent fiscal periods from $0.025 to $0.040 per 9-kilo volume-fill container or equivalent of kiwifruit handled under the marketing order (order). The Committee locally administers the order, and is comprised of growers of kiwifruit operating within the area of production. Assessments upon kiwifruit handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period begins on August 1 and ends July 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Effective February 4, 2016.
Kathie Notoro, Marketing Specialist, or Martin Engeler, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email:
This rule is issued under Marketing Order No. 920, as amended (7 CFR part 920), regulating the handling of kiwifruit grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California kiwifruit handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein would be applicable to all assessable kiwifruit beginning on August 1, 2015, and continue until amended, suspended, or terminated.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This rule increases the assessment rate for the 2015-16 and subsequent fiscal periods from $0.025 to $0.040 per 9-kilo volume-fill container or equivalent of kiwifruit.
The California kiwifruit marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers of California kiwifruit. They are familiar with the Committee's needs and with the costs of goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.
For the 2013-14 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.
The Committee met on July 17 and September 16, 2015, and unanimously recommended 2015-16 fiscal year expenditures of $132,725 and an assessment rate of $0.040 per 9-kilo volume-fill container or equivalent of kiwifruit handled to fund Committee expenses. In comparison, last year's budgeted expenditures were $120,925. The assessment rate of $0.040 is $0.015 more than the rate currently in effect. The Committee's recommended 2015-16 expenditures are $11,800 higher than last year's budgeted expenditures. The primary reason for the increase is to provide funding for research. When applied to the Committee's crop estimate for the 2015-16 fiscal year of 2,297,000 9-kilo volume-fill containers or equivalent, the current assessment rate of $0.025 would not generate sufficient assessment income to anticipated expenses. The assessment rate of $0.040 per 9-kilo volume-fill container or its equivalent should generate assessment income of $91,880. Anticipated assessment income combined with financial reserve and interest income, should provide sufficient funds for the Committee to meet its budgeted expenses while maintaining its financial reserve within the limit authorized under the order. (§ 920.42)
The major expenditures recommended by the Committee for the 2015-16 fiscal period include $80,000 for management expenses; $14,000 for
The assessment rate recommended by the Committee was derived by considering the amount of revenue needed to meet anticipated expenses divided by expected shipments of California kiwifruit. As previously mentioned, kiwifruit shipments for the 2015-16 fiscal period are estimated at 2,297,000 9-kilo volume-fill containers, which should provide $91,880 in assessment income. Anticipated assessment income derived from handler assessments, along with interest income and $40,756 from the Committee's authorized financial reserve, should provide sufficient funds for the Committee to meet its budgeted expenses. It is anticipated that $29,119 would remain in the financial reserve at the end of July 2016, which would be within the maximum amount permitted by the order of approximately one fiscal year's expenses (§ 920.42).
The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.
Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2015-16 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 178 kiwifruit growers in the production area and approximately 28 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,000,000 (13 CFR 121.201).
The National Agricultural Statistical Service (NASS) reported total California kiwifruit production for the 2014 season at 27,400 tons, with an average price of $1,190 per ton. Based on the average price and shipment information provided by NASS and the Committee, it could be concluded that the majority of kiwifruit handlers would be considered small businesses under the SBA definition. Based on kiwifruit production and price information, as well as the total number of California kiwifruit growers, average annual grower revenue is less than $750,000. Thus, the majority of California kiwifruit growers may also be classified as small entities.
This rule increases the assessment rate collected from handlers for the 2015-16 and subsequent fiscal periods from $0.025 to $0.040 per 9-kilo volume-fill container or equivalent of kiwifruit. The Committee unanimously recommended 2015-16 expenditures of $132,725 and an assessment rate of $0.040 per 9-kilo volume-fill container. The assessment rate of $0.040 is $0.015 higher than the 2014-15 rate. The quantity of assessable kiwifruit for the 2015-16 fiscal period is estimated at 2,297,000 9-kilo volume-fill containers. Thus, the $0.040 rate should provide $91,880 in assessment income. Anticipated assessment income derived from handler assessments, along with financial reserve funds and interest income, should provide sufficient revenue for the Committee to meet its budgeted expenses, while maintaining its financial reserve within the maximum amount permitted by the order of approximately one fiscal year's expenses (§ 920.42).
The major expenditures recommended by the Committee for the 2015-16 fiscal period include: $80,000 for management expenses; $14,000 for two financial audits; $14,330 for research; $7,500 for IKO travel; $2,500 for a membership fee to Buy California; and $2,500 for IKO membership. Major budgeted expenses for the 2014-15 fiscal period were: $80,000 for management expenses; $7,500 for a financial audit; $5,000 for handler audits; $2,500 for a membership fee to Buy California; $2,500 for IKO membership; and $12,500 for IKO travel.
Prior to arriving at this budget and assessment rate, the Committee considered alternative expenditure levels, to include maintaining the current assessment rate, but ultimately determined that the current assessment rate would generate insufficient revenue to meet its expenses.
According to data from NASS, the seasonal average producer price was $11.09 per 9-kilo volume-fill container in 2013 and $11.78 per 9-kilo volume-fill container in 2014. A review of historical information and preliminary information pertaining to the upcoming fiscal period indicates that the grower price for 2015-16 could range between $11.09 and $11.78 per 9-kilo volume-fill container of assessable kiwifruit. Therefore, estimated assessment revenue for the 2015-16 fiscal year as a percentage of total producer revenue could be between 0.34 percent and 0.36 percent.
This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. However, these costs would be offset by the benefits derived by the operation of the marketing order. In addition, the Committee's meetings were widely publicized throughout the California kiwifruit industry and all interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. The July 17 and September 16, 2015, meetings were public meetings. All entities, both large and small, were able to express views on this issue.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0189. No changes in those requirements are
This rule imposes no additional reporting or recordkeeping requirements on either small or large California kiwifruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
A proposed rule concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Kiwifruit, Marketing agreements, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 920 is amended as follows:
7 U.S.C. 601-674.
On and after August 1, 2015, an assessment rate of $0.040 per 9-kilo volume-fill container or equivalent of kiwifruit is established for kiwifruit grown in California.
National Institute of Food and Agriculture (NIFA), USDA.
Final rule.
This rule updates the list of institutions that are granted HSACU certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2015, and ending September 30, 2016.
This rule is effective February 3, 2016 and applicable October 1, 2015.
Lisa DePaolo; Policy Analyst; National Institute of Food and Agriculture; U.S. Department of Agriculture; STOP 2272; 1400 Independence Avenue SW.; Washington, DC 20250-2272; Voice: 202-401-5061; Fax: 202-401-7752; Email:
This rule makes changes to the existing list of institutions in Appendix B of 7 CFR part 3434. The list of institutions is amended to reflect the institutions that are granted HSACU certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2015, and ending September 30, 2016.
As stated in 7 CFR 3434.4, an institution must meet the following criteria to receive HSACU certification: (1) Be a Hispanic-Serving Institution (HSI), (2) offer agriculture-related degrees, (3) not appear on the Excluded Parties List System (EPLS), (4) be accredited, and (5) award at least 15% of agriculture-related degrees to Hispanic students over the two most recent academic years.
NIFA obtained the latest report from the U.S. Department of Education's National Center for Education Statistics that lists all HSIs and the degrees conferred by these institutions (completion data) during the 2013-14 academic year. NIFA used this report to identify HSIs that conferred a degree in an instructional program that appears in Appendix A of 7 CFR part 3434 and to confirm that over the 2012-13 and 2013-14 academic years at least 15% of the degrees in agriculture-related fields were awarded to Hispanic students. NIFA further confirmed that these institutions were nationally accredited and were not listed in the System for Award Management (
The updated list of HSACUs is based on (1) completions data from 2012-13 and 2013-14, and (2) enrollment data from Fall 2014. NIFA identified 101 institutions that met the eligibility criteria to receive HSACU certification
As set forth in Section 7101 of the Agricultural Act of 2014 (Pub. L. 113-79), which amends 7 U.S.C. 3103, an institution that is eligible to be designated as an HSACU may notify the Secretary of its intent not to be considered an HSACU. To opt out of designation as an HSACU, an authorized official at the institution must submit a declaration of intent not to be considered an HSACU to NIFA by email at
In FY 2014 and FY 2015, six institutions opted out of their HSACU designation and received NLGCA designation, hence they are excluded from the FY 2016 HSACU list.
As set forth in 7 CFR 3434.8, NIFA will permit HSIs that are not granted HSACU certification to submit an appeal within 30 days of the publication of this notice.
This rule relates to internal agency management. Accordingly, pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity for comment are not required, and this rule may be made effective less than 30 days after publication in the
Administrative practice and procedure; Agricultural research, education, extension; Hispanic-Serving Institutions; Federal assistance.
Title 7, part 3434, of the Code of Federal Regulations is amended accordingly as set forth below:
7 U.S.C. 3103.
The institutions listed in this appendix are granted HSACU certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2015, and ending September 30, 2016. Institutions are listed alphabetically under the state of the school's location, with the campus indicated where applicable.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective February 3, 2016. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125), Telephone: 405-954-4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPs, Takeoff Minimums and/or ODPs. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective February 3, 2016. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C 553(d), good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
RESCINDED: On December 7, 2015 (80 FR 75926), the FAA published an Amendment in Docket No. 31046, Amdt No. 3669, to Part 97 of the Federal Aviation Regulations under section 97.33. The following entry for Richmond, KY, effective December 10, 2015 is hereby rescinded in its entirety:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and
This rule is effective February 3, 2016. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 3, 2016.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS-420) Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone: (405) 954-4164.
This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective February 3, 2016. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 3, 2016.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS-420) Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) telephone: (405) 954-4164.
This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034;
Air Traffic Control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Delaware River Basin Commission.
Final rule.
The Delaware River Basin Commission is amending its regulations to provide for the One Process/One Permit Program. The Program is intended to promote interagency cooperation and collaboration on shared mission objectives, achieve regulatory program efficiencies, avoid unnecessary duplication of effort, and reduce the potential for confusion on the part of regulated entities and the public regarding regulatory requirements applicable to projects.
This final rule will be effective March 4, 2016.
Technical information: David Kovach,
The Delaware River Basin Commission (“DRBC” or “Commission”) is a federal-interstate compact agency charged with managing the water resources of the Delaware River Basin on a regional basis without regard to political boundaries. Its members are the governors of the four basin states—Delaware, New Jersey, New York and Pennsylvania—and the North Atlantic Division Commander of the U.S. Army Corps of Engineers, representing the federal government.
Specifically, this final rule amends subchapter A—Administrative Manual, part 401—Rules of Practice and Procedure, subpart C—Project Review Under Section 3.8 of the Compact by the addition of a new section 401.42, providing for DRBC and each of the parties to the
Currently, the sponsors of many water resource-related projects in the Delaware River Basin are required to apply to both the DRBC and a state agency, among others, for approvals. New section 401.42 provides for the DRBC and the administrative agencies of the Signatory Parties to identify regulatory programs that by mutual agreement will be managed through a single process that may result in one decision or approval. The program, known as One Process/One Permit (hereinafter, “the Program or “One Permit”) is intended to promote interagency cooperation and collaboration on shared mission objectives, achieve regulatory program efficiencies, avoid unnecessary duplication of effort, and reduce the potential for confusion on the part of regulated entities and the public regarding regulatory requirements applicable to projects. Importantly, the rule expressly preserves the authorities of the DRBC and each of its Signatory Parties and effects no change to federal, state or DRBC substantive standards and requirements.
In accordance with this final rule, administrative agreements between DRBC and Signatory Party agencies to implement the Program may be approved by the Commission after each such agreement undergoes a duly noticed public hearing. In accordance with Resolution No. 2015-4 of the Commission, which was adopted on March 11, 2015 following a public hearing on March 10, 2015, an administrative agreement between the DRBC and the New Jersey Department of Environmental Protection (NJDEP) was executed, in part to demonstrate how the Program would operate in New Jersey. With adoption of the final rule, DRBC and NJDEP will fully implement their March 2015 agreement.
Notably, each Signatory Party may choose whether and when to initiate an agreement or agreements with DRBC under the Program. No draft agreements with Signatory Party agencies other than the NJDEP to implement the Program have yet been published for comment.
The Commission introduced One Permit to the basin community during meetings with regulated entities, environmental organizations and other stakeholders on February 12 and March 3, 2015 and through publication on the DRBC Web site of a press release and a set of FAQs on February 27, 2015. During the Commission's quarterly public meeting on March 10-11, 2015, the Commission approved Resolution No. 2015-4, in part authorizing and directing the Executive Director to initiate rulemaking to amend DRBC's
Notice of the proposed amendments also appeared in the
Notable aspects of the final rule include the following:
• Section 401.42(b) provides that applications for approvals required by the Compact and Commission regulations, but not within the scope of the Program, must continue to be submitted to the Commission.
• To ensure continued public access to information on the status of all projects under review pursuant to the
• Section 401.42(h) provides that DRBC's current Project Review Fee Schedule as set forth in Resolution No. 2009-2 will be the operative fee schedule for projects reviewed under the Program.
• Section 401.42(i) provides mechanisms for the efficient disposition of Commission dockets during the transition to One Permit. Section 401.42(i)(1) provides that for projects covered by the Program, the most recent docket will be deemed administratively continued when a renewal application is timely submitted to the Signatory Party Agency. Section 401.42(i)(2) provides that unless the Executive Director or the Commission otherwise directs, upon the Signatory Party Agency's final action on an application for a project subject to the Program, (a) any existing or administratively continued docket will terminate as to all of its provisions and conditions within the scope of the Signatory Party Agency approval; and (b) such docket will continue in effect as to any provisions and conditions outside the scope of the Signatory Party Agency approval, including for example, addition of a project to the Comprehensive Plan.
• The rule authorizes Signatory Party agencies, in accordance with an applicable administrative agreement, to issue in their approvals for projects to be administered under the Program the finding and determination required by section 3.8 of the
• The final rule also makes clear (1) that participation in the program by Signatory Party agencies is voluntary; and (2) that the scope of a Signatory Party Agency's participation is defined by an administrative agreement between DRBC and the agency that has been duly adopted in accordance with § 401.42(d).
Additional materials can be found on the Commission's Web site at
Administrative practice and procedure, Project review, Water pollution control, Water resources.
For the reasons set forth in the preamble, the Delaware River Basin Commission amends part 401 of title 18 of the Code of Federal Regulations as follows:
Delaware River Basin Compact (75 Stat. 688), unless otherwise noted.
(a)
(b)
(1) Are reviewable under the Compact;
(2) Meet the thresholds for review set forth in § 401.35 of these
(3) Are subject to review by a Signatory Party Agency under its own statutory authorities; and
(4) Are within regulatory programs that have been identified in a duly adopted Administrative Agreement between the Commission and a Signatory Party Agency under this section. For any project that requires an approval under the Compact that is outside the scope of the Signatory Party Agency's approval issued in accordance with an Administrative Agreement under this section, the project sponsor shall apply to the Commission in accordance with procedures established by the Commission.
(c)
(d)
(1) Except as provided in paragraphs (b) and (e) of this section or in an Administrative Agreement that has been duly executed by the Commission and the Signatory Party Agency under this section, an application for initial approval, renewal or revision of any project subject to the One Permit Program shall be filed only with the Signatory Party Agency.
(2) To enable the Commission to compile and make available to the public a current list of pending applications for projects within the Basin subject to Commission jurisdiction, the Signatory Party Agency shall notify the Commission at least monthly of applications the Signatory Party has received during the preceding month that may be eligible for review under the One Permit Program.
(3) For those categories of projects identified in the Administrative Agreement as requiring Commission input, the Commission staff shall provide the Signatory Party Agency with such input, including where specified by the Administrative Agreement, a recommendation as to any conditions of approval that may be necessary or appropriate to include in the project review determination under Section 3.8 of the Compact as to those regulatory programs identified in an Administrative Agreement in accordance with paragraph (b) of this section.
(4) Unless the Signatory Party Agency disapproves the project or the Administrative Agreement provides for separate Commission action under Section 3.8 of the Compact, the Signatory Party Agency shall make the project review determination under Section 3.8 of the Compact, as specified in the Administrative Agreement, as to the regulatory program covered by the Signatory Party Agency's approval and include the determination and any associated conditions of approval within the permit or other approval instrument that it issues to the project sponsor. If in accordance with the applicable Administrative Agreement the determination under Section 3.8 of the Compact is made by the Commission, the Signatory Party Agency may include the determination together with any associated conditions of approval in its permit or other approval instrument covering the project.
(5) The Commission will maintain on its Web site a list of all projects being administered pursuant to the Program.
(e)
(f)
(g)
(h)
(i)
(1) Unless the Executive Director or Commission otherwise directs, if a docket holder submits, or has submitted, a timely application to a Signatory Party Agency for a project subject to review under an Administrative Agreement duly adopted under paragraph (d) of this section, the most recent docket for the project shall, upon expiration, be deemed administratively continued until final action is taken in accordance with paragraph (i)(2) of this section.
(2) Unless the Executive Director or Commission otherwise directs, upon a Signatory Party Agency's final action on an application for a project subject to the One Permit Program:
(i) Any existing or administratively continued docket for such project shall terminate as to all of its provisions and conditions that pertain to regulatory programs administered by the Signatory Party Agency under the Administrative Agreement (“the Covered Programs”); and
(ii) The docket shall continue in effect as to any provisions and conditions not pertaining only to Covered Programs, including, as applicable, the incorporation of the project in the Commission's Comprehensive Plan.
(j)
(k)
Food and Drug Administration, HHS.
Final rule; technical amendments.
The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices.
This rule is effective February 3, 2016.
Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-2112.
Various regulations pertaining to human food have incorporated materials by reference. In general, the regulations have identified a library at the Center for Food Safety and Applied Nutrition (CFSAN), which was (at the time the regulations were published) located in Washington, DC, or in College Park, MD. We recently consolidated our library holdings at our main campus in Silver Spring, MD. Consequently, we are making technical amendments to our regulations at parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700 (21 CFR parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700) to state that the materials can be found at the FDA Library in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices. The amendments are as follows:
• We are revising §§ 73.165, 73.585, 165.110, and 173.300 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising §§ 101.4, 101.81(c)(2)(ii)(A) introductory text and (B)(1) and (2), 101.83, 165.110, 172.155, 172.785, 172.833, 173.25, 173.45, 173.340, 173.357, 173.370, 177.1350, 177.1360, 177.1390, 177.1520, 177.2600, 178.3297, 184.1063, 184.1148, 184.1150, 184.1250, 184.1387, 184.1420, 184.1444, 184.1866, 189.5, 589.2001, and 700.27 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising § 101.80 to update the library address from “Center for Food Safety and Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100 Paint Branch Pkwy., College Park, MD” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising § 101.81(c)(2)(ii)(A)(5) to update the library address from “Center for Food Safety and Applied Nutrition Library, 5100 Paint Branch Pkwy., College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising §§ 118.8 and 165.110 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, 301-436-2163” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising § 165.110 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 200 C St. NW., Washington DC” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising §§ 165.110, 172.723, 172.736, 172.804, 172.809, 172.864, 172.886, 173.375, 177.1345, 177.1585, 177.1637, 178.1010, 184.1007, 184.1257, 184.1259, 184.1282, 184.1293, 184.1472, 184.1530, 184.1699, 184.1979, 184.1979a, 184.1979b, and 184.1979c to update the library address from “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising §§ 172.167 and 173.356 to update the library address from “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising § 172.736 to update the library address from “in the library at the Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740” to “at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising § 172.829 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., rm. 1C-100, College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising § 173.325 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740 20204-0001” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising § 184.1311 to update the library address from “Center for Food Safety and Applied Nutrition's library, 5100 Paint Branch Pkwy., College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
• We are revising § 101.83(c)(2)(ii)(A)(
• We are revising § 118.8 to replace “The FDA” with “FDA”.
• We are revising § 173.300 to add the words “Office of Food Additive Safety”.
• We are revising § 173.340 to remove the words “Division of Petition Control” and “(HFS-215)” and in their place adding “Office of Food Additive Safety (HFS-200)”.
• We are revising § 173.357 to remove the words “Division of Petition Control” and “(HFS-215)” and in their place adding “Office of Food Additive Safety (HFS-200)”.
• We are updating §§ 177.1520 and 177.1585 to remove the words “Office of Premarket Approval” and in their place adding the “Office of Food Additive Safety”.
Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). These amendments are merely updating the address of CFSAN references and the names of CFSAN offices. FDA, therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary.
Color additives, Cosmetics, Drugs, Medical devices.
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Egg and egg products, Incorporation by reference, Recordkeeping requirements, Safety.
Beverages, Bottled water, Food grades and standards, Incorporation by reference.
Food additives, Reporting and recordkeeping requirements.
Food additives.
Food additives, Food packaging.
Food additives, Food packaging.
Food additives.
Food additives, Food packaging.
Animal feeds, Animal foods, Food additives.
Cosmetics, Packaging and containers.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700 are amended as follows:
21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.
21 U.S.C. 321, 331-334, 342, 371, 381, 393; 42 U.S.C. 243, 264, 271.
21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.
21 U.S.C. 321, 341, 342, 348, 371, 379e.
21 U.S.C. 321, 342, 348.
(a) * * *
(4) * * *
(a) * * *
(2) * * *
21 U.S.C. 321, 342, 348, 379e.
(b) * * *
21 U.S.C. 321, 342, 348, 379e.
(e) * * *
21 U.S.C. 321, 342, 348, 371.
21 U.S.C. 321, 342, 348, 371, 381.
21 U.S.C. 321, 342, 343, 348, 371.
21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374.
Postal Regulatory Commission.
Final rule.
The Commission is updating the product lists. This action reflects a publication policy adopted by Commission order. The referenced policy assumes periodic updates. The updates are identified in the body of this document. The product lists, which is republished in its entirety, includes these updates.
David A. Trissell, General Counsel, at 202-789-6800.
This document identifies updates to the product lists, which appear as 39 CFR Appendix A to Subpart A of Part 3020—Mail Classification Schedule. Publication of the updated product lists in the
1. Competitive International Merchandise Return Service Agreements with Foreign Postal Operators (MC2015-68 and CP2015-99) (Order No. 2639), added August 4, 2015.
2. Priority Mail Contract 144 (MC2015-84 and CP2015-140) (Order No. 2734), added September 29, 2015.
3. Parcel Select Contract 10 (MC2015-85 and CP2015-141) (Order No. 2735), added September 29, 2015.
4. Priority Mail Contract 143 (MC2015-83 and CP2015-139) (Order No. 2737), added September 29, 2015.
5. Priority Mail Contract 142 (MC2015-82 and CP2015-138) (Order No. 2738), added September 29, 2015.
6. Priority Mail Express Contract 28 (MC2016-2 and CP2016-2) (Order No. 2761), added October 16, 2015.
7. Priority Mail Contract 145 (MC2016-1 and CP2016-1) (Order No. 2762), added October 16, 2015.
8. Priority Mail Contract 146 (MC2016-3 and CP2016-3) (Order No. 2763), added October 16, 2015.
9. Priority Mail Contract 147 (MC2016-4 and CP2016-4) (Order No. 2764), added October 16, 2015.
10. Global Expedited Package Services Contracts—Non-Published Rates 8 (MC2016-5 and CP2016-5) (Order No. 2774), added October 23, 2015.
11. Priority Mail Contract 148 (MC2016-6 and CP2016-6) (Order No. 2777), added October 23, 2015.
12. Priority Mail Contract 149 (MC2016-8 and CP2016-10) (Order No. 2794), added November 2, 2015.
13. Priority Mail Express, Priority Mail & First-Class Package Service Contract 5 (MC2016-9 and CP2016-11) (Order No. 2796), added November 2, 2015.
14. Priority Mail Contract 150 (MC2016-11 and CP2016-12) (Order No. 2799), added November 3, 2015.
15. Priority Mail Contract 151 (MC2016-12 and CP2016-14) (Order No. 2802), added November 5, 2015.
16. Priority Mail Contract 152 (MC2016-13 and CP2016-15) (Order No. 2803), added November 5, 2015.
17. Priority Mail Express & Priority Mail Contract 21 (MC2016-14 and CP2016-17) (Order No. 2822), added November 17, 2015.
18. Priority Mail Contract 153 (MC2016-17 and CP2016-23) (Order No. 2846), added December 2, 2015.
19. Priority Mail Express Contract 29 (MC2016-16 and CP2016-22) (Order No. 2847), added December 2, 2015.
20. Priority Mail Express, Priority Mail & First-Class Package Service Contract 6 (MC2016-21 and CP2016-27) (Order No. 2848), added December 4, 2015.
21. Priority Mail Contract 154 (MC2016-18 and CP2016-24) (Order No. 2849), added December 4, 2015.
22. Priority Mail Contract 155 (MC2016-19 and CP2016-25) (Order No. 2851), added December 4, 2015.
23. Priority Mail Express & Priority Mail Contract 22 (MC2016-20 and CP2016-26) (Order No. 2852), added December 7, 2015.
24. Priority Mail Express & Priority Mail Contract 23 (MC2016-26 and CP2016-32) (Order No. 2873), added December 15, 2015.
25. Priority Mail Contract 156 (MC2016-22 and CP2016-28) (Order No. 2875), added December 15, 2015.
26. Priority Mail Contract 158 (MC2016-24 and CP2016-30) (Order No. 2876), added December 15, 2015.
27. Priority Mail Contract 157 (MC2016-23 and CP2016-29) (Order No. 2878), added December 15, 2015.
28. Priority Mail Contract 159 (MC2016-25 and CP2016-31) (Order No. 2879), added December 15, 2015.
29. Parcel Select Contract 11 (MC2016-28 and CP2016-34) (Order No. 2883), added December 17, 2015.
30. Priority Mail Express & Priority Mail Contract 24 (MC2016-27 and CP2016-33) (Order No. 2890), added December 17, 2015.
31. Priority Mail Contract 160 (MC2016-29 and CP2016-35) (Order No. 2891), added December 17, 2015.
32. Priority Mail Contract 161 (MC2016-30 and CP2016-36) (Order No. 2902), added December 21, 2015.
33. Priority Mail Express Contract 30 (MC2016-32 and CP2016-38) (Order No. 2906), added December 21, 2015.
34. Priority Mail Contract 162 (MC2016-31 and CP2016-37) (Order No. 2907), added December 21, 2015.
35. First-Class Package Service Contract 38 (MC2016-33 and CP2016-39) (Order No. 2910), added December 22, 2015.
36. Priority Mail & First-Class Package Service Contract 8 (MC2016-34 and CP2016-40) (Order No. 2911), added December 22, 2015.
37. Priority Mail Contract 163 (MC2016-35 and CP2016-41) (Order No. 2912), added December 22, 2015.
38. Priority Mail Contract 164 (MC2016-36 and CP2016-42) (Order No. 2913), added December 22, 2015.
39. First-Class Package Service Contract 39 (MC2016-38 and CP2016-47) (Order No. 2926), added December 24, 2015.
40. Parcel Select Contract 12 (MC2016-37 and CP2016-46) (Order No. 2927), added December 24, 2015.
41. Priority Mail & First-Class Package Service Contract 9 (MC2016-44 and CP2016-59) (Order No. 2965), added December 30, 2015.
42. Priority Mail Express & Priority Mail Contract 25 (MC2016-45 and CP2016-60) (Order No. 2966), added December 30, 2015.
43. Global Expedited Package Services Contracts—Non-Published Rates 9 (MC2016-46 and CP2016-61) (Order No. 2967), added December 30, 2015.
44. Competitive Products Price Changes Rates of General Applicability (CP2016-9) (Order No. 2814), changed Standard Post to Retail Ground, November 13, 2015.
The following negotiated service agreements have expired and are being deleted from the Mail Classification Schedule:
1. Priority Mail Contract 40 (MC2012-38 and CP2012-46) (Order No. 1444).
2. Priority Mail Contract 42 (MC2012-47 and CP2012-57) (Order No. 1475).
3. Priority Mail Contract 43 (MC2012-48 and CP2012-58) (Order No. 1476).
4. Priority Mail Contract 45 (MC2013-4 and CP2013-4) (Order No. 1518).
5. Priority Mail Contract 46 (MC2013-6 and CP2013-6) (Order No. 1524).
6. Priority Mail Contract 47 (MC2013-7 and CP2013-7) (Order No. 1525).
7. Priority Mail Express & Priority Mail Contract 9 (MC2012-29 and CP2012-38) (Order No. 1397).
8. Parcel Select Contract 3 (MC2012-32 and CP2012-40) (Order No. 1414).
9. Parcel Select Contract 4 (MC2012-33 and CP2012-41) (Order No. 1415).
10. Parcel Select Contract 6 (MC2013-13 and CP2013-13) (Order No. 1538).
11. First-Class Package Service Contract 16 (MC2012-49 and CP2012-61) (Order No. 1494).
12. First-Class Package Service Contract 17 (MC2012-50 and CP2012-62) (Order No. 1495).
13. First-Class Package Service Contract 18 (MC2012-51 and CP2012-63) (Order No. 1496).
14. First-Class Package Service Contract 19 (MC2012-52 and CP2012-64) (Order No. 1497).
15. First-Class Package Service Contract 20 (MC2012-53 and CP2012-65) (Order No. 1498).
16. First-Class Package Service Contract 21 (MC2013-8 and CP2013-8) (Order No. 1526).
17. First-Class Package Service Contract 22 (MC2013-9 and CP2013-9) (Order No. 1527).
18. First-Class Package Service Contract 23 (MC2013-10 and CP2013-10) (Order No. 1528).
19. First-Class Package Service Contract 24 (MC2013-11 and CP2013-11) (Order No. 1529).
20. First-Class Package Service Contract 25 (MC2013-12 and CP2013-12) (Order No. 1537).
21. First-Class Package Service Contract 26 (MC2013-15 and CP2013-14) (Order No. 1547).
22. First-Class Package Service Contract 27 (MC2013-17 and CP2013-16) (Order No. 1558).
23. First-Class Package Service Contract 28 (MC2013-18 and CP2013-17) (Order No. 1559).
24. First-Class Package Service Contract 29 (MC2013-19 and CP2013-18) (Order No. 1560).
25. First-Class Package Service Contract 30 (MC2013-20 and CP2013-19) (Order No. 1561).
26. First-Class Package Service Contract 31 (MC2013-21 and CP2013-29) (Order No. 1603).
27. First-Class Package Service Contract 32 (MC2013-22 and CP2013-30) (Order No. 1604).
28. First-Class Package Service Contract 33 (MC2013-23 and CP2013-31) (Order No. 1606).
29. First-Class Package Service Contract 34 (MC2013-24 and CP2013-32) (Order No. 1605).
30. Priority Mail Express, Priority Mail & First-Class Package Service Contract 1 (MC2012-46 and CP2012-55) (Order No. 1474).
31. Priority Mail & First-Class Package Service Contract 1 (MC2013-5 and CP2013-5) (Order No. 1519).
32. Global Direct Contracts 1 (MC2010-17 and CP2010-18) (Order No. 386).
33. Valassis NSA (MC2012-14 and R2012-8) (Order No. 1448).
34. Market Test of Experimental Product—Metro Post (MT2013-1) (Order No. 2243).
Administrative practice and procedure, Postal Service.
For the reasons discussed in the preamble, the Postal Regulatory Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:
39 U.S.C. 503; 3622; 3631; 3642; 3682.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of cyazofamid in or on the herb subgroup 19A and the bulb vegetable group 3-07. Interregional Research Project Number 4 (IR-4) requested the herb subgroup 19A tolerances, and ISK Biosciences requested the bulb vegetable group 3-07 tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective February 3, 2016. Objections and requests for hearings must be received on or before April 4, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0263, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0263 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 4, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0263, by one of the following methods:
•
•
•
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for cyazofamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyazofamid follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The target organ for cyazofamid in rats is the kidney, with an increased incidence of basophilic tubules, increased urinary volume, pH, and protein noted in male rats after subchronic exposure. Female rats were less sensitive, with only a marginal increase in urinary volume, and pH. These findings were noted in a 90-day oral toxicity study, and similar findings were noted in the 28-day oral toxicity range-finding study in rats. In the two-generation reproductive study in rats, there was an increased incidence of inflammation and nephropathy in the high-dose male rats as compared to the controls. Basophilic tubules are indicative of a regenerative process, but they can be more difficult to identify in older animals (
The pre- and post-natal toxicology database for cyazofamid includes rat and rabbit developmental toxicity studies and a two-generation reproduction toxicity study in rats. The prenatal developmental study in rats showed evidence of increased quantitative susceptibility following
No adverse effects were seen in a route-specific dermal toxicity study. Skin lesions were observed in males following oral exposure in the mouse carcinogenicity study, and are thought to be caused by an allergic reaction to systemic exposure because they did not occur following exposure via the dermal route. Cyazofamid is classified as “not likely to be carcinogenic to humans” based on the lack of evidence for carcinogenicity in mice and rats and a lack of mutagenic potential.
Specific information on the studies received and the nature of the adverse effects caused by cyazofamid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for cyazofamid used for human risk assessment is shown in Table 1 of this unit.
1.
i.
ii.
iii.
iv.
2.
The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for cyazofamid and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyazofamid and its degradates. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of the degradate CTCA for chronic exposures are estimated to be 133.5 parts per billion (ppb) for surface water and 211 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 211 ppb was used to assess the contribution to drinking water.
3.
Cyazofamid is currently registered for use on turf at golf courses, sod farms, seed farms, college and professional sports fields, residential and commercial lawns, and on ornamental plants in landscapes and those grown in commercial greenhouses and nurseries. EPA assessed residential exposure using the following scenarios:
• Adult handlers. The worst-case scenario was determined to be short-term inhalation exposures from mixing, loading, and applying cyazofamid to turf; and
• Children. The worst-case scenario was determined to be short-term post-application incidental oral exposure from hand-to-mouth activities on turf.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found cyazofamid to share a common mechanism of toxicity with any other substances, and cyazofamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyazofamid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
1.
2.
3.
i. The toxicity database for cyazofamid is complete.
ii. There is no indication that cyazofamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. As noted in Section D.2., there was increased quantitative susceptibility in the rat developmental study, however, concern is low due to the reasons cited.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyazofamid and its degradates in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cyazofamid.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 14,000 for adults and 6,100 for children 1-2 years old. Because EPA's level of concern for cyazofamid is a MOE of 100 or below, these MOEs are not of concern.
4.
An intermediate-term adverse effect was identified; however, cyazofamid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for cyazofamid.
5.
6.
An enforcement method for non-fatty commodities is available, FDA's Multi-residue Protocol D (without cleanup). The method completely recovers (>80% recovery) cyazofamid and its metabolite (4-chloro-5-(4-methylphenyl)-1
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Aliment-arius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Aliment-arius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
There are no Codex MRLs established for cyazofamid in/on the commodities included in this action.
Therefore, tolerances are established for residues of cyazofamid (4-chloro-2-cyano-
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions read as follows:
(a)
Federal Communications Commission.
Final rule.
In this
Effective April 1, 2016.
You may submit comments, identified by WC Docket No. 07-245, GN Docket No. 09-51 and FCC 15-151, by any of the following methods:
•
•
Jonathan Reel, Wireline Competition Bureau, Competition Policy Division, (202) 418-0637, or send an email to
This is a summary of the Commission's
1. In this
2. As detailed below, the Commission takes these actions in response to a Petition for Reconsideration or Clarification in this proceeding. The rule revisions that the Commission adopts amend the Commission's rules by defining “cost,” for the purpose of calculating the rates that telecommunications carriers pay for pole attachments, as a percentage of fully allocated costs that will depend on whether the average number of attaching entities in a service area is 2, 3, 4, or 5. The rates that attachers pay to attach to poles are currently determined, among other things, by whether the attacher is a “cable television system solely . . . provid[ing] cable service” or a “telecommunications
3. In response to NCTA's petition, and to the record developed in this proceeding, Commission now introduces new cost allocators for poles with 2 attaching entities (0.31 percent of costs) and 4 attaching entities (0.56 percent of cost). When the average number of attaching entities is a fraction, the percentage cost allocator will be located between the whole numbers at the point where it most closely approximates the cost used in the cable rate formula. This flexible series of cost allocators should more fully realize the intent of the Commission in its
4. The Commission additionally acts to support incentives for deployment of broadband facilities, particularly in rural areas, and to harmonize regulatory treatment between states where the Commission regulates the rates, terms, and conditions for pole attachments and states where such matters are regulated by the state. Subjecting cable operators to higher pole attachment rates merely because they also provide telecommunications services, such as broadband Internet access, could deter investment in states subject to Commission pole regulation, which would undermine the Commission's broadband deployment policy. By keeping pole attachment rates unified and low, the Commission furthers its overarching goal to accelerate deployment of broadband by removing barriers to infrastructure investment and promoting competition.
5. On April 7, 2011, in its
6. In 1978, Congress added section 224 to the Act. As established in 1978, section 224 directed the Commission to ensure that the rates, terms, and conditions of attaching cable television systems' facilities to utility-owned poles were just and reasonable. Section 224 also identified the maximum rate for pole attachments as a percentage of fully-allocated costs. In 1987, the U.S. Supreme Court found that the cable rate formula adopted by the Commission provides pole owners with adequate compensation, and thus does not result in an unconstitutional taking.
7. The 1996 Act expanded the definition of pole attachments to include attachments by providers of telecommunications service, and granted both cable operators and telecommunications carriers an affirmative right of access to utility poles. The 1996 Act also included a separate provision for calculating a cost-based rate paid by telecommunications carriers—the telecom rate formula—which incorporates “the cost of providing space on a pole.” As implemented by the Commission, the telecom rate formula generally resulted in significantly higher pole rental rates than rates derived from the cable rate formula. The Commission concluded that cable systems that provided Internet access in addition to video services should continue to pay the cable rate; that conclusion was reversed on appeal but later upheld by the Supreme Court.
8. In the intervening years, the Commission considered a variety of possible reforms to its pole attachment regulations in light of their importance to the deployment of communications networks. The Commission issued a Notice of Proposed Rulemaking in 2007, to respond to petitions for rulemaking regarding pole access and incumbent LEC pole attachment issues, and to seek comment on pole rate issues. In 2010, in response to a directive in the American Recovery and Reinvestment Act of 2009, the Commission released the National Broadband Plan (NBP), identifying access to rights-of-way—including access to poles—as having a significant impact on the deployment of broadband networks. Accordingly, the NBP included several recommendations regarding pole attachment access, enforcement, and pricing policies to further advance broadband deployment. Following on the recommendations in the NBP, in its 2010
9. In the
10. In order to promote broadband while ensuring that attaching entities continue to support the poles on which they depend, the
11. The Commission also established a second, alternative measure of cost that utilities may use. This alternative approach is based on the principle of “cost causation,” under which the “customer—the cost causer—pays a rate that covers” the costs for which it is “causally responsible.” Under this approach, a pole owner may recover its administrative and maintenance costs through the telecom rate, but not capital costs other than those associated with make-ready expenses. The Commission also noted that capital costs caused by a telecommunications attacher have long been recovered through make-ready charges, which “the utility itself sets” without regard to “any mandatory rate formula set by the Commission.” Other capital costs (
12. On February 26, 2013, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) rejected utilities' challenge to the Commission's action to bring the traditionally higher telecom rate more in line with the cable rate, concluding that “[b]ecause the Commission's methodology is consistent with the unspecified cost terms contained in section 224(e), and the Commission's justifications are reasonable, the revision [to the telecom rate formula] warrants judicial deference.” In particular, the court observed that section 224(e) is “less specific” than section 224(d) in prescribing how the statutory rate formula should be implemented. The court agreed with the Commission that “the term `cost' in section 224(e)(2) and (3) is necessarily ambiguous, and could thus `yield a range of rates from the existing fully-allocated cost approach at the high end to a rate closer to incremental cost at the low end.'” The D.C. Circuit thus affirmed the Commission's interpretation and implementation of section 224(e).
13. On June 8, 2011, Petitioners filed the NCTA Petition, seeking reconsideration or clarification of the newly adopted cost allocation rule. The NCTA Petition points out that, when paired with the Commission's presumptive numbers of attachers (5 in urbanized and 3 in non-urbanized areas), the 66 percent and 44 percent cost allocators almost exactly reproduce the 7.4 percent of costs used as an input in the cable rate formula. The Petitioners report, however, that pole owners in fact often rebut the Commission's presumptions with much lower average numbers. For example, if the owner rebuts the urban presumption (5 attaching entities) with an actual count average of 2.6 attaching entities, the telecom rate can be as much as 70 percent higher than the cable rate. To “achieve the Commission's goal of providing pole attachment rates that are close to uniform as possible, and to ensure that all attachers contribute similar costs to pole owners,” the Petitioners ask the Commission to address this gap between the intended effect of the cost allocators and their function as applied by ceasing to distinguish between urbanized and non-urbanized areas.
14. Specifically, the Petitioners ask the Commission either to clarify that 66 percent and 44 percent are mere illustrations of the new rule, or to revise the rule to “provide corresponding cost adjustments to other entity counts.” The NCTA Petition presents a model rule with additional cost allocators for 4 and 2 attachments, each of which aligns costs with the Commission's cable rate formula as effectively as the current rule does for the Commission's presumptive averages of 5 urbanized and 3 non-urbanized attachments. In service areas where the number of attaching entities is not a whole number, petitioners' proposed cost allocator would be interpolated from the allocators of the nearest whole numbers of attaching entities. On June 20, 2011, the Commission sought comment on the NCTA Petition.
15. On February 26, 2015, the Commission adopted the
16. The Commission adopts the Petitioners' proposal to broaden the use of cost allocators in the telecom rate formula. Specifically, the Commission adds cost allocators for poles with 2 and 4 attaching entities to augment the current cost allocators that target poles with 3 and 5 attaching entities. The Commission also provides that, for fractional attaching-entity averages, cost allocators are to be interpolated from the whole-number cost allocators. The Commission takes this step to further its goal of promoting consistent, cross-industry attachment rates that encourage deployment and adoption of broadband Internet access services by fulfilling the Commission's intent, expressed clearly in 2011 and upheld in court in 2013, to bring cable and telecom rates for pole attachments into parity at the cable-rate level.
17. The Petitioners maintain, and the Commission agrees, that the cost allocators adopted in the
18. There is widespread agreement that the real average number of attaching entities is regularly far lower than the Commission's presumptions, and that this disparity causes rates calculated with the telecom rate formula to be around 70 percent higher than rates calculated with the cable rate formula. NCTA also reports that, in reality, pole owners routinely rebut the Commission's presumptions with averages such as 2.6 attaching entities. No commenter disputes NCTA's claim or alleges that the number “2.6” is an outlier. Verizon reports several similarly frequent rebuttals to attacher numbers below three. Averages of 2.6 attaching entities rebut both the urban and non-urbanized presumptions, which casts doubt not only on the credibility of the presumptions, but on the validity of the underlying urbanized/non-urbanized distinction as well. Rebuttals that consistently show lower average numbers based on tracking actual attachments may reflect the fact that, under its rules, service territories count as “urban” if any part of them is urban. This approach dilutes the density of these nominally urban areas, and undercuts the Commission's original assumption that such areas would likely have a higher average of attaching entities.
19. Recognizing that the rate reforms of 2011 have failed to align the results of the two pole attachment rate formulas as fully as intended, the Commission adopts the Petitioners' proposal as a template for corrective measures. By introducing new cost allocators of 0.31 percent and 0.56 percent for poles with 2 and 4 attaching entities respectively, with interpolated allocators between the closest whole numbers for fractional averages, the Commission brings parity to pole attachment rates at the cable rate formula level. The Petitioners' proposed solution does not require us to revisit the presumptions themselves; these continue to perform as intended with the 66% and 44% cost allocators that the Commission adopted in 2011. The Commission therefore retains the presumptions for the same reasons the Commission adopted them in 2011: to “expedite the process” and to help utilities “avert the expense” of applying demographic categories. Broadening the effect of the cost allocation system as the NCTA Petition proposes will greatly reduce the effect of, and the need for, the rebuttals. This approach to defining “cost” for purposes of the telecom rate formula achieves results that are consistently close to the cable rate. The new system also satisfies the fundamental purposes for using presumptions: To reduce reporting and recordkeeping requirements, to minimize administrative burdens, and to provide a level of predictability and efficiency in calculating the appropriate rate.
20. The Commission adopts this multiple cost-allocator approach for the same reasons that motivated the initial (but ultimately incomplete) reforms in 2011: To advance the deployment and adoption of broadband Internet access, which remains a fundamental policy goal that guides its implementation of the telecom rate formula. The Commission recognizes that pole rental rates are but one of many considerations underlying marketplace deployment decisions. That said, the Commission promotes broadband deployment on numerous fronts, and has sought public comment and advice on other measures to advance this overarching policy. When discussing pole attachments policy, the Commission refers consistently to incentives for investment. By the same token, it remains the Commission's policy to minimize disincentives to investment, including artificially high pole attachment rates. Lower pole rental rates serve to encourage broadband investment, and Commission continues to use its section 224 authority as one of the tools it brings to bear to on its broadband goals. The Commission also continues to support and subsidize deployment of broadband Internet access in high-cost areas. In contrast, increased pole attachment rates would ultimately be recovered from consumers, and could lead some consumers to cut back or even discontinue their service. Thus, the Commission views pole attachment rate reform as part of the Commission's fundamental mission to advance the availability and adoption of broadband in America.
21. The Commission also intends this action to avoid the unintended consequence of higher pole attachment rates for cable providers that also offer broadband Internet access service, in those cases where the utility rebuts the Commission's attaching party presumptions. Comcast, for example, asserts that “[a]bsent grant of the NCTA/COMPTEL Petition, a costly and time consuming process will ensue whereby utilities will seek to rebut the Commission's attaching entity presumptions, and cable operator attachers will then seek to refute the utilities' attachment studies.” And NCTA observes that, because most cable operators may become subject to the telecom rate, and large numbers of associated attachments are implicated, utilities would have increased incentives to rebut the Commission's presumed number of attachers in areas where they had not done so previously. As a result, this could lead to pole rate increases for both cable operators and pre-existing telecommunications carriers in those areas. In the
22. The Commission also is concerned that unless it closes what one commenter refers to as the “telecom formula loophole,” the resulting rate disparity would, more broadly, frustrate the Commission's policy goals by artificially and incrementally deterring investment in states subject to Commission pole regulation in favor of investment in areas with more favorable state-regulated pole attachment regimes. As the Commission previously has observed, “[c]ommenters report that many [states that have elected to exercise jurisdiction over pole attachments in lieu of the Commission] apply a uniform rate for all attachments used to provide cable and telecommunications services, and have done so by establishing a rate identical or similar to the Commission's cable rate formula.” Thus, if the Commission's telecom rate frequently yielded rates materially above the cable rate, telecommunications service providers that operate in multiple states or are deciding where to enter the marketplace, would have an artificial disincentive to invest in states governed by the Commission's 2011 telecom rate rule relative to states that established a uniform rate identical or similar to the Commission's cable rate formula. Although the Commission's action in this
23. Moreover, the record developed here demonstrates that pole owners routinely rebut the Commission presumptions with averages close to 2.6 attachers. This means that the Commission's standard examples of telecom rates, which presuppose fully-allocated costs and use the Commission's presumptions, have seriously underestimated the pre-reform disparity between cable- and telecom-rate outcomes. In this proceeding, the Commission has compared estimated telecom costs of 11.2 percent in urban areas and 16.9 percent in non-urban areas with fixed cable costs of 7.4 percent. Applying the 2.6 cost allocator that the record supports shows that the telecom rate formula cost estimate would have been 19.1 percent for both urban and rural areas. The discrepancy between the presumed numbers of attachers (5 in urban areas and 3 in rural areas) and actual numbers of attachers used in pole owner rebuttals and reported in the record (often at or close to 2.6) illustrates the substantial problem attachers face when applying the rate reform of the Commission's
24. Along with the forgoing policy considerations, the Commission continues to seek to balance the “legitimate concerns of pole owners and other parties” by preserving incentives to invest in poles and avoiding the imposition of an undue burden on utility ratepayers. In 2011, the Commission ultimately concluded that the level of recovery provided by the cable rate best balanced its broadband deployment mandates and the concerns of pole owners and utility ratepayers. Consistent with that analysis, the Commission explains above that the cable rate frequently is lower than the telecom rate as it previously had been implemented by the Commission, and reducing the telecom rate to cable rate level would further numerous policy goals. The Commission further observed that the cable rate had not produced a “shortage of pole capacity,” and, therefore, approximating that rate in the telecom formula likely would not diminish pole owners' “incentives to invest in poles.” The Commission also found “persuasive the views of consumer advocates . . . recommend[ing] that the cable rate `should be used for all pole attachments.' ”
25. The Commission thus remains persuaded that utility cost recovery at the level of the cable rate best balances the relevant policy considerations. Consequently, the Commission rejects arguments that the rule revision, which will more consistently and accurately ensure that the Commission's policy goals are achieved, will somehow upset the Commission's intended balance, unfairly burden utility ratepayers, or undermine the sharing of infrastructure costs. Likewise, while some commenters observe that other aspects of the
26. Utilities dismiss this policy balancing on several grounds, none of which persuade the Commission. The Utilities Telecom Council (UTC) argues that pole attachment rental is insignificant compared to other operating costs of large cable companies. Electric Utilities state that capital expenditure, and not pole attachment rental, drives deployment, and that pole attachment rental accounts for less than 2 percent of the cost of deploying fiber optic cable. UTC argues that there has been only a slow rate of broadband deployment since the telecom rate was adjusted in 2011, which proves the futility of lowering pole attachment rates, and that any cost savings from lower pole attachment rates have not been passed on to consumers, but rather, as a result of industry consolidation, have been pocketed by providers instead.
27. The Commission is skeptical that sums alleged to “unfairly and negatively impact utilities and their ratepayers” are “insignificant” in the context of broadband deployment. While the record does not include quantifiable information regarding the exact effect on deployment of pole attachment rates, insofar as keeping attachment rates reasonable for cable companies prevents them from shelving even a small number of projects, the Commission would not consider that result “insignificant.” There remains room for improvement in the rate of broadband expansion, and the Commission cannot afford to dismiss the importance of even potentially small increments. Commenters state that cable companies continue to deploy facilities, and Commission intend to avert any destabilization of those plans that might arise from a large and sudden pole attachment rate increase. The Commission is particularly mindful of the potential for harm to rural areas, which are the least served areas in the nation, and where the most additional pole attachments are needed to reach additional customers.
28. Utilities further argue that granting the NCTA Petition would unfairly reduce their revenue from pole attachments. They argue that the
29. Utilities argue that increasing demand for pole space should lead to increased prices, and that any downward rate adjustment runs counter to economic principles. The Commission attaches no significance to this assertion. The express reason for the statutory imposition of cost-based, regulated rates is to bypass the economic principle that “ `public utilities by virtue of their size and exclusive control over access to pole lines, are unquestionably in a position to extract monopoly rents . . . in the form of unreasonably high pole attachment rates.' ” By enacting cost-based rate formulas, Congress has already accounted for the economics of scarcity that so favor pole owners. Attachment rates agreed to by broadband-only providers before reclassification may indeed be called into question, but that is because these entities are now within the ambit of Section 224, and not because the Commission revises the method of cost allocation used in the telecom rate formula.
30. Utilities claim that “downward pressure” on rates “weakens the predictability and timeliness of the access process” but this argument makes little sense. Attachers pay (and owners recover) the entire cost of access through make-ready fees paid before the attacher's facilities are mounted on
31. The modified telecom rate rule adopted in this
32. The
33. As a threshold matter, this Order leaves unaltered the section 1.1409(e)(2)(ii) `cost-causation'-based calculation. That calculation still will be performed whenever the Commission's telecom rate rule is used, and even utility commenters concede that it does “not do away with apportioning the costs among all attaching entities” in accordance with section 224(e). The definition of cost for purposes of that provision excludes capital costs and was designed to yield a rate that approached the incremental cost of attachment.
34. The question of whether, and to what extent, to allow utilities to go beyond the recovery permitted by the section 1.1409(e)(2)(ii) telecom rate calculation and recover some capital costs ultimately depends on a further policy evaluation. As the Commission explained in 2011, and as the Commission reiterates above, its implementation of section 224 is guided in significant part by its mandate to encourage the deployment of broadband. That policy, if overriding other considerations, might counsel in favor of relying solely on the rate yielded by the `cost-causation' calculation in section 1.1409(e)(2)(ii), rather than permitting higher rates as just and reasonable under section 224(e). But the Commission also sought—and continues to seek—to balance the “legitimate concerns of pole owners and other parties” by preserving incentives to invest in poles and avoiding the imposition of an undue burden on utility ratepayers.
35. As described above, in 2011 the Commission adopted rules that it anticipated would result in a telecom rate that generally approximated the cable rate. In practice, however, the rule the Commission adopted has only poorly reflected the balancing of policy interests that the Commission anticipated attaining in 2011 because the facts on the ground differed significantly from the Commission presumptions upon which the 2011 rule was predicated. As a result, telecom rates calculated based on the Commission's rules frequently were higher than the levels the Commission generally sought to achieve as just and reasonable under section 224(e)—
36. Thus, the Commission adopts the Petitioners' proposal and modifies section 1.1409(e)(2)(i) of the rules by redefining the ambiguous term “cost” as a percentage of fully allocated costs that depends on whether the average number of attaching entities in an area is 2, 3, 4, or 5. The specific percentage of fully allocated costs that Commission adopts in each of those instances will yield a rate under section 1.1409(e)(2)(i) that more closely and consistently approximates the cable rate.
37. Although this definition of cost is based on an integer average number of attachers in an area, consistent with the Commission's efforts to ensure that it implements section 224(e) in a “readily administrable” manner, the proposal the Commission adopts incorporates a mechanism to allow parties, should they so choose, to continue to rely on non-integer average numbers of attachers in a service area by interpolating from the specified cost allocators in section 1.1409(e)(2)(i) of the rules in a manner that does not undermine the definition of cost adopted above. In pertinent part, section 224(e)(2) is focused on allocating the “cost”—however defined—of providing space on a pole other than useable space. Although a given pole only will have an integer number of attaching entities, for administrability the Commission has long permitted pole attachment rates to be calculated based on surveys or averages of the number of attaching entities in the relevant service area, which has the potential to yield an average number of attachers that is not an integer number. The use of a non-integer number of attaching entities in conjunction with the new definition of cost adopted for areas with 2, 3, 4, or 5 average attaching entities in revised section 1.1409(e)(2)(i) of the rules would result in similar, even if not always as extensive, deviations from the cable rate as the Commission found to result under the version of the rule adopted in 2011. The Commission concludes that such deviation is at odds with the balancing of policy interests it seeks to achieve through its revisions to section 1.1409(e)(2)(i) and also anticipates that it would increase the likelihood of disputes. The Commission thus adopts the interpolation mechanism in Petitioners' proposal, which will leave parties free to continue using non-integer average number of attachers should they choose to do so, without undermining its ability to ensure just and reasonable rates under section 224(e) in an administrable manner.
38. Insofar as the reclassification of broadband Internet access service results in most Commission-regulated attachments becoming subject to the telecom rate, that counsels in favor of its redefinition of cost, contrary to the claims of some commenters. The Commission recognizes that the
39. The Commission also disagrees with the suggestions of some commenters that only certain types of policy considerations can form the basis for its interpretation and implementation of the ambiguous term “cost” in section 224(e). As the D.C. Circuit recognized in
40. Nor does modification of the telecom rate rule render section 224(e)(2) of the Act a nullity, as some allege. For one, the Commission's telecom rate rule requires a comparison of the output of two calculations, and as explained above, even utilities appear to concede that the cost-causation-based calculation in section 1.1409(e)(2)(ii) gives meaning to section 224(e)(2). Moreover, under revised section 1.1409(e)(2)(i) the apportionment specified in section 224(e)(2) is given meaning because it is only by applying that apportionment to the definition of “cost” adopted above that the resulting rate will closely approximate the cable rate, and thus be just and reasonable under the analysis above.
41. The Commission also rejects claims that its approach to interpreting “cost” otherwise is at odds with Congressional intent and the text and structure of section 224. The
42. In implementing section 224(e), the Commission considers the broader purposes of section 224, as also informed by other statutory goals and mandates. As in the
43. The Commission also is not persuaded by arguments that section 224(e)(2) limits the costs to be borne by pole owners. As described above, the Commission's fundamental responsibility under section 224(e) is to ensure that regulated rates “for pole attachments used by telecommunications carriers to provide telecommunications services” are just, reasonable, and nondiscriminatory. Read in that context, the Commission interprets section 224(e)(2) only to govern the apportionment of the “cost”—however defined—of unusable space in the rates pole owners charge to telecom attachers. It is true that the methodology used to calculate the apportionment of “cost” to a telecom attacher under section 224(e)(2) involves a calculation of what “all attaching entities” would bear assuming hypothetically that they all bore an equal apportionment of such cost. But it does not actually govern the cost to be borne by entities other than telecom attachers—whether the pole owner or other attachers.
44. Adopting this change to section 1.1409(e)(2)(i) of the rules is procedurally proper. Following the Commission's 2010
45. The Commission also rejects claims that additional notice and comment is needed before it can proceed under the theory that the action in this Order effectively would modify sections 1.1417(c) and (d) of the rules. Section 1.1417(c) specifies the Commission's rebuttable presumptions of 5 attaching entities in urbanized areas and 3 attaching entities in non-urbanized areas. Section 1.1417(d) describes how a utility can instead establish its own presumptive average number of attaching entities, subject to rebuttal. As a threshold matter, the Commission is not persuaded by commenters' claims that the Petitioners' proposed revision to section 1.1409(e)(2)(i) would render those rules “moot.” Under the utilities' own theory, the Commission-specified presumptions in section 1.1417(c) would have increased, rather than diminished, significance when performing the section 1.1409(e)(2)(i) calculation because it would obviate the need for utilities to expend the effort to develop their own presumptive average numbers of attachers if they believe that variation in the number of attachers would not matter. Further, although the result of the calculation in section 1.1409(e)(2)(i) frequently will be higher than that yielded by the cost-causation-based calculation in section 1.1409(e)(2)(ii), its rules provide for both to be performed, with the possibility that there will be cases where the section 1.1409(e)(2)(ii) calculation is controlling. The outcome under section 1.1409(e)(2)(ii) unquestionably does vary with the number of attaching entities, and thus the utilities' ability to develop their own presumptive number of attaching entities under section 1.1417(d) remains important where the cost-causation-based calculation would be, or could be, controlling.
46. Although the Commission is not persuaded that any implications of its change to section 1.1409(e)(2)(i) of the rules for sections 1.1417(c) and (d) constitute substantive rule changes, even assuming
47. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).
48. As required by the Regulatory Flexibility Act of 1980 (RFA), the Commission includes in Appendix B a Supplemental Final Regulatory Flexibility Analysis (FRFA) relating to this
49. The Commission will send a copy of the
50. As required by the Regulatory Flexibility Act of 1980, as amended (RFA).
51. An Initial Regulatory Flexibility Analysis (IRFA) was included in the
52. In this
53. No comments relating to any of the IRFAs have been filed since the
54. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
55.
56.
57.
58. The Commission has included small incumbent local exchange carriers in this present RFA analysis. As noted above, a “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard (
59.
60. Competitive Local Exchange Carriers (“CLECs”), Competitive Access Providers (“CAPs”), “Shared-Tenant Service Providers,” and “Other Local Service Providers.” Neither the Commission nor the SBA has developed a small business size standard
61.
62.
63.
64.
65.
66. In 2001, the Commission completed the auction of 422 C and F Broadband PCS licenses in Auction 35. Of the 35 winning bidders in this auction, 29 qualified as “small” or “very small” businesses. Subsequent events, concerning Auction 35, including judicial and agency determinations, resulted in a total of 163 C and F Block licenses being available for grant. In 2005, the Commission completed an auction of 188 C block licenses and 21 F block licenses in Auction 58. There were 24 winning bidders for 217 licenses. Of the 24 winning bidders, 16 claimed small business status and won 156 licenses. In 2007, the Commission completed an auction of 33 licenses in the A, C, and F Blocks in Auction 71. Of the 14 winning bidders, six were designated entities. In 2008, the Commission completed an auction of 20 Broadband PCS licenses in the C, D, E and F block licenses in Auction 78.
67.
68.
69.
70.
71.
72.
73.
74. In addition, the SBA's Cable Television Distribution Services small business size standard is applicable to EBS. There are presently 2,032 EBS licensees. All but 100 of these licenses are held by educational institutions. Educational institutions are included in this analysis as small entities. Thus, the Commission estimates that at least 1,932 licensees are small businesses. Since 2007, Cable Television Distribution Services have been defined within the broad economic census category of Wired Telecommunications Carriers; that category is defined as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” The SBA has developed a small business size standard for this category, which is: All such firms having 1,500 or fewer employees. To gauge small business prevalence for these cable services the Commission must, however, use current census data that are based on the previous category of Cable and Other Program Distribution and its associated size standard; that size standard was: all such firms having $13.5 million or less in annual receipts. According to Census Bureau data for 2002, there were a total of 1,191 firms in this previous category that operated for the entire year. Of this total, 1,087 firms had annual receipts of under $10 million, and 43 firms had receipts of $10 million or more but less than $25 million. Thus, the majority of these firms can be considered small.
75.
76.
77.
78.
79.
80.
81.
82.
83.
84.
85. The new rule concerns a cost allocation method that parties use in a formula when negotiating just and reasonable pole attachment rental rates. Application of the cost allocation rule is expanded but not altered from the cost
86. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include (among others) the following four alternatives: (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities. Cost allocation methodologies used in pole attachment rate formulas are by nature the same for all entities that use them, regardless of size. No party suggested that the Commission develop alternative approaches to cost allocation based on entity size.
87. None.
88. Accordingly,
89.
90.
91.
92.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 1 Subpart J as follows:
15 U.S.C. 79,
(e) * * *
(2) * * *
(i) The following formula applies to the extent that it yields a rate higher than that yielded by the applicable formula in paragraph 1.1409(e)(2)(ii) of this section:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
In this final rule, NMFS allows large federally permitted U.S. longline vessels to fish in certain areas of the Large Vessel Prohibited Area (LVPA). NMFS will continue to prohibit fishing in the LVPA by large purse seine vessels. The fishing requirements for the Rose Atoll Marine National Monument remain unchanged. The intent of the rule is to improve the viability of the American Samoa longline fishery and achieve optimum yield from the fishery while preventing overfishing, in accordance with National Standard 1.
Effective January 29, 2016.
The Western Pacific Fishery Management Council (Council) prepared a regulatory amendment that provides background information on this final rule. The regulatory amendment, identified as NOAA-NMFS-2015-0080, includes an environmental assessment and regulatory impact review, and is available from
Jarad Makaiau, NMFS PIRO Sustainable Fisheries, 808-725-5176.
The American Samoa large vessel prohibited area (LVPA) extends seaward approximately 30-50 nm around the various islands of American Samoa (see 50 CFR 665.806(b)). Federal regulations restrict vessels 50 ft and longer from fishing for pelagic management unit species within the LVPA. The Council and NMFS established the LVPA in 2002 to prevent the potential for gear conflicts and catch competition between large and small fishing vessels. You may read more about the LVPA in the 2001 proposed rule (66 FR 39475, July 31, 2001) and 2002 final rule (67 FR 4369, January 30, 2002).
Since 2002, the American Samoa pelagic fisheries have changed such that the conditions that led the Council and NMFS to establish the LVPA are no longer present. The LVPA may be unnecessarily reducing the efficiency of the larger American Samoa longline vessels by displacing the fleet from a part of their historical fishing grounds.
To address the current fishery conditions, the Council recommended that NMFS allow federally permitted U.S. longline vessels 50 ft and longer to fish in portions of the LVPA. Specifically, this action allows large U.S. vessels that hold a Federal American Samoa longline limited entry permit to fish within the LVPA seaward of 12 nm around Swains Island, Tutuila, and the Manua Islands. NMFS will continue to prohibit fishing in the LVPA by large purse seine vessels. The fishing requirements for the Rose Atoll Marine National Monument also remain unchanged.
This action allows fishing in an additional 16,817 nm
The Council and NMFS will annually review the effects of this final rule on catch rates, small vessel participation, and sustainable fisheries development initiatives. Any future changes would be subject to additional environmental review and opportunity for public review and comment.
On August 25, 2015, NMFS published the proposed rule and draft environmental assessment (EA) for public comment (80 FR 51527). The comment period ended September 24, 2015. NMFS received comments from over 270 individuals, commercial and recreational fishermen, businesses, Territorial government offices (including the Governor of American Samoa and the American Samoa Department of Marine and Wildlife Resources), Federal agencies, and non-governmental organizations. NMFS responds to these comments below.
As described in the EA, fewer than 50 other small commercial and recreational vessels fish for yellowfin and skipjack tunas and billfishes in nearshore waters and on offshore banks around American Samoa. Therefore, even accounting for the potential for competition with pelagic troll and recreational vessels, the conditions that led to the establishment of the LVPA in 2002 no longer support the full extent (30-50 nm) of the original prohibited area for longlining.
While the LVPA may benefit a few small alia vessels and these other fishing sectors, the LVPA may be further reducing the fishing efficiency of large longline vessels in combination with reduced catch per unit of effort (CPUE), lower sale price of fish, and increasing operational costs.
This action would allow large longline vessels in American Samoa to fish within the LVPA to as close as 12 nm of shore around Tutuila, Aunuu, the Manua Islands, and Swains. Waters from the shoreline to 12 nm around these islands, and within the Rose Atoll Marine National Monument, will remain closed to large longline vessels. This would continue to afford all other vessels and fishing sectors adequate spatial separation from the large vessel longline fleet and minimize the potential for catch competition and potential for gear interactions. This exemption applies only to large longline vessels of the United States that hold an American Samoa limited entry longline permit under 50 CFR 665.801.
The American Samoa longline fishery does not operate within the boundaries of the National Marine Sanctuary of America Samoa, which extends from the shoreline out to a distance of approximately 3 nm. The American Samoa longline fleet targets highly migratory pelagic species such as albacore at considerable distances from the shoreline seaward of the outer-boundary of the American Samoa sanctuary. Because the action continues to prohibit longline fishing by large vessels from occurring within 12 nm of American Samoa and within the Sanctuary, NMFS does not expect the action would affect marine populations protected by the sanctuary.
The Council has been working with the American Samoa government on several fishery development initiatives, including the design of a new multi-purpose alia fishing vessel and training in fresh fish handling for local and export markets. Smaller, alia-type vessels are likely better suited to conduct fresh fish operations targeting yellowfin and bigeye tunas and, as such, would minimize the potential economic
Sport fishing vessels generally operate within 12 nm from shore and in offshore areas around banks and seamounts, which longline vessels actively avoid to reduce the potential for longline gear tangling on bottom substrates. Furthermore, sport fishing and subsistence fishing beyond 12 nm from shore does not occur at sufficient frequency or concentration to justify the continued restriction of large longline vessels out to the full 50 nm to control the potential for gear conflict or catch competition. Although NMFS allows recreational and non-commercial fishing within the Rose Atoll Marine National Monument beyond 12 nm with a federal permit, all commercial fishing, including longline fishing is prohibited throughout the monument out to a distance of approximately 50 nm around the atoll.
Furthermore, the frequency and concentration of small alia longline vessels and small non-longline vessels fishing seaward of 12 nm is lower than that of the large longline vessels. Many of these small vessels are recreational and do not operate on a daily basis. The EA discusses the potential impacts of fishery participants, including impacts to the small vessel fleets and indicates this action will continue to provide for sufficient spatial separation between small and large vessels. The Council and NMFS used the best available information provided by the American Samoa Department of Marine and Wildlife Resources (DMWR) creel survey to estimate the number of vessels operating in the LVPA. See also response to Comment 18.
NMFS took particular care to ensure that the views of American Samoa stakeholders, including fishermen, fishing communities, and the American Samoa government, were solicited and taken into account throughout the development of this action. Consistent with the Magnuson-Stevens Act, the Council and NMFS provided a number of opportunities for American Samoa's participation during all material phases of the development of this measure, including Council meetings to discuss the amendment, the Coastal Zone Management Act (CZMA) process, and public meetings held in American Samoa (see response to Comment 1).
Although participation and effort in the American Samoa longline fishery has varied and declined in recent years, NMFS expects that the level of participation, in terms of fleet-wide sets and hooks deployed, likely will return to historic levels. For this reason, the analysis in the 2015 BiOp anticipated the American Samoa longline fishery operating up to the level seen in 2007 when 29 vessels deployed 5,920 sets and approximately 17,554,000 hooks, and evaluated the potential environmental effects of the fishery operating at these levels. Additionally, NMFS anticipates the continued placement of observers on approximately 20 percent of all longline trips.
In the 2015 BiOp, NMFS concluded that the continued operation of the American Samoa longline fishery under existing federal regulations, and effort levels expected under the proposed action, is not likely to jeopardize the continued existence of any ESA-listed species, including sea turtles. NMFS based this conclusion on a thorough assessment of the effects of the action, together with the environmental baseline and the cumulative effects. The EA analysis considered the information presented in the 2015 BiOp and found that the expected level of fishery interactions under the proposed action would not result in significant population level effects for any ESA-listed species or their habitats, including sea turtles.
In the 2015 BiOp, NMFS estimated anticipated future interactions between the fishery and leatherbacks sea turtles. NMFS used previous, observed interactions and anticipated effort in the fishery to predict the future level of take. NMFS then used a discounting methodology to analyze the impact of this level of take on the leatherback population.
NMFS based the interaction estimates in the BiOp on a random sample of longline trips on which scientific observers are deployed. Relying on Table 7 of the 2015 BiOp, NMFS estimates 36 total leatherback interactions between 2011 and mid-2015 (based on eight observed interactions). NMFS used these interactions to calculate an average rate of interaction. That was then multiplied by the anticipated annual effort in the fishery to determine that 23 leatherback interactions are anticipated annually. NMFS then applied a leatherback mortality rate of 70.6, based on observed mortalities, injuries, and applying the NMFS post-hooking mortality criteria (Ryder et al. 2006).
Accordingly, NMFS anticipates 23 interactions to result in 16.28 (23 × 0.76 = 16.28) leatherback sea turtle mortalities. However, many of these interactions occur with juvenile sea turtles that already experience low survival rates even in the absence of fishing. Therefore, NMFS must apply a discount to the expected rate of annual interactions in order to estimate the risk that the proposed action would pose to the western Pacific leatherback sea turtle population.
NMFS first estimated the number of adult females or adult nester equivalents (ANE) harmed through injury or death related to the fishery. The American Samoa longline fishery interacts with male and female leatherback sea turtles, and they are predominantly juveniles (Van Houtan 2015). To estimate the number of adult females that could potentially be killed by 23 interactions, two adjustments were applied to the calculation above: (1) The proportion of females in the adult population (using a ratio of 65 percent females to 35 percent males); and (2) the adult equivalent represented by each juvenile interaction. The adult equivalent was determined using the discounting method (Van Houtan 2013, 2015). This discounting method summarized in the 2015 BiOp incorporates an exact demographic match to the observed interactions, and relies on length measurements by fishery observers of bycaught turtles, and conversion of these recorded lengths to ages. Therefore, of the estimated 16.28 leatherback sea turtle mortalities, NMFS estimates 10.58 would be females (16.28 × 0.65 = 10.58). Applying the adult equivalent discounting method (Van Houtan 2013, 2015), NMFS estimates 23 leatherback interactions would result in the mortality of 0.55 adult females annually, or one adult female mortality every 1.8 years from a nesting population of 2,739 females (Van Houtan 2015). This represents less than 0.0002, or 0.02 percent of the nesting population in the region. NMFS considers this level of impact to the population to be negligible, and it will not adversely affect the species' ability to survive, successfully reproduce, and recover.
NMFS believes that the commenter made several assumptions in the calculations that led to a flawed conclusion on sea turtle mortality. The commenter assumed, for instance, an observer coverage rate of 20 percent over the four-year period, and then apparently multiplied the observed number of injured and killed since 2010
The mortality rate is an average rate where mortality is 100 percent and injuries are assessed at a rate between 0 and 100 percent, based on the observed hooking or entanglement injuries and using the NMFS post-hooking mortality criteria (Ryder et al. 2006). Therefore, the mortality rate of 70.6 percent already accounts for all observed mortalities. Thus, applying this rate to the expanded, injured turtle count is an incorrect use of the mortality rate. Furthermore, the mortality rate of 70.6 percent is a conservative mortality rate because NMFS did not separate out the larger turtles from the younger, smaller turtles that have a much higher mortality rate. The five smaller turtles were boarded dead (a mortality rate of 100 percent) and the three larger turtles that were not boarded had a mortality rate of 21.7 percent. When using these individual mortality rates in the ANE calculation, the ANE is 0.33 rather than 0.55. While NMFS provided exact measurements for two turtles, it is incorrect to assume the other turtles were adults. In fact, the fishery predominantly interacts with juvenile turtles; of the eight observed interactions with leatherbacks in this fishery, five were juveniles and three were adults.
NMFS, therefore, believes that the data and analysis contained in the 2015 BiOp and EA are the best available science on which to base determinations of the impact by the fishery to protected marine species.
Based on the analysis in the 2015 BiOp, NMFS estimates the longline fishery would cause 0.55 adult female mortalities annually. This is the equivalent of one adult female mortality every 1.8 years from a nesting population of 2,739 females in the Western Pacific population. (Van Houtan 2015). This represents less than 0.0002 (0.02 percent) of the nesting population in the region. In the 2015 BiOp, NMFS concluded that this anticipated level of interactions and associated adult female mortalities under the proposed action is not likely to jeopardize the continued existence of leatherback sea turtle populations. The analysis in the EA further indicates that 0.55 adult female mortalities annually or 1.65 adult female mortalities over a 3-yr period is not likely to pose an appreciable risk or result in significant impacts to leatherback sea turtle populations in the Western Pacific region.
The targeting of swordfish generally requires deployment of hooks shallower than 100 meters. However, as described in the draft EA, current federal regulations require all hooks set by the fishery to be set deeper than 100 meters in order to minimize the risk of sea turtle interaction. Thus, current federal regulations prohibit American Samoa longline vessels from targeting swordfish with hooks set shallower than 100 meters in the American Samoa EEZ.
NMFS notes that the Council has taken action to recommend creating a shallow-set longline fishery in American Samoa. The Council, however, has not yet developed an amendment or associated environmental impact analyses describing such a fishery. Should the Council propose that action as an amendment, NMFS would conduct all necessary analyses to determine whether the action complies with the Magnuson-Stevens Act and all applicable laws. At this time, however, NMFS is satisfied that the final EA adequately assesses the cumulative impact of the Council action and all reasonably foreseeable actions.
In this final rule, NMFS made minor housekeeping changes in the tables of boundary coordinates in § 665.818(b). In the proposed rule, NMFS had labeled the points for each coordinate with simple numbers. Using the same numbers for each table could lead to confusion among fishermen and enforcement officials, so in this final rule, NMFS added prefixes for boundary point labels that are different for each island or island group. Specifically, the Tutuila coordinates carry the prefix “TU-,” the Manua coordinates carry the prefix “MA-,” and the Swains coordinates carry the prefix “SW-.”
Also in the proposed rule, in the table of boundary coordinates for Swain's Island at § 665.818(b)(3), NMFS only listed degrees and minutes in defining the latitude and longitude for each coordinate, and inadvertently omitted the seconds. In this final rule, NMFS corrects that omission by including degrees, minutes, and seconds for each boundary coordinate.
The final rule also corrects the first instance of the coordinate for MA point 1. The proposed rule listed the W. long. coordinate as 169°53′7″. The final rule
This final rule also clarifies that the datum used to define the boundary coordinates in § 665.818(b) is the World Geodetic System 1984 (WGS84).
The Regional Administrator, Pacific Islands Region, NMFS, has determined that this final rule is necessary for the conservation and management of the pelagic fisheries of American Samoa, and that it is consistent with the Magnuson-Stevens Act and other applicable laws.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. NMFS published the factual basis for the certification in the proposed rule and does not repeat it here. NMFS received no comments on this certification; as a result, a regulatory flexibility analysis is not required, and none has been prepared.
Because this rule relieves a restriction by increasing the geographical area where fishing is allowed, it is not subject to the 30-day delayed effectiveness provision of the APA pursuant to 5 U.S.C. 553(d)(1). Since 2002, NMFS has prohibited pelagic longline fishing by large U.S. vessels in the LVPA, which extended seaward approximately 30-50 nm around the various islands of American Samoa. At that time, the Council and NMFS intended the LVPA to prevent gear conflicts and catch competition between large and small fishing vessels. Since 2002, however, the conditions that led to the establishment of the LVPA in 2002 no longer support the full extent (30-50 nm) of the original prohibited area for longlining. The LVPA may be unnecessarily reducing the efficiency of the larger vessels by displacing them from a part of their historical fishing grounds. This action will allow large vessels to fish within the LVPA to as close as 12 nm around the islands. The action adds about 16,817 nm
This final rule has been determined to be not significant for purposes of Executive Order 12866.
Administrative practice and procedure, American Samoa, Fisheries, Fishing, Guam, Hawaiian natives, Northern Mariana Islands, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, NMFS amends 50 CFR part 665 as follows:
16 U.S.C. 1801
(a)
(2) A landing of western Pacific pelagic MUS for the purpose of this paragraph must have been properly recorded on a NMFS Western Pacific Federal daily longline form that was submitted to NMFS, as required in § 665.14.
(3) An exemption is valid only for a vessel that was registered for use with a Western Pacific general longline permit and landed western Pacific pelagic MUS in American Samoa on or prior to November 13, 1997, or for a replacement vessel of equal or smaller LOA than the vessel that was initially registered for use with a Western Pacific general longline permit on or prior to November 13, 1997.
(4) An exemption is valid only for the vessel for which it is registered. An exemption not registered for use with a particular vessel may not be used.
(5) An exemption may not be transferred to another person.
(6) If more than one person,
(b)
(1) EEZ waters around Tutuila Island enclosed by straight lines connecting the following coordinates (the datum for these coordinates is World Geodetic System 1984 (WGS84)):
(2) EEZ waters around the Manua Islands enclosed by straight lines connecting the following coordinates (WGS84):
(3) EEZ waters around Swains Island enclosed by straight lines connecting the following coordinates (WGS84):
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for pollock in Statistical Area 610 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2016 total allowable catch of pollock for Statistical Area 610 in the GOA.
Effective 1200 hrs, Alaska local time (A.l.t.), January 29, 2016, through 1200 hrs, A.l.t., March 10, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The A season allowance of the 2016 total allowable catch (TAC) of pollock in Statistical Area 610 of the GOA is 3,827 metric tons (mt) as established by the final 2015 and 2016 harvest specifications for groundfish of the GOA (80 FR 10250, February 25, 2015) and inseason adjustment (81 FR 188, January 5, 2016).
In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the A season allowance of the 2016 TAC of pollock in Statistical Area 610 of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 3,727 mt and is setting aside the remaining 100 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 610 of the GOA.
After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for pollock in Statistical Area 610 of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 28, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reallocation.
NMFS is reallocating the projected unused amount of Pacific cod from vessels using jig gear to catcher vessels less than 60 feet (18.3 meters) length overall using hook-and-line or pot gear in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the A season apportionment of the 2016 total allowable catch of Pacific cod to be harvested.
Effective February 1, 2016 through 2400 hours, Alaska local time (A.l.t.), December 31, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The A season apportionment of the 2016 Pacific cod total allowable catch (TAC) specified for vessels using jig gear in the BSAI is 1,887 metric tons (mt) as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and inseason adjustment (81 FR 184, January 5, 2016).
The 2016 Pacific cod TAC allocated to catcher vessels less than 60 feet (18.3 meters(m)) length overall (LOA) using hook-and-line or pot gear in the BSAI is 4,476 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and inseason adjustment (81 FR 184, January 5, 2016).
The Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that jig vessels will not be able to harvest 1,750 mt of the A season apportionment of the 2016 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)(
The harvest specifications for Pacific cod included in the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015)
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Pacific cod specified from jig vessels to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear. Since the fishery is currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 28, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2016 Pacific cod total allowable catch apportioned to vessels using pot gear in the Central Regulatory Area of the GOA.
Effective 1200 hours, Alaska local time (A.l.t.), February 1, 2016, through 1200 hours, A.l.t., June 10, 2016.
Obren Davis, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.
The A season allowance of the 2016 Pacific cod total allowable catch (TAC) apportioned to vessels using pot gear in the Central Regulatory Area of the GOA is 6,528 metric tons (mt), as established by the final 2015 and 2016 harvest specifications for groundfish of the GOA (80 FR 10250, February 25, 2015) and inseason adjustment (81 FR 188, January 5, 2016).
In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2016 Pacific cod TAC apportioned to vessels using pot gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 6,518 mt and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of Pacific cod for vessels using pot gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 28, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend the Animal Welfare Act regulations concerning the humane handling, care, treatment, and transportation of marine mammals in captivity. These proposed changes would affect sections in the regulations relating to variances and implementation dates, indoor facilities, outdoor facilities, space requirements, and water quality. We are also proposing to revise the regulations that relate to swim-with-the-dolphin programs. We believe these actions are necessary to ensure that the minimum standards for the humane handling, care, treatment, and transportation of marine mammals in captivity are based on current industry and scientific knowledge and experience.
We will consider all comments on this proposed rule that we receive on or before April 4, 2016. To be assured consideration, comments on the information collection requirements related to this proposal should be submitted on or before March 4, 2016.
You may submit comments by either of the following methods:
• Federal eRulemaking Portal: Go to
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2006-0085, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.
Supporting documents and any comments we receive on this docket may be viewed at
Dr. Barbara Kohn, Senior Staff Veterinarian, Animal Care, APHIS, 4700 River Road, Unit 84, Riverdale, MD 20737-1234; (301) 851-3751.
This proposed rule would affect sections in the regulations for the protection of all marine mammals in the United States relating to interactive programs (
The Animal Welfare Act (the Act) (7 U.S.C. 2131
We propose to revise swim-with-the-dolphin program regulations, for which enforcement was suspended effective April 2, 1999. This proposal contains revised standards that we propose to enforce for these programs. The proposed standards address interactive program facility space requirements, layout, operations, staffing, recordkeeping, and related matters. We set forth the proposed standards as performance-based standards wherever we believe such an approach is feasible and supportable by current information and scientific documentation.
The current subpart E regulations include minimum space requirements for the primary enclosure for species of marine mammals. We do not propose substantive changes to any of the minimum space requirements (§ 3.104), but we do propose clarifying how such areas are measured, updating and correcting discrepancies between formal calculations and current entries into space tables, and other enclosure matters.
We also propose some changes to the regulations concerning water quality in facilities. These changes would implement the results of our review of recent studies of water quality and waterborne pathogens affecting marine mammals.
The current regulations include conditions and deadlines for variance requests for space. These deadlines are out of date, but the ability for APHIS to grant temporary variances is an important tool when assuring the welfare of marine mammals. Therefore, we propose to update the conditions that can be addressed by a variance and identify the factors we use to approve or disapprove a variance request.
The current regulations also provide standards for air and water temperatures, ventilation, and lighting at regulated indoor facilities that house marine mammals. We propose to revise these requirements to apply current best practices and recent scientific studies in order to ensure the welfare of the animals with respect to temperature,
We also propose to revise the regulations covering standards for outdoor facilities, to require that the air and water temperature ranges at outdoor facilities be in accordance with the currently accepted husbandry practices for the species housed.
The Animal Welfare Act (the Act) (7 U.S.C. 2131
Under the Act, APHIS established regulations in 1979 for the humane handling, care, treatment, and transportation of marine mammals used for research or exhibition purposes. The regulations contain standards for the humane handling, care, treatment, and transportation of marine mammals (part 3, subpart E, §§ 3.100 through 3.118). Some sections of these regulations have not been substantively amended since 1984.
In 1995, we established a Marine Mammal Negotiated Rulemaking Advisory Committee (the Committee) to advise the Department on revisions to the marine mammal regulations. The Committee met for three sessions between 1995 and 1996. Under the rules governing the negotiated rulemaking process, and in accordance with the organization protocols established by the Committee, APHIS agreed to publish as a proposed rule any consensus language developed during the meetings unless substantive changes were made as a result of authority exercised by another Federal Government entity. The Committee developed consensus language for changes to 13 of the 18 sections that comprise the 1979 regulations and for 1 paragraph in a 14th section.
On February 23, 1999, we published a proposed rule in the
Although consensus language was developed by the Committee for 13 of the 18 sections of the regulations in their entirety, and for 1 paragraph of another section, the Committee conducted extensive discussions on all sections of the regulations. No consensus language was developed for four sections of the standards: § 3.100 on variances and implementation dates; § 3.102 on indoor facilities; § 3.103 on outdoor facilities; and § 3.106 on water quality. Consensus language was developed for general space requirements for the 14th section, but not on the specific space requirements for particular marine mammals. The Committee agreed that APHIS would develop and promulgate a proposed rule to address those parts of the regulations for which consensus language was not developed.
In addition to the 1979 regulation and the 2001 amendments, we published a proposed rule to establish standards for swim-with-the-dolphin programs in a new § 3.111 on January 23, 1995 (60 FR 4383-4389, Docket No. 93-076-2). The swim-with-the-dolphin rule was a new standard and not included in the goal of updating the existing standards in subpart E. After reviewing the comments for the swim-with-the-dolphin proposed rule and the results from a National Oceanic and Atmospheric Administration (NOAA)-sponsored study conducted between 1992-1994,
Following publication of the final rule, a number of parties affected by the rule contacted us and asserted that they did not fully understand the regulatory implications of the proposed and final rules for wading programs, encounter programs, and other interactive programs. Specifically, these regulated parties stated that it had not been clear to them that we intended the provisions of the rule to apply to shallow-water interactive programs. Shallow-water interactive programs are programs in which members of the public enter the primary enclosure of a cetacean to interact with the animal, and in which the participants remain primarily stationary and nonbuoyant. The regulated parties stated that, because of this misunderstanding, they had not been able to participate fully in the rulemaking process.
In response to these concerns, on October 14, 1998 (63 FR 55012, Docket No. 9307612), we announced that, as of the effective date of the September 4, 1998, final rule, and until further notice, we would not enforce the standards relating to space for the interactive area and human participant/attendant ratio to shallow-water interactive programs. Subsequently, on April 2, 1999 (64 FR 15918-15920, Docket No. 93-076-13), we suspended enforcement of all of § 3.111. This meant that only the specific requirements of § 3.111 would be excluded from citation of noncompliant items. All interactive programs were and still are at AWA licensed facilities and thereby required to comply with all other regulations and standards appropriate for that facility. The facility and animals remained under AWA oversight by USDA.
On May 30, 2002 (67 FR 37731-37732, Docket No. 93-076-17), we published in the
A commenter recommended that § 3.100, “Special considerations regarding compliance and/or variance,” should be deleted, stating that there is no good reason to grant a variance from the space requirements. Another commenter suggested that temporary
Several commenters asserted that rigid standards for air and water temperatures would be counterproductive and would not guarantee the health and well-being of the marine mammals. These commenters said that animals may be acclimated to temperatures outside of any ranges that APHIS may establish. On the other hand, another commenter said that water temperature requirements are necessary because water that is too warm is stressful to the animal and facilitates the spread of disease. Another commenter stated that APHIS should prohibit polar bear exhibits in tropical locales.
One commenter recommended that APHIS establish standards for sound that address decibel levels as well as the type of sound. Another commenter suggested that pools be required to have sloping walls in order to lessen underwater echoes.
A number of commenters stated that the regulations for ventilation and lighting were adequate; however, these commenters also stated that it wasn't unreasonable to require 6 hours of uninterrupted darkness per day.
Several commenters stated that some portion of an outdoor pool must be shaded. Other commenters suggested that the regulations concerning shade be amended to require that shade be provided if deemed necessary by a veterinarian.
One commenter recommended that seagull harassment of marine mammals be specifically addressed in the regulations. The commenter also recommended that pools be cleaned daily by a qualified diver.
A commenter asked APHIS to explore alternatives to chlorine to improve water quality. Several commenters suggested that requirements for water quality be established for each species based on the conditions the animal may encounter in the wild. Similarly, a commenter stated that marine species should be housed in saltwater tanks and freshwater species housed in freshwater tanks.
Some commenters recommended that enclosures resemble an animal's natural habitat. One commenter suggested that marine mammals should be moved from concrete enclosures to manmade lakes.
A number of commenters supported an increase in the space requirements for marine mammals. Several commenters stated that pool depth and volume should be used to determine the space requirements. These commenters stated that the average adult length of a species should be used to determine the minimum depth requirements and that the tables setting out the average adult length for each species should be updated. Finally, these same commenters stated that the space requirements should not take into account minimum width or longest straight-line swimming distance.
A commenter recommended that space requirements should be based on the maximum adult length of an animal instead of the average adult length. Several commenters suggested that APHIS match or exceed the minimum space requirements used in the United Kingdom, Brazil, and Italy. Some commenters recommended that pools be at least 300 feet wide and 60 feet deep. One commenter recommended that pools be at least 25 meters deep. One commenter suggested that the current space requirements be doubled within the next 5 years, while another commenter suggested a tenfold increase in the current space requirements.
A number of commenters claimed that it would be unfair and costly to require facilities to retrofit their marine mammal enclosures to comply with new space requirements. Several commenters stated that it would be financially unfeasible to retrofit facilities.
Some commenters stated that the regulations for interactive programs should be flexible enough to accommodate the wide variety of interactive programs in the United States. These commenters went on to state that the current regulations provide the necessary protection for marine mammals used in interactive programs.
One commenter asserted that APHIS should require that dolphins and humans participating in an interactive program be free of disease. The commenter noted that certain human diseases pose a threat to dolphins (
Several commenters argued that petting pools and dolphin-assisted therapy should be regulated as interactive programs. Another commenter stated that feeding and petting pools should be eliminated.
One commenter stated that interactive programs should be allowed only if the interactions are tightly controlled at all times by professional trainers and the animals are allowed to choose whether or not to participate.
A commenter stated that any release of a marine mammal into the wild should be authorized by the U.S. Fish and Wildlife Service or the National Marine Fisheries Service prior to the release. Finally, a number of commenters asked APHIS to free or retire a killer whale named Lolita.
Based on our review of the ANPR comments, information submitted by exhibitors and professional organizations, a review of published scientific studies and current standards for lighting, ventilation, water quality, etc., and our experience with the marine mammal standards, we are now proposing to amend the regulations concerning the humane handling, care, treatment, and transportation of marine mammals in captivity. These proposed changes would affect sections in the regulations relating to variances, indoor facilities, outdoor facilities, space requirements, and water quality. We are also proposing to revise the regulations that relate to swim-with-the-dolphin programs. Each of these changes is discussed in detail below.
We are proposing to amend § 1.1 of the regulations, “Definitions,” by revising the terms
Section 1.1 defines an
Section 1.1 defines a
Section 1.1 defines a
Section 1.1 defines
We would remove the definition of
The proposed definition of
Finally, we would remove from § 1.1 the definition of
Section 3.100 contains the conditions under which a regulated facility may request and qualify for a variance for a limited period of time from one or more of the space requirements in § 3.104. The provisions were put into place to allow regulated facilities time to come into compliance with the space requirements made in 1984. These provisions are no longer applicable because we are not increasing the space requirements.
There were few recommendations on the implementation dates and variances in the comments on the ANPR. One commenter recommended that § 3.100, “Special considerations regarding compliance and/or variance,” be deleted because there is no good reason to grant a variance from the space requirements. Another commenter suggested that temporary variances be granted for 6 months with only one extension and that lifetime variances be granted only when necessary. The commenter also stated that APHIS should confiscate animals at facilities that fail to comply with the regulations after the expiration of the variance.
We propose to revise § 3.100 to make it operative once again with respect to exhibition and research facilities covered by the regulations. This will provide regulated facilities greater flexibility in complying with the regulations and standards. Regarding the comment about animal confiscation, APHIS' confiscation authority under the AWA is outlined in § 2.129 of the AWA regulations and standards. The animal must be found to be suffering as a result of noncompliance with the regulations and standards and the licensee fails to provide the remedy required by APHIS.
Section 3.102 provides the standards for air and water temperatures, ventilation, and lighting at regulated facilities that house marine mammals.
Paragraph (a) of § 3.102 provides that the air and water temperatures in indoor facilities shall be sufficiently regulated by heating or cooling to protect the
Animals kept in a temperature range appropriate to their species benefit from improved health and welfare.
We are proposing no substantive changes to § 3.102(a). The question of ambient and environmental temperatures was discussed in depth during the negotiated rulemaking process. While the members of the Committee acknowledged the importance of maintaining marine mammals within their optimum temperature range, there was not enough published scientific data available to develop a list of acceptable temperature ranges for each marine mammal species. We are unaware of any definitive publications that combine the habitat ranges of marine mammals with the environmental temperature ranges in that habitat. This information would be beneficial to USDA and our licensees and we request any and all such data appropriate to marine mammal species during the comment period. That may not be possible, though, as we think it would require using diverse sources from fisheries data, biological oceanography species distributions, and physical oceanography sources on temperatures and salinity. Habitat usage budgets would also be needed in order to determine the most appropriate temperature range for the marine mammal. Since this information is not readily tabulated, we will continue to use the health and behavior of the marine mammals in assessing the adequacy and appropriateness of the pools and enclosure temperatures.
Several commenters on the ANPR asserted that rigid standards for air and water temperatures would be counterproductive and would not guarantee the health and well-being of the marine mammals. These commenters said that animals may be acclimated to temperatures outside of any ranges that APHIS may establish. On the other hand, another commenter said that water temperature requirements are necessary because water that is too warm is stressful to the animal and facilitates the spread of disease. As noted earlier, another commenter stated that APHIS should prohibit polar bear exhibits in tropical locales.
Taking into account the discussions regarding air and water temperatures during the negotiated rulemaking process and in the ANPR comments, we are retaining the performance-based standards of the current regulations and, as needed, will develop guidelines for appropriate temperature ranges for marine mammal species based on scientific and published data when, and if, it becomes available. We request any and all such data appropriate to marine mammal species during the comment period.
Paragraph (b) of § 3.102 contains the ventilation standards for indoor facilities housing marine mammals. It provides that facilities shall be ventilated by natural or artificial means to provide a flow of fresh air for the marine mammals and to minimize the accumulation of chlorine fumes, other gases, and objectionable odors.
The benefit of providing adequate ventilation for indoor marine mammal enclosures is improved animal welfare. Improved ventilation can reduce the effects of skin and mucous membrane irritation in marine mammals. Improvements in ventilation can also result in less accumulation of moisture and potential trapping of bacteria and particles on walls. Excessive moisture may allow for bacterial and mold growth in the enclosure area, risking the health and well-being of the marine mammals. These same considerations apply to personnel working in enclosure and exhibit areas, and potentially to the general public.
Few comments on the ANPR addressed the current ventilation requirements. Those commenters who did address the ventilation standards stated that the current performance-based standard was sufficient. However, based on our experience regulating marine mammal facilities and on commonly accepted human standards for ventilation followed by engineers and architects for buildings throughout the United States, we are proposing to modify the ventilation standards in several ways. The majority of the changes are performance-based in nature. Instead of stating that the ventilation shall minimize the accumulation of chlorine fumes, other gases, and objectionable odors, we are proposing that the ventilation would have to prevent the accumulation of chlorine/chloramine fumes, ammonia fumes, ozone, other gases, or odors at levels that would be objectionable or harmful to a person of average sensitivity. We would also add that the ventilation would have to maintain relative humidity at a level that prevents condensation in order to minimize the potential for bacterial, fungal, or viral contamination from condensation. Relative humidity can be controlled by a variety of methods, including increased ventilation with drier air or the use of dehumidifiers. Furthermore, we would provide that the average ventilation rate should exceed 0.2 cubic feet per minute per kilogram (cfm/kg) of animal. An average ventilation rate is the rate at which indoor air enters and leaves a building. We are proposing to require that the average ventilation rate should exceed 0.2 cfm/kg of animal in facilities with marine mammals because that is the rate necessary to dilute odors and limit the concentration of carbon dioxide and airborne pollutants harmful to marine mammals and humans.
Paragraph (c) of § 3.102 contains performance-based standards for lighting in indoor housing facilities, providing that the lighting shall: (1) Be of a quality, distribution, and duration that is appropriate for the species involved; (2) allow for routine inspections, observations, and cleaning; and (3) prevent exposure of the marine mammals to excessive illumination.
The ANPR commenters that addressed this issue stated that the current requirements for lighting were adequate; however, the commenters also stated that it was not unreasonable to require 6 hours of uninterrupted darkness per day for marine mammals.
Ensuring the health and normal functioning of metabolic systems for animals used to a diurnal light pattern (day and night periods) can be impacted by the use of artificial lighting and changes to the normal pattern of diurnal fluctuations in the day and night light patterns. Natural light sources, such as large windows and skylights for indoor enclosures, provide marine mammals with both natural light variations and full-spectrum lighting. Full spectrum lighting approximates natural sunlight by providing all natural wavelengths of light from an artificial light source. Studies in animals suggest that natural and full spectrum lighting may be beneficial for animal welfare, behavior, physiology, and regulating diurnal cycles. When natural light sources are not available or light patterns do not closely mimic natural patterns of light and dark provided by the sun, there can be negative impacts on the health and metabolism of terrestrial and aquatic animals.
In addition, sufficient light is needed to allow observation of the animals by the caretakers and the APHIS inspectors. This requirement is not changed in this docket, but the level of light recommended assures the ability to adequately observe the animals in the enclosure.
To better provide for the well-being of marine mammals, we believe the lighting standards need to be more specific. Accordingly, we propose to amend § 3.102(c) to state that, in addition to the general standards already provided, artificial lighting must provide full spectrum lighting. We are proposing this change so that the environment these mammals are housed in more closely resembles the natural world. We would also require that artificial light levels measured 1 meter above pools or decks should not exceed 500 lux, which is the minimum unit of measure of light sufficient to provide proper illumination for marine mammal primary enclosures.
Facilities would be required to provide at least 6 hours of uninterrupted darkness during each 24-hour period, which mimics the normal diurnal cycles of light and dark that marine mammals are adapted to. When possible, the lighting should approximate the lighting conditions encountered by the animal in its natural environment. For example, if a species of marine mammal is primarily tropical, the lighting conditions for that animal should be as close to 12 hours of light and 12 hours of dark as possible, whereas the lighting conditions for other species of marine mammals may be closer to 10 hours of light and 14 hours of dark. Whatever the facilities' hours are, a minimum of 6 hours of dark must be provided to give all animals some period of night. We request comment on information on this minimum period of darkness, and whether it should be shorter or longer. We chose 6 hours as a reasonable minimum, since we think it may correspond with typical work hours at a facility. The lighting must not cause overexposure, discomfort, or trauma.
The standards for lighting that we are proposing are based on our review of findings and recommendations in scientific literature for lighting animal enclosures.
Section 3.103 of the regulations provides the standards for air and water temperature, shelter, and perimeter fencing at outdoor facilities housing marine mammals. Paragraph (a) of § 3.103 provides that marine mammals shall not be housed in outdoor facilities unless the air and water temperature ranges they may encounter do not adversely affect their health and comfort. Paragraph (a) further provides that marine mammals shall not be introduced to an outdoor housing facility until they are acclimated to the air and water temperature ranges that they will encounter there.
We are proposing to make several changes to § 3.103(a). We are proposing to require that the air and water temperature ranges at outdoor facilities be in accordance with the currently accepted husbandry practices for the species housed.
Paragraph (a)(3) of § 3.103 provides that no sirenian or warm water dwelling species of pinnipeds or cetaceans shall be housed in outdoor pools where water temperature cannot be maintained within the temperature range to meet their needs. To clarify what we mean by the “needs” of marine mammals, we would revise this standard by specifying instead that the water temperature for these particular marine mammals be maintained within the temperature range needed to maintain their good health and to prevent discomfort in accordance with currently accepted practices as cited in appropriate professional journals or reference guides.
Paragraph (b) of § 3.103 contains the standards for providing shelter for marine mammals housed in outdoor facilities. It provides that natural or artificial shelter, as appropriate for the particular species when local climatic conditions are taken into consideration, shall be provided for all marine mammals kept outdoors to afford them protection from the weather or from direct sunlight.
Several commenters on the ANPR stated that some portion of an outdoor pool must be shaded. Other commenters suggested that the regulations concerning shade be amended to require that shade be provided if deemed necessary by a veterinarian.
Because marine mammals are susceptible to overheating and sunburn and/or eye damage from direct and/or reflected sunlight, and UV light reflections can cause or exacerbate damage to marine mammal eyes,
Section 3.104 contains the minimum space requirements for primary enclosures, including pools of water, housing marine mammals. These space requirements are based on standards and scientific information available at the time the regulations were promulgated in 1979, and amended in 1984. The current space requirements are based on circular pools which, while prevalent 30 years ago, have been largely replaced by more intricately shaped pools.
As discussed previously, some commenters on the ANPR recommended that enclosures resemble an animal's natural habitat. A number of commenters supported an increase in the space requirements for marine mammals, although the majority of commenters focused on the space requirements for cetaceans. A number of commenters claimed that it would be unfair and costly to require facilities to retrofit their marine mammal enclosures to comply with new space requirements. Several commenters stated that it would be financially unfeasible to retrofit facilities.
We are proposing to make a number of changes to § 3.104, as discussed in detail below. However, we are not proposing changes to the minimum space requirements (
Paragraph (a) of § 3.104 provides a general description of the space requirements for primary enclosures, including pools, that house marine mammals and sets out some of the requirements for temporary use of smaller enclosures. The general standards provided in § 3.104(a) reflect the consensus language that was developed by the Committee during the negotiated rulemaking sessions. We are proposing no substantive changes to the minimum space requirements (
In proposed § 3.104(a)(2), we would provide that only those areas that meet or exceed the minimum depth requirement could be used in determining whether the other parameters of MHD, volume, and surface area meet the space requirements. This requirement already appears elsewhere in § 3.104 when referring to the minimum depth requirements for primary enclosures housing particular species of marine mammals. We would include this standard in § 3.104(a) since it is a general requirement applicable to all enclosures housing marine mammals. Indeed, this standard is the basis for determining whether naturalistic or irregularly shaped pools meet the space requirements. In addition, we would provide that APHIS would be authorized to determine if partial obstructions of a horizontal dimension compromise the intent of the regulations and/or significantly restrict the freedom of movement of the animal(s) in the enclosure.
Paragraph (b) of § 3.104 provides that primary enclosures housing cetaceans shall contain a pool of water and may consist entirely of a pool of water. It further provides that, in determining the minimum space required in a pool holding cetaceans, requirements relating to MHD, depth, volume, and surface area must be satisfied.
We propose to remove the statement in current § 3.104(b), “Primary enclosures housing cetaceans shall contain a pool of water and may consist entirely of a pool of water.” This statement is unnecessary because cetaceans only need a pool of water.
In addition, we propose to amend § 3.104(b) by removing Tables I through IV and by adding a new Table 1 that sets out the average adult length and corresponding minimum space requirements for Group I and Group II cetaceans. We have also corrected a longstanding discrepancy between the figures in tables for volume required for additional animals and the actual calculated volume required. The proposed tables correct these entries, which have been included in the tables since 1984. In the last 30 years, however, this error has not presented any welfare issues, as the written formulas have been used only for calculations.
We would also remove paragraph (b)(2) of § 3.104, which provides that those parts of the primary enclosure pool which do not meet the minimum depth requirements cannot be included when calculating space requirements. As discussed previously, we would make this provision applicable to all marine mammal primary enclosures (proposed § 3.104(a)(2)) so it is unnecessary to include it here.
We have been requested to consider updating the average adult lengths of certain cetaceans ((the Beluga whale (
We welcome comments and data addressing this approach, including comments on the reliability and utility of the empirical average adult length data that is the basis for this proposed change.
Paragraph (c) of § 3.104 provides that primary enclosures housing sirenians shall contain a pool of water and may consist entirely of a pool of water. Space requirements are based on meeting MHD and depth parameters.
We propose to remove the statement in current § 3.104(c), “Primary enclosures housing sirenians shall contain a pool of water and may consist entirely of a pool of water.” This statement is unnecessary since sirenians only need a pool of water. We would also add a new Table 2 which would provide average adult lengths for different sirenian species that are currently held by exhibitors on public display. Finally, we propose to remove the statement that those parts of the primary enclosure pool which do not meet the minimum depth requirement cannot be included when calculating space requirements for sirenians. As discussed previously, we propose to include this requirement in proposed § 3.104(a)(2) since it is a general requirement applicable to all enclosures housing marine mammals.
Paragraph (d) of § 3.104 provides that primary enclosures housing pinnipeds shall contain a pool of water and a dry resting or social activity area that must be close enough to the water to allow easy access for entering or leaving the pool. Despite this requirement, APHIS is aware of instances where animals have shown difficulties getting in and out of pools when the distance between the water and the dry resting area has been too much for them to easily negotiate, either due to the size and strength of the animal, such as young animals, or health, such as older animals or those animals with injuries or infirmities such as arthritis.
Therefore, we propose to require that pool exit and entry areas be of a depth and grade that allows for easy access and exit for pinnipeds of all ages and infirmities. These changes would ensure that young, elderly, and ill or infirm pinnipeds are able to get out of the water to access their dry resting or social activity area. As a ramp or platform may cut down on the swimming space in a smaller pool, designing of the ramps or platforms which factors in the minimum space requirements is essential.
The list of Group I and Group II pinnipeds and their average adult length in feet and meters would be provided in a new Table 3. In proposed Table 3, we would reverse the order of displaying average adult length, with feet being shown first followed by meters. The average adult length information, which currently appears as part of Table 3 of the regulations, would not be changed except that we would add
We would also reference a proposed new Table 4, which would summarize the minimum space requirements for pinnipeds in captivity, including MHD, depth, and surface area, as well as the required dry resting and social activity area required for different pinniped species. This table would provide user-friendly calculations of space requirements that should spare licensees and other stakeholders from having to perform the calculations themselves.
Finally, we propose to remove the statement that those parts of the primary enclosure pool which do not meet the minimum depth requirement cannot be included when calculating space requirements for pinnipeds. As discussed previously, we propose to make this requirement applicable to all marine mammals (proposed § 3.104(a)(2)) and it is unnecessary to include it here.
Paragraph (e) of § 3.104 sets out the space requirements for primary enclosures housing polar bears. It provides that primary enclosures housing polar bears shall consist of a pool of water, a dry resting and social activity area, and a den.
We are proposing to amend § 3.104(e) to require that pool exit and entry areas be of a depth and grade that allows for easy access and exit for polar bears of all ages and infirmities. This change would ensure that young, elderly, and
Paragraph (f) of § 3.104 covers the space requirements for primary enclosures housing sea otters. Currently, paragraph (f) of § 3.104 provides that primary enclosures for sea otters must consist of a pool of water and a dry resting area. The minimum dry resting area required for one or two sea otters is based on the sea otter's average adult length, and is provided in Table V.
We propose to require that pool exit and entry areas be of a depth and grade that allows for easy access and exit for sea otters of all ages and infirmities. This change would ensure that young, elderly, and ill or infirm sea otters are able to get out of the water to access their dry resting or social activity area.
The regulations currently do not provide a surface area requirement. We would not change the existing formula for calculating the minimum dry resting area per animal. However, since sea otters do not readily use shared resting areas, we propose to add a requirement that individual areas or visual barriers separating appropriately sized individual resting spaces must be used.
Finally, we would redesignate Table V as Table 5. However, the information in the table would not be changed.
Currently, § 3.106 provides water quality standards for facilities housing marine mammals. Paragraph (a) provides a general introductory statement. Paragraphs (b), (c), and (d) contain requirements relating to bacterial standards, salinity, and filtration and water flow. We are proposing to make a number of changes throughout this section.
While sterile water was once considered the ideal standard, recent scientific research supports the point that non-sterile water is better for marine mammals. Non-sterile water seems to support the development of a healthy immune system, providing improved ability for marine mammals to better handle routine and novel types of bacteria. The presence of water quality test results that consistently show no bacteria may be indicative of an overly disinfected system, which may negatively impact the animals by causing skin and eye irritations from overchlorination. Over-disinfection may also reduce the effectiveness of the filtration system, which usually depends on a healthy microbial population for proper operation.
Paragraph (b) of § 3.106 contains the bacterial standards and related water quality testing requirements for facilities housing marine mammals. The bacterial standards provided in § 3.106(b) are based on accepted measures for monitoring water quality for human use at the time the regulations were promulgated in 1979. However, based on a review of the scientific literature
Most of the marine mammal standards were originally promulgated in 1979. The bacterial standards of § 3.106(b)(1) were based on the drinking water quality standards of that time and focused on coliform bacteria. Based on testing methods used during that time, the unit of measure was “most probable number” (MPN), a statistical measurement based on inoculation series (dilution series) using 1 mL aliquots of the sample. Usually 5-10 samples (diluted by powers of 10) were incubated and the actual number of bacteria present was estimated for a 100 ml sample.
With the advent of filtration techniques, the MPN method was no longer used as the sole measure of bacterial contamination in water samples. With MPN, actual numbers of bacteria in a 100 mL sample could now be measured and counted.
As with other areas of technology, test kits have been developed to test for coliforms. These kits focus on enzymes and characteristic chemical properties to simplify bacterial testing and identification. The EPA is responsible for setting Recreational Water Quality Criteria recommendations for primary contact recreational uses (
The bacterial standards requirements in this section are devised to not only protect the health and well-being of the marine mammals housed in the enclosures, but to conform with the EPA and related standards that address human activities, such as swimming (interactive programs). Accepted criteria recommendations in place at the time of implementation of the current standards (1984) have been in use since that time. APHIS has not found that marine mammal facilities routinely have compliance issues with these historic requirements. We do acknowledge that testing techniques and accepted criteria recommendations have changed since 1984, and we are proposing to update this section to reflect those changes. We are requesting data and references that would support or refute these criteria.
The AWA does not require a specific methodology for coliform testing, but rather defines an upper limit for total coliforms. If the methodology selected provides an actual colony count, then that is interchangeable with MPN.
Current paragraph (b)(1) of § 3.106 provides that the coliform bacteria count of the primary enclosure pool shall not exceed 1,000 MPN per 100 mL of water. Should the coliform bacterial count exceed 1,000 MPN, two subsequent samples may be taken at 48-hour intervals and averaged with the first sample. If the average count does not fall below 1,000 MPN, then the water in the pool is deemed unsatisfactory, and the condition must be corrected immediately.
Paragraph (b)(3) of § 3.106 requires water samples to be taken and tested on a weekly basis for coliform count. We are proposing that the coliform count can be either a total coliform count or a fecal coliform count. In the case of a total coliform count, we propose that the coliform count shall not exceed 500 colonies per 100 mL. If a fecal coliform test is used, we propose that the fecal count shall not exceed 400 colonies per 100 mL.
These tests are used to indicate fecal contamination as well as pathogens in the water. Enterococci are bacteria that are primarily from the intestinal tract and can be a sensitive indicator of fecal contamination. If a facility only performs a total coliform test, this test would indicate the fecal portion of the coliform contamination. Pseudomonas is a bacterial pathogen very common to lung infections in marine mammals. Its presence in a water sample may indicate either an infection on an animal or the contamination of the environment of the animal with pathogenic bacteria. Staph bacteria can be pathogenic or non-pathogenic in all animals. It is a skin pathogen, and can also cause infections internally. Its presence can be an indicator of contamination and/or possible danger to the animals. We would require that one of these other bacterial tests be conducted, in addition to a total coliform or fecal coliform test, in order to obtain a more complete picture of the water quality of facilities housing marine mammals.
We propose to redesignate current § 3.106(b)(2), which covers chemical treatment of water, and § 3.106(b)(3), which concerns water sampling procedures, as § 3.106(b)(4) and § 3.106(b)(5), respectively, to accommodate the addition of new paragraphs § 3.106(b)(2) and (b)(3).
Proposed new paragraph § 3.106(b)(2) provides that if any of the above tests yield results that exceed the allowable bacterial count levels, then two followup samples must be taken to repeat the tests(s) for those bacterial contaminants identified as being present at levels exceeding the standards. The first followup sample would have to be taken immediately after the initial test result, while the second followup sample would have to be taken within 48 hours of the first followup sample. This timing requirement would differ from the existing standard in § 3.106(b), which provides that the two followup samples may be taken at 48-hour intervals.
The rationale regarding retesting after 48 hours is based on the fact that the lab testing (inoculation or filtration and incubation) takes 48 hours.
This amendment is to clarify the timing of the follow-up test. At it currently reads, some entities interpret the testing to be after the first test results are known. The coliform test, if using traditional microbiological techniques (culture and incubation) takes 48 hours. If the first test is 500 (proposed) MPN, the retesting should be done immediately (relative to knowing the test results).
In the last 3 years, approximately four citations issued to marine mammal facilities involved high coliform counts without the required retesting.
Over the years there has been some confusion among regulated facilities and inspectors as to exactly when the followup samples should be taken. This change would address this problem by clarifying that the first followup sample has to be carried out immediately following the initial test result and the second followup sample has to be taken within 48 hours of the first followup sample. We would continue to require that the test results of the three samples be averaged and, if the averaged value of the three samples still exceeds the allowable bacterial counts referenced above, then the pool water would be considered unsatisfactory and its condition would have to be corrected immediately.
Proposed new paragraph § 3.106(b)(3) would provide that additional testing for suspect pathogenic organisms must be conducted when there is evidence of health problems at the facility or a potential health hazard to the animals. In the past, we have suspected that water-borne pathogens contributed to the poor health of animals at certain facilities; however, the regulations did not require additional testing for pathogens. This change would address that issue in the regulations.
As discussed above, we would redesignate current § 3.106(b)(2) as § 3.106(b)(4). That paragraph provides that whenever the water is chemically treated, the chemicals shall be added so as not to cause harm or discomfort to the marine mammals, such as eye and skin irritation. We propose to amend the standard to state that any chemicals added to a pool must not cause harm or discomfort to the marine mammals during the introduction of the chemical or during the chemical's presence in the enclosure (in the water, on the surfaces, or in the air). This change would clarify that the health, safety, and welfare of the marine mammals must be taken into consideration not only when chemicals are added to the water, but whenever chemicals are present in and around the water.
As discussed previously, we would redesignate current paragraph § 3.106(b)(3) as § 3.106(b)(5). That paragraph contains the standards for water sampling and states that water samples shall be taken and tested at least weekly for coliform count and at least daily for pH and any chemicals (
We would remove the references to coliform testing in paragraphs (b)(1) and (b)(3) of § 3.106, since this subject would be covered in proposed § 3.106(b)(1). Under proposed § 3.106(b)(5), we would continue to provide that facilities must conduct daily testing for pH, as well as for any chemicals (
Finally, we would move the discussion of water sampling recordkeeping from current § 3.106(b)(3) to a new paragraph, § 3.106(b)(6). This amendment would require that all water quality records be kept on site, not at a management office if that is located elsewhere. This will save APHIS time and effort in reviewing the records. APHIS needs to review the records at every inspection, as assessing the bacterial loads and the chemical make-up of the water is necessary to ensuring the health and welfare of the animals. For example, by reviewing such records, chlorine levels could be correlated with the eye issues of the animals in the enclosure. Identifying a probable cause not only will improve the welfare and health of the animal, but may speed the diagnosis of the underlying issue so that proper care can be provided.
We would also require that, in addition to noting the time of testing, the facility must document the date and location of the testing, including the particular pool and the sampling site within the pool. We would continue to provide that the records be maintained for a 1-year period. However, instead of providing that the records be maintained “by management,” which could be at a location away from the facility, we propose to require that the records be maintained “at the facility.” This would ensure that the records would be readily available to APHIS inspectors during inspections. We would also clarify the current requirement that records “must be made available for inspection purposes on request” to instead state that the records “must be made readily available to APHIS inspectors.”
Paragraph (c) of § 3.106 contains the salinity standards for primary enclosure pools, providing that such pools of water shall be salinized for marine cetaceans as well as for those other marine mammals which require salinized water for their good health and well-being. The current standards provide that water salinity shall be maintained within a range of 15-36 parts per thousand.
We are proposing to amend the salinity standards in § 3.106(c) to reflect the current level of scientific knowledge and accepted industry practices. Specifically, instead of providing that the salinity standards shall apply “to marine cetaceans and other marine mammals that require salinized water for their good health and well-being,” we would be more specific in stating that “all primary enclosure pools must be salinized for cetaceans, pinnipeds, and sea otters.” However, we would specifically exempt from this requirement enclosures housing river dolphins and other species in fresh water, as well as enclosures housing pinnipeds that are provided salt supplements at appropriate levels, as determined by the attending veterinarian, and daily saltwater eye baths. We expect this will minimize additional costs and renovations at existing facilities.
We are also proposing to amend the currently required salinity range of 15-36 parts per thousand to a range of 24-36 parts per thousand in order to more closely approximate the salinity levels marine mammals encounter in their natural environments beyond certain coastal areas.
The benefits of requiring salinity monitoring and increasing the lower limit that is acceptable will benefit the health and well-being of the animals by maintaining pools closer to the actual conditions the animals would find in nature. The combination of the requirements regarding salinity will allow our inspectors to better assess the welfare of the marine mammals and potentially prevent any ongoing eye
Paragraph (d) of § 3.106 currently covers filtration and water flow. We are proposing to redesignate § 3.106(d) as § 3.106(e). In addition, we propose to add that water quality may also be maintained through naturally occurring tidal flow. This change would address those facilities with natural lagoon or coastal enclosures.
Finally, we propose to add a new § 3.106(d) covering the subject of water clarity. Although this subject is addressed generally in § 3.106(a), in recent years members of the public have contacted APHIS to express concern over the appearance of pool water at facilities. For our purposes, we believe pool water should be clear enough for caretakers to observe the animals. Therefore, under proposed § 3.106(d), we would require that pools be maintained in such a manner as to provide sufficient water clarity to view the animals in order to observe them and monitor their behavior and health. This performance-based requirement would provide flexibility while ensuring that the animals can be observed at any depth or placement in the pool in order to promote their health and well-being. If an animal cannot be observed clearly, it cannot be provided adequate animal welfare.
Section 3.111 contains additional regulatory requirements covering swim-with-the-dolphin (SWTD) programs. Specifically, § 3.111 includes provisions relating to space requirements, water clarity, employees and attendants, program animals, handling, recordkeeping, and veterinary care.
As previously discussed, in 1999 we suspended enforcement of the SWTD requirements found in § 3.111 and related definitions found in § 1.1. At that time, we solicited public comment on all aspects of the suspended regulations and on all human/marine mammal interactive programs. We accepted comments until July 1, 1999, and received 20 comments by that date.
The proposed changes to § 3.111 are based on the information contained in those comments; on our review of the comments received in response to the January 23, 1995, proposed rule; on information made available to us by the public following publication of the September 4, 1998, final rule; on our review of the ANPR comments; and on our experience enforcing the Act and the regulations. The proposed changes to § 3.111 are intended to address the need to monitor interactive programs, while giving consideration to program
Throughout proposed § 3.111, we would use the term “marine mammal(s)” in place of “cetaceans.” We would also use the term “interactive program(s)” in place of SWTD program(s). These changes are designed to clarify that programs may involve animals other than cetaceans (
The current introductory paragraph to § 3.111 provides that SWTD programs shall comply with the requirements in this section, as well as with all other applicable requirements of the regulations pertaining to marine mammals. We propose to amend this introductory paragraph to more specifically provide that all marine mammal interactive programs must comply in all respects with the regulations set forth in 9 CFR parts 2 and 3, which address animal welfare.
Paragraph (a) of § 3.111 provides the space requirements for the primary enclosure used by animals in an interactive program. This includes the interactive area, a buffer area, and the sanctuary area. The regulations provide that none of these areas shall be made uninviting to the animals, and that movement of cetaceans into the buffer or sanctuary area shall not be restricted in any way. The space requirements for each of the three areas are based upon the “horizontal dimension,” the minimum surface area, the average depth, and minimum volume.
• Up to two cetaceans: Surface area = (3 × average adult body length/2)
• Three cetaceans: Surface area = (3 × average adult body length/2)
• Additional surface area for each animal in excess of three: Surface area = (2 × average adult body length\2)
Generally, the average depth for sea pens, lagoons, and similar natural enclosures at low tide shall be at least 9 feet. The average depth for manmade enclosures or other structures not subject to tidal action shall also be at least 9 feet. The minimum volume required for each animal must equal 9 times the minimum surface area.
We are proposing that the sanctuary area for interactive programs meet the space requirements set forth in current and proposed § 3.104. The interactive area, however, would not have to meet the space requirements set forth in proposed § 3.104. Instead, we are proposing to require that the interactive area provide sufficient space for all marine mammals to freely swim or move about, consistent with the type of interaction. We believe that this performance-based standard would provide flexibility while promoting the health and well-being of the animals. We seek comment on this, and request any published scientific data or studies on this issue.
We are also proposing to remove the requirement for a separate buffer area. We are removing this requirement because we have found that it is unnecessary to require both a buffer area and a sanctuary area as long as the animal has unrestricted access to a sanctuary area. The intent of the buffer area was to provide a place where the animals could leave the interactive area but still be eligible for recall to the interactive area. This requirement has not been shown to be necessary for the welfare of the animals during the 20 years that these programs have been under USDA jurisdiction, and the requirement of no recall from the sanctuary area is sufficient to safeguard the animals during the interactive sessions. The sanctuary area is sufficient to safeguard the animal during the interactive sessions.
As proposed, § 3.111(a) would provide that each animal must have unrestricted access to the interactive area and the sanctuary area during an interactive session. Neither area shall be made uninviting to the animals. As previously discussed, the interactive area would not have to meet the minimum space requirements set forth in proposed § 3.104, but it must provide sufficient space for all marine mammals to freely swim or move about, consistent with the type of interaction, even with a full complement of public participants and employees in the area. We propose to require that the sanctuary area meet the minimum space requirements provided in § 3.104. Proposed paragraph (a) of § 3.111 would also provide that the sanctuary area may be within the enclosure containing the interactive area or it may be within a second enclosure to which free and unrestricted access is provided during the interactive session. The degree of free and unrestricted access would be assessed by the facility and the inspector through observation of whether the animals move freely between the areas during non-interactive periods.
Under current § 3.111(b), interactive programs are subject to certain water clarity standards. Paragraph (b) provides that sufficient water clarity be maintained so that attendants are able to observe cetaceans and humans at all times while within the interactive area. If water clarity does not allow these observations, the interactive sessions shall be canceled until the required clarity is provided. We propose to make only one change to § 3.111(b). We would substitute the phrase “marine mammals and the human participants” in place of “cetaceans and humans” for the reasons discussed previously.
Paragraph (c) of § 3.111 sets forth the minimum qualification requirements for personnel associated with a SWTD program. Each program must have a licensee or manager with at least 6 years of experience dealing with captive cetaceans; at least one head trainer/behaviorist with at least 6 years of experience in training cetaceans for SWTD behaviors, or an equivalent amount of experience involving in-water training of cetaceans; at least one full-time staff member with at least 3 years training and/or handling experience involving human/cetacean interaction programs; an adequate number of staff members who are adequately trained in the care, behavior, and training of the program animals; and at least one staff or consultant veterinarian who has at least the equivalent of 2 years full-time experience with cetacean medicine
We are proposing to amend § 3.111(c) so that personnel qualifications are not based entirely on job titles and absolute years of experience and training. We would instead provide standards that are based on the level of knowledge and skill needed to be a head trainer, or other trainers and attendants. This would provide the licensee or registrant greater flexibility to hire the most qualified individuals. We would also remove from § 3.111(c) the specific standards for the attending veterinarian. We believe that the current requirements in § 2.40 and § 3.110 provide sufficient oversight and guidance on this subject; interactive programs have not been shown to need additional restrictions.
In proposed § 3.111(c), we would change the heading from “Employees and attendants” to “Employees.” We propose to require that each interactive program have a sufficient number of adequately trained personnel to meet the husbandry and care requirements for the animals and comply with all training, handling, and attendant requirements of the regulations. We propose to provide that, during interactive sessions, there must be a trainer, handler, and sufficient number of adequately trained attendants, as specified in § 3.111(d)(4), which is discussed below.
In proposed § 3.111(c)(1), we would require that the head trainer/supervisor of the interactive program have demonstrable in-depth knowledge of the husbandry and care requirements of the family and species of marine mammals being exhibited, demonstrable knowledge of and skill in currently accepted professional standards and techniques in animal training and handling, and the ability to recognize normal and abnormal behavior and signs of behavioral stress in the animal families and species being exhibited. This proposed standard would differ from the current regulations, which focus on the person having a specific number of years of appropriate experience.
In proposed § 3.111(c)(2), we would require that all interactive program trainers and attendants have the knowledge and skill level sufficient to safely conduct and monitor an interactive session.
Current paragraph (d) of § 3.111 specifies what animals are eligible to participate in SWTD programs, providing only for cetaceans that meet certain requirements with respect to training and conditioning in human interaction, as well as being under the control of a trainer, handler, or attendant during sessions with the public as described and defined in the NOAA-sponsored study by Samuels and Spradlin (1994 and 1995) cited above. Such animals must also be in good health. We are proposing to remove this paragraph in its entirety, removing the provision that limits program animals to cetaceans. The standards relating to conditioning, the presence of trainers or attendants, and animal health are sufficiently covered in other paragraphs of § 3.111.
The introductory text of current paragraph (e) of § 3.111 covers the handling of cetaceans used in interactive sessions. With the removal of § 3.111(d) on program animals, we would redesignate § 3.111(e) as § 3.111(d), as well as make a number of other changes to simplify and clarify the handling requirements.
Paragraph (e)(1) of § 3.111 provides that the interaction time for “each cetacean” shall not exceed 2 hours per day and that each program cetacean shall have at least one period in each 24 hours of at least 10 continuous hours without public interactions. In newly designated § 3.111(d)(1), we propose to provide that the interactive time between marine mammals and the public (
Paragraph (e)(2) of § 3.111 provides that cetaceans used in interactive sessions shall be adequately trained and conditioned in human interaction, with the head trainer/behaviorist, trainer/supervising attendant, or attendant maintaining control of the nature and extent of the animal's interaction with the public at all times consistent with the findings and recommendations in the NOAA-sponsored study by Samuels and Spradlin (1994 and 1995) cited above. In newly designated § 3.111(d)(2), we propose to simplify this requirement to apply to the “trainer, handler, or attendant.”
Newly designated § 3.111(d)(3) would parallel § 3.111(e)(3) of the current regulations by requiring that marine mammals be free of infectious disease and in good health. In addition, we would provide that marine mammals undergoing veterinary treatment may be used in interactive sessions only with the written approval of the attending veterinarian.
Current paragraph (e)(4) of § 3.111 provides that the ratio of human participants to cetaceans shall not be greater than 3 to 1. Paragraph (e)(4) also provides that the ratio of human participants to attendants or other authorized SWTD personnel (
We also propose to require at least one attendant per marine mammal in the session, and at least one attendant positioned to monitor each session. We would also provide that the number of public participants per marine mammal must not exceed the number that the attendant can monitor safely, appropriate to the type of interactive session.
Paragraph (e)(5) of § 3.111 provides that, prior to participating in an SWTD interactive session, public participants shall be provided with oral and written rules and instructions for the session, to include the telephone and fax numbers for APHIS, Animal Care, for reporting injuries or complaints. Public participants must agree in writing to abide by the rules and instructions before participating in an interactive session. Any public participant who fails to follow the rules or instructions will be removed from the interactive session by the facility.
Under newly redesignated § 3.111(d)(5), we would continue to require that participants be provided with oral rules and instructions prior to participating in the session; however, we propose to remove the requirement that participants must agree in writing to abide by the rules and instructions before being allowed to participate in the session. This requirement is unnecessary since we can enforce the regulations whether or not a participant has signed such an agreement. We would add a requirement that a copy of the written rules be made available to APHIS during an inspection. Furthermore, instead of requiring that participants be provided telephone and FAX numbers for APHIS, Animal Care, for reporting injuries or complaints, we propose to require that participants be provided with contact information for the appropriate Animal Care Field Operations office. We propose that this could be provided either in the form of a written handout to attendees, or in a notice, posted in a highly visible location, that summarizes the rules and instructions for the session and includes contact information for the appropriate Animal Care Field Operations office for reporting injuries or complaints.
We would also clarify the grounds for expelling session participants by providing that any participant who fails to follow the rules and instructions and jeopardizes human or animal safety or health must be immediately removed from the session by the facility management.
Paragraph (e)(6) of § 3.111 provides that all interactive sessions shall have at least two attendants or other authorized personnel (
We are proposing to remove paragraph (e)(6) in its entirety. The requirements regarding the presence of session attendants at an interactive session would be covered as part of newly designated § 3.111(d)(4). Proposed § 3.111(d)(4) would require that there be at least one attendant per marine mammal in the session, and at least one attendant positioned to monitor the session. However, the new standards in proposed § 3.111(d)(4) would not include specific language requiring APHIS consultations with the trainer to discuss personnel changes in cases where the facility has had more than two session incidents over a year's time that would be considered dangerous or harmful to the animal or the human participant. We do not believe this provision is necessary based on the available accident and injury data and taking into account our authority under the Act to respond to any incident.
Current paragraph (e)(7) of § 3.111 provides that all SWTD programs shall limit interaction between cetaceans and humans so that the interaction does not harm the cetaceans, does not remove the element of choice from the cetaceans by actions such as, but not limited to, recalling the animal from the sanctuary area, and does not elicit unsatisfactory, undesirable, or unsafe behaviors from the cetaceans. All SWTD programs shall prohibit grasping or holding of the cetacean's body, unless under the direct and explicit instruction of an attendant eliciting a specific cetacean behavior, and shall prevent the chasing or other harassment of the cetaceans.
We propose to amend these provisions to simplify and clarify them. The amended standards would be located in newly designated § 3.111(d)(6) and in a new § 3.111(d)(7). In newly designated § 3.111(d)(6), we would provide that all interactive programs would have to limit interactions between marine mammals and human participants so that the interaction does not present an undue risk of harm to the marine mammal or humans, and does not restrict by word, action, or enclosure design, the ability of the animal to leave the interactive area and session as it chooses. Recalling animals from the sanctuary area would still not be allowed. If an animal removes itself or is removed from a session, the facility must maintain the appropriate balance of public participants per marine mammal, as discussed previously under proposed § 3.111(d)(4), by either removing human participants from the interactive area or introducing another animal.
In proposed § 3.111(d)(7), we would provide that all interactive programs must prohibit grasping or holding of the animal's body unless it is done under the direct and explicit instruction of the attendant. In addition, we would provide that all interactive programs must prohibit the chasing or other harassment of the animal(s). The proposed language in newly redesignated § 3.111(d)(7) would closely parallel requirements that appear in the current § 3.111(e)(7).
Paragraph (e)(8) of § 3.111 provides that, in cases where cetaceans exhibit unsatisfactory, undesirable, or unsafe behaviors during an interactive session, including, but not limited to, charging, biting, mouthing, or sexual contact with humans, such cetaceans shall either be removed from the interactive area or the session shall be terminated. Written criteria shall be developed by each SWTD program, and shall be submitted to and approved by APHIS regarding conditions and procedures for maintaining compliance with the required ratios of human participants to cetaceans and human participants to attendants, procedures for the termination of a session when removal of a cetacean is not possible, as well as procedures for handling program animals exhibiting unsatisfactory, undesirable, or unsafe behaviors, including retraining time and techniques, and removal from the program and/or facility, if appropriate. Paragraph (e)(8) provides that the head trainer/behaviorist shall determine when operations will be terminated, and when they may resume. In the absence of the head trainer/behaviorist, the determination to terminate a session shall be made by the trainer/supervising attendant. Only the head trainer/behaviorist may determine when a session may be resumed.
We would redesignate § 3.111(e)(8) as § 3.111(d)(8). In newly designated § 3.111(d)(8), we propose to provide that marine mammals that exhibit unsatisfactory, undesirable, or unsafe behaviors, including, but not limited to, charging, biting, mouthing, or sexual
Paragraph (g) of § 3.111 requires that the attending veterinarian carry out certain duties with regard to animals used in interactive programs. This includes on-site evaluations of each cetacean at least once a month, as well as examination of related behavioral, feeding, and medical records, and discussion of each animal with the appropriate animal care personnel at the facility. The attending veterinarian must record the nutritional and reproductive status of each cetacean. The attending veterinarian must also observe an interactive session at the facility at least once a month. In addition, the attending veterinarian is required to conduct a complete physical examination of each cetacean at least once every 6 months, which must include a complete blood count and serum chemistry analysis, as well as the taking of smear tests for cytology and parasite evaluation. The attending veterinarian is responsible for examining water quality records. Paragraph (g) of § 3.111 also provides a timetable for conducting a necropsy in the event a cetacean dies. Complete necropsy results, including all appropriate histopathology, shall be recorded in the cetacean's individual file and shall be made available to APHIS officials during facility inspections, or as requested by APHIS.
We would remove § 3.111(g) as written and provide a new paragraph, § 3.111(e), on veterinary care. In response to the large number of comments on the lack of supporting evidence for requiring veterinary care measures beyond those required for all other marine mammals, we would provide that the facility would have to comply with all provisions in §§ 2.33, 2.40, and 3.110. Section 2.33 contains provisions on attending veterinarians and adequate veterinary care at research facilities, while § 2.40 contains provisions on attending veterinarians and adequate veterinary care applicable to animals held by dealers or exhibitors of animals. Section 3.110 provides veterinary care standards for marine mammals generally, as well as necropsy requirements should a marine mammal die in captivity. In addition to meeting the requirements of §§ 2.33, 2.40, and 3.110, proposed § 3.111(e) would require the attending veterinarian to observe an interactive session at least once a month or observe each interactive session if they are offered less frequently than twice a month, and review the feeding records, behavior records, and water quality records at least biannually or as often as needed to assure the health and well-being of the marine mammals.
Paragraph (f) of § 3.111 contains the recordkeeping requirements for facilities with interactive programs. We are proposing to amend § 3.111(f) by streamlining its content to reduce the burden on the regulated parties while continuing to require certain documentation for effective enforcement of the regulations and standards.
Paragraph (f)(1) of § 3.111 provides that each facility shall provide APHIS with a description of its program at least 30 days prior to initiation of the program, or not later than October 5, 1998 in the case of any program in place before September 4, 1998. The description shall include at least the following information: Identification of each cetacean in the program; a description of the educational content and agenda of planned interactive sessions, and the anticipated average and maximum frequency and duration of encounters per cetacean per day; the content and method of pre-encounter orientation, rules, and instructions; a description of the SWTD facility, including the primary enclosure and other SWTD animal housing or holding enclosures at the facility; a description of the training, including actual or expected number of hours each cetacean has undergone or will undergo prior to participation in the program; the resume of the licensee and/or manager, the head trainer/behaviorist, the trainer/supervising attendant, any other attendants, and the attending veterinarian; the current behavior patterns and health of each cetacean, to be assessed and submitted by the attending veterinarian; for facilities that employ a part-time attending veterinarian or consultant arrangements, a written program of veterinary care (APHIS form 7002), including protocols and schedules of professional visits; and a detailed description of the monitoring program to be used to detect and identify changes in the behavior and health of the cetaceans.
In proposed § 3.111(f)(1), we would continue to require that each facility provide APHIS with a description of its program at least 30 days prior to initiation of the program, or in the case of any program in place before the date a final rule is published, not later than 30 days after the effective date of the final rule. We also propose to provide that facilities that submitted the required documentation during the period of October through December 1998, and received approval letters, need only submit information that has changed. These letters were issued to approximately 16 facilities.
In proposed § 3.111(f)(1)(ii), we would clarify that the session agenda would have to include, at a minimum, written information distributed, topics addressed prior to entry in the water, and the planned program, including behaviors and activities expected to be presented or performed. We propose to delete current § 3.111(f)(1)(iii), which requires that the program description cover pre-encounter orientation. A similar requirement would appear in proposed § 3.111(f)(1)(ii). With the deletion of § 3.111(f)(1)(iii), we would redesignate paragraphs (f)(1)(iv) through (f)(1)(vi) of § 3.111 as (f)(1)(iii) through (f)(1)(v).
Current paragraph (f)(1)(iv) of § 3.111 requires that the program description include a description of the SWTD facility, including the primary enclosure and other SWTD animal housing or holding enclosures at the facility. In newly designated § 3.111(f)(1)(iii), we propose to clarify this requirement by providing that the program description must include a description of the interactive program enclosures, including identification of nonsession housing enclosures, sanctuary area, and interactive area. All enclosures housing or used by program animals would have to be covered in the description.
Current paragraph (f)(1)(v) of § 3.111 provides that the program description cover the training each cetacean has undergone or will undergo prior to
We propose to eliminate the requirements, currently appearing in § 3.111(f)(1)(vii) through (ix), that the facility description include information regarding the current behavior patterns and health of each cetacean, a written program of veterinary care for facilities that utilize a part-time attending veterinarian or consultant, and a detailed description of the monitoring program to be used to detect and identify changes in the behavior and health of the cetaceans. These requirements are redundant to what would already be required elsewhere in the regulations for maintaining medical and behavioral records for marine mammals held in captivity.
Current paragraph (f)(2) of § 3.111 provides that all SWTD programs shall comply in all respects with the regulations and standards set forth in 9 CFR parts 2 and 3. We would remove this language. A similar requirement would instead appear in the introductory paragraph at the beginning of § 3.111.
Paragraph (f)(3) of § 3.111 requires that all individual animal veterinary records, including all examinations, laboratory reports, treatments, and necropsy reports, be kept at the facility site for at least 3 years, while § 3.111(f)(4) requires that the facility retain for at least 3 years individual feeding and behavioral records. These records must be made available to APHIS officials during inspection. We would combine the information provided in paragraphs (f)(3) and (f)(4) into one paragraph, newly designated § 3.111(f)(2), which would require that medical, feeding, water quality, and any behavioral records be kept at the facility for at least 1 year. This is consistent with other recordkeeping requirements in the subpart. We would, however, continue to require that necropsy records be maintained for 3 years (§ 3.110(g)(2)). We would also continue to require that the records be made available to APHIS officials during inspection.
Paragraph (f)(5) of § 3.111 requires that the facility retain for at least 3 years certain statistical summaries involving the amount of time each day that animals participated in an interactive session, as well as the number of persons who participated in the interactive sessions per month. We propose to amend this requirement, to appear at newly designated § 3.111(f)(3), to instead provide that records of individual animal participation times (date, start time of interactive session, and duration) must be maintained by the facility for a period of at least 1 year and be made available to APHIS officials during inspection. It would no longer be necessary for facilities to maintain statistical summaries of the number of persons who participated in the interactive program each month.
Paragraph (f)(6) of § 3.111 requires the facility to submit on a semi-annual basis a description of any changes made in the SWTD program. We propose to remove this paragraph. A new paragraph addressing these requirements on program changes would appear as proposed § 3.111(f)(5), discussed below.
Current § 3.111(f)(7) provides that facilities must maintain records regarding all incidents resulting in injury to either cetaceans or humans participating in an interactive session. All such incidents shall be reported to APHIS within 24 hours of the incident and a written report of the incident that provides a detailed description of the incident and a plan of action for the prevention of further occurrences shall be submitted to the Administrator within 7 days. We would make certain changes to this provision, which would appear at newly designated § 3.111(f)(4). We propose to expand the applicability of this provision to apply not only in cases of injury to human participants or marine mammals, but also to other members of the public and facility staff. In addition, we propose to require that incidents that occur during training sessions also be reported. We would require this reporting so that we would have information about all incidents at a facility, not just those incidents involving members of the public, and we would be able to identify any patterns or problem areas that need to be addressed. We would continue to require that the incident be reported to APHIS within 24 hours of its occurrence, with a written report to be submitted to APHIS within 7 days. We would clarify that the 7-day deadline means 7 calendar days. We would add that, in addition to detailing the incident, the written report must also describe the facility's response to the incident. We would no longer require that the written report specifically include a plan of action for the prevention of further occurrences. We are proposing the latter change as we have determined from experience that working directly with the licensee after an incident is a more timely and flexible means to ensure that adequate measures are in place to prevent such an incident from occurring again.
We propose to add a new paragraph, to appear at § 3.111(f)(5), which would provide that any changes to the interactive program, such as, but not limited to, personnel, animals, facilities (enclosures and interactive areas), and behaviors used, must be submitted to APHIS within 30 calendar days of the change. As long as the change is consistent with requirements, no additional approval from APHIS would be needed. If there is any question of the change being consistent with requirements, APHIS would relay the information to the inspector to discuss with the licensee. This requirement would replace an existing requirement found at § 3.111(f)(6) that provides that the facility must submit on a semi-annual basis a description of any changes made in the SWTD program.
We also propose to make a number of minor editorial changes in various sections for clarity and consistency.
This proposed rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.
We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of
Based on the information we have, there is no reason to conclude that adoption of this proposed rule would result in any significant economic effect on a substantial number of small entities. However, we do not currently have all of the data necessary for a comprehensive analysis of the effects of this proposed rule on small entities. Therefore, we are inviting comments on potential effects. In particular, we are interested in determining the number and kind of small entities that may incur benefits or costs from the implementation of this proposed rule.
We are proposing to amend six sections of 9 CFR part 3 subpart E: § 3.100 on variances and implementation dates; § 3.102 on indoor facilities; § 3.103 on outdoor facilities; § 3.104 on space requirements, § 3.106 on water quality; and § 3.111 on swim-with-the-dolphin programs. Objectives of this proposed rule are to provide regulated facilities with more flexibility in meeting the space requirements (§ 3.100); prevent the accumulation of chlorine/chloramine fumes, ammonia fumes, ozone, other gases, and odors; maintain relative humidity; and provide lighting that simulates natural lighting patterns for healthy animal metabolism (§ 3.102); ensure proper air and water temperature standards, and provide shelter to protect animals from overheating and sunburn due to direct sunlight (§ 3.103); provide easy access and exit for pinnipeds, polar bears, and sea otters of all ages and infirmities to ensure that young, elderly, and ill or infirm animals are able to get out of the water to access their dry resting or social activity area (§ 3.104); provide water quality standards including requirements relating to bacterial standards, salinity, filtration, and water flow (§ 3.106); and address the need to avoid promulgation of redundant provisions and enable APHIS to again enforce regulations covering marine mammal interactive programs which have been suspended since 1999 (§ 3.111).
The entities primarily affected by this proposed rule would be 115 facilities that handle or maintain marine mammals in captivity, such as aquariums, zoos, marine life parks, marine mammal rehabilitation and conservation facilities that are open to the public, and research facilities. Other stakeholders include, but are not limited to, organizations and individuals who are dedicated to improving the welfare of marine mammals in captivity, other Federal agencies that are responsible for the protection and conservation of marine mammals, as well as members of the general public who view and interact with marine mammals in captivity.
A total of 1,544 marine mammals are listed in the latest APHIS inspection data: Dolphins (35 percent), sea lions (25 percent), and seals (21 percent) are the principal species housed at regulated facilities, followed by polar bears (5 percent), sirenians (4 percent), sea otters (3 percent), whales other than killer whales (3 percent), killer whales (2 percent) and walruses (1 percent). The number of marine mammals housed per facility varies from fewer than 4 animals (48 facilities or 42 percent of the 115 facilities) to over 50 animals (4 facilities or 3 percent of the total). Two-thirds of the 115 facilities currently house fewer than 9 marine mammals, and 13 facilities (11 percent) house more than 25 marine mammals. The average number of marine mammals housed is 13.
This proposed rule would directly impact these regulated facilities. Categories of expected benefits and costs of the proposed rule are summarized in Table 1.
As shown in Table 1, we expect that the proposed rule would not result in significant costs for most of the regulated facilities.
Facilities that house marine mammals for exhibition purposes are grouped under the following industries by the North American Industry Classification System: Zoos, Aquariums, and Botanical Gardens (NAICS 712130), Amusement and Theme Parks (NAICS 713110), and Nature Parks and other Similar Institutions (NAICS 712190). Establishments in these three industries are considered small according to the Small Business Administration's (SBA) size standards if annual receipts are, respectively, not more than $27.5 million (NAICS 712130), $38.5 million (NAICS 713110) and $7.5 million (NAICS 712190). Facilities that maintain marine mammals for research purposes (NAICS 541712) are considered small if they have 500 or fewer employees. In 2012, the average annual value of sales per entity for Zoos, Aquariums, and Botanical Gardens (NAICS 712130) was $5.2 million; for Amusement and Theme Parks (NAICS 713110), $27.6 million; and for Nature Parks and Other Similar Institutions (NAICS 712190), $1.1 million. Ninety-eight percent of the facilities that maintain marine mammals for research purposes (NAICS 541712) had fewer than 500 employees. Based on this information most if not all businesses in these industries are considered to be small.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. The Act does not provide administrative procedures which must be exhausted prior to a judicial challenge to the provisions of this rule.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
We are proposing to amend the Animal Welfare Act regulations concerning the humane handling, care, treatment, and transportation of marine mammals in captivity. These proposed changes would affect sections in the regulations relating to variances, indoor facilities, outdoor facilities, space requirements, and water quality. We are also proposing to revise the regulations that relate to swim-with-the-dolphin programs. These proposed amendments may increase paperwork by requiring more records pertaining to water quality and by creating more frequent requests concerning variances and variance extensions from space requirements and other requirements for marine mammals. For interactive programs, the proposed amendments will decrease the amount of recordkeeping and reporting. However, because of an increase in these types of programs and a more inclusive definition of interactive programs under the proposed rule, a larger number of facilities may be required to maintain and report such records. In addition, the estimated annual number of respondents is the number of respondents that we estimate will respond to all of the information collections annually. We are soliciting comments from the public (as well as affected agencies) concerning our proposed reporting, third party disclosure, and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology;
Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
Animal welfare, Pets, Reporting and recordkeeping requirements, Research.
Animal welfare, Marine mammals, Pets, Reporting and recordkeeping requirements, Research, Transportation.
Accordingly, we propose to amend 9 CFR parts 1 and 3 as follows:
7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
The addition and revisions read as follows:
7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
(a) All persons subject to the Animal Welfare Act who maintain or otherwise handle marine mammals in captivity must comply with the provisions of this subpart, except that they may request a variance
(b) An application for a variance must be made to the Deputy Administrator in writing. The request must include:
(1) The species, number, and gender of animals involved;
(2) A statement from the attending veterinarian certifying the age and health status of the animals involved and how the granting of a variance would be beneficial or detrimental to the marine mammals involved;
(3) Each provision of § 3.104 that is not being met;
(4) The time period requested for a variance;
(5) The specific reasons why a variance is requested; and
(6) The estimated cost of coming into compliance, if construction is involved.
(c) After receipt of an application for a variance, APHIS may require the submission in writing of a report by two recognized experts selected by the Deputy Administrator concerning potential adverse impacts on the animals involved or on other matters relating to the effects of the requested variance on the health and well-being of such marine mammals. Such a report will be required in those cases where the Deputy Administrator determines that such expertise is necessary to determine whether the granting of a variance would cause a situation detrimental to the health and well-being of the marine mammals involved. All costs associated with such a report will be borne by the applicant.
(d) Variances may be granted for facilities because of ill or infirm marine mammals that cannot be moved without placing their well-being in jeopardy, or for facilities within 1 foot (0.3048 meters) of compliance with any linear space requirement. Such variances may
(e) The Deputy Administrator will deny any application for a variance if it is determined that the requested variance is not justified under the circumstances or that allowing it will be detrimental to the health and well-being of the marine mammals involved.
(f) A research facility may be granted a variance from specified requirements of this subpart when such variance is necessary for research purposes, is fully explained in the experimental design, and has the appropriate scientific research permit under the Marine Mammal Protection Act, Endangered Species Act, and Institutional Animal Care and Use Committee (IACUC) approval. Any time limitation stated in this section will not be applicable in such case. This provision cannot be used to avoid complying with § 3.104.
(g) A facility may be granted a variance from specified requirements of this subpart when such variance is necessary due to an emergency or temporary special circumstance. Any time limitation stated in this section will not be applicable in such case. This provision cannot be used to avoid complying with § 3.104.
(a)
(b)
(c)
The revisions read as follows:
(a)
(3) Sirenians and primarily warm water dwelling species of pinnipeds or cetaceans must not be housed in outdoor pools where water temperature cannot be maintained within the temperature range needed to maintain their good health and prevent discomfort in accordance with currently accepted practices as cited in appropriate professional journals or reference guides.
(b)
The additions and revision read as follows:
(a) * * *
(2) Only those areas that meet or exceed the minimum depth requirement may be used in determining compliance with minimum horizontal dimension (MHD), volume, and surface area. APHIS will determine if partial obstructions in a horizontal dimension compromise the intent of the regulations and/or significantly restrict freedom of movement of the animal(s) in the enclosure.
(b) * * *
(1) * * *
(iv) * * *
(c) * * *
(1) * * * See Table 2 for the average adult lengths of sirenians.
(d) * * *
(1) Primary enclosures housing pinnipeds shall contain a pool of water and a dry resting area or social activity area that must be close enough to the
(e) * * * Exit and entry area to the pool shall be of a depth and grade to allow easy access and exit for all animals regardless of age or infirmity. * * *
(f) * * *
(1) * * * Exit and entry area to the pool shall be of a depth and grade to allow easy access and exit for all animals regardless of age or infirmity.* * *
(a)
(b)
(i) Total coliform count (count shall not exceed 500 colonies per 100 mL) or fecal coliform count (count shall not exceed 400 colonies per 100 mL); and
(ii) Enterococci count (count shall not exceed 35 colonies per 100 mL); or
(iii) Pseudomonas count (count shall not exceed 10 colonies per 100 mL); or
(iv) Staphylococcus count (count shall not exceed 10 colonies per 100 mL).
(2) Should any of the bacterial counts exceed these levels, two followup samples must be taken to repeat the test(s) for those bacterial contaminants identified as being present at levels exceeding the standards. The first followup must be taken immediately after the initial test result and the second followup must be taken within 48 hours of the first followup. The results of the initial test result, first followup test result, and second follow up test result must be averaged. If the averaged value exceeds the acceptable levels above, the pool water is unsatisfactory and conditions must be corrected immediately.
(3) Additional testing for suspect pathogenic organism(s) should be conducted when there is sufficient evidence of health problems at the facility or of a potential health hazard to the animals.
(4) The addition of any chemicals to a pool must be done in a manner that will not cause harm or discomfort to the marine mammals during the introduction of the chemical or during its presence in the enclosure (in the water, on the surfaces, or in the air).
(5) Water samples must be taken at least daily for pH, salinity, and any chemicals (
(6) Records must be kept documenting the date, time, location (pool and sampling site within the pool) of the sample collection and the results of the sampling. Records of all such test results must be maintained at the facility for a 1-year period and made readily available to APHIS inspectors.
(c)
(i) River dolphins; or
(ii) Pinnipeds where oral administration of sodium chloride (salt) supplements at appropriate levels for the species, as determined by the attending veterinarian, is provided and saltwater eye baths are used on a daily basis.
(2) Salinity must be maintained within the range of 24-36 parts per thousand except in natural lagoon or coastal enclosures, where the salinity must be no less than 15 parts per thousand.
(3) The requirements in paragraphs (c)(1) and (2) of this section do not preclude the use of other salinity levels when prescribed by the attending veterinarian to appropriately treat specific medical conditions.
(d)
(e)
All marine mammal interactive programs must comply with this section and all other appropriate provisions set forth in parts 2 and 3 of this subchapter.
(a)
(1) The interactive area must provide sufficient space for all marine mammals to freely swim or move about, consistent with the type of interaction, even with a full complement of public participants and employees in the area.
(2) The sanctuary area may be within the enclosure containing the interactive area or it may be within a second enclosure to which free and unrestricted access is provided during the interactive session. The sanctuary area must meet the minimum space requirements found in § 3.104.
(b)
(c)
(1) The head trainer/supervisor of the interactive program must have demonstrable in-depth knowledge of the husbandry and care requirements of the family and species of marine mammals being exhibited, demonstrable knowledge of and skill in current accepted professional standards and techniques in animal training and handling, and the ability to recognize normal and abnormal behavior and signs of behavioral stress in the animal families and species being exhibited.
(2) All interactive program trainers and attendants must have the knowledge and skill level sufficient to safely conduct and monitor an interactive session.
(d)
(2) All marine mammals used in an interactive session must be adequately trained and conditioned in human interaction so that they respond in the session to the attendants with appropriate behavior for safe interaction. The trainer, handler, or attendant must, at all times, control the nature and extent of the marine mammal interaction with the public during a session using the trained responses of the program animal.
(3) All marine mammals used in interactive sessions must be in good health, including, but not limited to, not being infectious. Marine mammals undergoing veterinary treatment may be used in interactive sessions only with the written approval of the attending veterinarian.
(4) There must be a sufficient number of session attendants (includes trainer, handler, or attendants) to effectively conduct the session in a safe manner. There must be at least one attendant per marine mammal in the session, and at least one attendant positioned to monitor each session. The number of public participants per marine mammal must not exceed the number that the attendant can monitor safely, appropriate to the type of interactive session.
(5) Prior to participating in an interactive session, members of the public must be provided with oral rules and instructions for the session. The program must also either provide to the attendees in a written handout, or post in a highly visible location, a notice that summarizes the rules and instructions for the session and includes contact information for the appropriate Animal Care Field Operations office for reporting injuries or complaints. A copy of the written rules must be made available to APHIS during an inspection. Any participant who fails to follow the rules and instructions and jeopardizes human or animal safety or health must be immediately removed from the session by the facility management.
(6) All interactive programs must limit interactions between marine mammals and human participants so that the interaction does not harm the marine mammal or human participants, does not elicit unsatisfactory, undesirable, or unsafe behaviors from the marine mammal, and does not restrict by word or action (including recalling), from the sanctuary area, or enclosure design, the ability of the animal to leave the interactive area and session as it chooses. If an animal removes itself or is removed from a session, the facility must maintain the ratios of § 3.111(d)(4) by either removing human participants from the interactive area or introducing another animal.
(7) All interactive programs must prohibit grasping or holding of the animal's body unless it is done under the direct and explicit instruction of the attendant, and must prohibit the chasing or other harassment of the animal(s).
(8) Marine mammals that exhibit unsatisfactory, undesirable, or unsafe behaviors, including, but not limited to, charging, biting, mouthing, or sexual contact with humans, must be removed from the interactive session immediately, or, if the animal cannot be removed, the session must be terminated. Such an animal must not be used in an interactive session until the trainer determines that the animal is no longer exhibiting the unsatisfactory, undesirable, or unsafe behavior. Written criteria for the termination of a session due to such behavior and the retraining of such an animal must be developed and maintained at the facility and be made available to APHIS during inspection or upon request. This document must also address the procedures to be used to maintain compliance with § 3.111(d)(4) during such disruption of an interactive session.
(e)
(f)
(i) Identification of each marine mammal in the interactive program, by means of name and/or number, sex, age, and any other means the Administrator determines to be necessary to adequately identify the animal;
(ii) An outline of the session agenda, including, but not limited to, written information distributed, topics addressed prior to entry in the water, an in-water program agenda, including behaviors and activities expected to be presented or performed;
(iii) A description of the interactive program enclosures, including identification of non-session housing enclosures, sanctuary area, and interactive area. All enclosures housing or used by program animals must be included;
(iv) Verification from the trainer that the program animals have received adequate and appropriate training for an interactive program; and
(v) Documentation of the experience and training of the trainer, handler, attendants, and attending veterinarian.
(2) Medical, feeding, water quality, and any behavioral records must be kept at the facility for at least 1 year or as otherwise required in this subchapter and be made available to APHIS during inspection or upon request.
(3) Records of individual animal participation times (date, start time of interactive session, and duration) must be maintained by the facility for a period of at least 1 year and be made available to APHIS officials during inspection or upon request.
(4) All incidents resulting in injury to either a marine mammal, members of the public, or facility staff during an interactive session or training session must be reported to APHIS within 24 business hours of the incident. A written report detailing the incident and the facility's response to the incident must be submitted to APHIS within 7 calendar days of the incident.
(5) Any changes to the interactive program, such as, but not limited to, personnel, animals, facilities (enclosures and interactive areas), and behaviors used, must be submitted to APHIS within 30 calendar days of the change.
Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy.
Notice of intent and announcement of public meeting.
The U.S. Department of Energy (“DOE” or, in context, “the Department”) is giving notice of a public meeting and that DOE intends to establish a negotiated rulemaking working group under the Appliance Standards and Rulemaking Federal Advisory Committee (“ASRAC”) in accordance with the Federal Advisory Committee Act (“FACA”) and the Negotiated Rulemaking Act (“NRA”) to negotiate proposed amended energy conservation standards for circulator pumps. The purpose of the working group will be to discuss and, if possible, reach consensus on a proposed rule regarding definitions, test procedures, and energy conservation standards, as authorized by the Energy Policy and Conservation Act (EPCA) of 1975, as amended. The working group will consist of representatives of parties having a defined stake in the outcome of the proposed standards, and will consult as appropriate with a range of experts on technical issues. Per the ASRAC Charter, the working group is expected to make a concerted effort to negotiate a final term sheet by September 30, 2016.
DOE will host the first Working Group meeting, which is open to the public, and will be broadcast via webinar on March 3, 2016 from 9 a.m. to 5 p.m. in Washington, DC.
Written comments and applications (
U.S. Department of Energy, Building Technologies Office, 950 L'Enfant Plaza SW., Washington, DC 20024, Room 6097. Individuals will also have the opportunity to participate by webinar. To register for the webinar and receive call-in information, please register
Interested person may submit comments and an application for membership (which must include a cover letter describing their experience on negotiating committees and their direct impact on the negotiations, if applicable, and listed qualifications for being selected to this working group and a resume,), identified by docket number EERE-2016-BT-STD-0004, via any of the following methods:
1.
2.
3.
4.
No telefacsimilies (faxes) will be accepted.
John Cymbalsky, U.S. Department of Energy, Office of Building Technologies (EE-2J), 950 L'Enfant Plaza SW., Washington, DC 20024. Phone: 202-287-1692. Email:
DOE is announcing its intent to negotiate proposed definitions, test procedures, and energy conservation standards for circulator pumps under the authority of sections 563 and 564 of the NRA (5 U.S.C. 561-570, Pub. L. 104-320). The regulation of circulator pump standards that DOE is proposing to develop under a negotiated rulemaking will be developed under the authority of EPCA, as amended, 42 U.S.C. 6311(1) and 42 U.S.C. 6291
As required by the NRA, DOE is giving notice that it is establishing a working group under ASRAC to discuss proposed energy conservation standards for circulator pumps.
DOE is supporting the use of the negotiated rulemaking process to discuss and develop proposed definitions, test procedures, and energy conservation standards for circulator pumps The primary reason for using the negotiated rulemaking process for this product is that stakeholders strongly support a consensual rulemaking effort. DOE believes such a regulatory negotiation process will be less adversarial and better suited to resolving complex technical issues. An important virtue of negotiated rulemaking is that it allows expert dialog that is much better than traditional techniques at getting the facts and issues right and will result in a proposed rule that will effectively reflect Congressional intent.
A regulatory negotiation will enable DOE to engage in direct and sustained dialog with informed, interested, and affected parties when drafting the regulation, rather than obtaining input during a public comment period after developing and publishing a proposed rule. A rule drafted by negotiation with informed and affected parties is expected to be potentially more pragmatic and more easily implemented than a rule arising from the traditional process. Such rulemaking improvement is likely to provide the public with the full benefits of the rule while minimizing the potential negative impact of a proposed regulation conceived or drafted without the full prior input of outside knowledgeable parties. Because a negotiating working group includes representatives from the major stakeholder groups affected by or interested in the rule, the number of public comments on the proposed rule may be decreased. DOE anticipates that there will be a need for fewer substantive changes to a proposed rule developed under a regulatory negotiation process prior to the publication of a final rule.
Usually, DOE develops a proposed rulemaking using Department staff and consultant resources. Congress noted in the NRA, however, that regulatory development may “discourage the affected parties from meeting and communicating with each other, and may cause parties with different interests to assume conflicting and antagonistic positions * * *.” 5 U.S.C. 561(2)(2). Congress also stated that “adversarial rulemaking deprives the affected parties and the public of the benefits of face-to-face negotiations and cooperation in developing and reaching agreement on a rule. It also deprives them of the benefits of shared information, knowledge, expertise, and technical abilities possessed by the affected parties.” 5 U.S.C. 561(2)(3).
Using negotiated rulemaking to develop a proposed rule differs fundamentally from the Department-centered process. In negotiated rulemaking, a proposed rule is developed by an advisory committee or working group, chartered under FACA, 5 U.S.C. App. 2, composed of members chosen to represent the various interests that will be significantly affected by the rule. The goal of the advisory committee or working group is to reach consensus on the treatment of the major issues involved with the rule. The process starts with the Department's careful identification of all interests potentially affected by the rulemaking under consideration. To help with this identification, the Department publishes a notice of intent such as this one in the
After an advisory committee or working group reaches consensus on the provisions of a proposed rule, the Department, consistent with its legal obligations, uses such consensus as the basis of its proposed rule, which then is published in the
The NRA enables DOE to establish an advisory committee or working group if it is determined that the use of the negotiated rulemaking process is in the public interest. DOE intends to develop Federal regulations that build on the depth of experience accrued in both the public and private sectors in implementing standards and programs.
DOE is supporting the use of the regulatory negotiation process in order to provide for obtaining a diverse array of in-depth input, as well as an opportunity for increased collaborative discussion from both private-sector stakeholders and government officials who are familiar with the energy efficiency of circulator pumps.
In initiating this regulatory negotiation process to develop definitions, test procedures, and energy conservation standards for circulator pumps, DOE is making a commitment to provide adequate resources to facilitate timely and successful completion of the process. This commitment includes making the process a priority activity for all representatives, components, officials, and personnel of the Department who need to be involved in the rulemaking, from the time of initiation until such time as a final rule is issued or the process is expressly terminated. DOE will provide administrative support for the process and will take steps to ensure that the advisory committee or working group has the dedicated resources it requires to complete its work in a timely fashion. Specifically, DOE will make available the following support services: properly equipped space adequate for public meetings and caucuses; logistical support; word processing and distribution of background information; the service of a facilitator; and such additional research and other technical assistance as may be necessary.
To the maximum extent possible consistent with the legal obligations of the Department, DOE will use the consensus of the advisory committee or working group as the basis for the rule the Department proposes for public notice and comment.
As discussed above, the negotiated rulemaking process differs fundamentally from the usual process for developing a proposed rule. Negotiation enables interested and affected parties to discuss various approaches to issues rather than asking them only to respond to a proposal developed by the Department. The negotiation process involves a mutual education of the various parties on the practical concerns about the impact of standards. Each advisory committee or working group member participates in resolving the interests and concerns of other members, rather than leaving it up to DOE to evaluate and incorporate different points of view.
A key principle of negotiated rulemaking is that agreement is by consensus of all the interests. Thus, no one interest or group of interests is able to control the process. The NRA defines consensus as the unanimous concurrence among interests represented on a negotiated rulemaking committee or working group, unless the committee or working group itself unanimously agrees to use a different definition. 5 U.S.C. 562. In addition, experience has demonstrated that using a trained mediator to facilitate this process will assist all parties, including DOE, in identifying their real interests in the rule, and thus will enable parties to focus on and resolve the important issues.
The following issues and concerns will underlie the work of the Negotiated Rulemaking Committee for circulator pumps and be limited to the items specified below:
• Definitions of circulator pumps,
• Test procedures for circulator pumps, and
• Energy conservation standards for circulator pumps.
To examine the underlying issues outlined above, all parties in the negotiation will need DOE to provide
A working group will be formed and operated in full compliance with the requirements of FACA and in a manner consistent with the requirements of the NRA. DOE has determined that the working group shall not exceed 25 members. The Department believes that more than 25 members would make it difficult to conduct effective negotiations. DOE is aware that there are many more potential participants than there are membership slots on the working group. The Department does not believe, nor does the NRA contemplate, that each potentially affected group must participate directly in the negotiations; nevertheless, each affected interest can be adequately represented. To have a successful negotiation, it is important for interested parties to identify and form coalitions that adequately represent significantly affected interests. To provide adequate representation, those coalitions must agree to support, both financially and technically, a member of the working group whom they choose to represent their interests.
DOE recognizes that when it considers adding covered products and establishing energy efficiency standards for residential products and commercial equipment, various segments of society may be affected in different ways—in some cases, producing unique “interests” in a proposed rule based on income, gender, or other factors. The Department will pay attention to providing that any unique interests that have been identified, and that may be significantly affected by the proposed rule, are represented.
FACA also requires that members of the public have the opportunity to attend meetings of the full committee and speak or otherwise address the committee during the public comment period. In addition, any member of the public is permitted to file a written statement with the advisory committee. DOE plans to follow these same procedures in conducting meetings of the working group.
DOE anticipates that the working group will comprise no more than 25 members who represent affected and interested stakeholder groups, at least one of whom must be a member of the ASRAC. As required by FACA, the Department will conduct the negotiated rulemaking with particular attention to ensuring full and balanced representation of those interests that may be significantly affected by the proposed rule governing standards for circulator pumps. Section 562 of the NRA defines the term “interest” as “with respect to an issue or matter, multiple parties which have a similar point of view or which are likely to be affected in a similar manner.” Listed below are parties the Department to date has identified as being “significantly affected” by a proposed rule regarding the energy efficiency of circulator pumps.
• The Department of Energy;
• Trade Associations representing refrigeration system manufacturers of circulator pumps;
• Manufacturers of circulator pumps system components and related suppliers;
• Distributors or contractors selling or installers of circulator pumps;
• Utilities;
• Energy efficiency/environmental advocacy groups; and
• Commercial customers.
One purpose of this notice of intent is to determine whether Federal regulations for circulator pumps will significantly affect interests that are not listed above. DOE invites comment and suggestions on its initial list of significantly affected interests.
Members may be individuals or organizations. If the effort is to be fruitful, participants in the working group should be able to fully and adequately represent the viewpoints of their respective interests. This document gives notice of DOE's process to other potential participants and affords them the opportunity to request representation in the negotiations. Those who wish to be appointed as members of the working group, should submit a request to DOE, in accordance with the public participation procedures outlined in the DATES and
• Attendance at approximately eight (8), one (1)- to two (2)-day meetings (with the potential for two (2) additional one (1)- or two (2)-day meetings);
• Travel costs to those meetings; and
• Preparation time for those meetings.
Members serving on the working group will not receive compensation for their services. Interested parties who are not selected for membership on the working group may make valuable contributions to this negotiated rulemaking effort in any of the following ways:
• The person may request to be placed on the working group mailing list and submit written comments as appropriate.
• The person may attend working group meetings, which are open to the public; caucus with his or her interest's member on the working group; or even address the working group during the public comment portion of the working group meeting.
• The person could assist the efforts of a workgroup that the working group might establish.
A working group may establish informal workgroups, which usually are asked to facilitate committee deliberations by assisting with various technical matters (
Every working group member must be willing to negotiate in good faith and have the authority, granted by his or her constituency, to do so. The first step is to ensure that each member has good communications with his or her constituencies. An intra-interest network of communication should be established to bring information from the support organization to the member at the table, and to take information from the table back to the support organization. Second, each organization or coalition, therefore, should designate as its representative a person having the credibility and authority to ensure that needed information is provided and decisions are made in a timely fashion. Negotiated rulemaking can require the appointed members to give a significant sustained for as long as the duration of the negotiated rulemaking. Other qualities of members that can be helpful are negotiating experience and skills,
Certain concepts are central to negotiating in good faith. One is the willingness to bring all issues to the bargaining table in an attempt to reach a consensus, as opposed to keeping key issues in reserve. The second is a willingness to keep the issues at the table and not take them to other forums. Finally, good faith includes a willingness to move away from some of the positions often taken in a more traditional rulemaking process, and instead explore openly with other parties all ideas that may emerge from the working group's discussions.
The facilitator will act as a neutral in the substantive development of the proposed standard. Rather, the facilitator's role generally includes:
• Impartially assisting the members of the working group in conducting discussions and negotiations; and
• Impartially assisting in performing the duties of the Designated Federal Official under FACA.
The DOE representative will be a full and active participant in the consensus building negotiations. The Department's representative will meet regularly with senior Department officials, briefing them on the negotiations and receiving their suggestions and advice so that he or she can effectively represent the Department's views regarding the issues before the working group. DOE's representative also will ensure that the entire spectrum of governmental interests affected by the standards rulemaking, including the Office of Management and Budget, the Attorney General, and other Departmental offices, are kept informed of the negotiations and encouraged to make their concerns known in a timely fashion.
After evaluating the comments submitted in response to this notice of intent and the requests for nominations, DOE will either inform the members of the working group that they have been selected or determine that conducting a negotiated rulemaking is inappropriate.
Per the ASRAC Charter, the working group is expected to make a concerted effort to negotiate a final term sheet by September 30, 2016.
DOE will advise working group members of administrative matters related to the functions of the working group before beginning. While the negotiated rulemaking process is underway, DOE is committed to performing much of the same analysis as it would during a normal standards rulemaking process and to providing information and technical support to the working group.
DOE requests comments on which parties should be included in a negotiated rulemaking to develop draft language pertaining to the energy efficiency of circulator pumps and suggestions of additional interests and/or stakeholders that should be represented on the working group. All who wish to participate as members of the working group should submit a request for nomination to DOE.
Members of the public are welcome to observe the business of the meeting and, if time allows, may make oral statements during the specified period for public comment. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, email
Due to the REAL ID Act implemented by the Department of Homeland Security (DHS) recent changes regarding ID requirements for individuals wishing to enter Federal buildings from specific states and U.S. territories. Driver's licenses from the following states or territory will not be accepted for building entry and one of the alternate forms of ID listed below will be required.
DHS has determined that regular driver's licenses (and ID cards) from the following jurisdictions are not acceptable for entry into DOE facilities: Alaska, Louisiana, New York, American Samoa, Maine, Oklahoma, Arizona, Massachusetts, Washington, and Minnesota.
Acceptable alternate forms of Photo-ID include: U. S. Passport or Passport Card; An Enhanced Driver's License or Enhanced ID-Card issued by the states of Minnesota, New York or Washington (Enhanced licenses issued by these states are clearly marked Enhanced or Enhanced Driver's License); A military ID or other Federal government issued Photo-ID card.
The Secretary of Energy has approved publication of today's notice of intent.
Board of Governors of the Federal Reserve System.
Proposed policy statement with request for public comment.
The Board is inviting public comment on a policy statement on the framework that the Board will follow in setting the amount of the U.S. countercyclical capital buffer for advanced approaches bank holding companies, savings and loan holding companies, and state member banks under the Board's Regulation Q (12 CFR part 217).
Comments must be received on or before March 21, 2016. Comments were originally due by February 19, 2016.
You may submit comments, identified by Docket No. R-1529 and RIN 7100 AE-43 by any of the following methods:
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All public comments will be made available on the Board's Web site at
William Bassett, Deputy Associate Director, (202) 736-5644, or Rochelle Edge, Deputy Associate Director, (202) 452-2339, Office of Financial Stability Policy and Research; Sean Campbell, Associate Director, (202) 452-3760, Division of Banking Supervision and Regulation; Benjamin W. McDonough, Special Counsel, (202) 452-2036, Mark Buresh, Senior Attorney, (202) 452-5270, or Mary Watkins, Attorney, (202) 452-3722, Legal Division.
The Board of Governors of the Federal Reserve System (Board) issued in June 2013 a final regulatory capital rule (Regulation Q) in coordination with the Office of the Comptroller of the Currency (OCC) and the Federal Deposit Insurance Corporation (FDIC) to strengthen risk-based and leverage capital requirements applicable to insured depository institutions and certain depository institution holding companies (banking organizations).
The CCyB is a macroprudential policy tool that the Board can increase during periods of rising vulnerabilities in the financial system and reduce when vulnerabilities recede.
The CCyB applies to banking organizations subject to the advanced approaches capital rules (advanced approaches institutions).
The CCyB functions as an expansion of the Capital Conservation Buffer (CCB). The CCB requires that a banking organization hold a buffer of common equity tier 1 capital in excess of the minimum risk-based capital ratios greater than 2.5 percent of risk-weighted assets to avoid limits on capital distributions and certain discretionary bonus payments.
As described in Regulation Q, the CCyB applies based on the location of exposures by national jurisdiction.
Regulation Q established the initial CCyB amount with respect to private-sector credit exposures located in the United States (U.S.-based credit exposures) at zero percent. Following a phase-in period, the amount of the CCyB will vary between 0 and 2.5 percent of risk-weighted assets. Under the phase-in schedule, the maximum potential amount of the CCyB for U.S.-based credit exposures is 0.625 percentage points in 2016, 1.25 percentage points in 2017, 1.875 percentage points in 2018, and 2.5 percentage points in 2019 and all subsequent years.
The Board expects to make decisions about the appropriate level of the CCyB on U.S.-based credit exposures jointly with the OCC and FDIC. In addition, the Board expects that the CCyB amount for U.S.-based credit exposures would be the same for covered insured depository institutions as for covered depository institution holding companies. The CCyB is designed to take into account the broad macroeconomic and financial environment in which banking organizations function and the degree to which that environment impacts the resilience of the group of advanced approaches institutions. Therefore, the Board's determination of the appropriate level of the CCyB for U.S.-based credit exposures would be most directly linked to the condition of the overall financial environment rather than the condition of any individual banking organization. But, the overall CCyB requirement for a banking organization will vary based on the organization's particular composition of private sector credit exposures located across national jurisdictions.
The proposed policy statement (Policy Statement) describes the framework that the Board would follow in setting the amount of the CCyB for U.S.-based credit exposures. The framework consists of a set of principles for translating assessments of financial-system vulnerabilities that are regularly undertaken at the Board into the appropriate level of the CCyB. Those assessments are informed by a broad array of quantitative indicators of financial and economic performance and a set of empirical models. In addition, the framework includes a discussion of how the Board would assess whether the CCyB is the most appropriate policy instrument (among available policy instruments) to address the highlighted financial-system vulnerabilities.
The proposed Policy Statement is organized as follows. Section 1 provides background on the proposed Policy Statement. Section 2 is an outline of the proposed Policy Statement and describes its scope. Section 3 provides a broad description of the objectives of the CCyB, including a description of the ways in which the CCyB is expected to protect large banking organizations and the broader financial system. Section 4 provides a broad description of the factors that the Board considers in setting the CCyB, including specific financial-system vulnerabilities and types of quantitative indicators of financial and economic performance, and outlines of empirical models the Board may use as inputs to that decision. Further, section 4 describes a set of principles that the Board expects to use for combining judgmental assessments with quantitative indicators to determine the appropriate level of the CCyB. Section 5 discusses how the Board will communicate the level of the CCyB and any changes to the CCyB. Section 6 describes how the Board plans to monitor the effects of the CCyB, including what indicators and effects will be monitored.
The Board seeks comment on all aspects of the proposed Policy Statement.
Section 722 of the Gramm-Leach-Bliley Act (Pub. L. 106-102, 113 Stat. 1338, 1471, 12 U.S.C. 4809) requires the Federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. The Board has sought to present the proposed policy statement in a simple and straightforward manner, and invites comment on the use of plain language.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3506), the Board has reviewed the proposed policy statement to assess any information collections. There are no collections of information as defined by the Paperwork Reduction Act in the proposal.
The Board is providing an initial regulatory flexibility analysis with respect to this proposed Policy Statement. As discussed above, the proposed Policy Statement is designed to provide additional information regarding the factors that the Board expects to consider in evaluating whether to change the CCyB applicable to private-sector credit exposures located in the United States. The Regulatory Flexibility Act, 5 U.S.C. 601
The proposed Policy Statement would relate only to advanced approaches institutions, which, generally, are banking organizations with total consolidated assets of $250 billion or more, that have total consolidated on-balance sheet foreign exposure of $10 billion or more, are a subsidiary of an advanced approaches depository institution, or that elect to use the advanced approaches framework.
Therefore, there are no significant alternatives to the proposal that would have less economic impact on small banking organizations. There are no projected reporting, recordkeeping, or other compliance requirements of the proposal. The Board does not believe that the proposal duplicates, overlaps, or conflicts with any other Federal rules. In light of the foregoing, the Board does not believe that the proposal, if adopted in final form, would have a significant economic impact on a substantial number of small entities. Nonetheless, the Board seeks comment on whether the proposal would impose undue burdens on, or have unintended consequences for, small organizations, and whether there are ways such potential burdens or consequences could be minimized in a manner consistent with the purpose of the proposal. A final regulatory flexibility analysis will be conducted after consideration of comments received during the public comment period.
Administrative practice and procedure, Banks, banking. Holding companies, Reporting and recordkeeping requirements, Securities.
For the reasons stated in the Supplementary Information, the Board of Governors of the Federal Reserve System proposes to add the Policy Statement as set forth at the end of the Supplementary Information as appendix A to part 217 of 12 CFR chapter II as follows:
12 U.S.C. 248(a), 321-338a, 481-486, 1462a, 1467a, 1818, 1828, 1831n, 1831o, 1831p-l, 1831w, 1835, 1844(b), 1851, 3904, 3906-3909, 4808, 5365, 5368, 5371.
The Board of Governors of the Federal Reserve System (Board) issued a final regulatory capital rule (Regulation Q) in coordination with the Office of the Comptroller of the Currency (OCC) and the Federal Deposit Insurance Corporation (FDIC) that strengthened risk-based and leverage capital requirements applicable to insured depository institutions and depository institution holding companies (banking organizations).
The CCyB is a macroprudential policy tool that the Board can increase during periods of rising vulnerabilities in the financial system and reduce when vulnerabilities recede. It is designed to increase the resilience of large banking organizations when policymakers see an elevated risk of above-normal losses. Increasing the resilience of large banking organizations should, in turn, improve the resilience of the broader financial system. Above-normal losses often follow periods of rapid asset price appreciation or credit growth that are not well supported by underlying economic fundamentals. The circumstances in which the Board would most likely use the CCyB as a supplemental, macroprudential tool to augment minimum capital requirements and other capital buffers would be to address circumstances when potential systemic vulnerabilities are somewhat above normal. By requiring large banking organizations to hold additional capital during those periods of excess and removing the requirement to hold additional capital when the vulnerabilities have diminished, the CCyB also is expected to moderate fluctuations in the supply of credit over time.
The Board expects to make decisions about the appropriate level of the CCyB on U.S.-based credit exposures jointly with the OCC and FDIC, and expects that the CCyB amount for U.S.-based credit exposures will be the same for covered depository institution holding companies and insured depository institutions. The CCyB is designed to take into account the macrofinancial environment in which banking organizations function and the degree to which that environment impacts the resilience of the group of advanced approaches institutions. Therefore, the appropriate setting of the CCyB for private sector credit exposures located in the United States (U.S.-based credit exposures) is not closely linked to the characteristics of an individual institution. However, the overall CCyB for each institution will differ because the CCyB is weighted based on a banking organization's particular composition of private-sector credit exposures across national jurisdictions.
This Policy Statement describes the framework that the Board will follow in setting the amount of the CCyB for U.S.-based credit exposures. The framework consists of a set of principles for translating assessments of financial-system vulnerabilities that are regularly undertaken by the Board into the appropriate level of the CCyB. Those assessments are informed by a broad array of quantitative indicators of financial and economic performance and a set of empirical models. In addition, the framework includes an assessment of whether the CCyB is the most appropriate policy instrument (among available policy instruments) to address the highlighted financial-system vulnerabilities.
The objectives of the CCyB are to strengthen banking organizations' resilience against the build-up of systemic vulnerabilities and reduce fluctuations in the supply of credit. The CCyB supplements the minimum capital requirements and the capital conservation buffer, which themselves are designed to provide substantial resilience to unexpected losses created by normal fluctuations in economic and financial conditions. The capital surcharge on global systemically important banking organizations adds an additional layer of defense for the largest and most systemically important institutions, whose financial distress can have outsized effects on the rest of the financial system and real economy.
The CCyB is expected to help provide additional resilience for advanced approaches institutions, and by extension the broader financial system, against elevated vulnerabilities primarily in two ways. First, advanced approaches institutions will likely hold more capital to avoid limitations on capital distributions and discretionary bonus payments resulting from implementation of the CCyB. Strengthening their capital positions when financial conditions are accommodative would increase the capacity of advanced approaches institutions to absorb outsized losses during a future significant economic downturn or period of financial instability, thus making them more resilient. The second and related goal of the CCyB is to promote a more sustainable supply of credit over the economic cycle.
During a credit cycle downturn, better-capitalized institutions have been shown to be more likely to have continued access to funding and less likely to take actions that lead to broader financial-sector distress and its associated macroeconomic costs, such as large-scale sales of assets at prices below their fundamental value and sharp contractions in credit supply.
Likewise, during a period of cyclically increasing vulnerabilities, advanced approaches institutions might react to an increase in the CCyB by tightening lending standards, otherwise reducing their risk exposure, augmenting their capital, or some combination of those actions. They may choose to raise capital by taking actions that would increase net income, reducing capital distributions through share repurchases or dividends, or issuing new equity. In this regard, an increase in the CCyB would not prevent advanced approaches institutions from maintaining their important role as credit intermediaries, but would reduce the likelihood that banking organizations with insufficient capital would foster unsustainable credit growth or engage in imprudent risk taking. The specific combination of adjustments and the relative size of each adjustment will depend in part on the initial capital positions of advanced approaches institutions, the cost of debt and equity financing, and the earnings opportunities presented by the economic situation at the time.
The Board regularly monitors and assesses threats to financial stability by synthesizing information from a comprehensive set of financial-sector and macroeconomic indicators, supervisory information, surveys, and other interactions with market participants.
The Board intends to monitor a wide range of financial and macroeconomic quantitative indicators including, but not limited to, measures of relative credit and liquidity expansion or contraction, a variety of asset prices, funding spreads, credit condition surveys, indices based on credit default swap spreads, options implied volatility, and measures of systemic risk.
However, no single indictor or fixed set of indicators can adequately capture all the key vulnerabilities in the U.S. economy and financial system. Moreover, adjustments in the CCyB that were tightly linked to a specific model or set of models would be imprecise due to the relatively short period that some indicators are available, the limited number of past crises against which the models can be calibrated, and limited experience with the CCyB as a macroprudential tool. As a result, the types of indicators and models considered in assessments of the appropriate level of the CCyB are likely to change over time based on advances in research and the experience of the Board with this new macroprudential tool.
The Board will determine the appropriate level of the CCyB for U.S.-based credit exposures based on its analysis of the above factors. Generally, a zero percent U.S. CCyB amount would reflect an assessment that U.S. economic and financial conditions are broadly consistent with a financial system in which levels of system-wide vulnerabilities are not somewhat above normal. The Board could increase the CCyB as vulnerabilities build, and a 2.5 percent CCyB amount for U.S.-based credit exposures would reflect an assessment that the U.S. financial sector is experiencing a period of significantly elevated or rapidly increasing system-wide vulnerabilities. Importantly, as a macroprudential policy tool, the CCyB will be activated and deactivated based on broad developments and trends in the U.S. financial system, rather than the activities of any individual banking organization.
Similarly, the Board would remove or reduce the CCyB when the conditions that led to its activation abate or lessen, rather than leaving the nonzero level of the buffer in place over periods when financial and
The pace and magnitude of changes in the CCyB will depend importantly on the underlying conditions in the financial sector and the economy as well as the desired effects of the proposed change in the CCyB. If vulnerabilities are rising gradually, then incremental increases in the level of the CCyB may be appropriate. Incremental increases would allow banks to augment their capital primarily through retained earnings and allow policymakers additional time to assess the effects of the policy change before making subsequent adjustments. However, if vulnerabilities in the financial system are building rapidly, then larger or more frequent adjustments may be necessary to increase loss-absorbing capacity sooner and potentially to mitigate the rise in vulnerabilities.
The Board will also consider whether the CCyB is the most appropriate of its available policy instruments to address the financial-system vulnerabilities highlighted by the framework's judgmental assessments and empirical models. The CCyB primarily is intended to address cyclical vulnerabilities, rather than structural vulnerabilities that do not vary significantly over time. Structural vulnerabilities are better addressed though targeted reforms or permanent increases in financial system resilience. Two key factors for the Board to consider are whether advanced approaches institutions are exposed—either directly or indirectly—to the vulnerabilities identified in the comprehensive judgmental assessment or by the quantitative indicators that suggest activation of the CCyB and whether advanced approaches institutions are contributing—either directly or indirectly—to these highlighted vulnerabilities.
The Board, in setting the CCyB for advanced approaches institutions that it supervises, plans to consult with the OCC and FDIC on their analyses of financial-system vulnerabilities and on the extent to which banking organizations are either exposed to or contributing to these vulnerabilities.
The Board expects to consider at least once per year the applicable level of the U.S. CCyB. The Board will review financial conditions regularly throughout the year and may adjust the CCyB more frequently as a result of those monitoring activities.
Further, the Board will continue to communicate with the public in other formats regarding its assessment of U.S. financial stability, including financial-system vulnerabilities. For example, the Board's biannual Monetary Policy Report to Congress, usually published in February and July, will continue to contain a section that reports on developments pertaining to the stability of the U.S. financial system.
The effects of the U.S. CCyB ultimately will depend on the level at which it is set, the size and nature of any adjustments in the level, and the timeliness with which it is increased or decreased. The extent to which the CCyB may affect vulnerabilities in the broader financial system depends upon a complex set of interactions between required capital levels at the largest banking organizations and the economy and financial markets. In addition to the direct effects, the secondary economic effects could be amplified if financial markets extract a signal from the announcement of a change in the CCyB about subsequent actions that might be taken by the Board. Moreover, financial market participants might react by updating their expectations about future asset prices in specific markets or broader economic activity based on the concerns expressed by the regulators in communications announcing a policy change.
The Board will monitor and analyze adjustments by banking organizations and other financial institutions to the CCyB. Factors that will be considered include (but are not limited to) the types of adjustments that affected banking organizations might undertake. For example, it will be useful to monitor whether a change in the CCyB leads to observed changes in risk-based capital ratios at advanced approaches institutions, as well as whether those adjustments are achieved passively through retained earnings, or actively through changes in capital distributions or in risk-weighted assets. Other factors to be monitored include the extent to which loan growth and spreads on loans issued by affected banking organizations change relative to loan growth and loan spreads at banking organizations that are not subject to the buffer. Another key consideration in setting the CCyB and other macroprudential tools is the extent to which the adjustments by advanced approaches institutions to higher capital buffers lead to migration of credit market activity outside of those banking organizations, especially to the nonbank financial sector. Depending on the amount of migration and which institutions are affected, those adjustments could cause the Board to favor either a higher or a lower value of the CCyB.
The Board will also monitor information regarding the levels of and changes in the CCyB in other countries. The Basel Committee on Banking Supervision is expected to maintain this information for member countries in a publically available form on its Web site.
U.S. Small Business Administration.
Notice of proposed rulemaking.
In this proposed rule, the U.S. Small Business Administration (SBA) is defining a new class of small business investment companies (SBICs) that will seek to generate positive and measurable social impact in addition to financial return. With the creation of this class of “Impact SBICs,” SBA is seeking to expand the pool of investment capital available primarily to underserved communities and innovative sectors as well as support the development of America's growing impact investing industry. This proposed rule sets forth regulations applicable to Impact SBICs with respect to licensing, leverage eligibility, fees, reporting and compliance requirements.
Comments on the proposed rule must be received on or before March 4, 2016.
You may submit comments, identified by RIN 3245-AG66, by any of the following methods:
SBA will post comments on
Nate T. Yohannes, Office of Investment and Innovation, (202) 205-6714.
“Impact investing” is a term used to describe an investment approach that combines the pursuit of financial return with the goal of generating measurable social, environmental or economic impact. The term “social impact investing” is often used synonymously with the term impact investing, and refers, collectively, to all types of impact investing, including social, environmental and economic. Impact investors are active throughout the capital markets, and though their strategies may vary, according to the Global Impact Investing Network, a non-profit organization dedicated to increasing the scale and effectiveness of impact investing, impact investors share three defining traits. First, impact investors invest with the explicit intention of generating a positive social impact. This is in contrast to other types of investors who attempt to avoid generating negative social impacts or who are entirely indifferent to the social outcomes resulting from their investments. Second, though their return requirements vary, impact investors are not grant providers and always expect a return on their invested capital. Finally, impact investors share a commitment to measure the effect of their investments on the employees, customers and communities of the companies in which they invest.
Impact investing currently constitutes a small segment of global investment activity. Each year, J.P. Morgan and the Global Impact Investing Network (“GIIN”) publish an annual survey of leading impact investors. In their May 2015 findings, available at
However, the size of the impact industry belies both its growth potential and that of the broader sustainable finance sector. This is a sector focused on “creating economic and social value through financial models, products and markets that are sustainable over time.”
SBA's formal efforts in the impact investing space began on April 7, 2011, when it announced the launch of the SBIC program's Impact Investing Initiative (the “Initiative”), building upon SBA's belief that targeting capital investments into segments of the U.S. economy where capital formation gaps exist, such as small businesses located in low-to-moderate income (“LMI”) and other underserved areas, has the potential to effect meaningful and sustained economic development impact in those areas. The Initiative made available $1 billion in debenture leverage, over the course of 5 years, to SBICs that committed to deploy at least 50 percent of their total invested capital in “impact investments.” Under the Initiative, investments in small businesses located in LMI areas, economically-distressed areas and rural areas generally qualified as impact investments, as did investments in small businesses active in the education and clean energy sectors.
Since 2011, SBA has made several changes to the Initiative in an effort to enhance its effectiveness. Most recently, in September 2014, SBA expanded the scope of the Initiative and renamed it the “Impact Investment Fund” to reflect SBA's commitment to extend its impact investing efforts beyond the Initiative's initial 5-year term.
This rule follows from that commitment and seeks to recognize, within the SBIC program's regulations, the important role impact investors can play in helping the SBIC program achieve its goal of providing capital and long-term loan funds for the growth, expansion and modernization of small businesses.
The definition of “Impact Investment” included in this proposed rule consists of two categories, each of which is also a defined term in the proposed rule: (1) SBA-Identified Impact Investments, which are investments in geographic areas and sectors of national priority that SBA designates in notices published from time to time on SBA's SBIC program Web site (
The regulatory definition of an Impact SBIC has several key points. First, an Impact SBIC must be organized as a limited partnership. Although the current regulations permit other forms of organization, the vast majority of existing SBICs are limited partnerships. SBA believes that having a degree of uniformity in organizational structure will facilitate a more timely and efficient licensing process for Impact SBICs.
Second, the “Impact SBIC” designation would apply only to SBICs licensed under this rule as well as those licensees designated as Impact SBICs after the launch of the Initiative in 2011 and before the effective date of this rule.
Third, an Impact SBIC must invest at least 50 percent of its financing dollars in small business concerns that meet the criteria set forth in the definition of Impact Investment in this rule (referred to hereafter as the “50 percent requirement”). SBA believes the 50 percent threshold indicates a significant focus, while still giving Impact SBICs flexibility in developing their portfolios. Per the proposed rule, follow-on investments in a portfolio company that qualified as an “Impact Investment” at the time of the SBIC's initial financing
An Impact SBIC may satisfy the 50 percent requirement exclusively through SBA-Identified Impact Investments or Fund-Identified Impact Investments, but may also satisfy the 50 percent requirement through a combination of these investments. Per proposed § 107.331, SBA must approve all Fund-Identified Impact Investment definitions and strategies during the licensing process, regardless of whether such investments will be used to meet all or only a portion of the 50 percent requirement.
However, § 107.301 would provide that in the event an Impact SBIC applicant were to ultimately be approved for an SBIC license as anything other than an Impact SBIC, SBA would be entitled to recover the value of any discounts the applicant received prior to licensing. This provision was added to cover cases in which an applicant decides mid-process, with SBA permission, to seek a standard SBIC license instead of an Impact SBIC license. These types of changes sometimes occur during the fundraising process as fund managers adjust to the expectations of private capital providers. Although licensees designated as Impact SBICs under the Initiative would be eligible for fee discounts as of the effective date of this rule, SBA will not return any fees these licensees paid prior to that date.
Finally, any Impact SBIC, whether licensed under the Initiative or under this rule, may submit a written request to SBA seeking to convert to a standard SBIC license. SBA would generally expect to grant such a request, provided that SBA recovers the value of any discounts the licensee received.
Under proposed § 107.331, Impact SBIC license applicants seeking approval to make Fund-Identified Impact Investments will be subject first and foremost to the evaluation process and qualification standards outlined in § 107.305, which are used to assess all SBIC applicants. An applicant's potential to generate social, environmental or economic impact will be considered relevant only to its eligibility to participate in the SBIC program as an Impact SBIC and will not serve as a substitute for any of the factors cited in § 107.305.
Using SBA Form 2181 (Applicant Narrative), applicants will be expected to provide definition(s) of the Fund-Identified Impact Investments they intend to make for the purposes of complying with the requirement that 50 percent of the total dollar amount of their financings be deployed in Impact Investments. Applicants will also be required to describe, using qualitative and quantitative analysis, the expected social, environmental or economic impact of their proposed Fund-Identified Impact Investments.
SBA will review any Fund-Identified Impact Investment definition(s), along with an applicant's overall investment strategy, in order to determine whether the proposed definitions and strategy are consistent with SBA's mission, as well as the letter and spirit of the SBIC program's regulations. For instance, a Fund-Identified Impact Investment definition that targets financial intermediaries would not be approved if SBA determines it risks running afoul of the regulatory prohibition on financing “relenders” or “reinvestors.”
SBA will next determine whether the applicant's proposed Fund-Identified Impact Investments are likely to yield a positive impact when all the potential social, environmental and economic effects of the investments are considered. SBA's evaluation may consider factors such as whether the strategy will include investments in Portfolio Concerns that increase services to low income communities, engage in environmentally sustainable business practices or manufacture environmentally sustainable products, or that operate in industries of national priority other than in the sectors identified by SBA as an SBA-Identified Impact Investment. The Agency acknowledges that reaching a definitive and objective conclusion regarding a strategy's overall impact may be challenging. Impact is often described in qualitative, rather than quantitative terms. In anticipation of that challenge, the proposed rule has been drafted to mitigate the risk that SBA would be put in the position of having to accept or reject a proposed definition based solely on a value judgment.
Applicants will be expected to make reasonable arguments, supported by convincing evidence, that their proposed definitions can meet the impact requirements of this rule. In this regard, the process SBA will use to evaluate proposed Fund-Identified Impact Investment definitions differs little from the process used to assess fund manager qualifications. SBA will use its standard due diligence tools, including principal interviews and reference calls, to test the strength of an applicant's proposal and the validity of the evidence presented therein. Just as a standard SBIC applicant might be rejected for making unsubstantiated track record claims, so too could a Fund-Identified Impact Investment definition be turned down if diligence suggests it lacks credibility.
SBA takes a nuanced approach to its licensing decisions and does not rely solely on easy-to-measure financial metrics. An applicant's past financial performance is always carefully weighed against less tangible factors such as the level of cohesion among the proposed management team members; the alignment of incentives between the fund manager and private investors; and
SBA expects to receive few, if any, Fund-Identified Impact Investment definition proposals that are intended solely to obtain the fee reduction benefits of an Impact SBIC license. The fee reductions in the proposed rule are not material compared to the amount of capital raised by an SBIC applicant, and Impact SBIC licensees are subject to enhanced regulatory reporting requirements. Moreover, fund managers that have expressed interest in SBA's impact investing efforts have, to-date, all proposed strategies with clear benefits and no obvious risk of yielding negative effects. The following are examples of the types of impact investments being made in the market today and which SBA anticipates Impact SBICs applying under this section may target:
In addition to approving an applicant's proposed definition of a Fund-Identified Impact Investment, SBA must be satisfied with the applicant's impact measurement and assessment plan, which an applicant must submit in accordance with proposed § 107.331(b). Under this section, the applicant must outline its plan to comply with proposed § 107.665, which requires Impact SBICs making Fund-Identified Impact Investments to obtain an assessment of their impact (1) from an independent, third-party assessment provider, (2) using an SBA-approved impact measurement standard, a list of which SBA will publish on its Web site from time to time, and (3) using an assessment process that is both transparent and comprehensive.
Impact measurement is a defining characteristic of impact investors. Without it, impact fund managers and their capital providers face a much bigger challenge in determining whether their goal of generating positive social impact has been met. Unfortunately, determining whether a fund has reached its impact target is far more complicated than evaluating its financial performance. The process requires establishing a standard by which the targeted outcomes will be measured, then crafting an evaluation framework capable of weighing the resulting measurements to yield an overall assessment of impact.
With regard to measurement, the proposed rule would require Impact SBICs licensed under this section to measure their impact using one of several pre-approved measurement standards. At the outset, SBA intends to approve the use of the three sets of standards listed below, although SBA may approve additional standards as they become more widely adopted by the impact investing industry:
The purpose of these standards is to establish a common language companies and investors can use to report the positive and negative impacts that result from their activities. These standards are part of a broader industry effort to bring to impact measurement what the Generally Accepted Accounting Standards (“GAAP”) provide for financial reporting. When comparing the GAAP-compliant financial statements of two different companies, an investor can be confident the same set of rules was used to report items such as revenue, inventory and operating cash flow in both statements. GAAP does not provide guidance on how to interpret the data, but it does ensure consistency in reporting.
Impact measurement standards were developed to offer the same proposition. Consider the simple example of two Impact SBICs, both of which are pursuing similar strategies to create high-wage jobs in a particular region. In the absence of a measurement standard, the tasks of defining a “job” and calculating a “wage” are left to the funds themselves, which leaves room for methodological discrepancies. One fund may include the value of benefits in its calculation of wages, while the other restricts its definition to direct cash payments. An investor trying to determine which fund has been more effective in reaching its impact goal would have difficulty in this scenario. Measurement standards help reduce these definitional challenges. Were the two funds to use IRIS metrics, for instance, they could both rely on the IRIS definition of a “full-time” or “permanent” employee and use the method IRIS has established for calculating the wages of those employees.
The impact investing industry has yet to coalesce around a single set of measurement standards and may never do so. However, the three standards SBA intends to approve were selected, in part, because of their prominence in the industry and the flexibility they provide for different types of impact strategies. Of the three, IRIS is likely the best-known and most widely used set of standards. GRI has a focus on sustainability, which may provide environmentally focused Impact SBICs additional flexibility. Finally, SASB's standards are designed primarily for public corporations and may facilitate reporting for Impact SBICs with portfolio companies that are already public or intend to go public.
With clear options available for the measurement of impact, Impact SBICs can turn to the second component of SBA's proposed evaluation system, which deals with the assessment of impact. As noted above, impact measurement standards only provide guidance on how to report impact data. They are silent on how to interpret that data. Returning to the example above, the two fund managers may report IRIS-compliant employee and wage data to their investors, but an assessment framework is needed to determine what constitutes a “strong” level of employment growth, what threshold determines a wage is “high”, or how to weigh the growth in wages against the growth in employment when evaluating the funds' overall impact.
As with financial performance, each individual investor is empowered to reach his or her own conclusions about what constitutes “success” with regard to impact. While numbers, such as an internal rate of return, cannot be easily manipulated by a fund manager, investors could receive biased reports on impact returns if a fund manager were to selectively choose metrics and the weighting associated with those metrics. The use of independent and transparent assessment systems not only helps reduce the risk of selective reporting, but it also promotes the use of best practices across the industry.
For these reasons, SBA considers the assessment component of its proposed impact evaluation system critical to the credibility of the program. Impact SBIC
One assessment system SBA has already approved for use under its current Impact Investment Fund policy is the Global Impact Investment Ratings System (“GIIRS”), a product of the non-profit organization B Lab, which uses a standard set of IRIS impact metrics. GIIRS was created to bring to the impact investment industry the kind of consistent and comparable rating reports traditional finance has had for decades in the form of mutual fund ratings or credit ratings. With each investment fund they rate, B Lab staff collects a standard set of IRIS impact metrics from each company in the portfolio. That data is then run through the GIIRS assessment criteria, each of which is assigned a specific weight. The end result is a ratings report with an overall impact score and scores for each individual sub-component of the overall assessment. Since each rating uses the same set of core metrics, assessment criteria and weightings, one investment fund's score can be compared to that of another.
With each new Impact SBIC licensed under this section, SBA will build a portfolio of investment strategies and impact reports that it hopes will help guide future applicants to the program. Both to facilitate that learning process and to ensure program transparency, Section 107.331(d) allows the Agency to publish information about the investment strategies and assessment systems the Impact SBICs licensed under this section have employed.
However, the provisions of paragraph (d) will not release SBA from its responsibility to protect the confidential business information of its licensees. SBA intends only to publish general descriptions of the investment strategies it has approved and will not reveal any details that might compromise an applicant or licensee's confidential business information. Similarly, the Agency will make public the names of assessment providers it has approved and descriptions of the assessment systems those providers use, but will not reveal the results of any individual impact assessment.
The paragraph would require different levels of certification depending on the type of Impact Investment. SBA-Identified Impact Investments will be based on certifications from both the Impact SBIC and its portfolio concerns; Fund-Identified Impact Investments will only require the certification of the Impact SBIC. Since SBA-Identified Impact Investments will be based on definitions in federal regulation and will generally depend on specific statistics collected at the company level, it is reasonable to expect the leaders of those businesses to certify the accuracy of their information. By contrast, Fund-Identified Impact Investments may be based on sector data or other information outside the control of the small business being financed. Therefore, for Impact SBICs making Fund-Identified Impact Investments, the regulation places the full certification burden on the Impact SBIC.
As noted above, per the proposed rule, follow-on financings in Impact Investments would count towards the 50 percent requirement, and therefore, SBA will not require Impact SBICs to re-certify the investment as part of a follow-on financing. SBA believes that requiring Impact SBICs to re-certify their follow-on financings as Impact Investments might deter them from making long-term capital commitments out of concern that future financings might not count towards the “50 percent requirement.” Nonetheless, SBA is soliciting comments from the public on whether such follow-on investments should count towards the 50 percent requirement only if the Impact SBIC re-certifies the investment as an Impact Investment at the time a follow-on investment is made.
Impact SBICs subject to this section will face penalties if they fail to obtain impact assessments, but SBA will neither penalize nor reward an Impact SBIC based solely on the results of those impact assessments. One purpose of permitting Impact SBICs to make Fund-Identified Impact Investments is to encourage innovative approaches to social, environment and economic challenges. Penalizing licensees that fail to meet their impact goals, despite their best efforts, would be counterproductive. Instead, the Agency trusts that successful fund managers will earn their rewards in the market place, using the strength of their financial and social returns to attract private capital. SBA will also look favorably on subsequent Impact SBIC applicants with a record of strong social and financial performance. By contrast, Impact SBICs with poor impact assessments are more likely to face difficulty raising private capital and obtaining a subsequent Impact SBIC license.
Second, under proposed § 107.1810(f)(14), it would be an event of default if an Impact SBIC licensed under an SBA-approved plan to make Fund-Identified Impact Investments fails to obtain an acceptable independent, third-party assessment to measure the social, environmental or economic impact of the fund's Impact Investment strategy within the time frames required by proposed § 107.665. If the Impact SBIC fails to cure to SBA's satisfaction, SBA could invoke the remedies in existing § 107.1810(g), which include the right to declare outstanding debenture leverage immediately due and payable.
SBA included these additional remedies to address two areas of concern. First, the events of default proposed under § 107.1810(f) would only apply to Impact SBICs with outstanding leverage. As a result, Impact SBICs that are licensed as non-leveraged funds or those that pre-pay their leverage in full would not be subject to any remedies if they were to fall out of compliance with the 50 percent requirement or, as applicable, the assessment requirement. Second, the fee discounts proposed under this rule generally reward Impact SBIC applicants and licensees for future, rather than past behavior. For instance, an Impact SBIC will be eligible for a 60 percent discount on its licensing fee based on its proposal to deploy at least 50 percent of its capital in Impact Investments. Without the provisions proposed under this section, SBA would have limited authority to recover those benefits or otherwise take action against the fund if it fails to follow through on that commitment.
The Office of Management and Budget has determined that this rule is a “significant” regulatory action under Executive Order 12866. The Regulatory Impact Analysis is set forth below.
The Small Business Investment Act of 1958, as amended, established the SBIC program to “stimulate and supplement the flow of private equity capital and long-term loan funds” to U.S.-based small businesses. 15 U.S.C. 661. As part of that effort, the Act contains several provisions aimed at promoting the flow of capital to several special categories of small business, including those located in low income geographic areas, those engaged in energy-saving activities and “smaller” businesses.15 U.S.C. 683(b)(2)(C), 683(b)(2)(D), 683(d).
Over the past several years, SBA's focus on achieving these economic development goals has yielded results, but progress has come at a slower pace than anticipated. Despite the recent growth in the number of SBIC-financed businesses located in LMI areas, which rose from 216 in fiscal year (“FY”) 2012 to 229 in FY 2014, the program has yet to return to the high level achieved in FY 2011, during which SBICs financed 351 businesses located in LMI areas. The LMI Debenture, a leverage instrument meant to help facilitate these types of investments, is rarely used. Similarly, there has yet to be a single draw of SBA's Energy Savings Debenture, which has been available since 2012 to help finance small businesses involved in reducing the use of non-renewable energy sources.
The proposed rule was crafted to enhance the SBIC program's effectiveness in channeling much-needed capital to these and other underserved segments of the U.S. economy. From an overall economic development perspective, SBA believes that capital investments made into small businesses located in LMI and other underserved areas have the potential to have the most meaningful and sustained impact due to the capital formation gaps in those areas.
SBA considered several alternatives to the proposed regulation, each of which will be discussed below. First, SBA considered pursuing its impact investment objectives solely through existing policy initiatives. Based on extensive feedback received from SBIC fund managers, lower-middle market industry representatives, impact investment fund managers, impact policy thought leaders and others, SBA rejected this alternative. SBA's existing impact investing policies impose additional burdens without providing sufficient incentives to attract Impact SBIC fund managers to the program. Further, given that SBIC licensees have operational lives of ten years or more, the market will be reluctant to embrace SBA's impact investing efforts unless the Agency demonstrates a lasting commitment to the space by promulgating regulations.
SBA faced a challenge in developing a definition of an “Impact Investment” that dealt appropriately with the subjectivity inherent in any non-financial measure of performance. Initially, SBA considered restricting the
The proposed rule has been drafted to allow Impact SBIC applicants to make SBA-Identified Impact Investments, which target federal priority areas, or make Fund-Identified Impact Investments that align with their own definitions of impact. This approach expands the reach of SBA's impact investing efforts beyond the limited sub-set of investments that meet existing regulatory criteria. The Agency also recognizes the complexities Fund-Identified Impact Investments may introduce to the SBIC licensing and monitoring process.
SBA had to carefully consider the bases on which it would approve an Impact SBIC's proposed Fund-Identified Impact Investment definition. One option the Agency considered was to outline, as part of this regulation, a series of sector-specific eligibility requirements that Fund-Identified Impact Investments would have to satisfy. Working with colleagues at the U.S. Department of Education, SBA staff made an initial attempt at preparing guidelines for investments in the education sector but quickly discovered the impracticality of the approach. Even within a single sector, there exists such a tremendous diversity of economic activity that establishing requirements specific-enough to be useful would require an inordinate commitment of time and resources.
An alternative approach would be to remove SBA from the approval process altogether and give Impact SBIC applicants complete latitude to pursue Fund-Identified Impact Investments of their choice. Under this approach, SBA would evaluate Impact SBICs using its existing licensing process without any additional consideration of the impact-related aspects of the applicant's proposal. A key advantage of this approach is that it would allow SBA to fully cede the definitional challenge of impact to fund managers and their private investors. It would also ensure the program remains open to innovative impact strategies.
SBA will always encourage applicants to propose innovative investment strategies, but the Agency must retain the ability to review and approve proposed Fund-Identified Impact Investment definitions. Not only must the Agency ensure that SBICs are making investments that are consistent with the letter and spirit of program regulations, but it must also consider the reputation of the SBIC program within the private investor community. The statute underlying the SBIC program, known as the Small Business Investment Act, makes clear that the program should be implemented in a manner that “insure[s] the maximum participation of private financing sources.” 15 U.S.C. 661. Were SBA to ignore an applicant's proposed Fund-Identified Impact Investment definitions, private impact investors might take the Agency's approach as a signal of indifference to market development.
In fact, the approach SBA has taken reflects the Agency's interest in not only enhancing the impact of the SBIC program, but also promoting industry best practices. SBA is as concerned with the process used to make Fund-Identified Impact Investments as it is with the outcomes of those investments. Each Impact SBIC applicant will have the burden of demonstrating, with qualitative or quantitative analysis, that its investment strategy will, in aggregate, generate a measurable positive impact. SBA staff will supplement their evaluation of the applicant's analysis and its other application materials with the results obtained using the standard tools of due diligence, such as interviews with the management team, reference calls, consultations with industry experts, public record searches and other research.
As long as a fund manager is qualified and its definition does not run afoul of the Agency's mission, statutes, regulations or policies, SBA intends to give applicants substantial leeway in defining their Fund-Identified Impact Investments. The measurement and assessment requirements of the proposed rule ensure that even those Impact SBICs that fail to meet their targeted social returns will contribute to market development. Measuring results, good and bad, contributes to the industry's understanding of the relationship between financial and social returns and helps investors identify the most talented managers.
SBA confronted two key questions as it considered how to create a robust measurement and assessment process. First, what means should SBA use to assess the impact of Fund-Identified Impact Investments? Second, what consequences, if any, should Impact SBICs face based on the result of their impact assessments?
With regard to the first question, SBA could have assumed the full burden of evaluating each Fund-Identified Impact Investment to determine its impact. This alternative was rejected because SBA staff lack sufficient time, resources and expertise to properly evaluate the full range of potential Fund-Identified Impact Investments. A second alternative was to leverage the expertise of Impact SBIC fund managers themselves and allow them to prepare their own assessments. While it may be appropriate to have Impact SBIC applicants argue the merits of their Fund-Identified Impact Investment definitions during the licensing process, SBA considered it imprudent to allow Impact SBICs to evaluate their own success.
The proposed rule instead requires Impact SBICs to obtain independent, third-party impact evaluations based on industry-adopted standards. The use of independent third parties helps reduce the bias inherent in a fund's own impact evaluation and relieves SBA of the potentially significant burden of assessing a wide range of impact investment strategies.
With regard to the second question, SBA has chosen not to penalize licensees based on the results of their impact assessments. As noted above, assessments provide private capital with greater transparency regarding an applicant's track record of generating impact. Given that most fund managers seek to follow their first investment vehicle with a second, the assessment process itself creates sufficient risk that investors will decline to invest in a second fund. Accordingly, SBA does not believe that an Impact SBIC should incur regulatory penalties based on the results of an impact assessment.
The proposed rule offers two primary benefits to SBA and its stakeholders. First, it offers the potential to enhance the overall social, environmental and economic impact of the SBIC program. Existing SBICs already have tremendous impact on America's small business economy. In FY 2014, SBICs together invested nearly $5.5 billion in more than 1,000 small business concerns, helping them to grow and modernize their operations. The introduction of Impact SBICs will increase the portion of those annual financings that are
SBA also hopes the proposed rule will support the development of the impact investing industry more broadly. The rule has been drafted to incorporate impact investing best practices, especially with regard to the measurement and assessment of impact. As more and more SBA- and Fund-Identified Impact Investments are made, the SBIC program will have more data to contribute to the industry on the balance between financial and social performance.
In terms of costs, Impact SBICs are anticipated to have an additional 3% higher loss rate than regular SBICs, due to the risks that may be associated with Impact Investments contemplated under the proposed rule. Although SBA is targeting $200 million in commitments per year in terms of licensing, the number of Impact SBICs that SBA may license or the amount of debenture leverage commitments that may be approved for Impact SBICs in any year is subject to the limitations set forth in annual appropriations acts or in other statutes or regulations. In addition, both newly licensed Impact SBICs and previously licensed Impact SBICs have the opportunity to receive new leverage commitments in any year. The SBIC program subsidy model for FY 2017 has been formulated to reflect the provision proposed in this rule that Impact SBICs are allowed to be licensed as Early Stage SBICs. Early Stage SBICs are expected to have approximately a 10% higher loss rate than regular SBICs. The resulting fee of 34.7 basis points for FY 2017 remains well within historical ranges for the SBIC Debenture annual fee.
This action meets applicable standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. The action does not have retroactive or presumptive effect.
The proposed rule will not have substantial direct effects on the States, or the distribution of power and responsibilities among the various levels of government. Therefore, for the purposes of Executive Order 13132, Federalism, SBA determines that this proposed rule has no federalism implications warranting the preparation of a federalism assessment.
In drafting this proposed rule, SBA considered the input of impact investment industry experts on ways to facilitate the growth of private-sector led impact investing as a strategy to create jobs and strengthen communities. With the assistance of the White House Office of Social Innovation and Civic Participation, which included a White House hosted event in June 2014 (
SBA has determined that this rulemaking proposes additional reporting requirements as defined by the Paperwork Reduction Act. Specifically, as discussed above, all Impact SBICs utilizing a Fund-Identified Impact strategy would be required to submit to SBA independent, third-party evaluations of the impacts of such investments. This proposed rule would also codify two other reporting requirements that are already imposed on Impact SBICs based on the terms and conditions of the Impact Investment Fund established by SBA on April 11, 2011, as amended on September 25, 2014, available at
The hourly burden for these respondents would be negligible, as the assessment work would be completed by an independent third-party. The total time required to contact the provider and initiate an assessment is estimated at a total of 24 hours per assessment. Impact SBICs subject to the third-party assessment requirement must submit a total of two assessments over the course of their 10 year fund life. On an annualized basis, these applicants each will spend 4.8 hours per year. With an estimated 6 Impact SBICs making Fund-Identified Impact Investments in the portfolio at any given time, the total annual hourly burden is estimated at 28.8 hours.
When an agency promulgates a rule, the Regulatory Flexibility Act requires the agency to prepare an initial regulatory flexibility analysis (IRFA) which describes the potential economic impact of the rule on small entities and alternatives that may minimize that impact. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an IRFA, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.
This proposed rule would affect all SBICs issuing debentures, of which there are currently 193, most of which are small entities. Therefore, SBA has determined that this proposed rule would have an impact on a substantial number of small entities. However, SBA has determined that the impact on entities affected by the rule will not be significant. SBA keeps the SBIC program at a zero subsidy cost to taxpayers by charging up front and annual fees on its leverage. SBA calculates the annual fee each year using historical data to assess the appropriate fee to keep the program at zero subsidy cost. Because SBA expects Impact SBICs to be riskier than standard SBICs, SBA adjusted the SBIC debenture program budget formulation model which determines the annual fee needed to keep the debenture program at a zero subsidy cost.
The projected leverage allocation to Impact SBICs would increase the annual fee charged to all SBICs seeking new debenture commitments by approximately 6.1 basis points. The annual fee would remain in line with historical levels. Since 2000, the annual fee has ranged from a high of 100 basis points (1 percent) to a low of 29 basis points, with a 15-year median of 83 basis points. The annual fee for FY 2015 is approximately 74.2 basis points. Although the cost will vary in the future based on economic factors and assumptions used to develop the annual fee, SBA expects the fee to remain under 1 percent, comparable to historical annual fees and below the statutory maximum of 1.38 percent. Accordingly, the Administrator of the SBA hereby certifies that this rule will not have a significant impact on a substantial number of small entities. SBA welcomes comment from members of the public who believe there will be a significant impact either on SBICs, or on companies that receive funding from SBICs.
Investment companies, Loan programs—business, Licensing fees, Examination fees, Small businesses.
For the reasons stated in the preamble, SBA proposes to amend part 107 of title 13 of the Code of Federal Regulations as follows:
15 U.S.C. 681
(a) All applicants seeking to be licensed as an Impact SBIC will receive a 60 percent discount, rounded to the nearest one-hundred dollars, on any fees to which they are subject under § 107.300.
(b) In the event an applicant seeking to be licensed as an Impact SBIC is licensed as anything other than an Impact SBIC, SBA reserves the right to recover, prior to licensing, the full dollar amount of any licensing fee discounts the applicant has received.
SBA will evaluate each applicant seeking to be licensed as an Impact SBIC based on the same factors applicable to
If an applicant intends to qualify for an Impact SBIC license based on investments in Fund-Identified Impact Investments, SBA will evaluate the applicant's proposed definition(s) of a Fund-Identified Impact Investment and its plan to comply with the measurement and reporting requirements of § 107.665, and will approve the same in writing at the time of licensing based the applicant's satisfaction of the following:
(a)
(b)
(1) The applicant's proposed assessment system(s) must employ at least one approved measurement standard, from a list of approved standards published by SBA on its Web site from time to time.
(2) The applicant's proposed assessment system must comply with the following:
(i) The assessment system's criteria and weightings are publicly available; and
(ii) The assessment system is capable of producing an assessment of the social, environmental and/or economic effects of impact investments.
(3) The applicant's proposed assessment provider(s) must each be an independent, third-party. An assessment provider will not be considered an independent third-party if any of the following conditions exist at the time of licensing or assessment:
(i) The assessment provider is an Associate of the Impact SBIC or any of its Portfolio Concerns; or
(ii) The assessment provider is materially financed by an association that represents the interests of the specific industry in which the Impact SBIC or its Portfolio Concerns are engaged.
(c)
(i) General descriptions of impact investment strategies pursued by Impact SBICs licensed to make Fund-Identified Impact Investments; and
(ii) Detailed descriptions of the assessment systems SBA has approved for use by Impact SBICs licensed to make Fund-Identified Impact Investments.
(b) Impact SBIC applicants must declare their intention to apply for an Impact SBIC license in any solicitation to investors.
(c) Impact SBIC licensees must indicate that they have obtained an Impact SBIC license from SBA in any solicitation to investors.
(g) For each SBA-Identified Impact Investment:
(i) A certification by the concern, dated as of the date of application for SBIC financing, as to the basis for its qualification as an Impact Investment; and
(ii) A certification by the Impact SBIC, made contemporaneously with the certification of the concern, that the concern qualifies as an Impact Investment as of the date of the concern's certification and the basis for such qualification.
(h) For each Fund-Identified Impact Investment, a certification by the Impact SBIC, as of the date of the financing, that the concern qualifies as a Fund-Identified Impact Investment under the definition(s) approved in writing by SBA and the basis for such qualification.
Impact SBICs that SBA approved in writing to make Fund-Identified Impact Investments must obtain an assessment of their impact investment strategy from an independent, third-party provider within two years after licensing and again between five and seven years after licensing. Without prior written SBA approval, the Impact SBIC may not use an assessment system(s) or assessment provider(s) different from those the Impact SBIC identified and SBA approved during the licensing process. Each assessment must be submitted to SBA within 30 days of its completion.
An Impact SBIC will receive a 10% discount on its examination base fee, rounded to the nearest one-hundred dollars, subject to the following:
(a) The discount will be calculated based on the examination base as determined prior to any adjustments provided for under § 107.692.
(b) Impact SBICs also licensed as Early Stage SBICs are entitled to any additional discounts, but exempt from any premium, that Early Stage SBICs would otherwise be required to pay under § 107.692.
(l) If you are an Impact SBIC, certify in writing that, in accordance with § 107.1810(f)(13), at least 50 percent of the aggregate dollar amount of your Financings will qualify as Impact Investments defined in § 107.50.
(f) * * *
(13)
(14)
(a) For any occurrence (as determined by SBA) of one or more of the events in this paragraph (a), SBA may avail itself of one or more of the remedies in paragraph (b) of this section.
(1) Failure by an Impact SBIC to meet investment requirements. You are an Impact SBIC and, beginning on the first fiscal quarter end when your cumulative total Financings (in dollars) are at least equal to your Regulatory Capital, you have not made at least 50 percent of such Financings to Small Businesses that at the time of your initial Financing were Impact Investments.
(2) Failure by an Impact SBIC to meet assessment requirements. You are an Impact SBIC making Fund-Identified Impact Investments and you fail to obtain an independent, third-party assessment within two years of your licensing date and, again, between five and seven years from your licensing date, pursuant to the requirements under § 107.665.
(b) SBA may exercise any or all of the following rights:
(1) Convert your Impact SBIC license to a standard SBIC license (including, in SBA's discretion, requiring you to promptly notify your investors of the conversion); and
(2) Require you to refund to SBA up to the full dollar amount of any licensing or examination fee discounts you have received prior to the date of your written notice.
(c) SBA may invoke the remedies in paragraph (b) of this section only if:
(1) It has given you at least 15 days to cure the noncompliance;
(2) You fail to cure the noncompliance to SBA's satisfaction within the allotted time.
This document was received for publication by the Office of the Federal Register on January 29, 2016.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Moriarty, NM. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures developed at Moriarty Airport, for the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Comments must be received on or before March 21, 2016.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2015-8060; Docket No.15-ASW-4, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Raul Garza Jr., Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone: 817-222-5874.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Moriarty Airport, Moriarty, NM.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-8060/Airspace Docket No. 15-ASW-4.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This document would amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
The FAA is proposing an amendment to Title 14, Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface within an 7.5-mile radius of Moriarty Airport, Moriarty, NM, to accommodate new standard instrument approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the airport.
Class E airspace designations are published in Section 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air)
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 7.5-mile radius of Moriarty Airport.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Advanced notice of proposed rulemaking (ANPR).
Through this notice, HUD announces that it is considering rulemaking to ensure that individuals and families residing in HUD public housing in fact continue to need housing assistance from HUD after admission. HUD's consideration of rulemaking is prompted by a report recently issued by HUD's Office of Inspector General (OIG). The report found, through comparison of annual household income reported in HUD's Public and Housing Information Center for approximately 1.1 million families to the applicable 2014 admission income limit, that as many as 25,226 families were subsequently over-income. Some of those families significantly exceeded the income limits. HUD seeks comment from PHAs and other interested parties and members of the public on the questions presented in this notice, including how HUD can structure policies to reduce the number of individuals and families in public housing whose incomes significantly exceed the income limit and have significantly exceeded the income limit for a sustained period of time after initial admission.
Interested persons are invited to submit comments to the Office of the General Counsel, Regulations Division, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500.
Note: To receive consideration as public comments, comments must be submitted using one of the two methods specified above. Again, all submissions must refer to the docket number and title of the notice.
Todd Thomas, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 7th Street SW., Room 4100, Washington DC 20410-4000; telephone number (678) 732-2056 (this is not a toll-free number). Persons with hearing or speech impairments may contact this number via TTY by calling the toll-free Federal Relay Service at 800-877-8339.
The United States Housing Act of 1937 (42 U.S.C. 1437
The parameters for income limits that determine initial eligibility for public housing are developed by HUD and outlined in 24 CFR part 5, subpart F. In general, HUD sets the low-income limit at 80 percent and very low-income limit at 50 percent of the median income for the county or metropolitan area in which the household resides. Income limits vary from area to area and may be adjusted based on local market conditions.
On July 21, 2015, HUD's OIG issued an audit report that presented the results of OIG's review of the number of families residing in HUD public housing whose income exceed the current income limits used in determining eligibility for such housing, several of whom significantly exceeded the income limits. The families identified by HUD OIG met the income limits at the time of admission to public housing but their income now exceeds such income limits. Currently, the regulations do not prohibit a family from continued occupancy when their income rises above the limit for initial admission. An increase in income is a good and welcomed event for families, and when a family's income steadily rises, it may be an indication that the family is on its way to self-sufficiency. However, an increase in income may be minimal or temporary, and a minimal or temporary rise in income should not be the basis for termination of public housing assistance. This ANPR solicits comment on how to structure policies to reduce the number of individuals and families whose incomes significantly exceed the income limit and have significantly exceeded the income limit for a sustained period of time after initial admission.
HUD takes seriously its obligation to provide clean, safe affordable housing to the neediest population. The Public Housing program is an essential resource for some of the nation's most vulnerable families. HUD strongly supports the efforts of PHAs to further the goals of providing quality affordable housing to eligible families in a manner that moves families toward increased and sustained self-sufficiency. At the same time, scarce public resources must be provided to those most in need of affordable housing. Any changes that would require the termination of tenancy for over-income families should be enacted with caution so as not to impede a family's progress towards self-sufficiency.
In a final rule published on November 26, 2004, at 69 FR 68786, HUD gave PHAs the authority to terminate the tenancy of or evict over-income residents.
HUD is considering revising HUD's regulations at 24 CFR 960.261 (Restriction on eviction of families based on income) in a manner that would continue to give PHAs discretion on when to evict or terminate the tenancies of over-income families but narrow that discretion by providing circumstances that would require a PHA to terminate tenancy or evict an over-income family. Specifically, HUD is considering whether a family whose income significantly exceeds the income limit and has exceeded such limit for a sustained period of time must be notified by the PHA that the family will be evicted or tenancy terminated. HUD is also considering what a reasonable period of time to find alternative housing would be.
HUD is not considering whether to alter the existing statutorily based exceptions to eviction or termination of tenancy related to income limits. Specifically, a family over the income limits who has a valid contract for participation in a Family Self-Sufficiency (FSS) program administered under HUD regulations in 24 CFR part 984 would not be subject to eviction or termination of tenancy. Additionally, a PHA may not evict a family over the income limits if the family is currently receiving the earned income disallowance authorized by the 1937 Act (
In a letter provided to PHAs on September 3, 2015, HUD strongly recommended that PHAs adopt local over-income policies while considering many factors, including, but not limited to how over-income is defined, income stability, length of time to provide a safety net for fluctuating incomes, preference for return and hardship policies.
1. How should HUD define income that “significantly” exceeds the income limit for public housing residency? Should such higher amount be determined by dollar amount, by a percentage, or as a function of the current income limit, and what should the amount be?
2. Should area cost of living and family finances be taken into consideration when determining whether an individual or family no longer needs public housing assistance? Are there limits to the circumstances in which said data should be requested and applied in a determination?
3. What period of time in which an individual or family has had income that significantly exceeds the income limits should be determined as indicative that the individual or family no longer needs public housing assistance?
4. How should local housing market conditions or housing authority wait list data be considered?
5. What period of time should be allowed for an individual or family to find alternative housing?
6. Are there exceptions to eviction or termination of tenancy that HUD should consider beyond those listed in HUD's regulation in 24 CFR 960.261?
7. Should HUD allow over-income individuals or families to remain in public housing, while paying unsubsidized or fair market, rent? How would such a provision impact PHA operations and finances?
8. Should HUD require a local appeals process for individuals or families deemed over-income?
9. Where over-income policies have been implemented, what were the results to public housing residents and PHAs? What were the specific positive and negative impacts?
10. What financial impact would over-income policies have on PHA operations, and how can any negative impacts be mitigated?
11. What are the potential costs and benefits to public housing residents and PHAs that could result from the forcible eviction of public housing tenants?
12. What evidence currently exists in favor of or against the adoption of this type of policy?
It is the responsibility of HUD and PHAs to ensure that public housing units are available to those who need HUD assistance. All comments directed to steps that HUD and PHAs can take to ensure availability of public housing units for individuals and families meeting the income limits are welcome.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to change the operating schedule that governs the Norfolk Southern Railroad Bridge over Broad Creek, mile 8.0, at Laurel, DE. This proposed rule will change the current regulation requiring a four-hour advance notice and allow the bridge to remain in the closed position for the passage of vessels.
Comments and related material must reach the Coast Guard on or before March 21, 2016.
You may submit comments identified by docket number USCG-2015-1011 using Federal eRulemaking Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or email Mrs. Jessica Shea, Fifth Coast Guard District (dpb), at (757) 398-6422, email
The current operating schedule for the bridge is set out in 33 CFR 117.233 (a) issued September 11, 2006. As outlined in this regulation, the Norfolk Southern Railroad Bridge shall open on signal if at least four hours notice is given. The Fifth Coast Guard District Commander received a request from the bridge owner in July 2015 to consider making a permanent change to the operating regulation for the Norfolk Southern Railroad Bridge per 33 CFR 117.8(a).
The Norfolk Southern Railroad Bridge over Broad Creek, mile 8.0, at Laurel, DE, has a vertical clearance of fourteen feet above mean high water in the closed position and is unlimited in the open position. The charted depth at the bridge is four feet. The existing structure is a swing bridge that was authorized in 1910. The structure has been used by trains since it was completed in 1915; however, the bridge owner reported that no openings have been requested since it was acquired by Norfolk Southern in 1999.
Milford Fertilizer had a dock that was used by commercial traffic upstream of the railroad bridge when the existing structure was issued a bridge permit in 1910. Prior to publishing this NPRM, the Coast Guard contacted the fertilizer company to determine if there would be any impacts to their operations. The fertilizer plant modified the operations conducted in this location and has not used the dock since the 1970s. There is no record of any other commercial maritime traffic on Broad Creek, DE. There are residential docks and municipal boat ramps downstream of the Norfolk Southern Railroad Bridge. Recreational traffic is present during the boating season with the peak during the summer months.
This NPRM proposes to change the status of the Norfolk Southern Railroad Bridge to need not open for the passage of vessels. In order to align the operating schedule of the bridge with observed marine traffic, the proposed change amends the regulation to state that the bridge need not open. The lack of requests from vessels for bridge openings since 1999 illustrate that the vessels that use this waterway can safely navigate while the drawbridge is in the closed-to-navigation position.
We developed this proposed rule after considering numerous statutes and Executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on 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 NPRM has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget. Based on current maritime traffic, using Norfolk Southern documentation and notes in the Coast Guard bridge files, there will be few, if any, vessels impacted by this proposed change as there has not been a requested opening since 1999.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, since there have been no requests for openings since 1999, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.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 preliminary determination that this action is one of a category of
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. 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 document, and all public comments, are in our online docket at
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(a) The draw of the Norfolk Southern bridge at mile 8.0, at Laurel, need not open for the passage of vessels.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes regulations to implement Amendment 110 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP). If approved, Amendment 110 and this proposed rule would improve the management of Chinook and chum salmon bycatch in the Bering Sea pollock fishery by creating a comprehensive salmon bycatch avoidance program. This action is necessary to minimize Chinook and chum salmon bycatch in the Bering Sea pollock fishery to the extent practicable while maintaining the potential for the full harvest of the pollock total allowable catch within specified prohibited species catch limits. Amendment 110 is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMP, and other applicable laws.
Comments must be received no later than March 4, 2016.
You may submit comments on this document, identified by NOAA-NMFS-2015-0081 of the following methods:
•
•
Electronic copies of Amendment 110 and the Environmental Assessment/Regulatory Impact Review/Initial Regulatory Flexibility Analysis (EA/RIR/IRFA) prepared for this action (collectively the “Analysis”) may be obtained from
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this rule may be submitted by mail to NMFS Alaska Region, P.O. Box 21668, Juneau, AK 99802-1668, Attn: Ellen Sebastian, Records Officer; in person at NMFS Alaska Region, 709 West 9th Street, Room 420A, Juneau, AK; and by email
Gretchen Harrington or Alicia Miller, 907-586-7228.
NMFS manages the groundfish fisheries in the exclusive economic zone of the Bering Sea and Aleutian Islands Management Area (BSAI) under the FMP. The North Pacific Fishery Management Council (Council) prepared the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801
This proposed rule would implement Amendment 110 to the FMP. The Council has submitted Amendment 110 for review by the Secretary of Commerce, and a Notice of Availability (NOA) of this amendment was published in the
The following sections describe the fisheries and the current management programs that would be affected by Amendment 110 and this proposed rule: (1) The Bering Sea pollock fishery, (2) salmon bycatch in the Bering Sea pollock fishery, (3) importance of salmon in western Alaska, (4) management of salmon bycatch in the Bering Sea and Aleutian Islands, (5) objectives of and rationale for Amendment 110 and this proposed rule, (6) proposed salmon bycatch management measures, (7) proposed changes to monitoring and enforcement requirements, and (8) other regulatory changes in the proposed rule.
Amendment 110 and this proposed rule would apply to owners and operators of catcher vessels, catcher/processors, motherships, inshore processors, and the six Western Alaska Community Development Quota (CDQ) Program groups participating in the pollock (
The pollock fishery is the largest single species fishery, by volume, in the United States. The wholesale gross value of this fishery was more than 1.329 billion dollars in 2013, the most recent year of complete wholesale value data. The pollock fishery is managed under the American Fisheries Act (AFA) (16 U.S.C. 1851 note). In October 1998, Congress enacted the AFA, which “rationalized” the pollock fishery by identifying the vessels and processors eligible to participate in the fishery and allocating pollock among those eligible participants. For more information on the AFA, please see the final rule implementing the AFA (67 FR 79692, December 30, 2002).
Under the AFA, 10 percent of the pollock total allowable catch (TAC) is allocated to the CDQ Program. After the CDQ Program allocation is subtracted, an amount needed for the incidental catch of pollock in other non-pollock groundfish fisheries is subtracted from the TAC. In 2015, the pollock TAC was 1,310,000 metric tons (mt). In 2015, the CDQ allocation was 131,000 mt of pollock and the incidental catch allowance was 47,160 mt. The “directed fishing allowance” is the remaining amount of pollock, after subtraction of the CDQ Program allocation and the incidental catch allowance. The directed fishing allowance is then allocated among the AFA inshore sector (50 percent), the AFA catcher/processor sector (40 percent), and the AFA mothership sector (10 percent). Annually, NMFS further apportions the pollock allocations to the CDQ Program and the AFA sectors between two seasons—40 percent to the A season (January 20 to June 10) and 60 percent to the B season (June 10 to November 1) (see § 679.20(a)(5)(i)(B)(
The allocation of pollock to the CDQ sector is further allocated among the six non-profit corporations (CDQ groups) that represent the 65 communities eligible for the CDQ Program under section 305(i)(1)(D) of the Magnuson-Stevens Act. The current percentage allocations of pollock among the six CDQ groups were approved by NMFS in 2005 based on recommendations from the State of Alaska (State). These percentage allocations are now the required allocations of pollock among the CDQ groups under section 305(i)(1)(B) of the Magnuson-Stevens Act. More information about the allocations of pollock, other groundfish, crab, and prohibited species (including Chinook salmon) among the six CDQ groups is provided in the
CDQ groups typically sell or lease their pollock allocations to harvesting partners, including vessels owned, in part, by the CDQ group. Although CDQ groups are not required to partner with AFA-permitted vessels to harvest CDQ pollock, to date, the vessels harvesting CDQ pollock have also been AFA-permitted vessels. Specifically, the CDQ pollock allocations have most often been harvested by AFA catcher/processors, and to a lesser extent, AFA catcher vessels delivering to a mothership. A relatively small amount of CDQ pollock has been harvested by AFA catcher vessels delivering to inshore processing plants.
The AFA allows for the formation of fishery cooperatives within the non-CDQ sectors. A purpose of these AFA cooperatives is to further subdivide each sector's or inshore cooperative's pollock allocation among participants in the sector or cooperative through private contractual agreements. The cooperatives manage these allocations to ensure that individual vessels and companies do not harvest more than their agreed upon share. The cooperatives also facilitate transfers of pollock among the cooperative members, enforce contract provisions, and participate in an intercooperative agreement to minimize non-Chinook salmon bycatch and an incentive plan agreement to minimize Chinook salmon bycatch.
Each year, catcher vessels eligible to deliver pollock to the seven eligible AFA inshore processors may form inshore cooperatives associated with a particular inshore processor. NMFS permits the inshore cooperatives, allocates pollock to them, and manages these allocations through a regulatory prohibition against an inshore cooperative exceeding its pollock allocation. The amount of pollock allocated to each inshore cooperative is based on the member vessel's pollock catch history from 1995 through 1997, as required under section 210(b) of the
The AFA catcher/processor sector is made up of the catcher/processors and catcher vessels eligible under the AFA to deliver to catcher/processors. Owners of the catcher/processors that are listed by name in the AFA and are still active in the pollock fishery have formed a cooperative called the Pollock Conservation Cooperative (PCC). Owners of the catcher vessels eligible to deliver pollock to the catcher/processors have formed a cooperative called the High Seas Catcher's Cooperative (HSCC). Collectively, the AFA catcher/processor sector operates as a single entity and coordinates the harvesting of its pollock allocation. All participants that harvest pollock allocated to the catcher/processor sector are members of the two cooperatives, except for one participant. Section 208(e)(21) of the AFA expressly limits the amount of harvest by the one participant in the catcher/processor sector who is not a member of a cooperative to 0.5 percent of the TAC allocated to the catcher/processor sector.
The AFA mothership sector is made up of three motherships named in the AFA that are eligible to receive and process pollock harvested by catcher vessels, and the catcher vessels eligible under the AFA to deliver pollock to these motherships. All catcher vessels delivering to these three motherships have formed a cooperative called the Mothership Fleet Cooperative (MFC). The primary purpose of the cooperative is to sub-allocate the mothership sector pollock allocation among the catcher vessels authorized to harvest this pollock and to manage these allocations.
The cooperatives control the harvest by their member vessels so that the pollock allocation to the sector is not exceeded. However, NMFS monitors pollock harvest by all members of the catcher/processor sector and mothership sector. NMFS retains the authority to close directed fishing for pollock by a sector if vessels in that sector continue to fish once the sector's seasonal allocation of pollock has been harvested.
Pollock is harvested with fishing vessels using trawl gear, which are large nets towed through the water by the vessel. Pollock can occur in the same locations as Chinook salmon and chum salmon. Consequently, Chinook salmon and chum salmon are incidentally caught in the nets as fishermen target pollock.
Section 3 of the Magnuson-Stevens Act defines bycatch as fish that are harvested in a fishery, which are not sold or kept for personal use. Therefore, Chinook salmon and chum salmon caught in the pollock fishery are considered bycatch under the Magnuson-Stevens Act, the FMP, and NMFS regulations at 50 CFR part 679. Bycatch of any species, including discard or other mortality caused by fishing, is a concern of the Council and NMFS. National Standard 9 and section 303(a)(11) of the Magnuson-Stevens Act require the Council to select, and NMFS to implement, conservation and management measures that, to the extent practicable, minimize bycatch and bycatch mortality.
The bycatch of culturally and economically valuable species like Chinook salmon and chum salmon, which are fully allocated and, in some cases, facing conservation concerns, are categorized as prohibited species under the FMP. They are the most regulated and closely managed category of bycatch in the groundfish fisheries off Alaska, and specifically in the BS pollock fishery. In addition to Pacific salmon, other species including steelhead trout, Pacific halibut, king crab, Tanner crab, and Pacific herring are classified as prohibited species in the groundfish fisheries off Alaska. As a prohibited species, fishermen must avoid salmon bycatch and any salmon caught must either be donated to the Prohibited Species Donation (PSD) Program (see regulations at § 679.26), or returned to Federal waters as soon as is practicable, with a minimum of injury, after an observer has determined the number of salmon and collected any scientific data or biological samples.
The PSD Program was established to reduce the amount of edible protein discarded under prohibited species catch (PSC) regulatory requirements (see regulations § 679.21). One reason for requiring the discard of prohibited species is that some of the fish may live if they are returned to the sea with a minimum of injury and delay. However, salmon caught incidentally in trawl nets die as a result of that capture due to damage they suffer within the nets. The PSD Program allows permitted seafood processors to retain salmon bycatch for distribution to economically disadvantaged individuals through tax-exempt hunger relief organizations. Section 4.5.6 of the Analysis provides additional detail on the PSD Program and donations received and processed through that program.
The pollock fishery catches more than 95 percent of the Chinook salmon taken incidentally in the BSAI groundfish fisheries, based on data from 1992 through 2014. However, the amount of Chinook salmon bycatch taken by the pollock fishery has declined since 2007. From 1992 through 2001 the average Chinook salmon bycatch in the pollock fishery was 32,482 fish per year. Bycatch increased substantially from 2002 through 2007, to an average of 74,067 Chinook salmon per year. A historic high of approximately 122,000 Chinook salmon was taken in the pollock fishery in 2007. However, since 2007 Chinook salmon bycatch declined substantially to an average of 15,500 Chinook salmon per year from 2008 to 2014. The decline is most likely due to a combination of factors, including changes in abundance and distribution of Chinook salmon and pollock, as well as changes in fleet behavior to avoid salmon bycatch.
In years of historically high Chinook salmon bycatch in the pollock fishery (2002 through 2007), the rate of Chinook salmon bycatch averaged 52 Chinook salmon per 1,000 tons of pollock harvested. With so few salmon relative to the large amount of pollock harvested, Chinook salmon encounters are difficult to predict or avoid. Vessel-level cooperation to share information about areas of high Chinook salmon encounter rates probably is the best tool that the industry currently has to quickly identify areas of high bycatch and to avoid fishing there. However, it will continue to be difficult to predict when and where large amounts of Chinook salmon bycatch will be encountered by the pollock fleet, primarily because of the current lack of understanding of the biological and oceanographic conditions that influence the distribution and abundance of salmon in the areas where the pollock fishery occurs.
Chinook salmon taken in the pollock fishery originate from river systems in Alaska, the Pacific Northwest, and Canada. Estimates vary from year to year, but on average approximately 65 percent of the Chinook salmon bycatch in the pollock fishery may be destined for western Alaska. Western Alaska includes the Bristol Bay, Kuskokwim, Yukon, and Norton Sound areas. Chinook salmon destined for elsewhere in Alaska, the Pacific Northwest, and Canada comprise approximately 28 percent of the bycatch. Section 3.4 of
The pollock fishery catches over 95 percent of the chum salmon taken incidentally as bycatch in the BSAI groundfish fisheries. The pollock fishery catches chum salmon almost exclusively in the B season (after June 10). The pollock fishery has caught large numbers of chum, with a historic high of approximately 700,000 chum salmon taken in 2005. Since then, bycatch levels in the pollock fishery have been quite variable, ranging from a low of 13,280 chum salmon in 2010 to a high of 309,646 chum salmon in 2006. Average chum salmon bycatch from 2006 through to 2014 was 115,190 chum salmon. In 2014, the pollock fishery caught 219,428 chum salmon.
Genetic information indicates that the majority of the chum salmon caught in the pollock fishery are of Asian origin (approximately 60 percent) while a smaller percentage (approximately 21 percent) originate from aggregate streams in western Alaska. Chum salmon from elsewhere in Alaska, the Pacific Northwest, and Canada comprise the remaining percentage of the bycatch (approximately 19 percent). While the genetics cannot differentiate hatchery-origin fish from wild Asian chum salmon, given the high proportion of Pacific Rim hatchery-released chum from Japan, much of the Asian origin chum observed in the bycatch is likely to be of Asian hatchery-origin. Alaska chum salmon runs have indicated a history of volatility in run sizes, and chum salmon stocks in Alaska are generally at higher levels of abundance than historical periods. Section 3.4 of the Analysis provides additional information about chum salmon biology, distribution, and stock assessments by river system or region (see
The Council and NMFS have been concerned about the potential impact of Chinook and chum salmon bycatch on returns to western Alaska given the relatively large proportion of bycatch from these river systems that occurs in the pollock fishery. Chinook salmon and chum salmon destined for western Alaska support commercial, subsistence, sport, and personal use fisheries. The Alaska Board of Fisheries adopts regulations through a public process to conserve salmon and to allocate salmon to the various users. The State of Alaska Department of Fish and Game manages the salmon commercial, subsistence, sport, and personal use fisheries. The first management priority is to meet spawning escapement goals to sustain salmon resources for future generations. The next priority is for subsistence use under both State and Federal law. Salmon is a primary subsistence food in some areas. Subsistence fisheries management includes coordination with U.S. Federal agencies where Federal rules apply under the Alaska National Interest Lands Conservation Act. Section 3.4 of the Analysis provides a detailed description of the State and Federal management process. Appendix A-4 of the Analysis provides an overview of the importance of subsistence salmon harvests and commercial salmon harvests.
Over the last 20 years, the Council and NMFS have adopted and implemented several management measures to limit salmon bycatch in the BSAI trawl fisheries, and particularly in the pollock fishery. Management measures have focused on minimizing Chinook salmon bycatch, chum salmon bycatch, and non-Chinook salmon bycatch. Non-Chinook bycatch is a category that includes all salmon species except Chinook salmon, but is comprised predominantly of chum salmon.
In 1994, the Chum Salmon Savings Area in the eastern Bering Sea was established by an emergency rule (59 FR 35476, July 12, 1994). This Chum Salmon Savings Area corresponded to a region of historically high chum salmon bycatch compared to other areas in the Bering Sea. The Council subsequently recommended maintaining the Chum Salmon Savings Area under Amendment 35 to the FMP (60 FR 34904, July 5, 1995). Amendment 35 closed the Chum Salmon Savings Area to all trawling from August 1 through August 31 and established a 42,000 non-Chinook salmon PSC limit for trawl vessels operating in the Bering Sea. A PSC limit is effectively a bycatch limit; it constrains fishing once the amount of PSC is reached. Amendment 35 also established a separate Catcher Vessel Operational Area. The Catcher Vessel Operational Area corresponds to another region in the eastern Bering Sea where trawl catcher vessels had historically been observed to have high non-Chinook salmon (
In 1995, NMFS also established the Chinook Salmon Savings Area, which was implemented under Amendment 21b to the FMP (60 FR 61215, November 29, 1995). The Chinook Salmon Savings Area was established based on historic information regarding the location and timing of Chinook salmon bycatch. Regulations implementing Amendment 21b established annual PSC limits for Chinook salmon and specific seasonal no-trawling zones in the Chinook Salmon Savings Area that would close when the limits were reached. Once the 48,000 Chinook salmon PSC limit was reached, these regulations prohibited trawling in the Chinook Salmon Savings Area through April 15.
In 2000, NMFS implemented Amendment 58 to the FMP, which reduced the Chinook Salmon Savings Area PSC limit from 42,000 to 29,000 Chinook salmon, redefined the Chinook Salmon Savings Area as two non-contiguous areas (Area 1 in the Aleutian Islands subarea and Area 2 in the Bering Sea subarea), and established new closure periods (65 FR 60587, October 12, 2000).
In 2005, NMFS implemented Amendment 82 to the FMP. Amendment 82 established the Aleutian Islands Chinook salmon PSC limit of 700 fish. If the limit is reached, NMFS will close the directed pollock fishery in the Aleutian Islands Chinook Salmon Savings Area (70 FR 9856, March 1, 2005).
In 2007, NMFS implemented Amendment 84 to the FMP to enhance the effectiveness of salmon bycatch measures. The Council and NMFS were concerned that increases in Chinook salmon and non-Chinook (predominantly chum) salmon bycatch in the pollock fishery were occurring despite Chinook and chum salmon PSC limits being reached and the closures of the Chinook Salmon Savings Area and Chum Salmon Savings Area (72 FR 61070, October 29, 2007). Amendment 84 exempted pollock vessels from Chinook Salmon Savings Area and Chum Salmon Savings Area closures if they participate in an intercooperative agreement (ICA) to reduce salmon bycatch. Amendment 84 also exempted vessels participating in non-pollock trawl fisheries from Chum Salmon Savings Area closures because these
The ICA allowed vessels participating in the pollock fishery to use their internal cooperative structure to reduce Chinook salmon and non-Chinook salmon bycatch using a method called the voluntary rolling hotspot system. Amendment 84 required that parties to the ICA include the AFA cooperatives; the six CDQ groups; at least one third-party group, including any organizations representing western Alaskans who depend on salmon and have an interest in salmon bycatch reduction but do not directly fish in a groundfish fishery; and at least one entity retained to facilitate bycatch avoidance behavior and information sharing. All AFA cooperatives and CDQ groups participated in the ICA and continue to do so to avoid incidentally catching non-Chinook salmon.
Amendment 84 continues to exempt vessels participating in the ICA from the Chum Salmon Savings Area closure. Closure of the Chum Salmon Savings Area was designed to reduce the total amount of chum salmon bycatch by closing areas with historically high levels of chum salmon bycatch. The ICA operates in lieu of a fixed area closure, and is required to identify and close areas of high salmon bycatch and move vessels to other areas.
Fishery participants provide the ICA with real-time salmon bycatch information and the ICA uses that information to inform other fishery participants to avoid areas of high non-Chinook salmon bycatch rates. Using a system specified in regulations, the ICA assigns vessels in a cooperative to certain tiers, based on bycatch rates of vessels in that cooperative relative to a base rate established in regulations, and implements large area closures for vessels in tiers associated with higher bycatch rates. The ICA managers monitor salmon bycatch in the pollock fisheries and announce area closures for areas with relatively high salmon bycatch rates. Monitoring and enforcement are accomplished through private contractual arrangements. The efficacy of voluntary closures and bycatch reduction measures are reported to the Council annually.
Amendment 91, as implemented in 2010 to manage Chinook salmon bycatch in the pollock fishery (75 FR 53026, August 30, 2010), combined a limit on the amount of Chinook salmon that may be caught incidentally with a novel approach designed to minimize bycatch to the extent practicable in all years and prevent bycatch from reaching the limit in most years, while providing the fleet the flexibility to harvest the pollock TAC. Amendment 91 removed Chinook salmon from the Amendment 84 regulations, and established two Chinook salmon PSC limits for the pollock fishery—60,000 and 47,591 Chinook salmon. Under Amendment 91, the PSC limit is 60,000 Chinook salmon if some, or all, of the pollock fishery participates in an industry-developed contractual arrangement, called an incentive plan agreement (IPA). An IPA establishes an incentive program to minimize bycatch at all levels of Chinook salmon abundance. Participation in an IPA is voluntary; however, any vessel or CDQ group that chooses not to participate in an IPA is subject to a restrictive opt-out allocation (also called a backstop cap). Since Amendment 91 was implemented, all AFA vessels have participated in an IPA.
To ensure participants develop effective IPAs, participants provide the Council and NMFS an annual report that describes the efforts each IPA is taking to accomplish the intent of the program that each vessel actively avoids Chinook salmon at all times while fishing for pollock and, collectively, that bycatch is minimized in each year. The IPA system is designed to be flexible, responsive, and can be tailored by each sector to fit its operational needs. The IPAs impose rewards for avoiding Chinook salmon bycatch or penalties for failure to avoid Chinook salmon bycatch at the vessel level. While the IPAs provide an incentive to minimize bycatch in all years to a level below the limit, a limit of 60,000 Chinook salmon provides the industry the flexibility to harvest the pollock TAC in high-encounter years when bycatch is difficult to avoid.
Since implementation, all the participants in the pollock fishery are currently participating in IPA agreements. There are three NMFS-approved IPA agreements currently in place: the Inshore Chinook Salmon Savings Incentive Plan Agreement, the Mothership Salmon Savings Incentive Plan Agreement, and the Catcher Processor Chinook Salmon Bycatch Reduction Incentive Plan and Agreement. Section 2.1.2.3 of the Analysis provides details on the features of the current IPA agreements.
Under Amendment 91, if fishery participants do not form any IPAs, the 47,591 Chinook salmon PSC limit applies rather than the 60,000 Chinook salmon PSC limit. This PSC limit was the approximate 10-year average of Chinook salmon bycatch from 1997 to 2006, the years considered by the Council and NMFS when developing Amendment 91. The 47,591 Chinook salmon PSC limit constrains Chinook salmon bycatch in the pollock fishery if no other incentives, namely the IPAs, are operating to minimize bycatch below this level.
Both the 60,000 and 47,591 Chinook salmon PSC limits are apportioned between the A and B seasons and allocated to the AFA catcher/processor sector, the AFA mothership sector, the AFA inshore sector, and CDQ Program. NMFS further allocates the AFA inshore sector PSC among the inshore cooperative and the CDQ Program PSC among the CDQ groups. Chinook salmon PSC allocations made to sectors, inshore cooperatives, and the CDQ groups are transferable. Transferability mitigates the variation in the salmon encounter rates among sectors, inshore cooperatives, and CDQ groups, in a given pollock season. It allows eligible participants to obtain a larger portion of the PSC allocation in order to harvest their pollock allocation or to transfer surplus PSC allocation to other entities. When a Chinook salmon PSC allocation is reached, the affected sector, inshore cooperative, or CDQ group must stop fishing for pollock for the remainder of the season even if its pollock allocation has not been fully harvested.
Amendment 91 also established a performance standard as an additional tool to ensure that the IPA is effective and that the AFA sectors and the CDQ Program do not fully harvest their Chinook salmon PSC allocations under the 60,000 Chinook salmon PSC limit in most years. For an AFA sector or the CDQ Program to continue to receive Chinook salmon PSC allocations under the 60,000 Chinook salmon PSC limit, that AFA sector or the CDQ Program may not exceed its annual threshold amount in any three years within seven consecutive years. If this performance standard is not met, that AFA sector or CDQ Program will permanently be allocated a portion of the 47,591 Chinook salmon PSC limit. The risk of bearing the potential adverse economic impacts of a reduction from the 60,000 PSC limit to the 47,591 PSC limit creates incentives for fishery participants to cooperate in an effective IPA.
Before each fishing year, NMFS calculates each sector's annual threshold amount. If some, but not all, members of a sector were to participate in an IPA, NMFS would reduce that
Additional information the provisions of Amendment 91 are provided in the final rule prepared for that action (75 FR 53026, August 30, 2010).
In April 2015, the Council adopted Amendment 110. The objective of Amendment 110 and this proposed rule is to create a comprehensive salmon bycatch avoidance program that would work more effectively than the current salmon bycatch programs to avoid Chinook salmon bycatch and Alaska-origin chum salmon bycatch. The Council's action is designed to consider the importance of continued production of critical chum salmon runs in western Alaska by focusing on bycatch avoidance of Alaskan chum salmon runs. These runs have a history of volatility in run sizes, and are of historic importance in the subsistence lifestyle of Alaskans. Additional protections to other chum stocks outside of Alaska are embedded in the Council's objective to avoid the high bycatch of chum salmon overall, recognizing that most non-Alaska chum salmon are likely from Asian hatcheries.
The Council recognized that the chum salmon bycatch reduction program under Amendment 84 does not meet the Council's objective for the pollock fishery to effectively avoid both Chinook salmon and chum salmon bycatch. Amendment 84 did not provide the flexibility necessary to avoid Chinook salmon when fishermen encountered both species, avoid Alaska chum salmon stocks, or to harvest pollock in times and places that best support those goals.
The Council recognized that Chinook salmon are an extremely important resource to Alaskans who depend on local fisheries for their sustenance and livelihood. Multiple years of historically low Chinook salmon abundance have resulted in significant restrictions for subsistence users in western Alaska and failure to achieve conservation objectives. The current Chinook salmon bycatch reduction program under Amendment 91 was designed to minimize bycatch to the extent practicable in all years, under all conditions of salmon and pollock abundance. While Chinook salmon bycatch impact rates have been low under the program, the Council determined that there is evidence that improvements could be made to ensure the program is reducing Chinook salmon bycatch at low levels of salmon abundance. An analysis of the possible improvements is provided in section 3.5.3 of the Analysis.
The Council considered a broad suite of measures to induce some level of behavior change to further avoid salmon bycatch, which is the primary objective of this action. Experience has shown that salmon avoidance requires flexibility and the ability of vessels to adjust to real-time information and fishery conditions. The Council also considered the trade-offs between the potential salmon saved and the forgone pollock catch.
In selecting the proposed salmon bycatch avoidance program, the Council considered five alternatives, with many options, to assess the impacts of minimizing Chinook salmon and chum salmon bycatch to the extent practicable while maintaining the potential for the full harvest of the pollock TAC. The Analysis contains a complete description of the alternatives and a comparative analysis of the potential impacts of the alternatives (see
The Council recommended all four action alternatives as Amendment 110. Amendment 110 would adjust the existing Chinook salmon bycatch program to incorporate revised chum salmon bycatch measures into the existing IPAs. In addition, the Council sought to provide greater incentives to avoid Chinook salmon by strengthening incentives during times of historically low Chinook salmon abundance in western Alaska. Thus, the management measures included in Amendment 110 focus on retaining the incentives to avoid Chinook salmon bycatch at all levels of abundance as intended by Amendment 91. The Council also expressed that it remains extremely important to provide the incentives to avoid Alaska-origin chum salmon while maintaining the flexibility to avoid Chinook salmon.
In developing Amendment 110, the Council and NMFS considered consistency with the Magnuson-Stevens Act's 10 National Standards and sought to balance the competing demands of the National Standards. Specifically, the Council and NMFS recognized the need to balance and be consistent with both National Standard 9 and National Standard 1. National Standard 9 requires that conservation and management measures minimize bycatch to the extent practicable. National Standard 1 requires that conservation and management measures prevent overfishing while achieving, on a continuing basis, the optimum yield from each fishery for the U. S. fishing industry. Amendment 110 meets National Standards 1 and 9, as well as the other eight National Standards. Amendment 110 also retains the structure and meets the original goals of Amendment 91, but makes improvements by providing greater incentives to minimize salmon bycatch in all conditions of abundance, while also providing a reasonable opportunity to harvest the full pollock TAC each year and to achieve the optimum yield for pollock over the long term.
The provisions of Amendment 110, and the rational for each provision, are described in the following section on the proposed salmon bycatch management measures.
Amendment 110 and this proposed rule would—
• incorporate chum salmon avoidance into the IPAs established under Amendment 91 to the FMP, and remove the non-Chinook salmon bycatch reduction ICA previously established under Amendment 84 to the FMP;
• modify the requirements for the content of the IPAs to increase the incentives for fishermen to avoid Chinook salmon;
• change the seasonal apportionments of the pollock TAC to allow more pollock to be harvested earlier in the year;
• reduce the Chinook salmon PSC limit and performance standard in years with low Chinook salmon abundance in western Alaska; and
• improve the monitoring of salmon bycatch in the pollock fishery.
Currently, Chinook salmon and chum salmon bycatch are managed under two different programs (Amendment 84 for chum salmon bycatch and Amendment 91 for Chinook salmon bycatch). This has created inefficiencies, as having separate programs does not allow participants in the pollock fishery the flexibility to modify harvest patterns
Amendment 110 and this proposed rule would incorporate chum salmon avoidance into the IPAs established under Amendment 91. This proposed rule would remove the Amendment 84 implementing regulations by removing § 679.21(g). However, Amendment 110 and this proposed rule would maintain the current non-Chinook salmon PSC limit of 42,000 fish and the closure of the Chum Salmon Savings Area to the pollock fishery when the 42,000 non-Chinook salmon PSC limit has been reached (see the above section
Incorporating chum salmon into the IPAs meets the purpose of this action by providing measures to prevent high chum salmon bycatch, while also giving participants in the pollock fishery the flexibility to avoid Alaska chum stocks, and to use coordinated management under the IPAs to adapt quickly to changing conditions. The Council determined and NMFS agreed that this action for chum bycatch would strike an appropriate balance between regulatory requirements and adaptive management.
To incorporate chum salmon into the IPAs, the proposed rule would modify the required contents of the IPAs at § 679.21(f)(12), to include the following:
• The incentives for the operator of each vessel to avoid Chinook salmon and chum salmon bycatch under any condition of pollock and Chinook salmon abundance in all years.
• An explanation of how the incentives to avoid chum salmon do not increase Chinook salmon bycatch.
• The rewards for avoiding Chinook salmon, and the penalties for failure to avoid, Chinook salmon at the vessel level.
• An explanation of how the incentive measures in the IPA are expected to promote reductions in a vessel's Chinook salmon and chum salmon bycatch rates relative to what might have occurred in absence of the incentive program.
• An explanation of how the incentive measures in the IPA promote Chinook salmon savings and chum salmon savings in any condition of pollock abundance or Chinook salmon abundance in a manner that is expected to influence operational decisions by vessel operators to avoid Chinook salmon and chum salmon.
• An explanation of how the IPA ensures that the operator of each vessel governed by the IPA will manage that vessel's Chinook salmon bycatch to keep total bycatch below the performance standard for the sector in which the vessel participates.
• An explanation of how the IPA ensures that the operator of each vessel governed by the IPA will manage that vessel's chum salmon bycatch to avoid areas and times where the chum salmon are likely to return to western Alaska.
• The rolling hot spot program for salmon bycatch avoidance and the agreement to provide notifications of closure areas and any violations of the rolling hot spot program to at least one third party group representing western Alaskans who depend on salmon and do not directly fish in a groundfish fishery.
Amendment 110 and this proposed rule would maintain the important chum salmon avoidance features of the Amendment 84 ICAs. Amendment 110 and this proposed rule would: (1) Ensure that the operator of each vessel governed by the IPA will manage that vessel's chum salmon bycatch to avoid areas and times where the chum salmon are likely to return to western Alaska, (2) require the use of the rolling hot spot program for salmon bycatch avoidance, and (3) require notifications of closure areas and any violations of the rolling hot spot program to at least one third party group representing western Alaskans. Because Amendment 110 and this proposed rule would require a rolling hot spot program for both Chinook and chum salmon, the notification process would apply for both species. This proposed rule would also add reporting requirements to the IPA Annual Report in regulations at § 679.21(f)(13) to require the IPA representative to describe how the IPA addresses the goals and objectives in the IPA provisions related to chum salmon. Section 3.5.2 of the Analysis provides more detail on adding elements of chum salmon management.
Amendment 110 and this proposed rule would modify the IPAs to increase the incentives for fishermen to avoid Chinook salmon. The Council and NMFS recognize that the IPAs were effective at providing incentives for each vessel to avoid Chinook salmon, but that additional measures were necessary to address higher Chinook salmon PSC rates observed in October (the last month when the pollock fishery is authorized to operate) and to address concerns with individual vessels that consistently have significantly higher Chinook salmon PSC rates relative to other vessels fishing at the same time. The Council and NMFS wanted to ensure the use of salmon excluder devices (
These new provisions would increase the incentives to reduce Chinook salmon bycatch within the IPAs. To incorporate additional incentives for Chinook salmon savings into the IPAs, the proposed rule would modify the required contents of the IPAs at § 679.21(f)(12) to include the following six provisions.
• Restrictions or penalties targeted at vessels that consistently have significantly higher Chinook salmon PSC rates relative to other vessels fishing at the same time.
• Requirement that vessels to enter a fishery‐wide in‐season salmon PSC data sharing agreement.
• Requirement for the use of salmon excluder devices, with recognition of contingencies, from January 20 through March 31 and from September 1 until the end of the B season.
• Requirement for a rolling hotspot program that operates throughout the entire A and B seasons.
• For savings-credit-based IPAs, limititation on the salmon savings credits to maximum of three years.
• Restrictions or performance criteria to ensure that Chinook salmon PSC rates in October are not significantly higher than those achieved in the preceding months, thereby avoiding late-season spikes in salmon PSC.
The Council and NMFS also recognize that contingencies exist when vessels cannot use excluder devices. Trawl gear can have problems; therefore, salmon excluder devices would not be required during rare occasions such as when a net tears or a spare excluder device is not available. In order to allow for innovation that might lead to the development of better excluder devices, the requirement to use a salmon excluder device does not specify the type of design. Section 3.5.3.2 of the Analysis provides more detail on this addition to the IPA requirements (see
For IPAs based on savings credits, Amendment 110 and this proposed rule would limit the amount of time savings credits could be used to three years after the year that the savings credits are earned. The Council and NMFS reviewed the use of savings credits and concluded that limiting the duration of credits to three years would likely increase the incentive to earn credits and increase the incentive to reduce Chinook salmon PSC. Section 3.5.3.4 of the Analysis provides more detail on this addition to the IPA requirements (see
This proposed rule would change the pollock allocation between the A and B seasons at § 679.20(a)(5)(i)(B)(
Revising the season allocation would work in conjunction with the new IPA requirements to shift effort out of the late B season and provide fishery participants more flexibility to avoid Chinook salmon PSC in the late B season. Both the research on salmon migration patterns and Chinook salmon bycatch rates show the time at which there is the greatest overlap with Chinook salmon and pollock fishing. In general, more Chinook salmon are on the grounds in the early A season and the late B season, and less Chinook salmon on the grounds during the late A season and early B season. This provision is intended to shift pollock effort away from these high overlap periods and allow for more effort during the low overlap periods. With the existing rollover provision, this adjustment in the seasonal allocation of pollock does not mandate that more
Amendment 110 and this proposed rule would add a new lower Chinook salmon performance standard and PSC limit for the pollock fishery in years of low Chinook salmon abundance in western Alaska. The Council and NMFS determined that a lower performance standard and PSC limit would be appropriate at low levels of Chinook salmon abundance in western Alaska to accommodate the fact that most of the Chinook salmon bycatch comes from western Alaska. These provisions would work in conjunction with the proposed changes to the IPA requirements to ensure that Chinook salmon bycatch is avoided at all times, particularly at low abundance levels.
Each year, NMFS would determine whether Chinook salmon was at low abundance based on information provided by the State. By October 1 of each year, the State would provide an index of abundance based on the post-season in-river Chinook salmon run size for the Kuskokwim, Unalakleet, and Upper Yukon aggregate stock grouping. When this index is less than or equal to 250,000 Chinook salmon, the new lower performance standard and low PSC limit would apply.
The Council and State conducted an extensive analysis about the appropriate index to use to indicate a low Chinook salmon abundance year. Low Chinook salmon abundance years are years characterized by difficulty meeting escapement goals and in-river salmon fisheries being severely restricted or fully closed. Section 2.6 of the Analysis evaluates various indices and shows that the 3-system index (Unalakleet, Upper Yukon, and Kuskokwim river systems) meets the objectives. These river systems provide a broad regional representation of stocks and signify very important river systems and subsistence fisheries in western Alaska. Subsistence harvests from these three river systems account for up to 87 percent of the statewide subsistence harvest of Chinook salmon. As shown in the Analysis, having more than one system in the index and having broad regional representation makes the index more robust. The Analysis also shows a clear natural break in the data that index sizes less than 250,000 Chinook salmon correspond to years with historically low run sizes.
If NMFS determines it was a low Chinook salmon abundance year, NMFS would set the performance standard at 33,318 Chinook salmon and the PSC limit at 45,000 Chinook salmon for the following pollock fishing year. NMFS would publish the lower PSC limit and performance standard in the annual harvest specifications. In years when abundance is above 250,000 Chinook salmon, NMFS would manage under the current 47,591 Chinook salmon performance standard and 60,000 Chinook salmon PSC limit established under Amendment 91.
The performance standard of 33,318 Chinook salmon would function the same as the existing performance standard of 47,591 Chinook salmon under Amendment 91. The 33,318 performance standard would apply to each sector that has at least some members participating in an IPA. In each low Chinook salmon abundance year, NMFS would allocate the 33,318 performance standard as an “annual threshold amount” to the catcher/processor sector, the mothership sector, the inshore sector, and the CDQ Program. The same seasonal and sector apportionments would apply to both performance standards. Although Chinook salmon PSC allocations are made to the inshore cooperatives and the CDQ groups, the performance standard applies to the sector, not to individual inshore cooperatives or CDQ groups. In addition to participation by at least some members in an IPA, for each sector to continue to receive its allocation of the 45,000 Chinook salmon PSC limit in low Chinook salmon abundance years, the total annual Chinook salmon bycatch by all members of a sector participating in an IPA could not exceed the sector's annual threshold amount (the sector's annual portion of the performance standard) in any three years within a consecutive seven-year period. The 33,318 performance standard would also be the PSC limit in low abundance years if no IPA was approved or for a sector that had exceeded its performance standard.
If there is an approved IPA, then the PSC limit in low Chinook salmon abundance years would be 45,000 Chinook salmon. The 45,000 PSC limit would function the same as the 60,000 Chinook salmon PSC limit under Amendment 91. NMFS would issue allocations of the 45,000 PSC limit to the AFA catcher/processor sector, the AFA mothership sector, the AFA inshore cooperatives, and the CDQ groups using the same seasonal and sector apportionments. Separate allocations would be issued for the A season and the B season. Chinook salmon remaining from the A season could be used in the B season (“rollover”). Entities could transfer PSC allocations within a season and could also receive transfers of Chinook salmon bycatch to cover overages (“post-delivery transfers”).
The inclusion of a lower PSC limit and performance standard is based on the need to reduce bycatch when these Chinook salmon stocks are critically low in order to minimize the impact of the pollock fishery on the stocks. Any additional Chinook salmon returning to Alaska rivers improves the ability to meet the State's spawning escapement goals, which is necessary for long-term sustainability of Chinook salmon and the people reliant on salmon fisheries. While the performance standard is the functional limit in the IPAs, the Council and NMFS determined that the 60,000 PSC limit should also be reduced given the potential for decreased bycatch reduction incentives should a sector exceed its performance standard before the PSC limit is reached. The reduced PSC limit is intended to encourage vessels to avoid bycatch to a greater degree in years of low abundance, and to set a maximum permissible PSC limit that reduces the risk of adverse impact on stocks in western Alaska during periods of low abundance.
This proposed rule would amend the monitoring and enforcement regulations to clarify and strengthen those implemented by Amendment 91. These changes would: Revise salmon retention and handling requirements on catcher vessels; improve observer data entry and transmission requirements aboard catcher vessels; clarify the requirements applicable to viewing salmon in a storage container; and clarify the requirements for the removal of salmon from an observer sample area at the end of a haul or delivery.
Current catch handling practices on catcher vessels includes the delivery of “deckloaded” pollock to shoreside processors or stationary floating processors. Deckloading is the practice of retaining catch in the codend of the net rather than dumping the catch in refrigerated saltwater tanks (RSW). For reasons detailed in the Section 2.7 of the Analysis, NMFS has recognized deckloading as a historic and operationally important practice for
(1) All salmon must be retained until delivery to the processor.
(2) The vessel operator must notify the observer at least 15 minutes prior to the transfer of fish from one storage location to another, or any sorting, handling, or discard of catch prior to delivery.
(3) After the observer has completed sampling duties, catch must be secured on board the vessel until delivery. (Catch may be handled after securing it, but only if the observer is notified and catch re-secured after the completion of catch handling activity.)
These additional catch handling and notification requirements would facilitate observer sampling during the delivery, and ensure observers are given the opportunity to monitor all catch handling activities when sorting or discard of salmon may occur. This would ensure accurate salmon accounting at the processor receiving the vessel's catch.
Catcher vessels participating in the pollock fishery are required to carry an observer on all trips but only catcher vessels greater than or equal to 125 ft length overall (LOA) are required to provide a computer, data entry software, and data transmission capabilities to the observer. Currently, an observer on board a catcher vessel less than 125 ft LOA sends data to NMFS on paper forms via facsimile at the completion of each trip. Observer data sent to NMFS via fax can take a week or more to be available for management purposes. Access to a computer for electronic data entry significantly increases the speed at which observer data can be made available for inseason management and catch accounting. Further, the data validation measures built into the software improve initial data quality and decrease the need for corrections during the observer debriefing process. Additional information about the projected costs and benefits of this proposed regulatory amendment are detailed in Sections 2.7 and 4.8.4 of the Analysis.
This proposed regulatory amendment will clarify the existing observer data entry and communications requirements and expand the equipment and software requirements to apply to all catcher vessels less than 125 ft LOA participating in the pollock fishery. NMFS proposes to reorganize regulations at § 679.51(e)(1)(iii) to separate the equipment requirements from the applicability paragraphs to clearly identify which vessel operators must provide a computer, software, and data transmission capabilities. As a result of this proposed action, current requirements for observer data entry equipment, software, and transmission would remain, and the computer and software requirements would be expanded to apply to catcher vessels less than 125 ft LOA participating in the pollock fishery.
Regulations at § 679.28(d)(7)(ii) require that all salmon stored in the salmon storage container on a catcher/processor or mothership must remain in view of the observer at the observer sampling station at all times during the sorting of each haul. NMFS proposes to revise the wording of this regulation to better reflect the intent that the salmon storage container (and not each individual salmon in the container) must remain in view of the observer at the observer sampling station at all times during the sorting of each haul.
Current regulations do not require that all salmon be removed from the observer sampling area and the salmon storage location at the end of each haul or each delivery. NMFS proposes to modify regulations at § 679.21(f)(15)(ii)(A)(3) and § 679.21(f)(15)(ii)(C)(6) to require that all salmon must be removed, in the presence of the observer, from the salmon storage container and adjacent area at the end of each haul or delivery after the observer has completed his or her data collection duties. NMFS proposes this revision to the regulations to ensure that salmon are properly accounted for between hauls and deliveries.
NMFS proposes to revise to the regulations for clarity and efficiency, as follows—
• Remove Tables 47a, b, c, and d to part 679;
• Correct a cross reference error in paragraph (6) of the definition of a fishing trip in § 679.2.
• Remove the requirement to submit an application form with a proposed IPA or amended IPA at § 679.21(f)(12)(iii)(A) and § 679.21(f)(12)(v)(C);
• Remove the requirement at § 679.21(f)(12)(v)(C)(
• Move and consolidate the regulations for the non-Chinook salmon PSC limit and Chum Salmon Savings Area from § 679.21(e) to § 679.21(f)(14);
• Move and consolidate the regulations for Chinook salmon bycatch in the Aleutian Islands pollock fishery from § 679.21(e) to § 679.21(g);
• Correct a cross reference error in § 679.51(e)(2);
• Remove “aboard the vessel” from § 679.51(e)(2)(iii)(B)(
• Make additional very minor non-substantive technical edits.
NMFS proposes to remove Tables 47a, b, c, and d to part 679 from the regulations and would instead maintain these tables on the NMFS Alaska Region Web site. Removing these tables would not impose any costs on industry and would decrease the costs of regulatory amendments necessary to update the tables in the future.
NMFS added Tables 47a, b, c, and d to part 679 with the final rule to implement Amendment 91. At that time, Tables 47a, b, c, and d were the most efficient way to be transparent about the values NMFS uses in making the necessary calculations under Amendment 91: The percent of each sector's pollock allocation, numbers of Chinook salmon associated with each vessel in the sector used to calculate the opt-out allocation and annual threshold amounts, and the percent of the pollock allocation associated with each vessel that NMFS uses to calculate minimum participation in the IPAs.
Since these tables were published in August 2010, catcher vessels have changed names and consolidated pollock allocations. In June 2014, NMFS recalculated the pollock allocations and Chinook salmon limits for catcher vessels whose allocation and limits has changes since 2010. NMFS revised Table 47c to show the original and revised information and published the revised table on the NMFS Alaska Region's Web site.
However, a regulatory amendment is required to change these tables in the
The proposed rule would correct a cross reference error in paragraph (6) of the definition of a fishing trip in § 679.2. This paragraph defines a fishing trip for purposes of implementing the post-delivery transfer provisions under Amendment 91. These provisions are described in more detail on page 14026 and 14027 of the proposed rule for Amendment 91 (75 FR 14016; March 23, 2010). The cross reference to the CDQ Program prohibition in paragraph (6) of the fishing trip definition should refer to § 679.7(d)(5)(ii)(C)(
NMFS proposes to remove the requirement at § 679.21(f)(12)(iii)(A) and § 679.21(f)(12)(v)(C) that an IPA representative submit an application form along with a proposed IPA or amended IPA based on public comment under the Paperwork Reduction Act. Under the Paperwork Reduction Act, every three years NMFS is required to obtain approval from the Office of Management and Budget (OMB) to continue to collect information authorized under previous final rules. The most recent request for public comments on renewal of the information collection authorized under the AFA (OMB Control Number 0648-0401) was published in the
NMFS proposes to remove the requirement at § 679.21(f)(12)(v)(C)(
Regulations at § 679.21(e)(1)(vii), (e)(3)(i)(A)(
Regulations at § 679.21(e)(1)(viii), (e)(3)(i)(A)(
The proposed rule would correct a cross reference error in § 679.51(e)(2). This paragraph describes the applicability of manager responsibilities for a shoreside processor or stationary floating processor required to maintain observer coverage. The cross reference to the observer requirements for shoreside processors and stationary floating processors should refer to § 679.51(b) instead of § 679.51(d).
Regulations at § 679.51(e)(2)(iii)(B)(
Pursuant to sections 304(b) and 305(d) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration of comments received during the public comment period.
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866.
An RIR was prepared to assess all costs and benefits of available regulatory alternatives. The RIR considers all quantitative and qualitative measures. A copy of this analysis is available from NMFS (see
An IRFA was prepared for this action, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA for this proposed action describes the reasons why this action is being proposed; the objectives and legal basis for the proposed rule; the number of small entities to which the proposed rule would apply; any projected reporting, recordkeeping, or other compliance requirements of the proposed rule; any overlapping, duplicative, or conflicting Federal rules; 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 that would minimize any significant adverse economic impacts of the proposed rule on small entities. Descriptions of the proposed action, its
The proposed action applies only to those entities that participate in the directed pollock trawl fishery in the Bering Sea. These entities include vessels harvesting pollock under the AFA and the six CDQ groups that receive allocations of pollock.
The RFA requires consideration of affiliations among entities for the purpose of assessing if an entity is small. The AFA pollock cooperatives are a type of affiliation. All the non-CDQ entities directly regulated by the proposed action were members of AFA cooperatives in 2014 and, therefore, NMFS considers them “affiliated” large (non-small) entities for RFA purposes. Section 5.6 of the IRFA notes that all of the AFA cooperatives have gross annual revenues that are substantially greater than $20.5 million, the standard used by the Small Business Administration to define the annual gross revenue of a large (non-small) business engaged in finfish harvesting, such as pollock. Therefore, all the non-CDQ pollock fishery participants are defined as large (non-small) entities.
Due to their status as non-profit corporations, the six CDQ groups are identified as “small” entities for RFA purposes. This proposed action directly regulates the six CDQ groups. As described in regulations implementing the RFA (13 CFR 121.103), the CDQ groups' affiliations with other large entities do not define them as large entities.
The six CDQ groups, formed to manage and administer the CDQ allocations, investments, and economic development projects, are the Aleutian Pribilof Island Community Development Association, the Bristol Bay Economic Development Corporation, the Central Bering Sea Fishermen's Association, the Coastal Villages Region Fund, the Norton Sound Economic Development Corporation, and the Yukon Delta Fisheries Development Association. The 65 communities, with approximately 27,000 total residents, benefit from participation in the CDQ Program, but are not directly regulated by this action.
This proposed rule would revise some existing requirements and remove some requirements. The revised requirements are those related to—
• Development and submission of proposed IPAs and amendments to approved IPAs;
• An annual report from the participants in each IPA, documenting information and data relevant to the Bering Sea Chinook salmon bycatch management program; and
• Salmon handling and storage on board a vessel, and obligations to facilitate observer data reporting.
The proposed rule would remove the requirements for an application form for a proposed IPA or amended IPA.
No duplication, overlap, or conflict between this proposed action and existing Federal rules has been identified.
The proposed action is a comprehensive program to minimize Chinook and chum salmon bycatch that accomplished the stated objectives and is consistent with applicable statutes. No alternatives were identified in addition to those analyzed in the IRFA that had the potential to further reduce the economic burden on small entities, while achieving the objectives of this action. Section 2.10 of the Analysis contains a detailed discussion of alternatives considered and eliminated from further analysis (see
This proposed rule includes performance standards, rather than design standards, to minimize Chinook salmon and chum salmon bycatch, while limiting the burden on CDQ groups. A system of transferable PSC allocations and a performance standard, even in years of low Chinook salmon abundance, would allow CDQ groups to decide how best to comply with the requirements of this action, given the other constraints imposed on the pollock fishery (
Executive Order 13175 of November 6, 2000 (25 U.S.C. 450 note), the Executive Memorandum of April 29, 1994 (25 U.S.C. 450 note), the American Indian and Alaska Native Policy of the U.S. Department of Commerce (March 30, 1995), and the Tribal Consultation and Coordination Policy of the U.S. Department of Commerce (May 21, 2013), outline the responsibilities of NMFS in matters affecting tribal interests. Section 161 in Division H of Public Law 108-199 (188 Stat. 452), as amended by section 518 in Division H of Public Law 108-447 (118 Stat. 3267), extends the consultation requirements of Executive Order 13175 to Alaska Native corporations.
NMFS is obligated to consult and coordinate with federally recognized tribal governments and Alaska Native Claims Settlement Act regional and village corporations on a government-to-government basis pursuant to Executive Order 13175 which establishes several requirements for NMFS, including (1) to provide regular and meaningful consultation and collaboration with Indian tribal governments and Alaska Native corporations in the development of Federal regulatory practices that significantly or uniquely affect their communities, (2) to reduce the imposition of unfunded mandates on Indian tribal governments, and (3) to streamline the applications process for and increase the availability of waivers to Indian tribal governments. Executive Order 13175 requires Federal agencies to have an effective process to involve and consult with representatives of Indian tribal governments in developing regulatory policies and prohibits regulations that impose substantial, direct compliance costs on Indian tribal governments.
Section 5(b)(2)(B) of Executive Order 13175 requires NMFS to prepare a tribal summary impact statement as part of the final rule. This statement must contain (1) a description of the extent of the agency's prior consultation with tribal officials, (2) a summary of the nature of their concerns, (3) the agency's position supporting the need to issue the regulation, and (4) a statement of the extent to which the concerns of tribal officials have been met. If the Secretary of Commerce approves Amendment 110, a tribal impact summary statement that summarizes and responds to issues raised in all tribal consultations on the proposed action and describes the extent to which the concerns of tribal officials have been met will be included in the final rule for Amendment 110.
The consultation process for this action started during the Council process when the Council started developing Amendment 110. A number of tribal representatives and tribal organizations provided written public comments and oral public testimony to the Council during Council outreach meetings on Amendment 110 and at the numerous Council meetings at which Amendment 110 was discussed.
NMFS conducted two tribal consultations, one in December 2014 and one in April 2015, with representatives from the Tanana Chiefs Conference; the Association of Village Council Presidents; the Yukon River Drainage Fisheries Association; the Kawerak, Inc.; and the Bering Sea Fishermen's Association. These organizations prepared letters for the Council and requested the consultations to discuss the salmon bycatch management measures under consideration by the Council. NMFS posted reports from these consultations on the NMFS Alaska Region Web site at
NMFS continued the consultation process by sending a letter to all Alaska Native representatives when the Notice of Availability for Amendment 110 published in the
This proposed rule contains collection-of-information requirements subject to review and approval by OMB under the Paperwork Reduction Act (PRA). These requirements have been submitted to OMB for approval. The collections are listed below by OMB control number.
Public reporting burden is estimated to average 5 minutes per individual response for use of a vessel's computer, software, and data transmission; 5 minutes per individual response for notification of observer before handling the vessel's Bering Sea pollock catch; and 5 minutes for notification of crew person responsible for ensuring all sorting, retention, and storage of salmon.
Public reporting burden is estimated to average 8 hours per individual response for the Application to Receive Transferable Chinook Salmon PSC Allocations, including the attached contract; 4 hours for the amendment to contract; and 15 minutes for the Application for the Transfer of Chinook Salmon PSC Allocations.
Public reporting burden is estimated to average 40 hours per individual response for the Salmon Bycatch Incentive Plan Agreement (IPA); and 8 hours for the IPA Annual Report.
Public reporting burden includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Public comment is sought regarding (1) 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; (2) the accuracy of the burden estimate; (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, 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 Alaska Region at the
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. All currently approved NOAA collections of information may be viewed at:
Alaska, Fisheries, Recordkeeping and reporting 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
The revisions and additions read as follows:
(6) For purposes of § 679.7(d)(5)(ii)(C)(
The revisions and addition read as follows:
(d) * * *
(5) * * *
(ii) * * *
(B)
(C) * * *
(
(
(
(
(k) * * *
(8)
(iv)
(B) For the operator of a catcher vessel to fail to secure catch after the completion of catch handling and the collection of scientific data and biological samples as described in § 679.21(f)(15)(ii)(B)(
(a) * * *
(5) * * *
(i) * * *
(B) * * *
(
(
(
5. In § 679.21:
a. Remove and reserve paragraph (c);
b. Remove paragraphs (e)(1)(vi), (vii), and (viii); (e)(3)(i)(A)(
c. Revise paragraphs (f) and (g) to read as follows:
(f)
(2)
(i) An AFA sector will receive a portion of the 47,591 Chinook salmon PSC limit, or, in a low Chinook salmon abundance year, the 33,318 Chinook salmon PSC limit, if—
(A) No Chinook salmon bycatch incentive plan agreement (IPA) is approved by NMFS under paragraph (f)(12) of this section; or
(B) That AFA sector has exceeded its performance standard under paragraph (f)(6) of this section.
(ii) An AFA sector will receive a portion of the 60,000 Chinook salmon PSC limit, or, in a low Chinook salmon abundance year, the 45,000 Chinook salmon PSC limit, if—
(A) At least one IPA is approved by NMFS under paragraph (f)(12) of this section; and
(B) That AFA sector has not exceeded its performance standard under paragraph (f)(6) of this section.
(3)
(ii)
(iii)
(A) If a sector is managed under the 60,000 Chinook salmon PSC limit, the maximum amount of Chinook salmon PSC allocated to each sector in each season and annually is—
(B) If the sector is managed under the 45,000 Chinook salmon PSC limit, the sector will be allocated the following amount of Chinook salmon PSC in each season and annually:
(C) If the sector is managed under the 47,591 Chinook salmon PSC limit, the sector will be allocated the following amount of Chinook salmon PSC in each season and annually:
(D) If the sector is managed under the 33,318 Chinook salmon PSC limit, the sector will be allocated the following amount of Chinook salmon PSC in each season and annually:
(iv)
(B) If no entity is approved by NMFS to represent the AFA catcher/processor sector or the AFA mothership sector, then NMFS will manage that sector under a non-transferable Chinook salmon PSC allocation under paragraph (f)(10) of this section.
(v)
(vi)
(vii)
(viii)
(A) The Chinook salmon PSC allocations for each entity receiving a transferable allocation;
(B) The non-transferable Chinook salmon PSC allocations;
(C) The vessels fishing under each transferable or non-transferable allocation;
(D) The amount of Chinook salmon bycatch that accrues towards each transferable or non-transferable allocation;
(E) Any changes to these allocations due to transfers under paragraph (f)(9) of this section, rollovers under paragraph (f)(11) of this section, and deductions from the B season non-transferable allocations under paragraphs (f)(5)(v) or (f)(10)(iii) of this section; and
(F) Tables for each sector that provide the percent of the sector's pollock allocation, numbers of Chinook salmon associated with each vessel in the sector used to calculate the opt-out allocation and annual threshold amounts, and the percent of the pollock allocation associated with each vessel that NMFS will use to calculate IPA minimum participation assigned to each vessel.
(4)
(ii)
(B) If all members of an inshore cooperative do not participate in an approved IPA, the amount of Chinook salmon that remains in the inshore sector's allocation, after subtracting the amount of Chinook salmon associated with the non-participating inshore cooperative, will be reallocated among the inshore cooperatives participating in an approved IPA based on the proportion each participating cooperative represents of the Chinook salmon PSC initially allocated among the participating inshore cooperatives that year.
(iii)
(iv)
(5)
(6)
(i)
(ii)
(iii)
(7)
(8)
(A)
(B)
(C)
(D)
(ii)
(A)
(B)
(
(
(
(C)
(D)
(E)
(F)
(
(iii)
(
(
(
(
(B) Any vessel owner that is a member of an inshore cooperative, or a member of the entity that represents the catcher/processor sector or the mothership sector, may authorize the entity representative to sign a proposed IPA submitted to NMFS, under paragraph (f)(12) of this section, on his or her behalf. This authorization must be included in the contract submitted to NMFS, under paragraph (f)(8)(ii)(B) of this section, for the sector-level entities and in the contract submitted annually to NMFS by inshore cooperatives under § 679.61(d).
(iv)
(A) Be authorized to receive and respond to any legal process issued in the United States with respect to all owners and operators of vessels that are members of an entity receiving a transferable allocation of Chinook salmon PSC or with respect to a CDQ group. Service on or notice to the entity's appointed agent constitutes service on or notice to all members of the entity.
(B) Be capable of accepting service on behalf of the entity until December 31 of the year five years after the calendar year for which the entity notified the Regional Administrator of the identity of the agent.
(v)
(9)
(A) Entities receiving transferable allocations under the 60,000 PSC limit may only transfer to and from other entities receiving allocations under the 60,000 PSC limit.
(B) Entities receiving transferable allocations under the 45,000 PSC limit may only transfer to and from other entities receiving allocations under the 45,000 PSC limit.
(C) Entities receiving transferable allocations under the 47,591 PSC limit may only transfer to and from other entities receiving allocations under the 47,591 PSC limit.
(D) Entities receiving transferable allocations under the 33,318 PSC limit may only transfer to and from other entities receiving allocations under the 33,318 PSC limit.
(E) Chinook salmon PSC allocations may not be transferred between seasons.
(ii)
(iii)
(B)
(
(C)
(
(D)
(10)
(ii) All vessels fishing under a non-transferable Chinook salmon PSC allocation, including vessels fishing on behalf of a CDQ group, will be managed together by NMFS under that non-transferable allocation. If, during the fishing year, the Regional Administrator determines that a seasonal non-transferable Chinook salmon PSC allocation will be reached, NMFS will publish a notice in the
(iii) For each non-transferable Chinook salmon PSC allocation, NMFS will deduct from the B season allocation any amount of Chinook salmon bycatch in the A season that exceeds the amount available under the A season allocation.
(11)
(ii)
(12)
(A)
(B)
(ii)
(B) For a vessel owner in the catcher/processor sector or mothership sector to join an IPA, that vessel owner must be a member of the entity representing that sector under paragraph (f)(8).
(C) For a CDQ group to be a member of an IPA, the CDQ group must sign the IPA and list in that IPA each vessel harvesting BS pollock CDQ, on behalf of that CDQ group, that will participate in that IPA.
(D) Once a member of an IPA, a vessel owner or CDQ group cannot withdraw from the IPA during a fishing year.
(iii)
(A)
(B)
(C)
(D)
(E)
(
(
(
(
(
(
(
(
(
(
(
(
(
(F)
(G)
(iv)
(B)
(v)
(
(
(
(B)
(C)
(D)
(
(
(
(
(
(vi)
(13)
(i)
(ii)
(A) A comprehensive description of the incentive measures, including the rolling hot spot program and salmon excluder use, in effect in the previous year;
(B) A description of how these incentive measures affected individual vessels;
(C) An evaluation of whether incentive measures were effective in achieving salmon savings beyond levels that would have been achieved in absence of the measures, including the effectiveness of—
(
(
(
(D) A description of any amendments to the terms of the IPA that were approved by NMFS since the last annual report and the reasons that the amendments to the IPA were made.
(E) The sub-allocation to each participating vessel of the number of Chinook salmon PSC and amount of pollock (mt) at the start of each fishing season, and number of Chinook salmon PSC and amount of pollock (mt) caught at the end of each season.
(F) The following information on in-season transfer of Chinook salmon PSC and pollock among AFA cooperatives, entities eligible to receive Chinook salmon PSC allocations, or CDQ groups:
(
(
(
(
(
(G) The following information on in-season transfers among vessels participating in the IPA:
(
(
(
(
(
(14)
(ii) 10.7 percent of the non-Chinook PSC limit is allocated to the CDQ Program as a PSQ reserve.
(iii) If the Regional Administrator determines that 42,000 non-Chinook salmon have been caught by vessels using trawl gear during the period August 15 through October 14 in the Catcher Vessel Operational Area, NMFS will prohibit fishing for pollock for the remainder of the period September 1 through October 14 in the Chum Salmon Savings Area as defined in Figure 9 to this part.
(iv) Trawl vessels participating in directed fishing for pollock and operating under an IPA approved by NMFS under paragraph (f)(12) of this section are exempt from closures in the Chum Salmon Savings Area.
(15)
(i)
(ii)
(
(
(
(
(B) Operators of vessels delivering to shoreside processors or stationary floating processors must—
(
(
(
(
(C) Shoreside processors or stationary floating processors must —
(
(
(
(
(
(
(iii)
(iv)
(g)
(2)
(ii) 7.5 percent of the PSC limit is allocated to the CDQ Program as a PSQ reserve.
(3)
(i) From the effective date of the closure until April 15, and from September 1 through December 31, if the Regional Administrator determines that the annual limit of AI Chinook salmon will be attained before April 15.
(ii) From September 1 through December 31, if the Regional Administrator determines that the annual limit of AI Chinook salmon will be attained after April 15.
(a) * * *
(10)
(d) * * *
(7) * * *
(i) A salmon storage container must be located adjacent to the observer sampling station;
(ii) The salmon storage container must remain in view of the observer at the observer sampling station at all times during the sorting of each haul; and
(iii) The salmon storage container must be at least 1.5 cubic meters.
(e) * * *
(1) * * *
(iii)
(B) The operator of a catcher/processor, mothership, or catcher vessel 125 ft LOA or longer (except for a catcher vessel fishing for groundfish with pot gear) must provide the following equipment, software and data transmission capabilities:
(
(
(
(
(C) The operator of a catcher vessel participating in the Rockfish Program or a catcher vessel less than 125 ft LOA directed fishing for pollock in the BS must comply with the computer and software requirements described in paragraphs (e)(1)(iii)(B)(
(2)
(iii) * * *
(B) * * *
(
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 are requested regarding (1) 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; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by March 4, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
United States Commission on Civil Rights.
Revised briefing notice.
Gerson Gomez, Media Advisor at telephone: (202) 376-8371, TTY: (202) 376-8116 or email:
This briefing is open to the public. The public may listen on the following toll-free number: 1-888-510-1785 with passcode 2485466. Hearing-impaired persons who will attend the briefing and require the services of a sign language interpreter should contact Pamela Dunston at (202) 376-8105 or at
During the briefing, Commissioners will ask questions and discuss the briefing topic with the panelists. The public may submit written comments on the topic of the briefing to the above address for 30 days after the briefing. Please direct your comments to the attention of the “Staff Director” and clearly mark “Briefing Comments Inside” on the outside of the envelope. Please note we are unable to return any comments or submitted materials. Comments may also be submitted by email to
General Electric Transportation (GE Transportation) submitted a notification of proposed production activity to the FTZ Board for its facilities in Fort Worth and Haslet, Texas within FTZ 196. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on January 20, 2016.
A separate application for subzone designation at the GE Transportation facility was submitted and will be processed under Section 400.38 of the Board's regulations. The facility is used for the manufacturing, kitting, repairing, warehousing and distribution of locomotives, off-highway vehicle (OHV) wheels, OHV inverters, OHV brake systems, locomotive components, OHV components and drill equipment. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt GE Transportation from customs duty payments on the foreign-status components used in export production. On its domestic sales, GE Transportation would be able to choose the duty rates during customs entry procedures that apply to: AC combo units; AC motors; AC traction motors; air brakes; air brake arrangements; air brake supports; air duct assemblies; air inlets; angles; angle assemblies; armature assemblies; auxiliary cabs; axles; banding strips; bases; bearing housings; bearing kits; bearing retainers; bearing supports; blowers; blower cab assemblies; brackets; bracket assemblies; brake line brackets; brake shoes; electronic brake valve assemblies; breaker supports; bumpers; cab control desk-helper consoles; cables; cable assemblies; cams; cam assemblies; cam sections; cam shafts; cap assemblies; capacitors; carrier assemblies; casting assemblies; channel assemblies; cleat supports; conduits; conduit assemblies; conduit fittings; connecting rods; connection straps; console modules; contact assemblies; control groups; cover kits; deck plates; deck plate assemblies; doors; door arrangements; door assemblies; door latch clamps; door posts; door stop assemblies; electric panels—operator cab; electric panel assemblies; emergency valve assemblies; end plates; end sheet assemblies; exciter poles; fans; fan blades; fan hubs; fittings; flanges; flange assemblies; flexible conduits; floor trim kits; foot rests; frames; frame assemblies; frame structures; gas spring assemblies; gears; gear and pinion assemblies; gear and pinion shafts; guard assemblies; gussets; handrails; handrail support assemblies; handrail support bracket-bases; harnesses; hatch covers; hinges; hooks; hubs; identification tags; insulation; intercoolers; intercooler fans; interlocks; interlocking panels; inverters; locomotives; lube oil pumps; lube sticks; machined frames; machined torque tubes; magnetic valves; manifold assemblies; name plates; oil filters; oil pumps; panels; panel assemblies; pins; pin assemblies; pinion gears; pipes; plates—steel machined; reflectors; resistor panels; rings; ring gears; rocker arms; rods—steel support for battery box; rotor assemblies; rotor poles; rotor supports; rotor yokes; safety guard assemblies; sand support assemblies; sand trap sub-assemblies; sheetshields; shims; shrouds; side wall assemblies; slack adjusters; spacers for air rack assemblies; spacers for helpers consoles; stator assemblies; stator frames; steps; stiffener assemblies; banding strips; strongbacks for power assemblies; strut assemblies; support assemblies; support brackets; supports for air brake assemblies; supports for interlock assemblies; steel pipe supports for air brake assemblies; tape rails; threaded pipe fittings; tie rings; torque tubes; trucks; truck assemblies; truck modules; tube assemblies; machined u-tubes; valve assemblies; vent hoses; walkway assemblies; water discharge pipes; water pump assemblies; weldments; wheels; wheel hubs; windows; wire plugs; and, wire pull kits (duty rate ranges from duty-free to 9.9%) for the foreign-status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The components and materials sourced from abroad include: 12-Point bolts; 3-tone air horns; 45-degree elbows; AC coils; AC combination assemblies; AC combo units; AC motors; AC traction motors; accumulator over flows; acorn nuts; activators; adapters; adapter fittings; adapter plates; adhesives; adhesive tapes; adjustment rings for water pumps; aftercoolers; air brakes; air brake arrangements; air brake conduits; air brake supports; air cleaners; air compressors; air dryers; air ducts; air duct assemblies; air hoses; air inlets; air rack welds; air turners; alternators; alternator connection rings; angles; angle assemblies; antennas; antenna adapters; antenna cables; antenna mounts; antenna plates; anti-seize compounds; anti-skid coatings; arm rests; armatures; armature assemblies; aspect display units; audio alarm panels; auxiliary cab lists; auxiliary speed indicators; axles; back plates; baffles; bags; baggie filters; ball bearings; ball valves; ballast; ballast box assemblies; banding strips; banjo bolts; round and flat hot rolled steel bar; bar assemblies; barbed hose fittings; barrels—frame structure from casting; barrels—frame structure from rolled ring; barrel bolt assemblies; barrier assemblies; base assemblies; bases for auxiliary cab assemblies; bases for panel assemblies; bases for resistor panel assemblies; battery boxes; battery box liners; battery box weldments; battery switches; AC Euro auxiliary battery transformers; bearings; bearing caps; journal bearing caps; bearing housings; bearing kits; bearing retainers; bearing retainer rings; bearing supports; bells; blank labels; blocks for truck assemblies; blocks for motorized wheel assemblies; blocks for rotor assemblies; blocks for stator frames; blow out coils; blowers; blower cab assemblies; blower case castings; blower motor bushings; bobbins; bolsters; bolts; bolt locks; bottom plates; braces for backbone platform assemblies; brackets; bracket
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is March 14, 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,
For further information, contact Elizabeth Whiteman at
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Houma-Terrebonne Airport Commission, grantee of FTZ 279, requesting subzone status for the facilities of Thoma-Sea Marine Constructors, LLC, located in Houma and Lockport, Louisiana. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on January 28, 2016.
The proposed subzone would consist of the following sites in Terrebonne and Lafourche Parishes:
In accordance with the FTZ Board's regulations, Camille Evans of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.
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 March 14, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to March 29, 2016.
A copy of the application 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 Camille Evans at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
George McMahon or Samuel Brummitt AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1167 or (202) 482-7851, respectively.
On September 1, 2015, the Department of Commerce (the Department) published a notice of opportunity to request an administrative review of the antidumping duty order on certain lined paper products from India.
Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the party that requested a review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. The Department initiated the instant review on November 9, 2015.
The Department will instruct CBP to assess antidumping duties on all appropriate entries. For the companies for which this review is rescinded, Super Impex and SAB International, antidumping duties shall be assessed at rates equal to the cash deposit of
The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice.
This notice serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of doubled antidumping duties.
This notice serves as a final reminder to parties subject to administrative protective orders (APOs) of their responsibility concerning the disposition of proprietary information disclosed under an APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Every five years, pursuant to section 751(c) of the Tariff Act of 1930, as amended (“the Act”), the Department of Commerce (“the Department”) and the International Trade Commission automatically initiate and conduct a review to determine whether revocation of a countervailing or antidumping duty order or termination of an investigation suspended under section 704 or 734 of the Act would be likely to lead to continuation or recurrence of dumping or a countervailable subsidy (as the case may be) and of material injury.
The following Sunset Reviews are scheduled for initiation in March 2016 and will appear in that month's Notice of Initiation of Five-Year Sunset Review (“Sunset Review”).
The Department's procedures for the conduct of Sunset Reviews are set forth in 19 CFR 351.218. The Notice of Initiation of Five-Year (“Sunset”) Reviews provides further information regarding what is required of all parties to participate in Sunset Reviews.
Pursuant to 19 CFR 351.103(c), the Department will maintain and make available a service list for these proceedings. To facilitate the timely preparation of the service list(s), it is requested that those seeking recognition as interested parties to a proceeding contact the Department in writing within 10 days of the publication of the Notice of Initiation.
Please note that if the Department receives a Notice of Intent to Participate from a member of the domestic industry within 15 days of the date of initiation, the review will continue. Thereafter, any interested party wishing to participate in the Sunset Review must provide substantive comments in response to the notice of initiation no later than 30 days after the date of initiation.
This notice is not required by statute but is published as a service to the international trading community.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) is conducting a new shipper review (“NSR”) of the antidumping duty order on certain frozen fish fillets from the Socialist Republic of Vietnam (“Vietnam”). The period of review (“POR”) is August 1, 2014, through January 31, 2015. The review covers one exporter of subject merchandise: Hai Huong Seafood Joint Stock Company (“HHFISH”). The Department has preliminarily determined that HHFISH did not sell subject merchandise at less than normal value (“NV”). We invite interested parties to comment on the preliminary results.
Kenneth Hawkins, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6491.
On February 27, 2015, the Department initiated the NSR of the antidumping duty order on certain frozen fish fillets from Vietnam.
The product covered by the order is frozen fish fillets, including regular, shank, and strip fillets and portions thereof, whether or not breaded or marinated, of the species
The Department is conducting this review in accordance with section 751(a)(2)(B) of the Tariff Act of 1930, as amended (“the Act”) and 19 CFR 351.214. Export prices have been calculated in accordance with section 772 of the Act. Because Vietnam is a non-market economy within the meaning of section 771(18) of the Act, NV has been calculated in accordance with section 773(c) of the Act. For a full description of the methodology underlying our conclusions, please see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). ACCESS is available to registered users at
The Department preliminarily finds that the following margins exist for the period August 1, 2014, to January 31, 2015.
The Department intends to disclose calculations performed for these preliminary results to the parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties are invited to comment on the preliminary results of this review. Interested parties may submit case briefs and/or written comments no later than 30 days after the date of publication of the preliminary
Any interested party may request a hearing within 30 days of publication of these preliminary results.
The Department intends to issue the final results of these new shipper reviews, which will include the results of its analysis of issues raised in all comments and at any hearing, within 90 days of publication of these preliminary results, pursuant to section 751(a)(2)(B)(iv) of the Act.
Upon completion of the final results, pursuant to 19 CFR 351.212(b), the Department will determine, and U.S. Customs Border and Protection (“CBP”) shall assess, antidumping duties on all appropriate entries on a per-unit basis for HHFISH. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of review. Pursuant to 19 CFR 351.212(b)(1), we will calculate importer-specific (or customer) per-unit duty assessment rates. We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review if any importer-specific assessment rate calculated in the final results of this review is above
The following cash deposit requirements will be effective upon publication of the final results of this new shipper review for all shipments of subject merchandise from HHFISH entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For subject merchandise produced and exported by HHFISH, the cash deposit rate will be the rate established in the final results of this review (except, if a rate is zero or
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(2)(B) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Notice.
The Department of Commerce (“the Department”) is initiating a new shipper review (“NSR”) of the antidumping duty (“AD”) order on honey from the People's Republic of China (“PRC”) with respect to Shanghai Sunbeauty Trading Co., Ltd. (“Shanghai Sunbeauty”). The period of review (“POR”) for this NSR is December 01, 2014, through November 30, 2015.
Jessica Weeks, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-4877.
The AD order on honey was published in the
Pursuant to section 751(a)(2)(B) of the Act and 19 CFR 351.214(b)(2)(ii), Shanghai Sunbeauty certified that it did not export subject merchandise to the United States during the period of investigation (“POI”).
In addition to the certifications described above, pursuant to 19 CFR 351.214(b)(2)(iv), Shanghai Sunbeauty submitted documentation establishing the following: (1) The date on which it first shipped subject merchandise for export to the United States; (2) the volume of its first shipment and subsequent shipments; and (3) the date of its first sale to an unaffiliated customer in the United States.
Finally, the Department conducted a U.S. Customs and Border Protection (“CBP”) database query and confirmed the price and quantity reported by Shanghai Sunbeauty.
Pursuant to section 751(a)(2)(B) of the Act, 19 CFR 351.214(b), and 19 CFR 351.214(d)(1), and based on the evidence provided by Shanghai Sunbeauty, we find that its request meets the threshold requirements for initiation of the NSR for shipments of honey from the PRC produced by Xiping Haina Trade Co., Ltd. and exported by Shanghai Sunbeauty.
Absent a determination that the new shipper review is extraordinarily complicated, the Department intends to issue the preliminary results of this NSR within 180 days from the date of initiation and the final results within 90 days after the date on which the preliminary results are issued.
It is the Department's usual practice, in cases involving non-market economies (“NMEs”), to require that a company seeking to establish eligibility for an antidumping duty rate separate from the NME entity-wide rate provide evidence of
We will instruct CBP to allow, at the option of the importer, the posting, until the completion of this review, of a bond or security in lieu of a cash deposit for each entry of the subject merchandise from the requesting companies in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e). Because Shanghai Sunbeauty certified that its affiliate Xiping Haina Trade Co., Ltd. produced the subject merchandise which Shanghai Sunbeauty exported, the sales of which are the basis for the NSR request, we will instruct CBP to permit the use of a bond only for subject merchandise which Xiping Haina Trade Co., Ltd produced and Shanghai Sunbeauty exported.
Interested parties requiring access to proprietary information in this NSR should submit applications for disclosure under administrative protective order, in accordance with 19 CFR 351.305 and 19 CFR 351.306.
This initiation and notice are in accordance with section 751(a)(2)(B) of the Act, 19 CFR 351.214, and 19 CFR 351.221(c)(1)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Notice.
The request described below for a new shipper review of the antidumping duty (AD) order on crystalline silicon photovoltaic cells, whether or not assembled into modules, (“solar cells”) from the People's Republic of China (“PRC”) meets the statutory and regulatory requirements for initiation. The period of review (“POR”) for the new shipper review is December 1, 2014 through November 30, 2015.
Erin Kearney, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0167.
On December 7, 2012, the Department of Commerce (“Department”) published the AD order on solar cells from the PRC.
Anji DaSol stated that it is the producer and exporter of the subject merchandise upon which its request for a new shipper review is based. Pursuant to section 751(a)(2)(B)(i)(I) of the Act and 19 CFR 351.214(b)(2)(i), Anji DaSol certified that it did not export solar cells to the United States during the period of investigation (“POI”). In addition, pursuant to section 751(a)(2)(B)(i)(II) of the Act and 19 CFR 351.214(b)(2)(iii)(A), Anji DaSol certified that, since the initiation of the investigation, it has never been affiliated with any PRC exporter or producer who exported solar cells to the United States during the POI, including those not individually examined during the investigation. As required by 19 CFR 351.214(b)(2)(iii)(B), Anji DaSol also certified that its export activities were not controlled by the central government of the PRC.
In addition to the certifications described above, pursuant to 19 CFR 351.214(b)(2)(iv), Anji DaSol submitted documentation establishing the following: (1) The date on which the subject merchandise was first entered, or withdrawn from warehouse, for consumption in the United States; (2) the volume of its first shipment; and (3) the date of its first sale to an unaffiliated customer in the United States.
The Department conducted a CBP database query and confirmed by examining the results that the sale of subject merchandise that Anji DaSol reported to the Department entered the United States during the POR specified by the Department's regulations.
Pursuant to 19 CFR 351.214(g)(1)(i)(A), the POR for the new shipper review of Anji DaSol is December 1, 2014, through November 30, 2015.
Pursuant to section 751(a)(2)(B) of the Act, 19 CFR 351.214(b), and based on the information on the record, the Department finds that Anji DaSol meets the threshold requirements for initiation of a new shipper review of its shipment of solar cells from the PRC.
Pursuant to 19 CFR 351.221(c)(1)(i), the Department will publish the notice of initiation of a new shipper review no later than the last day of the month following the anniversary or semiannual anniversary month of the order. The Department intends to issue the preliminary results of this new shipper review no later than 180 days from the date of initiation, and the final results of this review no later than 90 days after the date the preliminary results are issued.
It is the Department's usual practice, in cases involving non-market economies (“NME”), to require that a company seeking to establish eligibility for an AD rate separate from the NME-wide entity rate provide evidence of
We will instruct CBP to allow, at the option of the importer, the posting, until the completion of the review, of a bond or security in lieu of a cash deposit for certain entries of the subject merchandise from Anji DaSol in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e). Because Anji DaSol certified that it exports and produces the subject merchandise that is the subject of this new shipper review, we will instruct CBP to permit the use of a bond only for entries of subject merchandise which Anji DaSol exported and produced.
Interested parties requiring access to proprietary information in this new shipper review should submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 351.306.
This initiation and notice are published in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214 and 351.221(c)(1)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Brenda E. Waters, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, telephone: (202) 482-4735.
Each year during the anniversary month of the publication of an antidumping or countervailing duty order, finding, or suspended investigation, an interested party, as defined in section 771(9) of the Tariff Act of 1930, as amended (“the Act”), may request, in accordance with 19 CFR 351.213, that the Department of Commerce (“the Department”) conduct an administrative review of that
All deadlines for the submission of comments or actions by the Department discussed below refer to the number of calendar days from the applicable starting date.
In the event the Department limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, the Department intends to select respondents based on U.S. Customs and Border Protection (“CBP”) data for U.S. imports during the period of review. We intend to release the CBP data under Administrative Protective Order (“APO”) to all parties having an APO within five days of publication of the initiation notice and to make our decision regarding respondent selection within 21 days of publication of the initiation
In the event the Department decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:
In general, the Department finds that determinations concerning whether particular companies should be “collapsed” (
Pursuant to 19 CFR 351.213(d)(1), a party that requests a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that the Department may extend this time if it is reasonable to do so. In order to provide parties additional certainty with respect to when the Department will exercise its discretion to extend this 90-day deadline, interested parties are advised that, with regard to reviews requested on the basis of anniversary months on or after February 2016, the Department does not intend to extend the 90-day deadline unless the requestor demonstrates that an extraordinary circumstance prevented it from submitting a timely withdrawal request. Determinations by the Department to extend the 90-day deadline will be made on a case-by-case basis.
The Department is providing this notice on its Web site, as well as in its “Opportunity to Request Administrative Review” notices, so that interested parties will be aware of the manner in which the Department intends to exercise its discretion in the future.
In accordance with 19 CFR 351.213(b), an interested party as defined by section 771(9) of the Act may request in writing that the Secretary conduct an administrative review. For both antidumping and countervailing duty reviews, the interested party must specify the individual producers or exporters covered by an antidumping finding or an antidumping or countervailing duty order or suspension agreement for which it is requesting a review. In addition, a domestic interested party or an interested party described in section 771(9)(B) of the Act must state why it desires the Secretary to review those particular producers or exporters. If the interested party intends for the Secretary to review sales of merchandise by an exporter (or a producer if that producer also exports merchandise from other suppliers) which was produced in more than one country of origin and each country of origin is subject to a separate order, then the interested party must state specifically, on an order-by-order basis, which exporter(s) the request is intended to cover.
Note that, for any party the Department was unable to locate in prior segments, the Department will not accept a request for an administrative review of that party absent new information as to the party's location. Moreover, if the interested party who files a request for review is unable to locate the producer or exporter for which it requested the review, the interested party must provide an explanation of the attempts it made to locate the producer or exporter at the same time it files its request for review, in order for the Secretary to determine if the interested party's attempts were reasonable, pursuant to 19 CFR 351.303(f)(3)(ii).
As explained in
Further, as explained in
Following initiation of an antidumping administrative review when there is no review requested of the NME entity, the Department will instruct CBP to liquidate entries for all exporters not named in the initiation notice, including those that were suspended at the NME entity rate.
All requests must be filed electronically in Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”) on Enforcement and Compliance's ACCESS Web site at
The Department will publish in the
For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period of the order, if such a gap period is applicable to the period of review.
This notice is not required by statute but is published as a service to the international trading community.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Respondents will be commercial fishing industry individuals, partnerships, and corporations which entered into Capital Construction Fund (CCF) agreements with the Secretary of Commerce allowing deferral of Federal taxation on fishing vessel income deposited into the fund for use in the acquisition, construction, or reconstruction of fishing vessels. Deferred taxes are recaptured by reducing an agreement vessel's basis for depreciation by the amount withdrawn from the fund for its acquisition, construction, or reconstruction. The interim Capital Construction Fund Agreement and Certificate Family of Forms is required pursuant to 50 CFR part 259.30 and P.L. 99-514 (The Tax Reform Act, 1986). The deposit/withdrawal information collected from agreement holders is required pursuant to 50 CFR part 259.35 and P.L. 99-514. The information collected from applicants for the Interim CCF Agreement is used to determine their eligibility to participate in the CCF Program. The information collected from agreement holders for the Certificate Family of Forms is used to identify their program eligible vessels, their program projects and to certify the cost of a project at completion. The information collected on the deposit/withdrawal report form is required to ensure that agreement holders are complying with fund deposit/withdrawal requirements established in program regulations and properly accounting for fund activity on their Federal income tax returns. The information collected on the deposit/withdrawal report must also be reported semi-annually to the Secretary of Treasury in accordance with the Tax Reform Act.
This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Department of the Army, DoD.
Notice to delete a System of Records.
The Department of the Army proposes to delete a system of records, A0351 AMC, “Student/Faculty Records: AMC Schools Systems” in its inventory of record systems subject to the Privacy Act of 1974, as amended. This system was used to determine applicant eligibility, monitor individual's progress, maintain record of student/faculty achievements, and to provide
Previously on October 3, 2012 (77 FR 60412), the Department of the Army published a deletion notice but later discovered that the records had not been transferred as indicated; a reinstatement notice was published October 30, 2015 (80 FR 66881). Subsequently, it has been confirmed that the training records are now collected in the Army Training Requirements and Resources System and are covered under A0351 DAPE, Army Training Requirements and Resources System (ATRRS) (January 3, 2002, 67 FR 311) system of records notice.
Comments will be accepted on or before March 4, 2016. This proposed action will be effective on the day following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
* Federal Rulemaking Portal:
Follow the instructions for submitting comments.
* Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.
Instructions: All submissions received must include the agency name and docket number for this
Ms. Tracy Rogers, Department of the Army, Privacy Office, U.S. Army Records Management and Declassification Agency, 7701 Telegraph Road, Casey Building, Suite 144, Alexandria, VA 22325-3905 or by calling (703) 428-6185.
The Department of the Army's notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
AMC Schools Systems (October 30, 2015, 80 FR 66881)
The Army organization hosting these training records was relocated from Rock Island, Illinois to McAlester Army Ammunition Plant, Oklahoma in 1995, due to base realignment and new missions. These records are no longer collected from trainees at the ammunition training site. Training sites are no longer available and all ammunition training is done online through the Army Training Requirement and Resources System (ATRRS). Previous training records were transferred to the National Personnel Records Center, 9700 Page Boulevard, St. Louis, MO 63132-5200, with the soldiers and government civilian personnel records upon separation or retirement from the Army. Faculty and instructor qualification records were destroyed after five years in accordance with the disposition schedule. Training records are now collected in the Army Training Requirements and Resources System and are covered under A0351 DAPE, Army Training Requirements and Resources System (ATRRS) (January 3, 2002, 67 FR 311) system of records notice. Therefore, A0351 AMC, Student/Faculty Records: AMC Schools Systems can be deleted.
Office of the Secretary of Defense, DoD.
Notice to delete a System of Records.
The Office of the Secretary of Defense is deleting a system of records notice from its existing inventory of record systems subject to the Privacy Act of 1974, as amended. The system of records notice is JS006CND, Department of Defense Counternarcotics C4I System (February 22, 1993, 58 FR 10557).
Comments will be accepted on or before March 4, 2016. This proposed action will be effective on the day following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
*
Ms. Cindy Allard, Chief, OSD/JS Privacy Office, Freedom of Information Directorate, Washington Headquarters Service, 1155 Defense Pentagon, Washington, DC 20301-1155, or by phone at (571)372-0461.
The Office of the Secretary of Defense systems of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
Department of Defense Counternarcotics C4I System (February 22, 1993, 58 FR 10557).
Based on a recent review of JS006CND, Department of Defense Counternarcotics C4I System, it has been confirmed that this system of records transferred from the Joint Staff to the Defense Information System Agency (DISA) in 1993. All records that were housed at the JS have been destroyed according to the National Archives and Records Administration 10-year disposition schedule. Since the transfer to DISA, they provide all required reporting in terms of information assurance, programmatic, and budgeting. The remaining applications hosted by the system at DISA do not collect personally identifiable information; therefore, the Department of Defense Counternarcotics C4I System of Records Notice can be deleted.
United States Office of the Secretary of Defense through the United States Department of Defense for North Atlantic Treaty Organization (NATO) STANAG 4703 Custodial Support Team (CST), DoD.
Collection of technical comments from Industry on STANAG 4703.
The NATO STANAG 4703 CST is seeking points of contact (POC) from U.S. UAS Unmanned Aircraft System Industry who are interested in participating in a formal review of STANAG 4703 Edition 1. The STANAG 4703 CST is seeking written comments and/or concerns from industry that will be provided to the CST for review and consideration for incorporation in future editions of the STANAG. NATO STANAG 4703 contains a set of technical airworthiness requirements intended for the airworthiness certification of fixed-wing light military UAS with a maximum take-off weight not greater than 150 kg that intend to regularly operate in non-segregated airspace over all population densities. These requirements represent the minimum acceptable airworthiness requirements for design and construction of military fixed-wing UAS intended to operate in non-segregated airspace. STANAG 4703 is intended to be implemented for airworthiness certification of Light UAS within each nation's national regulatory framework. Interested participant POC information will be forwarded to the STANAG 4703 CST Chairman by the STANAG 4703 U.S. Head of Delegation. A copy of STANAG 4703 will be provided to interested participants once the POC information is received by the U.S. Delegation. The intent of this effort is to collect comments from NATO member Fixed Wing UAS Industries, to disposition the comments, and at a future date hold an Industry Day to discuss industry comments provided in an open forum. Keywords: Fixed Wing, Light, UAS, UAV, Remotely Piloted Vehicle, Unmanned Aircraft, Unmanned Air Vehicle, Unmanned Aircraft Systems, Unmanned Air System, Airworthiness.
We request POC information be provided to Mrs. Sandra A. Greeley at the email address in the
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before April 4, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Kashka Kubzdela at
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.323A.
These priorities are:
The Assistant Secretary for Special Education and Rehabilitative Services establishes a priority to assist SEAs in reforming and improving their systems for personnel (as that term is defined in section 651(b) of IDEA) preparation and professional development of individuals providing early intervention, educational, and transition services in order to improve results for children with disabilities.
In order to meet this priority, an applicant must demonstrate in the SPDG State Plan it submits as part of its application under section 653(a)(2) of IDEA that its proposed project will—
(1) Use evidence-based (as defined in this notice) professional development practices that will increase implementation of evidence-based practices and result in improved outcomes for children with disabilities;
(2) Provide ongoing assistance to personnel receiving SPDG-supported professional development that supports the implementation of evidence-based practices with fidelity (as defined in this notice); and
(3) Use technology to more efficiently and effectively provide ongoing professional development to personnel, including to personnel in rural areas and to other populations, such as personnel in urban or high-need local educational agencies (LEAs) (as defined in this notice).
1.
An applicant must submit a State Personnel Development Plan that identifies and addresses the State and local needs for the personnel preparation and professional development of personnel, as well as individuals who provide direct
(a) Is designed to enable the State to meet the requirements of section 612(a)(14) and section 635(a)(8) and (9) of IDEA;
(b) Is based on an assessment of State and local needs that identifies critical aspects and areas in need of improvement related to the preparation, ongoing training, and professional development of personnel who serve infants, toddlers, preschoolers, and children with disabilities within the State, including—
(1) Current and anticipated personnel vacancies and shortages; and
(2) The number of preservice and inservice programs;
(c) Is integrated and aligned, to the maximum extent possible, with State plans and activities under the Elementary and Secondary Education Act of 1965, as amended (ESEA); the Rehabilitation Act of 1973, as amended; and the Higher Education Act of 1965, as amended (HEA);
(d) Describes a partnership agreement that is in effect for the period of the grant, which agreement must specify—
(1) The nature and extent of the partnership described in accordance with section 652(b) of IDEA and the respective roles of each member of the partnership, including, if applicable, an individual, entity, or agency other than the SEA that has the responsibility under State law for teacher preparation and certification; and
(2) How the SEA will work with other persons and organizations involved in, and concerned with, the education of children with disabilities, including the respective roles of each of the persons and organizations;
(e) Describes how the strategies and activities the SEA uses to address identified professional development and personnel needs will be coordinated with activities supported with other public resources (including funds provided under Part B and Part C of IDEA and retained for use at the State level for personnel and professional development purposes) and private resources;
(f) Describes how the SEA will align its personnel development plan with the plan and application submitted under sections 1111 and 2112, respectively, of the ESEA;
(g) Describes strategies the SEA will use to address the identified professional development and personnel needs and how such strategies will be implemented, including—
(1) A description of the programs and activities that will provide personnel with the knowledge and skills to meet the needs of, and improve the performance and achievement of, infants, toddlers, preschoolers, and children with disabilities; and
(2) How such strategies will be integrated, to the maximum extent possible, with other activities supported by grants funded under section 662 of IDEA;
(h) Provides an assurance that the SEA will provide technical assistance to LEAs to improve the quality of professional development available to meet the needs of personnel who serve children with disabilities;
(i) Provides an assurance that the SEA will provide technical assistance to entities that provide services to infants and toddlers with disabilities to improve the quality of professional development available to meet the needs of personnel serving those children;
(j) Describes how the SEA will recruit and retain highly qualified teachers and other qualified personnel in geographic areas of greatest need;
(k) Describes the steps the SEA will take to ensure that economically disadvantaged and minority children are not taught at higher rates by teachers who are not highly qualified; and
(l) Describes how the SEA will assess, on a regular basis, the extent to which the strategies implemented have been effective in meeting the performance goals described in section 612(a)(15) of IDEA.
2.
Applicants must establish a partnership with LEAs and other State agencies involved in, or concerned with, the education of children with disabilities, including—
(a) Not less than one institution of higher education; and
(b) The State agencies responsible for administering Part C of IDEA, early education, child care, and vocational rehabilitation programs.
An SEA must work in partnership with other persons and organizations involved in, and concerned with, the education of children with disabilities, which may include—
(a) The Governor;
(b) Parents of children with disabilities ages birth through 26;
(c) Parents of nondisabled children ages birth through 26;
(d) Individuals with disabilities;
(e) Parent training and information centers or community parent resource centers funded under sections 671 and 672 of IDEA, respectively;
(f) Community-based and other nonprofit organizations involved in the education and employment of individuals with disabilities;
(g) Personnel as defined in section 651(b) of IDEA;
(h) The State advisory panel established under Part B of IDEA;
(i) The State interagency coordinating council established under Part C of IDEA;
(j) Individuals knowledgeable about vocational education;
(k) The State agency for higher education;
(l) Public agencies with jurisdiction in the areas of health, mental health, social services, and juvenile justice;
(m) Other providers of professional development who work with infants, toddlers, preschoolers, and children with disabilities;
(n) Other individuals; and
(o) An individual, entity, or agency as a partner in accordance with section 652(b)(3) of IDEA, if State law assigns responsibility for teacher preparation and certification to an individual, entity, or agency other than the SEA.
3.
(a) Professional Development Activities—Each SEA that receives a grant under this program must use the grant funds to support activities in accordance with the State's Personnel Development Plan, including one or more of the following:
(1) Carrying out programs that provide support to both special education and regular education teachers of children with disabilities and principals, such as programs that—
(i) Provide teacher mentoring, team teaching, reduced class schedules and caseloads, and intensive professional development;
(ii) Use standards or assessments for guiding beginning teachers that are consistent with challenging State student academic achievement and functional standards and with the requirements for professional development, as defined in section 9101 of the ESEA; and
(iii) Encourage collaborative and consultative models of providing early intervention, special education, and related services.
(2) Encouraging and supporting the training of special education and regular education teachers and administrators to effectively use and integrate technology—
(i) Into curricula and instruction, including training to improve the ability to collect, manage, and analyze data to improve teaching, decisionmaking, school improvement efforts, and accountability;
(ii) To enhance learning by children with disabilities; and
(iii) To effectively communicate with parents.
(3) Providing professional development activities that—
(i) Improve the knowledge of special education and regular education teachers concerning—
(A) The academic and developmental or functional needs of students with disabilities; or
(B) Effective instructional strategies, methods, and skills, and the use of State academic content standards and student academic achievement and functional standards, and State assessments, to improve teaching practices and student academic achievement;
(ii) Improve the knowledge of special education and regular education teachers and principals and, in appropriate cases, paraprofessionals, concerning effective instructional practices, and that—
(A) Provide training in how to teach and address the needs of children with different learning styles and children who are limited English proficient;
(B) Involve collaborative groups of teachers, administrators, and, in appropriate cases, related services personnel;
(C) Provide training in methods of—
(I) Positive behavioral interventions and supports to improve student behavior in the classroom;
(II) Scientifically based reading instruction, including early literacy instruction;
(III) Early and appropriate interventions to identify and help children with disabilities;
(IV) Effective instruction for children with low-incidence disabilities;
(V) Successful transitioning to postsecondary opportunities; and
(VI) Classroom-based techniques to assist children prior to referral for special education;
(D) Provide training to enable personnel to work with and involve parents in their child's education, including parents of low income and limited English proficient children with disabilities;
(E) Provide training for special education personnel and regular education personnel in planning, developing, and implementing effective and appropriate individualized education programs (IEPs); and
(F) Provide training to meet the needs of students with significant health, mobility, or behavioral needs prior to serving those students;
(iii) Train administrators, principals, and other relevant school personnel in conducting effective IEP meetings; and
(iv) Train early intervention, preschool, and related services providers, and other relevant school personnel in conducting effective individualized family service plan (IFSP) meetings.
(4) Developing and implementing initiatives to promote the recruitment and retention of highly qualified special education teachers, particularly initiatives that have proven effective in recruiting and retaining highly qualified teachers, including programs that provide—
(i) Teacher mentoring from exemplary special education teachers, principals, or superintendents;
(ii) Induction and support for special education teachers during their first three years of employment as teachers; or
(iii) Incentives, including financial incentives, to retain special education teachers who have a record of success in helping students with disabilities.
(5) Carrying out programs and activities that are designed to improve the quality of personnel who serve children with disabilities, such as—
(i) Innovative professional development programs (which may be provided through partnerships with institutions of higher education (IHEs)), including programs that train teachers and principals to integrate technology into curricula and instruction to improve teaching, learning, and technology literacy and that are consistent with the definition of professional development in section 9101 of the ESEA; and
(ii) The development and use of proven, cost effective strategies for the implementation of professional development activities, such as through the use of technology and distance learning.
(6) Carrying out programs and activities that are designed to improve the quality of early intervention personnel, including paraprofessionals and primary referral sources, such as—
(i) Professional development programs to improve the delivery of early intervention services;
(ii) Initiatives to promote the recruitment and retention of early intervention personnel; and
(iii) Interagency activities to ensure that early intervention personnel are adequately prepared and trained.
(b) Other Activities—Each SEA that receives a grant under this program must use the grant funds to support activities in accordance with the State's Personnel Development Plan, including one or more of the following:
(1) Reforming special education and regular education teacher certification (including re-certification) or licensing requirements to ensure that—
(i) Special education and regular education teachers have—
(A) The training and information necessary to address the full range of needs of children with disabilities across disability categories; and
(B) The necessary subject matter knowledge and teaching skills in the academic subjects that the teachers teach;
(ii) Special education and regular education teacher certification (including re-certification) or licensing requirements are aligned with challenging State academic content standards; and
(iii) Special education and regular education teachers have the subject matter knowledge and teaching skills, including technology literacy, necessary to help students with disabilities meet challenging State student academic achievement and functional standards.
(2) Programs that establish, expand, or improve alternative routes for State certification of special education teachers for highly qualified individuals with a baccalaureate or master's degree, including mid-career professionals from other occupations, paraprofessionals, and recent college or university graduates with records of academic distinction who demonstrate the potential to become highly effective special education teachers.
(3) Teacher advancement initiatives for special education teachers that promote professional growth and emphasize multiple career paths (such as paths to becoming a career teacher, mentor teacher, or exemplary teacher) and pay differentiation.
(4) Developing and implementing mechanisms to assist LEAs and schools in effectively recruiting and retaining highly qualified special education teachers.
(5) Reforming tenure systems, implementing teacher testing for subject matter knowledge, and implementing teacher testing for State certification or licensure, consistent with title II of the HEA (20 U.S.C. 1021
(6) Funding projects to promote reciprocity of teacher certification or licensing between or among States for special education teachers, except that no reciprocity agreement developed under this absolute priority may lead to the weakening of any State teacher certification or licensing requirement.
(7) Assisting LEAs to serve children with disabilities through the development and use of proven, innovative strategies to deliver intensive professional development programs that are both cost effective and easily
(8) Developing, or assisting LEAs in developing, merit-based performance systems and strategies that provide differential and bonus pay for special education teachers.
(9) Supporting activities that ensure that teachers are able to use challenging State academic content standards and student academic achievement and functional standards, and State assessments for all children with disabilities, to improve instructional practices and improve the academic achievement of children with disabilities.
(10) When applicable, coordinating with, and expanding centers established under section 2113(c)(18) of the ESEA to benefit special education teachers.
(c) Contracts and Subgrants—An SEA that receives a grant under this program—
(1) Must award contracts or subgrants to LEAs, IHEs, parent training and information centers, or community parent resource centers, as appropriate, to carry out the State Personnel Development Plan; and
(2) May award contracts and subgrants to other public and private entities, including the lead agency under Part C of IDEA, to carry out the State plan.
(d) Use of Funds for Professional Development—An SEA that receives a grant under this program must use—
(1) Not less than 90 percent of the funds the SEA receives under the grant for any fiscal year for the Professional Development Activities described in paragraph (a); and
(2) Not more than 10 percent of the funds the SEA receives under the grant for any fiscal year for the Other Activities described in paragraph (b).
Projects funded under this program must:
(a) Budget for a three-day project directors' meeting in Washington, DC, during each year of the project;
(b) Budget $4,000 annually for support of the State Personnel Development Grants Program Web site currently administered by the University of Oregon (
(c) If a project receiving assistance under this program authority maintains a Web site, include relevant information and documents in a form that meets a government or industry-recognized standard for accessibility.
The following definitions are from the NFP and 34 CFR 77.1, as marked.
For the purposes of this priority, the definition of “evidence-based” consists of the following definitions in 34 CFR 77.1:
(i) There is at least one study that is a—
(A) Correlational study with statistical controls for selection bias;
(B) Quasi-experimental design study that meets the What Works Clearinghouse Evidence Standards with reservations; or
(C) Randomized controlled trial that meets the What Works Clearinghouse Evidence Standards with or without reservations.
(ii) The study referenced in paragraph (i) of this definition found a statistically significant or substantively important (defined as a difference of 0.25 standard deviations or larger) favorable association between at least one critical component and one relevant outcome presented in the logic model for the proposed process, product, strategy, or practice.
(i) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the What Works Clearinghouse Evidence Standards without reservations [What Works Clearinghouse Procedures and Standards Handbook (Version 3.0, March 2014), which can currently be found at the following link:
(ii) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the What Works Clearinghouse Evidence Standards with reservations [What Works Clearinghouse Procedures and Standards Handbook (Version 3.0, March 2014), which can currently be found at the following link:
(i) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the What Works Clearinghouse Evidence Standards without reservations [What Works Clearinghouse Procedures and Standards Handbook (Version 3.0, March 2014), which can currently be found at the following link:
(ii) There are at least two studies of the effectiveness of the process, product, strategy, or practice being proposed, each of which: Meets the What Works Clearinghouse Evidence Standards with reservations [What Works Clearinghouse Procedures and Standards Handbook (Version 3.0, March 2014), which can currently be found at the following link:
The following definitions are from the NFP:
(a) That serves not fewer than 10,000 children from families with incomes below the poverty line (as that term is defined in section 9101(33) of the ESEA), or for which not less than 20 percent of the children served by the LEA are from families with incomes below the poverty line; and
(b) For which there is (1) a high percentage of teachers not teaching in the academic subjects or grade levels that the teachers were trained to teach, or (2) a high percentage of teachers with emergency, provisional, or temporary certification or licensing.
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.
The regulations in 34 CFR part 86 apply to IHEs only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 from the list of unfunded applications from this competition.
We will set the amount of each award after considering—
(1) The amount of funds available for making the grants;
(2) The relative population of the State or outlying area;
(3) The types of activities proposed by the State or outlying area;
(4) The alignment of proposed activities with section 612(a)(14) of IDEA;
(5) The alignment of proposed activities with State plans and applications submitted under sections 1111 and 2112, respectively, of the ESEA; and
(6) The use, as appropriate, of scientifically based research and instruction.
The Department is not bound by any estimates in this notice.
1.
Public Law 95-134, which permits the consolidation of grants to the outlying areas, does not apply to funds received under this competition.
2.
3.
(b) The grantee may award subgrants to entities it has identified in an approved application.
4.
1.
To obtain a copy via the Internet, use the following address:
You can contact ED Pubs at its Web site, also:
If you request an application package from ED Pubs, be sure to identify this competition as follows: CFDA Number 84.323A.
To obtain a copy from the program office, contact the person listed under
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, reference citations, and captions, as well as all text in charts, tables, figures, graphs, and screen shots.
• Use a font that is either 12 point or larger.
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.
The page limit and double-spacing requirements do not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the abstract (follow the guidance provided in the application package for completing the abstract), the table of contents, the list of priority requirements, the resumes, the reference list, the letters of support, or the appendices. However, the page limit and double-spacing requirements do apply to all of Part III, the application narrative, including all text in charts, tables, figures, graphs, and screen shots.
We will reject your application if you exceed the page limit in the application narrative section or if you apply standards other than those specified in this notice and the application package.
3.
Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet at the following Web site:
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:
7.
a.
Applications for grants under the SPDG competition, CFDA number 84.323A, must be submitted electronically using the Governmentwide Grants.gov Apply site at
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
You may access the electronic grant application for the SPDG competition at
Please note the following:
• 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.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.
Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you and email with a unique PR/Award number for your application.
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the Grants.gov system;
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Jennifer Coffey, U.S. Department of Education, 400 Maryland Avenue SW., room 4097, Potomac Center Plaza, Washington, DC 20202-2600. FAX: (202) 245-7617.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.323A), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
We will not consider applications postmarked after the application deadline date.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.323A), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
2.
In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
4.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
4.
• Projects use evidence-based professional development practices to support the attainment of identified competencies.
• Participants in SPDG professional development demonstrate improvement in implementation of SPDG-supported practices over time.
• Projects use SPDG professional development funds to provide activities designed to sustain the use of SPDG-supported practices.
• Highly qualified special education teachers, as defined in section 602(10) of IDEA, that have participated in SPDG-supported special education teacher retention activities remain as special education teachers two years after their initial participation in these activities.
Each grantee funded under this competition must collect and annually report data related to its performance on these measures in the project's annual and final performance report to the Department in accordance with section 653(d) of IDEA and 34 CFR 75.590. Applicants should discuss in the application narrative how they propose to collect performance data for these measures.
5.
In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
Jennifer Coffey, U.S. Department of Education, 400 Maryland Avenue SW., Room 4097, Potomac Center Plaza, Washington, DC 20202-2600. Telephone: (202) 245-6673.
If you use a TDD or a TTY, call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Department of Energy.
Notice.
On November 24, 2015, the Defense Nuclear Facilities Safety Board transmitted Recommendation 2015-1,
Comments, data, views, or arguments concerning the Secretary's response are due on or before March 4, 2016.
Please send to: Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004.
Mr. Dale Govan, Office of the Departmental Representative to the Defense Nuclear Facilities Safety Board, Office of Environment, Health, Safety and
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of open meetings.
The Department of Energy (DOE) announces public meetings and webinars for the Appliance Standards and Rulemaking Federal Advisory Committee (ASRAC). The Federal Advisory Committee Act requires that agencies publish notice of an advisory committee meeting in the
DOE will host public meetings on the following dates:
• February 26, 2016 (webinar only); 1:00pm-3:00pm
• April 28, 2016; 9:00 a.m.-3:30pm
Unless otherwise stated, the meetings will be held at: The U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585.
To register for the webinars and receive call-in information, please register for the appropriate meeting date at
John Cymbalsky, ASRAC Designated Federal Officer, U.S. Department of Energy (DOE), Office of Energy Efficiency and Renewable Energy, 950 L'Enfant Plaza SW., Washington, DC, 20024. Email:
DOE announces public meetings and webinars for the ASRAC. Members of the public are welcome to observe the business of the meeting and, if time allows, may make oral statements during the specified period for public comment. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, email
Due to the REAL ID Act implemented by the Department of Homeland Security (DHS) recent changes have been made regarding ID requirements for individuals wishing to enter Federal buildings from specific states and U.S. territories. Driver's licenses from the following states or territory will not be accepted for building entry and one of the alternate forms of ID listed below will be required.
DHS has determined that regular driver's licenses (and ID cards) from the following jurisdictions are not acceptable for entry into DOE facilities: Alaska, Louisiana, New York, American Samoa, Maine, Oklahoma, Arizona, Massachusetts, Washington, and Minnesota.
Acceptable alternate forms of Photo-ID include: U.S. Passport or Passport Card; an Enhanced Driver's License or Enhanced ID-Card issued by the states of Minnesota, New York or Washington (Enhanced licenses issued by these states are clearly marked Enhanced or Enhanced Driver's License); A military ID or other Federal government issued Photo-ID card.
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the Line WB2VA Integrity Project, proposed by Columbia Gas Transmission, LLC (Columbia) in the above-referenced docket. The Line WB2VA Integrity Project would include modifications to Columbia's existing facilities at 17 sites in Hardy County, West Virginia, and Shenandoah, Page, Rockingham, and Greene Counties, Virginia. Proposed modifications include installation of pig launchers and receivers;
The EA assesses the potential environmental effects of the construction and operation of the Line WB2VA Integrity Project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The U.S. Army Corps of Engineers, West Virginia Department of Natural Resources, and West Virginia Department of Environmental Protection participated as cooperating agencies in the preparation of the EA. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the NEPA analysis.
The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; and newspapers and libraries in the project area. In addition, the EA is available for public viewing on the FERC's Web site (
Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this project, it is important that we receive your comments in Washington, DC on or before February 27, 2016.
For your convenience, there are three methods you can use to file your comments to the Commission. In all instances, please reference the project docket number (CP15-150-000) with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the eComment feature on the Commission's Web site (
(2) You can also file your comments electronically using the eFiling feature on the Commission's Web site (
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on January 27, 2016, pursuant to sections 206, 306 and 309 of the Federal Power Act
Complainants certify that copies of the complaint were served on the contacts for Respondents, as listed on the Commission's list of Corporate Officials.
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 and 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 Respondents' answer and all interventions, or protests must be filed on or before the comment date. The Respondents' answer, motions to intervene, and protests must be served on 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 on January 27, 2016, pursuant to sections 206, 306 and 309 of the Federal Power Act
Complainants certify that copies of the complaint were served on contacts for Respondents, as listed in on the Commission's list of Corporate Officials.
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 and 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
This is a supplemental notice in the above-referenced proceeding of 3 Phases Renewables, Inc.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 17, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Rule 2010 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.2010, provides that, to eliminate unnecessary expense or improve administrative efficiency, the Secretary may establish a restricted service list for a particular phase or issue in a proceeding concerning non-public information. The restricted service list should contain the names of persons on the service list who, in the judgment of the decisional authority establishing the list, are active participants with respect to the phase or issue in the proceeding for which the list is established.
The Commission staff is consulting with the Maine Historic Preservation Commission (Maine SHPO) and the Advisory Council on Historic Preservation (Advisory Council) pursuant to the Advisory Council's regulations, 36 CFR part 800, implementing section 106 of the National Historic Preservation Act,
On November 18, 2014, Commission staff established a restricted service list for the Parr Hydroelectric Project. Since that time, the U.S. Forest Service requested to supplement the restricted service list because of personnel changes. The restricted service list is supplemented as follows:
Replace “Mike Harmon, U.S. Forest Service” with “James F. Bates or Representative, U.S. Forest Service.”
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
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, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
As announced in a Notice issued on January 13, 2016, the Federal Energy Regulatory Commission (Commission) will hold a technical conference on Thursday, February 4, 2016. The technical conference will focus on whether PJM Interconnection, LLC's (PJM) existing Auction Revenue Rights (ARR) and Financial Transmission Rights (FTR) tariff provisions are unjust and unreasonable and whether PJM's proposed revisions to its tariff addressing these matters are just and reasonable. The technical conference will commence at 9:30 a.m. and conclude at 5:00 p.m. and be held at the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. This technical conference is free of charge and open to the public. The technical conference will be led by Commission staff, and Commission members may be in attendance and participate.
The agenda and a list of participants/speakers for this technical conference are attached. A schedule for post-technical comments will be established at the technical conference.
Those who plan to attend the technical conference are encouraged to complete the registration form located at:
The technical conference will be transcribed. Transcripts of the technical conference will be available for a fee from Ace-Federal Reporters, Inc.
Commission technical 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:
You are receiving this letter because the staff of the Federal Energy Regulatory Commission (FERC or Commission) is evaluating route modifications to Transcontinental Gas Pipe Line Company, LLC's (Transco) proposed Dalton Expansion Project (Project). The general location of the Project is shown in appendix 1.
The FERC is the lead federal agency responsible for conducting the environmental review of the Project. The Commission's staff is preparing an environmental assessment (EA) that discusses the environmental impacts of the Project. This EA will be used to inform the Commission as it determines whether the Project is in the public convenience and necessity.
This Notice announces the opening of an additional scoping period the Commission will use to gather input from the new landowners potentially affected by the Project. Comments may be submitted in writing as described in the public participation section of this notice. Please note that comments on this Notice should be filed with the Commission by February 29, 2016.
The specific modifications being scoped by this Notice are listed in the table below.
Information in this notice was prepared to familiarize you with the new route modifications, the Project as a whole, the Commission's environmental review process, and instruct you on how to submit comments.
A pipeline company representative may have already contacted you or may contact you soon about surveys and/or to acquire an easement to construct, operate, and maintain the pipeline. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the Project, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.
To help potentially affected landowners better understand the Commission and its environmental review process, the “For Citizens” section of the FERC Web site (
Transco plans to construct and operate about 113 miles of new 16, 20, 24, and 30-inch-diameter natural gas pipeline and associated facilities in Coweta, Carroll, Douglas, Paulding, Bartow, Gordon, and Murray Counties, Georgia and a new compressor station in Carroll County, Georgia. Additionally, Transco plans to modify existing facilities along its mainline transmission system in Maryland, Virginia, and North Carolina to accommodate bidirectional flow. Transco has indicated that the Project would provide 448,000 dekatherms per day of incremental firm transportation service to markets in northwest Georgia.
The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us
In the EA we will discuss impacts that could occur as a result of the construction and operation of the Project under these general headings:
• Geology and soils;
• water resources, fisheries, and wetlands;
• vegetation and wildlife;
• endangered and threatened species;
• land use;
• socioeconomics;
• cultural resources;
• air quality and noise; and
• public safety.
We will also evaluate possible alternatives to the Project or portions of the Project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
We began our NEPA review under the Commission's pre-filing process on April 25, 2014. The purpose of the pre-filing process was to encourage the early involvement of interested stakeholders and to identify and resolve issues before the FERC receives an application. On October 21, 2014, FERC staff issued an initial
The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. We will also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before we make our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section of this notice.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic
You can make a difference by providing us with your specific comments or concerns about the Project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before February 29, 2016.
For your convenience, there are three methods you can use to submit your comments to the Commission. In all instances, please reference the Project docket number (CP15-117-000) with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the eComment feature located on the Commission's Web site (
(2) You can file your comments electronically using the eFiling feature located on the Commission's Web site (
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for Project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the Project.
Copies of the EA will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).
In addition to involvement in the EA scoping process, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the “Document-less Intervention Guide” under the “e-filing” link on the Commission's Web site. Motions to intervene are more fully described at
Additional information about the Project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public meetings or site visits will be posted on the Commission's calendar located at
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, service, and qualifying facilities filings can be found at:
A summary of the meeting will be prepared and filed in the Commission's public file for the project.
All local, state, and federal agencies, Indian tribes, and other interested parties are invited to participate by phone. Please contact Laura Washington at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared this environmental assessment (EA) for the Northern Supply Access Project (Project) proposed by Texas Gas Transmission, LLC (Texas Gas) in the above-referenced docket. Texas Gas requests authorization to construct and operate natural gas facilities in Ohio, Indiana, Kentucky, Tennessee, Mississippi, and Louisiana to provide an additional 384,000 million standard cubic feet per day of natural gas of north to south transportation capacity on Texas Gas's existing system.
The EA assesses the potential environmental effects of the construction and operation of the Project in accordance with the requirements of the National Environmental Policy Act. The FERC staff concludes that approval of the proposed Project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The Project involves modifications at eight existing compressor stations in Morehouse Parish, Louisiana; Coahoma County, Mississippi; Tipton County, Tennessee; Webster, Breckinridge, and Jefferson Counties, Kentucky; and Lawrence and Dearborn Counties, Indiana. Texas Gas would also construct one new 23,877 horsepower compressor station in Hamilton County, Ohio.
The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners within 0.5 mile of the above ground facilities; interested individuals and groups; newspapers and libraries in the project area; and parties to this proceeding. Everyone on our environmental mailing list will receive a CD version of the EA. In addition, the EA is available for public viewing on the FERC's Web site (
Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this Project, it is important that we receive your comments in Washington, DC on or before
For your convenience, there are three methods you can use to file your comments with the Commission. In all instances please reference the Project docket number (CP15-513-000) with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at 202-502-8258 or
(1) You can file your comments electronically using the eComment feature located on the Commission's Web site (
(2) You can also file your comments electronically using the eFiling feature on the Commission's Web site (
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Additional information about the Project is available from the Commission's Office of External Affairs, at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
On January 20, 2016, Advantage Investment Group, LLC (transferor) and Spencer Mountain Hydropower, LLC (transferee) filed an application for transfer of license of the Spencer Mountain Hydroelectric Project No. 2607. The project is located on the
The applicants seek Commission approval to transfer the license for the Spencer Mountain Hydroelectric Project from the transferor to the transferee.
Deadline for filing comments, motions to intervene, and protests: 30 days from the date that the Commission issues this notice. The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at
Western Area Power Administration, Department of Energy.
Record of decision.
The U.S. Department of Interior, Bureau of Reclamation, Eastern Colorado Area Office (Reclamation) prepared an Environmental Impact Statement (EIS) for the proposed Windy Gap Firming Project (Project) in North Central Colorado. The Municipal Subdistrict (Subdistrict), Northern Colorado Water Conservancy District, acting by and through the Windy Gap Firming Project Water Activity Enterprise, on behalf of the Project Participants, obtained approval from Reclamation for additional physical connections to Colorado-Big Thompson Project (C-BT) facilities in order to implement the proposed Project. Western Area Power Administration (Western), an agency within the U.S. Department of Energy (DOE), participated in the development of the EIS as a cooperating agency.
The EIS evaluated a no action alternative, along with four action alternatives each entailing the construction of new reservoirs along with pipelines and operational facilities at different locations. The action alternatives were designed to provide more reliable water deliveries to Front Range and West Slope communities and industry. Reclamation selected Alternative 2—Chimney Hollow Reservoir in its Record of Decision (ROD) dated December 19, 2014. In order to support Reclamation's decision, Western would need to relocate 3.8 miles of its existing Estes-Lyons 115-kilovolt (kV) wood H-frame transmission line away from the proposed Chimney Hollow Reservoir site to avoid its inundation.
For further information, please contact Mr. Matt Blevins, Western Area Power Administration, P.O. Box 281213, Lakewood, CO 80228-8213, telephone (720) 962-7261, or email:
Reclamation was the lead federal agency for the EIS (FES 11-19) and Western was a cooperating agency. The Notice of Availability for the Final EIS was published in the
Reclamation's selected alternative directly affects a portion of Western's existing Estes-Lyons 115-kV transmission line, which lies within the design footprint of the proposed new Chimney Hollow Reservoir. In order to support Reclamation's decision, Western would need to relocate its transmission line away from the proposed reservoir to an area that preserves system reliability, maintenance accessibility, and safety. Western's relocation of the transmission line at the Chimney Hollow Reservoir site was evaluated in the EIS, including acquiring a 100 foot right-of-way, constructing access roads, and rebuilding approximately 3.8 miles of transmission line to the west of the proposed Chimney Hollow Reservoir. After an independent review of the EIS, Western has concluded that its comments have been satisfied and with this notice is adopting the EIS for its participation in the Project.
Western's action is to support Reclamation's decision in selecting Alternative 2—Chimney Hollow Reservoir and to relocate a 3.8 mile portion of Western's existing Estes-Lyons 115-kV transmission line away from the proposed Chimney Hollow Reservoir site to avoid its inundation. Final transmission line location, pole placement, and spacing will be determined by Western during final design.
Reclamation executed a Memorandum of Agreement (MOA) with the Colorado State Historic Preservation Office regarding the Project on April 19, 2012. Reclamation and Western must adhere to the stipulations of that MOA. The MOA stipulates that prior to any construction of the Project, Reclamation's Eastern Colorado Area Office will inventory the remaining 17.2 acres in the Area of Potential Effect and consult with the State Historic Preservation Office on eligibility and effects of the Project pursuant to 36 CFR part 800, including mitigation that will be set forth in an amendment to the MOA.
Western's action would have no effect on federally listed terrestrial wildlife species or plants. However, the Project's Colorado River depletions could adversely impact four endangered Colorado River fish species. Impacts to the endangered species in the Colorado River were originally addressed in the 1981 U.S. Fish and Wildlife Service (Service) Biological Opinion for the original Windy Gap Reservoir based on an estimated average annual diversion of 57,300 acre feet (AF) of water. A
The RIP was intended to be the reasonable and prudent alternative for individual projects to avoid the likelihood of jeopardy to the endangered fishes from depletions from the Upper Colorado River Basin. A Section 7 agreement was implemented on October 15, 1993, by RIP participants, and on December 20, 1999, the Service issued a Final Programmatic Biological Opinion (PBO),
Reclamation considered in detail five alternatives, including
Reclamation considers both the No Action Alternative and Alternative 2—Chimney Hollow Reservoir to be the environmentally preferable alternatives because of each alternative's relative overall effect on natural resources as described in their ROD.
The EIS analysis includes identification of standard construction mitigation measures for transmission line construction. Western will adhere to its standard construction mitigation measures described in the EIS. Long-term operations of the transmission line will follow Western's standard operating procedures and will not be affected by this action. A Mitigation Action Plan is not required for Western's proposed action.
Western's decision is to modify its transmission system as described above in support of Reclamation's decision to select Alternative 2—Chimney Hollow Reservoir.
Western Area Power Administration, DOE.
Notice of Proposed Formula Rates for Network Integration Transmission Service and Ancillary Services.
The Western Area Power Administration (Western) Parker-Davis (P-DP) and Pacific Northwest-Pacific Southwest Intertie (Intertie) Projects' Network Integration Transmission Service (NITS) formula rates under Rate Schedules PD-NTS3, INT-NTS3 and Western Area Lower Colorado Balancing Authority's (WALC) Ancillary Services formula rates under Rate Schedules DSW-SD3, DSW-RS3, DSW-FR3, DSW-EI3, DSW-GI1, DSW-SPR3, and DSW-SUR3 expire on September 30, 2016. Western is proposing modifications to the existing formula rate schedules and adding two new rate schedules, referred to as Transmission Losses Services (DSW-TL1) and Penalty Rate for Unreserved Use of Transmission Service (DSW-UU1). Western will prepare a brochure that provides detailed information on the proposed formula rates. If adopted, the proposed formula rates, under Rate Schedules PD-NTS4, INT-NTS4, DSW-TL1, DSW-UU1, DSW-SD4, DSW-RS4, DSW-FR4, DSW-EI4, DSW-GI2, DSW-SPR4, and DSW-SUR4 will become effective October 1, 2016, and will remain in effect through September 30, 2021, or until superseded. Publication of this
The consultation and comment period begins today and will end May 3, 2016. Western will present a detailed explanation of the proposed formula rates and other modifications addressed
The location for both the public information forum and the public comment forum is the Western Area Power Administration, Desert Southwest Customer Service Regional Office, located at 615 South 43 Avenue, Phoenix, Arizona, 85009. Send written comments to Mr. Ronald E. Moulton, Regional Manager, Desert Southwest Customer Service Region, Western Area Power Administration, P.O. Box 6457, Phoenix, Arizona 85005-6457, email
As access to Western facilities is controlled, any United States (U.S.) citizen wishing to attend must present an official form of picture identification (ID) such as a U.S. driver's license, U.S. passport, U.S. Government ID, or U.S. Military ID prior to signing into Western. Foreign nationals should contact Western via Mr. Scott Lund, Rates Manager, telephone (602) 605-2442 or email
Mr. Scott Lund, Rates Manager, Desert Southwest Customer Service Region, Western Area Power Administration, P.O. Box 6457, Phoenix, Arizona 85005-6457, telephone (602) 605-2442 or email
Under the existing formula rate schedules approved under Rate Order No. WAPA-151,
Western proposes no changes to the NITS formula rates on the P-DP and Intertie, but proposes to make minor editorial changes to the rate schedule. Those edits would consist of removing the section setting forth the annual revenue requirements as well as moving the transmission losses language to a new rate schedule. In the future, the revenue requirements will be identified in a separate tracking document posted on Western's Web site, as well as posted on Western's Transmission Services Open Access Same Time Information System (OASIS) Web site for WALC.
Western proposes no changes to the existing transmission losses language and application; instead, it proposes moving the loss adjustment sections for each project into a single WALC formula rate schedule. This single WALC formula rate schedule will supersede the language in the existing individual schedules. WALC loss rates were developed in 2004 and are applied in three of Western's transmission systems: P-DP, Intertie and Central Arizona Project (CAP). Creating a single WALC formula rate schedule for transmission losses will ensure consistent language across projects.
Western proposes creating a new formula rate schedule for Penalty Rate for Unreserved Use of Transmission Service. Although charges are already assessed in each transmission rate schedule for any unreserved use of the transmission system, creating a new schedule will allow for consistent treatment across projects.
The proposed charge for unreserved use is two times the maximum allowable rate for the service at issue, assessed as follows: The penalty for a single hour of unreserved use is based on the daily short-term transmission rate. The penalty for more than one instance 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 WALC and associated with the unreserved use. Customers must pay for Ancillary Services based on the amount of transmission service used and not reserved.
Western proposes no changes to the Scheduling, System Control, and Dispatch formula rate, but plans to make minor editorial changes to the rate schedule. Those edits would consist of minor changes to the language within the “applicable” section and removing the section setting forth the annual charge. In the future, the annual charge will be identified in a separate tracking document posted on Western's Web site as well as the WALC OASIS Web site.
Western proposes no changes to the Reactive Supply and Voltage Control from Generation or Other Sources Service formula rate, but proposes to make minor editorial changes to the rate schedule. Those edits would consist of minor changes to the language within the “applicable” section and removing the section setting forth the annual charge. In the future, the annual charge will be identified in a separate tracking document posted on Western's Web site as well as the WALC OASIS Web site.
In order to more accurately allocate costs based on cost causation principles, Western is proposing a change to the current load-based assessment of the Regulation and Frequency Response Service (Regulation Service) formula rate. The current load-based assessment is applicable to (1) all load inside WALC and (2) installed nameplate capacity of all intermittent resources serving load inside WALC.
Western is not proposing any changes to the application of the load-based assessment for the load inside WALC. The charge will continue to be one-for-one for each megawatt (MW) of load inside WALC. Western is, however, proposing to modify the one-for-one MW load-based assessment for the installed nameplate of intermittent resources serving load inside WALC. It would instead include a “variable capacity multiplier” to be applied to the installed capacity for Variable Energy Resources (VER) serving load inside WALC.
The proposed formula rate for Regulation Service is as follows:
Regulation Service is necessary to provide continuous balancing of resources with obligations and for maintaining scheduled interconnection frequency at sixty cycles per second (60 Hz). Regulation Service is accomplished by committing on-line generation whose output is raised or lowered as necessary, predominantly through the use of automatic generation control equipment to follow moment-by-moment changes in load. The obligation to maintain this balance between resources and load lies with the Transmission Service Provider (TSP) or the Control Area operator who performs this function for the TSP. The TSP must offer this service when the transmission service is used to serve load within its balancing authority area.
Western markets the maximum amount of power from its Federal projects, leaving little flexibility for additional regulation needs within WALC. Connecting VER to the system would result in a significant increase in regulation needs and costs, and present operational constraints in managing the significant fluctuations normally associated with VER. These costs get spread to all customers taking Regulation Service regardless of their ability or inability to influence the condition.
The Annual Revenue Requirement for Regulation Service will not be affected by the inclusion of the multipliers. The proposed change will result in the denominator increasing because more units of capacity will be charged, which in turn will cause the overall Regulation Service charge to be lower. The lower charge will then be allocated to each unit of capacity, thereby lowering the costs incurred by the load and assigning more of the costs for regulating capacity to those customers predominately contributing to the need for Regulation Service.
In order to determine the “variable capacity multipliers”, Western has developed a regulation analysis tool that will allow WALC to determine the hourly impacts of both load and variable energy generation on WALC. The regulation analysis tool focuses on 95 percent (%) of the events where WALC's Area Control Error limit was exceeded within the 10 minute duration range.
WALC does not have a significant amount of wind or solar generation impacting its balancing authority area and, therefore, does not have sufficient data to perform a thorough analysis at this time. Therefore, Western proposes to assess a wind and solar capacity multiplier of 1.00 or 100%. This number does not change the current denominator, but it allows the denominator to change if and when VER becomes a resource within WALC.
In addition, Western proposes to make minor editorial changes to the Regulation Service rate schedule. Those edits would consist of minor changes to the language within the “applicable” section and removing the section setting forth the annual charge. In the future, the annual charge will be identified in a separate tracking document posted on Western's Web site as well as the WALC OASIS Web site.
Western is proposing a change to the off-peak penalty bandwidths for Energy and Generator Imbalance Services (Imbalance Services). The off-peak penalty and bandwidth structure will consist of three deviation bands similar to the on-peak structure. This would coincide with FERC Order 890 guidelines with adjustments for WALC operating conditions. The proposed bandwidths are as follows:
(1) Off-Peak Hours +/− 0 percent to 1.5 percent of metered load/generation (0 to 4 MW minimum) with no penalty within bandwidth.
(2) Off-Peak Hours +/−1.5 percent to 7.5 percent of metered load/generation (4 to 10 MW minimum) with 110 percent return for under-deliveries and 75 percent return for over-deliveries.
(3) Off-Peak Hours > +/−7.5 percent of metered load/generation (>10 MW minimum) with 125 percent return for under-deliveries and 60 percent for over-deliveries.
In addition, Western proposes to make minor editorial changes to the Imbalance Services rate schedules. Those edits would consist of minor changes to the language within the “applicable” section and removing the section setting forth the annual charge. In the future, the annual charge will be identified in a separate tracking document posted on Western's Web site as well as the WALC OASIS Web site.
Western proposes no changes to the Spinning and Supplemental Reserves Service formula rates, but proposes to make minor editorial changes to the rate schedules. Those edits would consist of changes to the language within the “applicable” section and removing the section setting forth the annual charge. In the future, the annual charge will be identified in a separate tracking document posted on Western's Web site as well as the WALC OASIS Web site.
Western will hold both a public information forum and a public comment forum. After review of public comments, Western will take further action on the proposed formula rates and other modifications addressed in this FRN, and follow procedures for public participation consistent with 10 CFR part 903.
Western is establishing P-DP and Intertie NITS and WALC Ancillary Services formula rates under the Department of Energy (DOE) Organization Act (42 U.S.C. 7152); the Reclamation Act of 1902 (ch. 1093, 32 Stat. 388), as amended and supplemented by subsequent enactments, particularly section 9(c) of the Reclamation Project Act of 1939 (43 U.S.C. 485h(c)) and section 5 of the Flood Control Act of 1944 (16 U.S.C. 825s); and other acts specifically applicable to the projects involved.
By Delegation Order No. 00-037.00A, effective December 25, 2013, the Secretary of Energy delegated: (1) The authority to develop power and transmission rates to Western's Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, to remand, or to disapprove such rates to the Federal Energy Regulatory Commission.
All brochures, studies, comments, letters, memorandums, or other documents Western initiates or uses to develop the proposed formula rates are available for inspection and copying at the Desert Southwest Customer Service Regional Office, Western Area Power Administration, located at 615 South 43rd Avenue, Phoenix, Arizona 85009. Many of these documents and supporting information are available on Western's Web site at:
In compliance with the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4321-4347; the Council on Environmental Quality Regulations for implementing NEPA (40 CFR parts 1500-1508); and DOE NEPA Implementing Procedures and Guidelines (10 CFR part 1021), Western is in the process of determining whether an environmental assessment or an environmental impact statement should be prepared or if this action can be categorically excluded from those requirements.
Western has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.
Western Area Power Administration, DOE.
Notice of Proposed Transmission, Ancillary Services, and Sale of Surplus Products Formula Rates.
The Western Area Power Administration (Western) Loveland Area Projects' (LAP) Transmission and Western Area Colorado Missouri Balancing Authority's (WACM) Ancillary Services formula rates under Rate Schedules L-NT1, L-FPT1, L-NFPT1, L-AS1, L-AS2, L-AS3, L-AS4, L-AS5, L-AS6, L-AS7, L-AS9, and L-UU1 expire on September 30, 2016. Western is proposing modifications to the existing formula rate schedules and also is proposing to add a new rate schedule, referred to as “LAP Marketing Sale of Surplus Products, L-M1.” Western has prepared a brochure that provides detailed information on the proposed formula rates. If adopted, the proposed formula rates, under Rate Schedules L-NT1, L-FPT1, L-NFPT1, L-AS1, L-AS2, L-AS3, L-AS4, L-AS5, L-AS6, L-AS7, L-AS9, L-UU1, and L-M1, will become effective October 1, 2016, and will remain in effect through September 30, 2021, or until superseded. Publication of this
The consultation and comment period begins today and will end May 3, 2016. Western will present a detailed explanation of the proposed formula rates and other modifications addressed within this FRN at a public information forum that will be held on March 28, 2016, at noon MDT. Western will accept oral and written comments at a public comment forum that will be held on March 28, 2016, from 2:30 p.m. to no later than 4:00 p.m. MDT. Western will accept written comments any time during the consultation and comment period.
The location for both the public information forum and the public comment forum is the Western Area Power Administration, Rocky Mountain Region, 5555 East Crossroads Boulevard, Loveland, Colorado. Send written comments to Mr. Bradley S. Warren, Senior Vice President, Rocky Mountain Regional Manager, Western Area Power Administration, 5555 East Crossroads Boulevard, Loveland, Colorado 80538-8986, or at email
As access to Western facilities is controlled, any United States (U.S.) citizen wishing to attend must present an official form of picture identification (ID), such as a U.S. driver's license, U.S. passport, U.S. Government ID, or U.S. Military ID prior to signing into Western. Foreign nationals should contact Western via Mrs. Sheila D. Cook, Rates Manager, at telephone number (970) 461-7211 or by email at
Mrs. Sheila D. Cook, Rates Manager, Rocky Mountain Region, Western Area Power Administration, 5555 East Crossroads Boulevard, Loveland, Colorado 80538-8986, at telephone number (970) 461-7211, or by email at
Under the existing formula rate schedules, approved under Rate Order No. WAPA-155,
Under this proposal, there will be no change to the existing formula rate for calculating the Annual Transmission Revenue Requirement (ATRR), which is applicable to both Network Integration and Point-to-Point transmission service. The ATRR is the annual cost of the LAP Transmission System, adjusted for Non-Firm Point-to-Point revenue credits, costs that increase the capacity available for transmission, other miscellaneous charges or credits, and the prior year true-up.
Western is proposing to shorten the forward-looking transmission rate projection period for this ATRR calculation from sixteen months to four months. In the previous rate adjustment process, Western incorporated a forward-looking transmission rate methodology to calculate the ATRR to recover transmission expenses and investments on a current basis rather than a historical basis. Presently, Western projects transmission costs two years into the future relying on current year actual data for approximately the first eight months of the year and projecting for the remaining four months of the year plus twelve additional months. Western is proposing to remove the last twelve months of projections, thus only having to true-up the projected costs for the four-month period of the current year. This method would allow Western to more accurately match cost recovery with cost incurrence without introducing unnecessary, large true-ups caused by estimating the second year. This proposal would be a change to the inputs for the annual charge, rather than a change to the formula rate.
When actual cost information for a year becomes available, Western will continue to calculate the actual revenue requirement. Revenue collected in excess of Western's actual revenue requirement will be included as a credit in the ATRR in the following year. Similarly, any under-collection of the revenue requirement will be recovered in the following year. This true-up procedure ensures Western recovers no more or no less than the actual transmission costs for the year. For example, as Fiscal Year (FY) 2016 actual financial data becomes available, the under- or over-collection of revenue for FY 2016 can be determined. When the FY 2018 charge is calculated, it would include an adjustment for revenue under- or over-collected in FY 2016.
Western proposes no changes to the Network Integration Transmission Service Formula Rate, but proposes to make minor edits to the rate schedule. Those edits would consist of rearranging the order of the sections and removing the section setting forth the annual ATRR. In the future, each year's ATRR will be identified in a separate tracking document posted on Western's Web site, as well as posted on Western's Transmission Services Open Access Same Time Information System (OASIS) Web site under Loveland Area Projects Transmission (LAPT).
Western proposes a change in the formula rate for Firm Point-to-Point transmission service to clarify the denominator of the formula includes both Firm Point-to-Point transmission capacity reservations and Network Integration transmission service capacity. Western proposes the denominator read as “Firm Transmission Capacity Reservations plus Network Integration Transmission Service Capacity” rather than the current language “LAP Transmission System Total Load.”
The proposed formula rate for Point-to-Point transmission service would be:
In addition, Western also proposes to make minor editorial changes to the firm and non-firm rate schedules. Those edits would consist of rearranging the order of the sections and deleting the sections setting forth the annual charges under the formula rates. In the future, the annual charges will be identified in a separate tracking document posted on Western's Web site as well as posted on the LAPT OASIS Web site.
Western proposes no changes to the Transmission Losses formula rate but proposes to make minor editorial changes to the rate schedule. Those edits would consist of rearranging the order of the sections, moving text within the sections, making minor edits to the language within the “applicable” section, and deleting the “rate” section.
Western proposes no changes to the Unreserved Use penalty formula rate but plans to make minor editorial changes to the rate schedule. Those edits would consist of rearranging the order of the sections, moving text within the sections, and deleting the “rate” section.
Western proposes no changes to the Scheduling, System Control, and Dispatch formula rate, but plans to make minor editorial changes to the rate schedule. Those edits would consist of adding LAPT and Colorado River Storage Project Transmission (CRCM) to the title, rearranging the order of the sections, and deleting the section setting forth the annual charge under the formula rate. In the future, the annual charge will be identified in a separate tracking document posted on Western's Web site as well as posted on the LAPT and CRCM OASIS Web sites.
Western proposes to eliminate Reactive Supply and Voltage Control from Generation or Other Sources (VAR Support Service) exemptions and begin assessing VAR Support Service charges for all transmission transactions on the
Historically, based on the assumption some LAPT and CRCM transmission customers have non-Federal generation resources inside WACM, and they have agreed to make their non-Federal generation resources inside WACM available to the WACM operator for VAR Support Service, Western has allowed some of these LAPT and CRCM transmission customers to receive an exemption from LAPT and CRCM VAR Support Service charges. As a result of these exemptions, the cost for LAPT and CRCM to provide VAR Support Service on their transmission systems has been shifted to the remaining (non-exempted) transmission customers. WACM, the Control Area operator, has always taken the position the non-Federal TSPs have adequate non-Federal generation resources to provide VAR Support Service on their transmission systems and therefore WACM has never charged any non-Federal TSPs for VAR Support Service. In the future, WACM plans to pursue efforts to verify that this presumption continues to be warranted for all of the non-Federal TSPs.
Western is now proposing to take the same position with the Federal TSPs,
Western is also proposing changes to both the numerator and the denominator of the formula rate for VAR Support Service. The numerator will be changed to include the annual cost of other resources used to provide VAR Support Service in addition to the revenue requirement for Federal generation. The denominator will be changed to state “Transmission Transactions in WACM Requiring VAR Support Service” rather than “Load in WACM requiring VAR Support Service.”
The proposed formula rate for VAR Support Service is as follows:
Numerator is: Annual Revenue Requirement for VAR Support Service = (Revenue Requirement for Generation × % of Resource Capacity Used for VAR Support Service (1 Minus Power Factor)) + Other Resources,
Denominator is: Transmission Transactions in WACM Requiring VAR Support Service = Transmission Capacity usage on Federal Transmission Systems (Point-to-Point Transmission Service as well as Network Integration Transmission Service on LAPT and CRCM Transmission Systems) + Transmission Capacity usage by other TSPs inside WACM.
In addition, Western also proposes to make edits to the VAR Support Service rate schedule. Those edits would consist of adding LAPT and CRCM to the title, rearranging the order of the sections, removing language regarding exemptions, clarifying the rate is applicable to Federal transmission customers serving load inside WACM and to non-Federal TSPs/owners/operators who request the service from WACM or who do not adequately supply VAR Support Service on their systems, and deleting the section setting forth the annual charge under the formula rate. In the future, the annual charge will be identified in a separate tracking document posted on Western's Web site as well as posted on the LAPT and CRCM OASIS Web sites.
In order to more accurately allocate costs based on cost causation principles, Western is proposing a change to the current load-based assessment of the Regulation and Frequency Response Service (Regulation Service) formula rate. The current load-based assessment is applicable to (1) all load inside WACM and (2) installed nameplate capacity of all intermittent resources serving load inside WACM.
Western is not proposing any changes to the application of the load-based assessment for the load inside WACM. The charge will continue to be one-for-one for each megawatt (MW) of load inside WACM. Western is, however, proposing to modify the one-for-one MW load-based assessment for the installed nameplate of intermittent resources serving load inside WACM. It would instead include a “variable capacity multiplier” to be applied to the installed capacity for Variable Energy Resources (VER) serving load inside WACM.
The proposed formula rate for Regulation Service is as follows:
Regulation Service is necessary to provide for the continuous balancing of resources with obligations and for maintaining scheduled interconnection frequency at sixty cycles per second (60 Hz). Regulation Service is accomplished by committing on-line generation whose output is raised or lowered as necessary, predominantly through the use of automatic generation control (AGC) equipment, to follow the moment-by-moment changes in load. The obligation to maintain this balance between resources and load lies with the TSP (or the Control Area Operator who performs this function for the TSP). The TSP must offer this service when the transmission service is used to serve load within its Control Area.
Western markets the maximum amount of power from its Federal projects, leaving little flexibility for additional regulation needs within WACM. More VER connecting to the system results in a significant increase in regulation needs and costs and presents operational constraints in managing the significant fluctuations normally associated with VER. These costs are allocated to all customers taking Regulation Service regardless of their ability or inability to influence the condition.
The Annual Revenue Requirement for Regulation Service will not be affected by the inclusion of the multipliers. The proposed change will result in the denominator increasing, because more units of capacity will be charged, which in turn will cause the overall Regulation Service charge to be lower. The lower charge will then be allocated to each unit of capacity, thereby lowering the costs incurred by the load and assigning more of the costs for regulating capacity to those customers predominantly contributing to the need for Regulation Service.
In order to determine the “variable capacity multipliers,” Western has developed a “Regulation Analysis” tool that allows Western to determine the hourly impacts of both load and variable energy generation on WACM. The Regulation Analysis tool focuses on 95 percent (%) of the events where the Control Area's Area Control Error (ACE) limit was exceeded within the 10 minute duration range. Recent analysis using the Regulation Analysis tool has shown wind resources consume a disproportionate amount of regulating capacity. As an example, the results for the July 2014 to June 2015 average indicate a 2.25 or 225% wind capacity multiplier.
WACM does not have a significant amount of solar generation impacting its balancing authority area and, therefore, does not have sufficient solar generation data available to perform a thorough analysis at this time. Therefore, Western proposes to identify a solar capacity multiplier of 1.00 or 100%. This multiplier does not change the current denominator, but allows the denominator to change if and when solar generation becomes more prevalent in the WACM footprint.
The Regulation Analysis will be completed on a monthly basis with an annual average, based on most current data available, typically July to June, used for the annual formula rate updates that go into effect each October 1 of the effective rate period.
In addition, Western proposes to make edits to the Regulation Service rate schedule. Those edits will consist of adding LAPT and CRCM to the title, rearranging the order of the sections, clarifying the rate is applicable to Federal transmission customers and non-Federal TSPs requesting the service that serve load within WACM, and removing the section setting forth the annual charge under the formula rate. In the future, the annual charge will be identified in a separate tracking document posted on Western's Web site as well as posted on the LAPT and CRCM OASIS Web sites.
Western proposes no changes to the Energy Imbalance Service or Generator Imbalance Service formula rates, but plans to make minor editorial changes to the rate schedules. Those edits would consist of adding LAPT to the title, rearranging the order of the sections, and deleting the “rate” section.
Western proposes no changes to the Spinning and Supplemental Reserves Service formula rates, but proposes to make editorial changes to the rate schedules. Those edits would consist of adding LAPT to the schedule, clarifying the “applicable” language, and rearranging the order of the sections.
Western is proposing to implement a new LAP Marketing rate schedule that would be applicable to the sale of LAP surplus energy and capacity products. At this time, Western proposes to include reserves, regulation, and frequency response. If LAP resources are available, the charge will be determined based on market rates plus administrative costs. In the future, if Western considers offering additional products for sale, a revised or new rate schedule will be proposed via a public rate adjustment process.
Western will hold both a public information forum and a public comment forum. After review of public comments, Western will take further action on the proposed formula rates and other modifications addressed in this FRN, and follow procedures for public participation consistent with 10 CFR part 903.
Western is establishing formula rates for LAP Transmission, WACM, LAPT, and CRCM Ancillary Services, and LAP Marketing Sales of Surplus Products under the Department of Energy (DOE) Organization Act (42 U.S.C. 7152); the Reclamation Act of 1902 (ch. 1093, 32
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 (3) the authority to confirm, approve, and place into effect on a final basis, to remand, or to disapprove such rates to FERC.
All brochures, studies, comments, letters, memorandums, or other documents Western initiates or uses to develop the proposed formula rates are available for inspection and copying at the Rocky Mountain Regional Office, located at 5555 East Crossroads Boulevard, Loveland Colorado 80538-8986. Many of these documents and supporting information are also available on Western's RMR Web site under the 2017 Rate Adjustment—Transmission and Ancillary Services section located at
In compliance with the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4321-4347; the Council on Environmental Quality Regulations for implementing NEPA (40 CFR parts 1500-1508); and DOE NEPA Implementing Procedures and Guidelines (10 CFR part 1021), Western is in the process of determining whether an environmental assessment or an environmental impact statement should be prepared or if this action can be categorically excluded from those requirements.
Western has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “Recordkeeping for Institutional Dual Use Research of Concern (iDURC) Policy Compliance” (EPA ICR No. 2530.01, OMB Control No. 2080-NEW) to the Office of Management and Budget (OMB) for emergency processing in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 4, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-ORD-2016-0010, 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.
Brendan Doyle, Office of Research and Development, Mail Code: 8801R, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-4584; 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
EPA is requesting emergency clearance of this ICR under 5 CFR 1320.13(a)(2)(i) because the iDURC policy's effective date has passed, but without PRA approval the recordkeeping provisions cannot yet be implemented. Standard processing of this ICR would further delay full implementation of the policy, which seeks to mitigate the risk of public harm from life sciences research being misapplied.
EPA requests that OMB authorize this ICR by February 29, 2016, for the maximum of 180 days.
Environmental Protection Agency (EPA).
Notice.
Notice is hereby given that the Environmental Protection Agency (EPA) has determined that, in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, the Farm, Ranch, and Rural Communities Advisory Committee (FRRCC) is a necessary committee which is in the public interest. Accordingly, the FRRCC will be renewed for an additional two-year period. The purpose of the FRRCC is to provide advice and recommendations to the EPA Administrator on environmental issues and policies that are of importance to agriculture and rural communities. Inquiries may be directed to Donna Perla, Designated Federal Officer for FRRCC, U.S. EPA (Mail Code 8101R), 1200 Pennsylvania Avenue NW., Washington, DC 20460, or
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Application for Registration and Pesticide Report for Pesticide-Producing and Device-Producing Establishments” (EPA ICR No. 0160.11, OMB Control No. 2070-0078) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before April 4, 2016.
Submit your comments, referencing Docket ID No. EPA-HQ-OECA-2011-0824, 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.
Michelle Stevenson, Office of Compliance, Monitoring, Assistance, and Media Programs Division, Pesticides, Waste & Toxics Branch (2225A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-4203; email:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
FIFRA Section 7(c) requires that any producer operating an establishment registered under Section 7 report to the Administrator within 30 days after it is registered, and annually thereafter by March 1st for certain pesticide or device production and sales or distribution information. The producers must report which types and amounts of pesticides, active ingredients, or devices are currently being produced, were produced during the past year, sold or distributed in the past year. The supporting regulations at 40 CFR part 167 provide the requirements and time schedules for submitting production information. EPA Form 3540-16, Pesticide Report for Pesticide-Producing and Device-Producing Establishments, is used to collect the pesticide
Establishment registration information, collected on EPA Form 3540-8, is a one-time requirement for all pesticide-producing and device-producing establishments. Pesticide and device production information, reported on EPA Form 3540-16, is required to be submitted within 30 days after the company is notified of their pesticide-producing or device-producing establishment number, and annually thereafter on or before March 1st.
Federal Trade Commission.
Notice and request for comment.
In compliance with the Paperwork Reduction Act (PRA) of 1995, the FTC is seeking public comments on its request to Office of Management and Budget (OMB) to extend for three years the current PRA clearance for the information collection requirements contained in the Health Breach Notification Rule. That clearance expires on March 31, 2016.
Comments must be received by March 4, 2016.
Interested parties may file a comment online or on paper by following the instructions in the Request for Comment part of the
Requests for additional information or copies of the proposed information requirements should be addressed to Cora Tung Han, 202-326-2441, Attorney, Privacy & Identity Protection, Bureau of Consumer Protection, 600 Pennsylvania Ave. NW., Washington, DC 20580.
On October 16, 2015, the FTC sought comment on the information collection requirements associated with the Rule. 80 FR 62530. The FTC received three comments. None of these however addressed either the burden associated with the Rule or any of the other issues raised by the public comment request. Pursuant to the OMB regulations, 5 CFR part 1320, that implement the PRA, 44 U.S.C. 3501
Total Annual Labor Cost: $61,764.
Total Annual Capital or Other Non-Labor Cost: $49,960.
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as 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 are required to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest.
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online, or to send it to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Health Breach Notification Rule, PRA Comments, P-125402” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before March 4, 2016. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at
Comments on the information collection requirements subject to review under the PRA should also be submitted to OMB. If sent by U.S. mail, address comments to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395-5167.
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 February 29, 2016.
Interested parties may file a comment at
Evan Zullow (202) 326-2914 or Courtney Estep (202) 326-2788, 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 January 28, 2016), 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 February 29, 2016. Write “Jim Koons Management Company—Consent Agreement; File No. 152-3104” 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
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 “Jim Koons Management Company—Consent Agreement; File No. 152-3104” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Jim Koons Management Company. 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 FTC 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.
The respondent is a car dealership that sells used motor vehicles. According to the FTC complaint, respondent has represented that the used motor vehicles it sells have been subject to rigorous inspection, including for safety issues, but has failed to disclose that the used motor vehicles it sells are subject to open recalls for safety issues.
For instance, the respondent has posted advertisements on the Web site
Even though it makes such claims, the respondent has allegedly advertised on its Web sites numerous certified used vehicles that were subject to open recalls for safety issues. In numerous instances, when the respondent allegedly advertised certified used vehicles that are subject to open recalls for safety issues, it provided no accompanying clear and conspicuous disclosure of this fact. The proposed complaint alleges that this failure to disclose constitutes a deceptive act or practice under section 5 of the FTC Act.
The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future. Part I prohibits the respondent from representing that used motor vehicles it offers for sale are safe, have been repaired for safety issues, or have been subject to an inspection for issues related to safety unless the used motor vehicles are not subject to any open recalls for safety issues or the respondent discloses, clearly and conspicuously, in close proximity to such representation, any material qualifying information related to open recalls for safety issues. Part II is a provision that orders the respondent to notify every consumer who purchased from it a certified used motor vehicle between July 1, 2013 and June 15, 2015 that some of the used vehicles it sold during this time had been recalled for safety issues which weren't repaired as of the date they were sold. The notice also specifies how consumers can check whether the vehicle is subject to an unrepaired recall at the National Highway Traffic Safety Administration's Web site,
Parts III through VII of the proposed order are reporting and compliance provisions. Part III requires the respondent to maintain for five years, and produce to the Commission upon demand, any relevant ads and associated documentary material. Part IV is an order distribution provision that requires the respondent to provide the Order to current and future principals, officers, directors, and managers, and to all current employees, agents, and representatives having responsibilities with respect to the subject matter of the Order. Part V requires the respondent to notify the Commission of corporate changes that may affect compliance obligations. Part VI requires the respondent to submit a compliance report to the Commission 60 days after entry of the order, and also additional compliance reports within 10 business days of a written request by the Commission. Part VII “sunsets” the order after twenty years, with certain exceptions.
The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.
By direction of the Commission.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of
Comments must be received on or before February 29, 2016.
Interested parties may file a comment at
Evan Zullow (202) 326-2914 or Courtney Estep (202) 326-2788, 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 January 28, 2016), 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 February 29, 2016. Write “General Motors LLC—Consent Agreement; File No. 152-3101” 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 “General Motors LLC—Consent Agreement; File No. 152-3101” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from General Motors, LLC. 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 FTC 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.
The respondent is an automobile manufacturer that sells the cars it manufactures through local franchise dealerships. According to the FTC complaint, the respondent has represented that the used motor vehicles it markets and advertises have been subject to rigorous inspection, including for safety issues, but has failed to disclose that these used motor vehicles are subject to open recalls for safety issues.
For instance, the respondent has posted advertisements on its Web site
Our 172-Point Vehicle Inspection and Reconditioning Process is conducted only by highly trained technicians and adheres to strict, factory-set standards to ensure that every vehicle's engine, chassis, and body are in excellent condition. The technicians ensure that everything from the drivetrain to the windshield wipers is in good working order, or they recondition it to our exacting standards. The vehicles are road-tested, put up on a lift for a complete underbody and frame inspection, and then completely checked for any cosmetic flaws.
And we do check it all. From the engine block to the shocks, right down to the floor mats, no major system is overlooked. If it fails a single point, we completely recondition it—or it won't be Certified.
Even though it makes such claims, the respondent has allegedly advertised on its Web site numerous Certified Pre Owned (“CPO”) vehicles that were subject to open recalls for safety issues. In numerous instances, when the respondent allegedly advertised CPO vehicles that are subject to open recalls for safety issues, it provided no accompanying clear and conspicuous disclosure of this fact. The proposed complaint alleges that this failure to disclose constitutes a deceptive act or practice under Section 5 of the FTC Act.
The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future. Part I prohibits the respondent from representing that used motor vehicles it markets or advertises are safe, have been repaired for safety issues, or have been subject to a rigorous inspection unless the used motor vehicles are not subject to any open recalls for safety issues or the respondent discloses, clearly and conspicuously, in close proximity to such representation, any material qualifying information related to open recalls for safety issues. Part II is a provision that orders the respondent to notify every consumer who purchased a CPO used motor vehicle from a GM dealership between July 1, 2013 and the date of entry of the Order, and whose vehicle has not had the open recall repaired, that (1) the consumer's vehicle has been recalled for safety issues that have not been repaired, and (2) how to get the vehicle repaired.
Parts III through VII of the proposed order are reporting and compliance provisions. Part III requires the respondent to maintain for five years, and produce to the Commission upon demand, any relevant ads and associated documentary material. Part IV is an order distribution provision that requires the respondent to provide the Order to certain current and future principals, officers, and directors, and to all current employees, agents, and representatives having responsibilities with respect to the subject matter of the Order. Part V requires the respondent to notify the Commission of corporate changes that may affect compliance obligations. Part VI requires the respondent to submit a compliance report to the Commission 60 days after entry of the order, and also additional compliance reports within 10 business days of a written request by the Commission. Part VII “sunsets” the order after twenty years, with certain exceptions.
The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.
By direction of the Commission.
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 February 29, 2016.
Interested parties may file a comment at
Evan Zullow (202) 326-2914 or Courtney Estep (202) 326-2788, 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 January 28, 2016), 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 February 29, 2016. Write “Lithia Motors, Inc.—Consent Agreement; File No. 152-3102” 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
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 “Lithia Motors, Inc.—Consent Agreement; File No. 152-3102” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Lithia Motors, Inc. 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 FTC 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.
The respondent is a car dealership that sells used motor vehicles. According to the FTC complaint, respondent has represented that the used motor vehicles it sells have been subject to rigorous inspection, including for safety issues, but has failed to disclose that the used motor vehicles it sells are subject to open recalls for safety issues.
For instance, the respondent has posted advertisements on its Web site that make the following representations about vehicles that carry a dealer-backed “60 Day/3000 Mile” warranty: “160-Point Quality Inspection—Lithia 60 Day/3,000 Mile vehicles are put through an exhaustive 160-checkpoint Quality Assurance Inspection. We want the vehicles to look, feel and smell as new as possible. We inspect everything from the tires and the brakes to the suspension, drive train, engine components and even the undercarriage. Only vehicles that pass all 160 checkpoints (as appropriate to vehicle content) can receive our 60 Day/3,000 miles Limited Warranty. See dealer for details.”
Even though it makes such claims, the respondent has allegedly advertised on its Web sites numerous Lithia 60-Day/3,000 Mile used vehicles that were subject to open recalls for safety issues. In numerous instances, when the respondent allegedly advertised Lithia 60-Day/3,000 Mile used vehicles that are subject to open recalls for safety issues, it provided no accompanying clear and conspicuous disclosure of this fact. The proposed complaint alleges that this failure to disclose constitutes a deceptive act or practice under Section 5 of the FTC Act.
The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future. Part I prohibits the respondent from representing that used motor vehicles it offers for sale are safe, have been repaired for safety issues, or have been subject to an inspection for issues related to safety unless the used motor vehicles are not subject to any open recalls for safety issues or the respondent discloses, clearly and conspicuously, in close proximity to such representation, any material qualifying information related to open recalls for safety issues. Part II is a provision that orders the respondent to notify every consumer who purchased from it a 60-Day/3,000 Mile used motor vehicle between July 1, 2013 and the date of entry of the Order that some of the used vehicles it sold during this time had been recalled for safety issues which weren't repaired as of the date they were sold, how to determine whether a vehicle is subject to an unrepaired recall, and information on how to get a vehicle fixed if it is subject to an open recall.
Parts III through VII of the proposed order are reporting and compliance provisions. Part III requires the respondent to maintain for five years, and produce to the Commission upon demand, any relevant ads and associated documentary material. Part IV is an order distribution provision that requires the respondent to provide the Order to current and future principals, officers, directors, and managers, and to all current employees, agents, and representatives having responsibilities with respect to the subject matter of the Order. Part V requires the respondent to notify the Commission of corporate changes that may affect compliance obligations. Part VI requires the respondent to submit a compliance report to the Commission 60 days after entry of the order, and also additional compliance reports within 10 business days of a written request by the Commission. Part VII “sunsets” the order after twenty years, with certain exceptions.
The purpose of this analysis is to aid public comment on the proposed order.
By direction of the Commission.
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (DHHS).
Notice of availability and request for comment.
This notice, prepared by the Agency for Toxic Substances and Disease Registry (ATSDR), announces the availability of the Toxicological Profile for Glutaraldehyde for review and comment. All toxicological profiles issued as “Drafts for Public Comment” represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. We are seeking public comments and additional information or reports on studies about the health effects of glutaraldehyde for review and potential inclusion in the profile.
Comments can include additional information or reports on studies about the health effects of glutaraldehyde. Although ATSDR will consider key studies for this substance during the profile development process, this
Written comments on this draft Toxicological Profile must be received on or before May 3, 2016.
You may submit comments, identified by docket number ATSDR-2016-0001, by any of the following methods:
•
•
Ms. Delores Grant, Division of Toxicology and Human Health Sciences, Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd. NE., MS F-57, Atlanta, GA, 30329. Phone: (800) 232-4636 or 770-488-3351.
The Superfund Amendments and Reauthorization Act of 1986 (SARA) (42 U.S.C. 9601
In addition, ATSDR has the authority to prepare toxicological profiles for substances not found at sites on the National Priorities List, in an effort to “establish and maintain inventory of literature, research, and studies on the health effects of toxic substances” under CERCLA Section 104(i)(1)(B), to respond to requests for consultation under section 104(i)(4), and as otherwise necessary to support the site-specific response actions conducted by ATSDR.
The public comments and other data submitted in response to the
The Glutaraldehyde Toxicological Profile is available online at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “List of Highest Priority Devices for Human Factors Review.” FDA is issuing this draft guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions. FDA believes these device types have clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices. This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 3, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions”.
•
An electronic copy of the guidance document is available for download from the Internet. See the
Shannon Hoste, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2531, Silver Spring, MD 20993-0002, 240-402-3747, or
Human factors testing is a valuable component of product development for medical devices. FDA recommends that manufacturers consider human factors testing for medical devices as a part of a robust design control subsystem. This draft guidance, if finalized, will inform medical device manufacturers which device types should have human factors data included in premarket submissions (
Elsewhere in this issue of the
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the list of highest priority devices for human factors review. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
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 collections of information in 21 CFR part 820 are approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 are approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E are approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H are approved under OMB control number 0910-0332; the collections of information in 21 CFR parts 801 and 809 are approved under OMB control number 0910-0485; and the collections of information in the guidance document entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” are approved under OMB control number 0910-0756.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by March 4, 2016.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize the marketing of a new tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) when appropriate. This guidance is intended to assist persons who seek meetings with FDA relating to their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products. The guidance has been revised to provide clarity.
In the guidance, the Agency discusses, among other things:
• What information FDA recommends persons include in a meeting request;
• How and when to submit a request; and
• What information FDA recommends persons submit prior to a meeting.
This guidance describes two collections of information: (1) The submission of a meeting request containing certain information and (2) the submission of an information package in advance of the meeting. The purpose of this proposed information collection is to allow FDA to conduct meetings with tobacco manufacturers, importers, researchers, and investigators in an effective and efficient manner. FDA issued this guidance as a level 2 guidance consistent with FDA's good guidance practices regulations (21 CFR 10.115).
1. Product name and FDA-assigned Submission Tracking Number (if applicable);
2. Product category (
3. Product use (indicate for consumer use or for further manufacturing);
4. Contact information for the authorized point of contact for the company requesting the meeting;
5. The topic of the meeting being requested (
6. A brief statement of the purpose of the meeting, which could include a discussion of the types of studies or data to be discussed at the meeting, the general nature of the primary questions to be asked, and where the meeting fits in the overall product development plans;
7. A preliminary list of the specific objectives/outcomes expected from the meeting;
8. A preliminary proposed agenda, including an estimate of the time needed and a designated speaker for each agenda item;
9. A preliminary list of specific questions, grouped by discipline (
10. A list of all individuals who will attend the meeting on behalf of the tobacco product manufacturer, importer, researcher, or investigator, including titles and responsibilities;
11. The date on which the meeting information package will be received by FDA; and
12. Suggested format of the meeting,
This information will be used by the Agency to: (1) Determine the utility of the meeting, (2) identify Agency staff necessary to discuss proposed agenda items, and (3) schedule the meeting.
1. Product composition and design data summary;
2. Manufacturing and process control data summary;
3. Nonclinical data summary;
4. Clinical data summary;
5. Behavioral and product use data summary;
6. User and nonuser perception data summary; and
7. Investigational plans for studies and surveillance of the tobacco product, including a summary of proposed study protocols containing the following information (as applicable):
a. Study objective(s);
b. Study hypotheses;
c. Study design;
d. Study population (inclusion/exclusion criteria, comparison group(s);
e. Human subject protection information, including Institutional Review Board information;
f. Primary and secondary endpoints (definition and success criteria);
g. Sample size calculation;
h. Data collection procedures;
i. Duration of follow up and baseline and follow up assessments, and
j. Data analysis plan(s).
The purpose of the information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. In the Agency's experience, reviewing such information is critical to achieving a productive meeting. For the information that was previously submitted in the meeting request, the information package should provide updated information that reflects the most current and accurate information available.
In the
FDA estimates the burden of this collection of information as follows:
FDA's estimate of the number of respondents for meeting requests in table 1 of this document is based on the number of meeting requests to be received over the next 3 years.
In the next 3 years of this collection, FDA estimates that 67 preapplication meetings will be requested. The number is not expected to change, as the public is more experienced in submitting applications for substantial equivalence, requests for nonsubstantial equivalence, etc.
Thus, FDA estimates the number of manufacturers, importers, researchers, and investigators who are expected to submit meeting requests in table 1 of this document to be 67 (50 year-1 requests + 100 year-2 requests + 50 year-3 requests ÷ 3). The hours per response, which is the estimated number of hours that a respondent would spend preparing the information recommended by this guidance to be submitted with a meeting request, is estimated to be approximately 10 hours each, and the total burden hours for meeting requests are expected to be 670 hours (10 hours preparation/mailing × 67 average respondents per year). Based on FDA's experience, the Agency expects it will take respondents this amount of time to prepare, gather, copy, and submit brief statements about the product and a description of the purpose and details of the meeting.
FDA's estimate of the number of respondents for compiling meeting information packages in table 1 of this document is based on 67 respondents each preparing copies of their information package and submitting them to FDA, for a total of 1,206 hours annually. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package as recommended by the guidance, is estimated to be approximately 18 hours per information package. Based on FDA's experience, the Agency expects
The total number of burden hours for this collection of information is 1,876 hours (670 hours to prepare and submit meeting requests and 1,206 hours to prepare and submit information packages).
Food and Drug Administration, HHS.
Notice of availability; request for comments.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.” When finalized, this draft document will describe the Agency's intent not to enforce, before September 24, 2021, the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to certain finished devices manufactured and labeled prior to September 24, 2018. In addition, when finalized, this draft guidance will describe the Agency's intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) until September 24, 2018. This draft guidance is not the final version of the guidance 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 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 April 4, 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
An electronic copy of the draft guidance document is available for download from the Internet. See the
UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002, 301-796-5995, email:
Section 226 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) and Section 614 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) amended the Federal Food, Drug, and Cosmetic Act to add section 519(f) (21 U.S.C. 360i(f)), which directs FDA to issue regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices. The final rule (UDI Rule), establishing the unique device identification system, was published on September 24, 2013 (78 FR 58786). Among other requirements, the UDI Rule requires that the label and every device package of a medical device distributed in the United States bear a UDI, unless an exception or alternative applies (21 CFR 801.20).
The unique device identification system is being phased in over seven years according to a series of compliance dates, based primarily on device classification. These compliance dates establish the dates after which devices placed into commercial distribution must bear a UDI on their labels and device packages as follows: September 24, 2014, for Class III devices and devices licensed under the Public Health Service Act (PHS Act); September 24, 2015, for implantable, life-supporting, or life-sustaining devices; September 24, 2016, for Class II devices; and September 24, 2018, for Class I and unclassified devices (78 FR 58786 at 58815).
To further the objectives of creating a national device identification system, the UDI Rule includes a provision that rescinds any NHRIC or NDC number, assigned to a medical device (21 CFR 801.57). Under § 801.57(a), on the date a device is required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded and may no longer be on the device label or on any device package. For a device not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and may no longer be on the device label or on any device package (§ 801.57(b)).
Currently, medical devices available through a pharmacy and potentially eligible for reimbursement from payers are generally labeled with an 11-digit reimbursement number, typically using an NHRIC or NDC number assigned to the device. The draft guidance, when finalized, would describe the Agency's intent not to enforce before September 24, 2021, the prohibition against providing NHRIC and NDC numbers on device labels and device packages of finished class III devices; devices licensed under the PHS Act; class II devices; and implantable, life-supporting or life-sustaining devices that are manufactured and labeled prior to September 24, 2018. This timeline would coincide with the schedule by which remaining class I and unclassified devices that do not qualify for an exception or alternative must bear a UDI on their labels and device packages. This enforcement policy, when finalized, would apply to the requirements under § 801.57(a) for class III devices; devices licensed under the PHS Act; class II devices; and implantable, life-supporting or life-sustaining devices only; it would not extend to any of the other requirements of the UDI Rule for these devices.
FDA believes that continued implementation of UDI requirements under 21 CFR 801 subpart B and 21 CFR 830 subpart E according to the scheduled compliance dates is important to achieving the objectives of the UDI Rule in a timely manner. However, it is not FDA's intent to cause disruption to existing reimbursement, supply chain, and procurement processes, or to interfere potentially with patient access to treatment. We therefore recognize that additional time is appropriate for stakeholders to make changes to ensure that medical device reimbursement, supply chain, and procurement systems and processes will not depend on NHRIC and NDC numbers.
Additionally, under § 801.57(c) and (d), a labeler may submit a request to FDA for continued use of a previously assigned FDA labeler code under a system for the issuance of UDIs. A labeler who has been assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers may continue to use that labeler code under a system for the issuance of UDIs provided that such use is consistent with the framework of the issuing Agency that operates that system and that the labeler submits, and obtains FDA approval of, a request for continued use of the assigned labeler code (§ 801.57(c)). Under § 801.57(c)(2), the deadline to submit such a request is September 24, 2014.
FDA intends to consider requests submitted to the Agency for continued use of an FDA labeler code under a system for the issuance of UDIs until September 24, 2018. In addition, FDA does not intend to take action against a labeler for incorporating a previously assigned FDA labeler code into its UDI without requesting approval to do so by the deadline set forth in § 801.57(c)(2), if that labeler submits a request that otherwise complies with § 801.57(c) and (d) by September 24, 2018. Labelers who have been granted continued use of an FDA labeler code by FDA should contact their FDA-accredited issuing Agency to incorporate the FDA labeler code into their UDIs.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices”. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
FDA is seeking additional information on this issue. FDA is particularly interested in receiving information relating to the following question:
• Is a time period through September 24, 2018, an appropriate amount of additional time for stakeholders to adopt medical device reimbursement, supply chain, and procurement systems that do not depend on having NHRIC and NDC numbers on the device label? If not, why is this not an appropriate amount of time and how much more time would be reasonable?
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
This draft guidance refers to previously approved collections of information described in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485, and the collections of information in 21 CFR part 830 have been approved under OMB control number 0910-0720.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices.” FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments. The recommendations in this guidance document are intended to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm. FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with medical device use.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
An electronic copy of the guidance document is available for download from the Internet. See the
Shannon Hoste, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2531, Silver Spring, MD 20993-0002, 240-402-3747 or
To understand use-related hazards, it is necessary to have an accurate and complete understanding of how a device will be used. Understanding and optimizing how people interact with technology is the subject of human factors engineering (HFE) and usability engineering (UE). HFE/UE considerations in the development of medical devices include the three major components of the device user system: (1) Device users; (2) device use environments; and (3) device user interfaces.
For safety-critical technologies such as medical devices, the process of eliminating or reducing design-related use problems that contribute to or cause unsafe or ineffective medical treatment is part of a process for controlling overall risk. For devices where harm could result from “use errors,” the dynamics of user interaction should be included in risk analysis and risk management. By incorporating these considerations into the device development process, manufacturers can reduce the overall risk level posed by their devices, thus decreasing adverse events associated with the device and avoiding potential device recalls.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Applying Human Factors and Usability Engineering to Medical Devices.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the 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 guidance refers to previously approved collections of information found in FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 820 are approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 are approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E are approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H are approved under OMB control number 0910-0332; the collections of information in 21 CFR parts 801 and 809 are approved under OMB control number 0910-0485; and the collections of information in the guidance document entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” are approved under OMB control number 0910-0756.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Biosimilar User Fee Cover Sheet; Form FDA 3792” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On June 23, 2015, the Agency submitted a proposed collection of information entitled “Biosimilar User Fee Cover Sheet; Form FDA 3792” to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0718. The approval expires on December 31, 2018. A copy of the supporting statement for this
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Postmarketing Adverse Drug Experience Reporting” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On July 1, 2015, the Agency submitted a proposed collection of information entitled “Postmarketing Adverse Drug Experience Reporting” to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0230. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On July 2, 2015, the Agency submitted a proposed collection of information entitled “Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application” to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0636. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.” This document provides guidance to industry and FDA staff on the underlying principles of human factors (HF) studies during the development of combination products. Combination products are comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product.
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 May 3, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• 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
Submit written requests for single copies of the draft guidance to the Office of Combination Products, Food and Drug Administration, Bldg. 32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Patricia Love, Deputy Director, Office of Combination Products, Office of Special Medical Programs, Office of Medical Products and Tobacco, Office of the Commissioner, Food and Drug Administration, at
FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.” This document provides guidance to industry and FDA staff on the underlying principles of HF studies during the development of combination products as defined under 21 CFR part 3. This draft guidance describes Agency recommendations regarding HF information in a combination product investigational or marketing application. It clarifies the different types of HF studies, offers recommendations for timing and sequencing of HF studies, and discusses how HF studies contribute to assuring that combination products are safe and effective for the intended users, uses and environments. The draft guidance also addresses process considerations for HF information in investigational or marketing applications to promote development and timely review of safe and effective combination products. In addition, the draft guidance describes how HF studies relate to other clinical studies.
This draft guidance refers to two existing guidance documents that provide related information on HF considerations. These are Guidance for Industry and FDA Staff, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” accessible at
This draft guidance provides examples of the use of HF studies for different types of combination products in different clinical settings. FDA welcomes comments to the docket on other examples of combination products and why they may or may not need HF studies. Additionally FDA seeks comments on what challenges and development risks may arise depending upon whether HF studies are conducted before, in parallel to, or after major clinical studies.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the document at
This draft guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
Presidential Commission for the Study of Bioethical Issues, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice of meeting.
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty fourth meeting on March 3, 2016. At this teleconference meeting, the Commission will discuss its ongoing development of pedagogical materials to facilitate the integration of bioethics into education in a range of traditional and non-traditional settings.
The teleconference meeting will take place March 3, 2016, from 2 p.m. to approximately 4 p.m.
The public teleconference will be conducted by telephone only. The agenda and call-in number will be posted at least one week in advance at
Lisa M. Lee, Executive Director, Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue NW., Suite C-100, Washington, DC 20005. Telephone: 202-233-3960. Email:
Pursuant to the Federal Advisory Committee Act of 1972, Public Law 92-463, 5 U.S.C. app. 2, notice is hereby given of the twenty fourth meeting of the Commission. The public teleconference will be open to the public with attendance limited to space available.
Under authority of Executive Order 13521, dated November 24, 2009, the President established the Commission. The Commission is an expert panel of not more than 13 members who are drawn from the fields of bioethics, science, medicine, technology, engineering, law, philosophy, theology, or other areas of the humanities or social sciences. The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner.
The main agenda for the Commission's twenty fourth meeting is to discuss its ongoing development of pedagogical materials to facilitate the integration of bioethics into education in a range of traditional and non-traditional settings. The draft meeting agenda, call-in number, and other information about the Commission will be available at
The Commission welcomes input from anyone wishing to provide public comment on any issue before it. Respectful consideration of opposing views and active participation by citizens in public exchange of ideas enhances overall public understanding of the issues at hand and conclusions reached by the Commission. The Commission is particularly interested in receiving comments and questions during the meeting that are responsive to specific sessions. Written comments will be accepted in advance, during, and after the meeting and are especially welcome. Comments will be publicly available, including any personally identifiable or confidential business information that they contain. Trade secrets should not be submitted.
Written comments will be accepted by email to
Anyone planning to call into the meeting, who needs special assistance or other reasonable accommodations, should notify Esther Yoo by telephone at (202) 233-3960, or email at
Department of Health and Human Services, Office of the Secretary, Office of
the Assistant Secretary for Health.
Notice; correction.
The meeting of the Presidential Advisory Council on HIV/AIDS (PACHA) scheduled for January 28 and 29, 2016, is postponed due to inclement weather. This meeting will be rescheduled at a future date.
Caroline Talev, MPA, Committee Manager, Hubert Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. Phone: 202-205-1178. Fax: 202-401-4005. Email:
In the
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, 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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, with change, of the following collection of information: 1625-0112, Enhanced Maritime Domain Awareness via Electronic Transmission of Vessel Transit Data. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before March 4, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2015-0911] to the Coast Guard using the Federal eRulemaking Portal at
(1)
(2)
(3)
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2015-0911], and must be received by March 4, 2016.
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
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (80 FR 64437, October 23, 2015) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collections.
The Coast Guard collects, stores, and analyzes data transmitted by Long Range Identification and Tracking (LRIT) and Automatic Identification System (AIS) to enhance Maritime Domain Awareness (MDA). Awareness and threat knowledge are critical for securing the maritime domain and the key to preventing adverse events. Data is also used for marine safety and environmental protection purposes.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of a revision to the following collection of information: 1625-0001, Report of Marine Casualty & Chemical Testing of Commercial Vessel Personnel. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before March 4, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2015-0910] to the Coast Guard using the Federal eRulemaking Portal at
(1)
(2)
(3)
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2015-0910], and must be received by March 4, 2016.
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
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day Notice (80 FR 64430, October 23, 2015) required by 44 U.S.C. 3506(c)(2). We received two comment submissions to the 60-day Notice.
The first commenter asked that future versions of the form CG-2692 be “unlocked” so that a computer application that the commenter's company uses may auto-fill in the form data elements. We are unable to accommodate this request at this time, as it is Coast Guard policy that public use forms be locked/secured so they may not be modified. However, this concern may be alleviated in the future as the Coast Guard moves to permit the online submission of marine casualty reports.
The second commenter raised five issues. The first issue raised by the commenter stated that the ICR title “Marine Casualty Information and Periodic Chemical Testing Drug and Alcohol Testing of Commercial Vessel Personnel” is in error and could lead to erroneous reporting of test results.
We agree with the commenter that the historical use of the term “Periodic” may result in some confusion resulting in unnecessary reporting of chemical test results to the Coast Guard. As a result, we revised the title to remove that term and to better reflect the intent of the collection. The revised title is “Report of Marine Casualty & Chemical Testing of Commercial Vessel Personnel”.
The second issue raised by the commenter addressed the wording found in the “Need” section of the 60-day Notice. The commenter questioned the appropriateness of the term “cured” noting that the opinion of a majority of substance abuse treatment specialists have determined that substance abuse is never cured, but rather, is a treatable medical condition. The commenter further noted that the Coast Guard regulation, 46 CFR 16.201(f), acknowledges that the individual is not required to be cured. Rather, that the individual is determined to be of sufficiently low-risk for misuse by a Medical Review Officer.
We agree with the commenter that the inclusion of the historical term “cured” is inconsistent with existing Coast Guard regulations regarding chemical testing requirements and that current substance-abuse rehabilitative science determines addiction to be a treatable condition that is not curable. For these reasons, we edited our “Need” section in this Notice to remove the term “cured” and inserted language that is both consistent with existing Coast Guard regulations and current substance-abuse rehabilitative science.
The third issue raised by the commenter was a statement questioning the data found on the form OMB 83-I of the ICR. The commenter stated that it was challenging to understand the quantitative dispersion of annual responses published in the ICR. The commenter asked for greater specificity as to the representative value of the 180,489 annual responses. The commenter requested additional information to include identification information of the responders, a summary of the responses, the timeframe in which the responses were received, a comparison of the 180,489 responses received in other years and finally, analytical data to determine the mean average of responses for the last five years.
We note that the form OMB 83-I information is a summary, and that a detailed breakdown of the responses are found in Appendix A to the Supporting Statement. The Supporting Statement and Appendix A are found in the docket to the Notice (see documents USCG-2015-0910-0004 and USCG-2015-0910-0005 respectively). Further we note that the number of 180,489 annual responses is generally consistent with year-over-year comparisons and represents neither the least or greatest annual response rate in recent years. Therefore, we hold this number to be both accurate and representative of the annual response burden upon industry. We do not agree with the commenter that an exhaustive analytical review of the data is necessary.
The fourth issue raised by the commenter questioned who is going to be responsible for the completion of the proposed new forms [CG-2692C & CG-2692D]? The commenter opined that the stated intent of the ICR, to streamline the reporting process and to reduce the burden upon industry, would not be the outcome of adding two new forms. The commenter further stated that it should be the responsibility of the Coast Guard to complete the new forms themselves.
As explained in the 60-day Notice section entitled “Why is the Coast Guard Proposing to Add 2 New Forms”, these two new forms do not seek to add any new information to be collected in the request. Instead, they take certain sections of the existing form CG-2692 and move them to these two new forms. Additionally, in the event there are multiple entries required (
The fifth issue raised by the commenter requested greater information concerning the evaluation of comments from the maritime industry and general public identifying the need to revise these forms and to add two new forms. Specifically, the commenter asked if the evaluation was published or if an information request was published to facilitate this evaluation?
The Coast Guard conducted multiple opportunities for marine industry and public participation to the evaluation of the marine casualty reporting process. This effort was made by the Coast Guard to ensure both the marine industry and the public were provided multiple opportunities to provide input to the revision of the marine casualty reporting process. The Coast Guard also conducted a deliberative internal review of process logistics to ensure that only information necessary to evaluating marine casualties was included as required reporting in the proposed new forms.
The Coast Guard engagement with the marine industry and the public was designed to ensure multiple opportunities for participation and to include a broad representative sample of input. In 2013, the Coast Guard's Towing Safety Advisory Committee (TSAC) was consulted in accordance with the Federal Advisory Committee Act. The input received from TSAC, advising revision to the marine casualty reporting process, contributed greatly to this proposal to reformat and restructure the existing form CG-2692.
Again in 2014, the Coast Guard sought-out input from the marine industry and the public when we issued a Notice of Availability and Request for Comments on January 14, 2014 (79 FR 2466) for a draft Navigation and Vessel Inspection Circular (NVIC). This publication provided guidance for the identification and reporting of marine casualties.
The comments received from the marine industry and the public to this NVIC proposal, advising revision to the marine casualty reporting process, contributed greatly to the proposal to reformat and restructure the existing form CG-2692.
1.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of a revision to the following collection of information: 1625-0016, Welding and Hot Works Permits; Posting of Warning Signs. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before March 4, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2015-0755] to the Coast Guard using the Federal eRulemaking Portal at
(1)
(2)
(3)
A copy of the ICR is available through the docket on the Internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2015-0755], and must be received by March 4, 2016.
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
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day Notice (80 FR 64434, October 23, 2015) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collection.
1.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Office of Community Planning and Development, HUD.
Notice; withdrawal.
Please be advised that the funds that were recaptured from the RHED program slated to be used for the Indian Community Capital Initiative has been “rescinded permanently.” As a result, HUD requested that the PRA for Indian Community Capital Initiative be canceled.
The notice published on November 28, 2015 at 80 FR 72105 is withdrawn as of February 3, 2016.
Thann Young, Office of Rural Housing and Economic Development, Department of Housing and Urban Development, 451 7th Street SW., Room 7240, Washington, DC 20410; email Thann Young at
This notice informs the public that HUD is withdrawing their approval from OMB for the information collection described in Section A.
Federally recognized Indian tribe means any tribal entity eligible to apply for funding and services from the Bureau of Indian Affairs by virtue of its status as an Indian tribe. The list of Federally recognized Indian tribes can be found in the notice published by the Department of the Interior on January 14, 2015 (
Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice of Final Fiscal Year (FY) 2016 Fair Market Rents (FMRs), Update.
Today's notice updates the FY 2016 FMRs for Portland-Vancouver-Hillsboro, OR-WA, HUD MSA, based on surveys conducted in November 2015 by the area public housing agencies (PHAs). The FY 2016 FMRs for these areas reflect the estimated 40th percentile rent levels trended to April 1, 2016.
For technical information on the methodology used to develop FMRs or a listing of all FMRs, please call the HUD USER information line at 800-245-2691 or access the information on the HUD USER Web site:
Questions related to use of FMRs or voucher payment standards should be directed to the respective local HUD program staff. Questions on how to conduct FMR surveys or concerning further methodological explanations may be addressed to Marie L. Lihn or Peter B. Kahn, Economic and Market Analysis Division, Office of Economic Affairs, Office of Policy Development and Research, telephone 202-402-2409. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339. (Other than the HUD USER information line and TDD numbers, telephone numbers are not toll-free.)
The FMRs appearing in the following table supersede the values found in Schedule B that became effective on December 11, 2015, and were printed in the December 11, 2015
The FMRs for the affected area are revised as follows:
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before March 4, 2016.
•
•
When submitting comments, please indicate the name of the applicant and the PRT# you are commenting on. We will post all comments on
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2281 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice,
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street address listed under
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The applicant requests a permit to export 10 male and 20 female captive-bred Arabian oryx (
The applicant requests a permit to import one captive-bred Sumatran orangutan (
The applicant requests a permit to export one male captive-bred giant panda (
The applicant requests a permit to export 10,000, captive-bred Kisansi spray toads (
The applicant requests a permit to import one, captive-bred, Amur leopard (
The applicant requests a permit to import biological samples from wild olive Ridley sea turtles (
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
U.S. Geological Survey (USGS), Interior.
Notice of revision of a currently approved information collection, (1028-0082).
We (the U.S. Geological Survey) are notifying the public that we have submitted to the Office of Management and Budget (OMB) the information collection request (ICR) described below. To comply with the Paperwork Reduction Act of 1995 (PRA) and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this ICR. This collection is scheduled to expire on January 31, 2016.
To ensure that your comments on this ICR are considered, OMB must receive them on or before March 4, 2016.
Please submit written comments on this information collection directly to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs, Attention: Desk Officer for the Department of the Interior, via email: (
Bruce Peterjohn, Patuxent Wildlife Research Center, U.S. Geological Survey, 12100 Beech Forest Rd., Laurel, MD 20708 (mail); 301-497-5646 (phone); or
The USGS Bird Banding Laboratory is responsible for monitoring the trapping and marking of wild migratory birds by persons holding Federal permits. The Bird Banding Laboratory collects information using three forms: (1) The Application for Federal Bird Marking and Salvage Permit, (2) The Permit Renewal Form, and (3) The Bird Banding Recovery Report.
We will protect information from respondents considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and it's implementing regulations (43 CFR part 2), and under regulations at 30 CFR 250.197, “Data and information to be made available to the public or for limited inspection.” Responses are voluntary. No questions of a “sensitive” nature are asked.
We have not identified any “non-hour cost” burdens associated with this collection of information.
We again invite comments concerning this ICR as to: (a) Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) how to enhance the quality, usefulness, and clarity of the information to be collected; and (d) how to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this notice are a matter of public record. Before including your personal mailing address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment, including your personally identifiable information, may be made publicly available at any time. While you can ask us and the OMB in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act (FLPMA), the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) a Boise, Idaho District Resource Advisory Council (RAC) subcommittee for the Proposed Tri-State Fuels Breaks Project will meet as indicated below.
On Wednesday, March 2, 2016, a Boise, Idaho District Resource Advisory Council (RAC) subcommittee for the Proposed Tri-State Fuels Breaks Project will meet at the Boise District Office, 3948 S. Development Avenue, Boise, Idaho, 83705. The meeting will begin at 9:00 a.m. and end no later than 3:00 p.m. The public comment period during the RAC subcommittee meeting will take place from 11:00 a.m. to 11:15 a.m.
MJ Byrne, Boise District RAC Coordinator, 3948 S. Development Avenue, Boise, Idaho, 83705, (208) 384-3393.
The 15-member RAC advises the Secretary of the Interior, through the Bureau of Land Management, on a variety of planning and management issues associated with public land management in Idaho. During the meeting on Feb. 2, 2016, RAC subcommittee members will be provided with an overview of the Proposed Tri-State Fuels Breaks Project by staff and managers from the Boise District BLM Office, and an overview of the literature research for the project. This will be the first meeting of the subcommittee, so the agenda includes discussion about the purpose for
Alaska State Office, Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act of 1976 as amended (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the Bureau of Land Management (BLM) Alaska Resource Advisory Council (RAC) will meet as indicated below.
The meeting will be held March 10, 2016, at the BLM Alaska Fairbanks District Office, 1150 University Avenue, Fairbanks, Alaska 99709-3844. The meeting starts at 9:00 a.m. in the Kobuk Conference Room. The council will accept comments from the public from 1:30-2:30 p.m.
Thom Jennings, RAC Coordinator, BLM Alaska State Office, 222 W. 7th Avenue #13, Anchorage, AK 99513;
The 15-member council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in Alaska. At this meeting, the council will discuss the Regional Mitigation Strategy for the Northeast National Petroleum Reserve in Alaska (NPR-A) and other topics of interest to the RAC. An agenda will be posted to the BLM Alaska RAC Web site (
National Park Service, Interior.
Notice; request for comments.
We (National Park Service, NPS) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on August 31, 2016. We 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.
To ensure we are able to consider your comments, we must receive them on or before April 4, 2016.
Please send your comments on the ICR to Madonna L. Baucum, Information Collection Clearance Officer, National Park Service, 12201 Sunrise Valley Drive, Room 2C114—Mail Stop 242, Reston, VA 20192 (mail); or
Lee Dickinson, Special Park Uses National Manager, 1849 C St. NW. (2465), Washington, DC 20240; via fax at (202) 208-4178; or via email at
Under 54 U.S.C. 100101 (National Park Service Act Organic Act), we must preserve America's natural wonders unimpaired for future generations, while also making them available for the enjoyment of the visitor. Meeting this mandate requires that we balance preservation with use. Maintaining a good balance requires both information and limits. In accordance with regulations at 36 CFR parts 1 through 7, 13, 20, and 34, we issue permits for special park uses. Special park uses cover a wide range of activities including, but not limited to, special events, First Amendment activities, grazing and agricultural use, commercial filming, still photography, construction, and vehicle access.
We currently use the below listed forms to collect information for special use permits.
• 10-930 (Application for Special Use Permit),
• 10-930S (Application for Special Use Permit (short form)). The short form will reduce the burden on applicants for smaller, less complicated activities, such as small picnics, gatherings, weddings, etc.
• 10-931 (Application for Commercial Filming/Still Photography Permit (short form)),
• 10-932 (Application for Commercial Filming/Still Photography Permit (long form)) to collect information for special use permits.
• Form 10-933 (Application for Vehicle Use). This new form applies specifically to vehicle access such as off-road, over-sand, or commercial vehicle access, as well as snow mobile and watercraft. We will only request
The information we collect in the special use applications allows park managers to determine if the requested use is consistent with the laws and NPS regulations referenced above and with the public interest. The park manager must also determine that the requested activity will not cause unacceptable impacts to park resources and values.
We invite comments concerning this information collection on:
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of the burden for this collection of information;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways to minimize the burden to respondents, including use of automated information techniques or other forms of information technology.
Please note that the comments submitted in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on December 28, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Advanced Silicon Technologies LLC of Portsmouth, New Hampshire. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain computing or graphics systems, components thereof, and vehicles containing same by reason of infringement of certain claims of U.S. Patent No. 6,339,428 (“the '428 patent”); U.S. Patent No. 6,546,439 (“the '439 patent”); U.S. Patent No. 6,630,935 (“the '935 patent”); and U.S. Patent No. 8,933,945 (“the '945 patent”). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone
The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2015).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain computing or graphics systems, components thereof, and vehicles containing same by reason of infringement of one or more of claims 1-6, 8, 9, 10-14, 16, 17, and 25-29 of the '428 patent; claims 1-11 and 14-16 of the '439 patent; claims 1, 2, and 4-8 of the '935 patent; and claims 1-11 and 21 of the '945 patent, and whether an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337;
(2) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties and other interested persons with respect to the public interest in this investigation, as appropriate, and provide the Commission with findings of fact and a recommended determination on this issue, which shall be limited to the statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is:
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; and
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this
By order of the Commission.
United States International Trade Commission.
Notice.
Joanna Lo (202-205-1888), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
On October 15, 2015, the Commission established a schedule for conducting the final phase of investigations on polyethylene terephthalate (PET) resin from Canada, China, India, and Oman (80 FR 68563, November 5, 2015). The Commission is revising its schedule by changing the time of the hearing.
The Commission's new schedule for the hearing in these investigations is as follows: The hearing will be held at the U.S. International Trade Commission Building at 10:30 a.m. on March 1, 2016. All other aspects of the schedule remain unchanged.
For further information concerning these investigations see the Commission's notice cited above.
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR part 503.25) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of open meetings as follows:
All meetings are held at the Foreign Claims Settlement Commission, 600 E Street NW., Washington, DC. Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Patricia M. Hall, Foreign Claims Settlement Commission, 600 E Street NW., Suite 6002, Washington, DC 20579. Telephone: (202) 616-6975.
Office of Justice Programs, U.S. Department of Justice
60-day notice.
The Department of Justice (DOJ), Office of Justice Programs (OJP), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for sixty days (60) until April 4, 2016.
If you have additional comments on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact: Maria Swineford, (202) 616-0109, Office of Audit, Assessment, and Management, Office of Justice Programs, U.S. Department of Justice, 810 Seventh Street NW., Washington, DC 20531 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
In accordance with section 223 of the Trade Act of 1974, as amended (19 U.S.C. 2273) the Department of Labor herein presents summaries of determinations regarding eligibility to apply for trade adjustment assistance for workers by (TA-W) number issued during the period of
In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of section 222(a) of the Act must be met.
I. Under section 222(a)(2)(A), the following must be satisfied:
(1) a significant number or proportion of the workers in such workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) the sales or production, or both, of such firm have decreased absolutely; and
(3) One of the following must be satisfied:
(A) imports of articles or services like or directly competitive with articles produced or services supplied by such firm have increased;
(B) imports of articles like or directly competitive with articles into which one or more component parts produced by such firm are directly incorporated, have increased;
(C) imports of articles directly incorporating one or more component parts produced outside the United States that are like or directly competitive with imports of articles incorporating one or more component parts produced by such firm have increased;
(D) imports of articles like or directly competitive with articles which are produced directly using services supplied by such firm, have increased; and
(4) the increase in imports contributed importantly to such workers' separation or threat of separation and to the decline in the sales or production of such firm; or
II. Section 222(a)(2)(B) all of the following must be satisfied:
(1) a significant number or proportion of the workers in such workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) One of the following must be satisfied:
(A) there has been a shift by the workers' firm to a foreign country in the production of articles or supply of services like or directly competitive with those produced/supplied by the workers' firm;
(B) there has been an acquisition from a foreign country by the workers' firm of articles/services that are like or directly competitive with those produced/supplied by the workers' firm; and
(3) the shift/acquisition contributed importantly to the workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected secondary workers of a firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of section 222(b) of the Act must be met.
(1) a significant number or proportion of the workers in the workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) the workers' firm is a Supplier or Downstream Producer to a firm that employed a group of workers who received a certification of eligibility under section 222(a) of the Act, and such supply or production is related to the article or service that was the basis for such certification; and
(3) either—
(A) the workers' firm is a supplier and the component parts it supplied to the firm described in paragraph (2) accounted for at least 20 percent of the production or sales of the workers' firm; or
(B) a loss of business by the workers' firm with the firm described in paragraph (2) contributed importantly to the workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected workers in firms identified by the International Trade Commission and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of section 222(e) of the Act must be met.
(1) the workers' firm is publicly identified by name by the International Trade Commission as a member of a domestic industry in an investigation resulting in—
(A) an affirmative determination of serious injury or threat thereof under section 202(b)(1);
(B) an affirmative determination of market disruption or threat thereof under section 421(b)(1); or
(C) an affirmative final determination of material injury or threat thereof under section 705(b)(1)(A) or 735(b)(1)(A) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)(1)(A) and 1673d(b)(1)(A));
(2) the petition is filed during the 1-year period beginning on the date on which—
(A) a summary of the report submitted to the President by the International Trade Commission under section 202(f)(1) with respect to the affirmative determination described in paragraph (1)(A) is published in the
(B) notice of an affirmative determination described in subparagraph (1) is published in the
(3) the workers have become totally or partially separated from the workers' firm within—
(A) the 1-year period described in paragraph (2); or
(B) not withstanding section 223(b)(1), the 1-year period preceding the 1-year period described in paragraph (2).
The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination.
The following certifications have been issued. The requirements of section 222(a)(2)(A) (increased imports) of the Trade Act have been met.
The following certifications have been issued. The requirements of section 222(a)(2)(B) (shift in production or services) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met.
In the following cases, the investigation revealed that the eligibility criteria for worker adjustment assistance have not been met for the reasons specified.
The investigation revealed that the criterion under paragraph (a)(1) or (b)(1) (employment decline or threat of separation) of section 222 has not been met.
The investigation revealed that the criteria under paragraphs (a)(2)(A)(i) (decline in sales or production, or both) and (a)(2)(B) (shift in production or services to a foreign country) of section 222 have not been met.
The investigation revealed that the criteria under paragraphs (a)(2)(A) (increased imports) and (a)(2)(B) (shift in production or services to a foreign country) of section 222 have not been met.
After notice of the petitions was published in the
The following determinations terminating investigations were issued because the petitioner has requested that the petition be withdrawn.
The following determinations terminating investigations were issued in cases where these petitions were not filed in accordance with the requirements of 29 CFR 90.11. Every petition filed by workers must be signed by at least three individuals of the petitioning worker group. Petitioners separated more than one year prior to the date of the petition cannot be covered under a certification of a petition under section 223(b), and therefore, may not be part of a petitioning worker group. For one or more of these reasons, these petitions were deemed invalid.
The following determinations terminating investigations were issued because the petitioning groups of workers are covered by active certifications. Consequently, further investigation in these cases would serve no purpose since the petitioning group of workers cannot be covered by more than one certification at a time.
The following determinations terminating investigations were issued because the petitions are the subject of ongoing investigations under petitions filed earlier covering the same petitioners.
I hereby certify that the aforementioned determinations were issued during the period of
Petitions have been filed with the Secretary of Labor under Section 221(a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Office of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to Section 221(a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Office of Trade Adjustment Assistance, at the address shown below, no later than February 16, 2016.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than February 16, 2016.
The petitions filed in this case are available for inspection at the Office of the Director, Office of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room N-5428, 200 Constitution Avenue NW., Washington, DC 20210.
Notice; correction.
The Department of Labor published a document in the
Contact Michel Smyth by telephone at 202-693-4129 (this is not a toll-free number) or by email to
In the
The OMB will consider all written comments that agency receives on or before January 29, 2016.
Notice; correction.
The Department of Labor published a document in the
Michel Smyth by telephone at 202-693-4129 (this is not a toll-free number) or by email to
In the
The OMB will consider all written comments that agency receives on or before February 11, 2016.
Notice; Correction.
The Department of Labor published a document in the
Contact Michel Smyth by telephone at 202-693-4129 (this is not a toll-free number) or by email to
In the
The OMB will consider all written comments that agency receives on or before February 11, 2016.
National Endowment for the Arts, National Foundation on the Arts and Humanities.
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 1 meeting of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.
All meetings are Eastern time and ending times are approximate:
National Endowment for the Arts, Constitution Center, 400 7th St. SW., Washington, DC 20506.
Further information with reference to these meetings can be obtained from Ms. Kathy Plowitz-Worden, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506;
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chairman of February 15, 2012, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation announces the following meeting:
Nuclear Regulatory Commission.
License renewal and record of decision; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued renewed facility operating license Nos. NPF-72 and NPF-77 to Exelon Generation Company, LLC (Exelon or the licensee), the operator of Braidwood Station, Units 1 and 2 (Braidwood), respectively. Renewed facility operating license Nos. NPF-72 and NPF-77 authorize the operation of Braidwood Units 1 and 2 at reactor core power levels not in excess of 3645 megawatts thermal each, in accordance with the provisions of the renewed licenses and technical specifications. In addition, the NRC has prepared a record of decision (ROD) that supports the NRC's decision to renew facility operating license Nos. NPF-72 and NPF-77.
The license renewal of facility operating license Nos. NPF-72 and NPF-77 were effective on January 27, 2016.
Please refer to Docket ID NRC-2013-0169 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Lois James, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
Notice is hereby given that the NRC has issued renewed facility operating license Nos. NPF-72 and NPF-77 to Exelon Generation Company, LLC, the operator of Braidwood Station. Renewed facility operating license Nos. NPF-72 and NPF-77 authorizes the operation of Braidwood Units 1 and 2 at reactor core power levels not in excess of 3645 megawatts thermal each, in accordance with the provisions of the Braidwood, Units 1 and 2 renewed licenses and technical specifications. The NRC's ROD that supports the decision to renew facility operating license Nos. NPF-72 and NPF-77 is available in ADAMS under Accession No. ML15322A317.
As discussed in the ROD and the final supplemental environmental impact statement (FSEIS) for Braidwood Station, Supplement 55 to NUREG-1437, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants Regarding Braidwood Station, Units 1 and 2,” issued in November 2015 (ADAMS Accession No. ML15314A814), the NRC considered a range of reasonable alternatives that included new nuclear generation, coal-integrated gasification combined cycle, natural gas combined-cycle (NGCC), combination (NGCC, wind, and solar generation), replacement power, and the no-action alternative. The ROD and FSEIS document the NRC's determination that the adverse environmental impacts of license renewal for Braidwood are not so great that preserving the option of license renewal for energy planning decision makers would be unreasonable.
Braidwood Station, Units 1 and 2, has two pressurized water reactors and is located in Will County, Illinois. The application for the renewed licenses, “License Renewal Application, Byron and Braidwood Stations, Units 1 and 2,” dated May 29, 2013 (ADAMS Accession Nos. ML13155A420 and ML13155A421), as supplemented by letters dated through April 13, 2015, with respect to Braidwood Station, complied with the standards and requirements of the Atomic Energy Act of 1954, as amended (AEA) and the NRC's regulations in Chapter I of title 10 of the
For further details with respect to this action, see: (1) Exelon Generation Company, LLC's (Exelon) license renewal application for Byron Station, Units 1 and 2, and Braidwood Station, Units 1 and 2, dated May 29, 2013, as supplemented by letters dated through April 13, 2015; (2) the NRC's safety evaluation report dated July 2015 (ADAMS Accession No. ML15182A051); (3) the NRC's final environmental impact statement (NUREG-1437, Supplement 55), for Braidwood, Units 1 and 2, published in November 2015; and (4) the NRC's ROD.
For the Nuclear Regulatory Commission,
On October 16, 2015, NYSE MKT LLC (the “Exchange” or “NYSE MKT”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to delete Rule 410B—Equities (“Rule 410B”), which sets forth certain regulatory reporting requirements for member or member organizations effecting off-Exchange transactions in Exchange listed securities that are not reported to the Consolidated Tape, and to make conforming amendments to Rule 476A to delete a reference to Rule 410B. The Exchange represents that Rule 410B is no longer necessary in light of changes in trade reporting and regulatory requirements that have been put in place since the Exchange adopted Rule 410B.
On July 30, 2007, the National Association of Securities Dealers, Inc. (“NASD”), New York Stock Exchange LLC (“NYSE”), and NYSE Regulation, Inc. (“NYSE Regulation”) consolidated their member-firm regulation operations to create the Financial Industry Regulatory Authority, Inc. (“FINRA”) and entered into a plan to allocate to FINRA regulatory responsibility for common rules and common members (“17d-2 Agreement”).
In 2008, the Exchange, NASD, NYSE, and NYSE Regulation also entered into a plan to allocate to FINRA regulatory responsibility, over exchange members that are also FINRA members, for surveillance, investigation, and enforcement of insider trading with respect to NYSE- and MKT-listed stocks, among others, irrespective of where the relevant trading occurred (the “Insider Trading Plan”).
In 1998, FINRA (then the NASD) established the Order Audit Trail System (OATS), as an integrated audit trail of order, quote, and trade information for OTC equity securities and equity securities listed and traded on The Nasdaq Stock Market, Inc. (“Nasdaq”).
According to the Exchange, Rule 410B also predates the establishment of a FINRA Trade Reporting Facility (“TRF”). FINRA Rule 6110 requires FINRA members to report transactions in NMS stocks
The Exchange proposes to delete Rule 410B in its entirety. The Exchange represents that, since 2010, surveillance and enforcement responsibilities across markets have been consolidated at FINRA, which conducts cross-market surveillances on the Exchange's behalf utilizing various data sources, including extensive trade and other information that FINRA collects pursuant to its rules. This trade information includes reports of off-exchange transactions.
The Exchange represents that all of its member organizations, with only nine exceptions, are members of FINRA and, as such, must report all off-exchange transactions to FINRA, including transactions away from the Exchange that are not reported to the Consolidated Tape. The Exchange further represents that this information is essentially duplicative of the Rule 410B reports the Exchange currently supplies to FINRA. The Exchange notes that one exception would be transactions in dually listed securities executed on and reported to a foreign securities exchange, which are not required to be reported because such trades are executed “on or through an exchange.”
The Exchange does not believe that eliminating the Rule 410B reporting requirement for the small number of NYSE MKT-only members
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act
Based on the Exchange's representations, the Commission believes that eliminating the Rule 410B reporting requirement will not reduce the amount of publicly available information about securities transactions and that it is not likely to hamper the ability of the Exchange to conduct regulatory oversight of its members. The Commission notes that Rule 410B does not currently provide for real-time, publicly disseminated reporting of transactions, but instead requires non-public, electronic reporting of trade data to the Exchange on a next-day basis for regulatory purposes only. The Commission further notes that the Exchange represents that its members would remain subject to federal and
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 the Options Regulatory Fee. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to decrease the Options Regulatory Fee (“ORF”) from $.0051 to $.0015 per contract in order to help ensure that revenue collected from the ORF, in combination with other regulatory fees and fines, does not exceed the Exchange's total regulatory costs. The proposed fee change would be operative on February 1, 2016.
The ORF is assessed by the Exchange to each Permit Holder for all options transactions executed or cleared by the Permit Holder that are cleared by The Options Clearing Corporation (“OCC”) in the customer range (
The ORF is designed to recover a material portion of the costs to the Exchange of the supervision and regulation of Permit Holder customer options business, including performing routine surveillances, investigations, examinations, financial monitoring, as well as policy, rulemaking, interpretive and enforcement activities. The Exchange believes that revenue generated from the ORF, when combined with all of the Exchange's other regulatory fees and fines, will cover a material portion, but not all, of the Exchange's regulatory costs. The Exchange notes that its regulatory responsibilities with respect to Permit Holder compliance with options sales practice rules have largely been allocated to FINRA under a 17d-2 agreement.
The Exchange will continue to monitor the amount of revenue collected from the ORF to ensure that it, in combination with its other regulatory fees and fines, does not exceed the Exchange's total regulatory costs. The Exchange monitors its regulatory costs and revenues at a minimum on a semi-annual basis. If the Exchange determines regulatory revenues exceed or are insufficient to cover a material portion of its regulatory costs, the Exchange will adjust the ORF by submitting a fee change filing to the Commission. The Exchange notifies Permit Holders of adjustments to the ORF via regulatory circular. The Exchange endeavors to provide Permit Holders with such notice at least 30 calendar days prior to the effective date of the change.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed fee change is reasonable because it would help the Exchange offset increased regulatory costs but would not result in total regulatory revenue exceeding total regulatory costs. Moreover, the Exchange believes the ORF ensures fairness by assessing higher fees to those Permit Holders that require more Exchange regulatory services based on the amount of customer options business they conduct. Regulating customer trading activity is much more labor intensive and requires greater expenditure of human and technical resources than regulating non-customer trading activity, which tends to be more automated and less labor-intensive. As a result, the costs associated with administering the customer component of the Exchange's overall regulatory program are materially higher than the costs associated with administering the non-customer component (
C2 does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, because it applies to all Permit Holders. The proposed ORF is comparable to fees charged by other options exchanges for the same or similar service. The Exchange believes any burden on competition imposed by the proposed rule change is outweighed by the need to help the Exchange adequately fund its regulatory activities to ensure compliance with the Exchange Act.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) 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 make minor changes to Rule 1064, Crossing, Facilitation and Solicited Orders.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the filing is to improve the readability of Rule 1064 with a few minor changes. Rule 1064 is lengthy and covers several complicated, related topics.
First, the Exchange proposes to add headings to certain paragraphs to make it easier to locate each of the following topics: Crossing,
Second, the Exchange also proposes to move the language from two commentaries into the body of the rule, also to improve readability. Specifically, the language in Commentary .03 is being moved to become the new Rule 1064(a)(iv), because it relates to crossing orders, which is covered in paragraph (a). Also, the language in Commentary .04 is being moved to become the new Rule 1064(d)(iii), which is related to the anticipatory hedging provisions currently in paragraph (d).
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. Because the proposal merely reorganizes a rule, it has no impact on either inter-market or intra-market competition.
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)
The Exchange proposes a rule change to reflect changes to the investment strategy for the PowerShares S&P 500® Downside Hedged Portfolio (the “Fund”). The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Commission previously approved listing and trading on the Exchange of shares (“Shares”) of the Fund, a series of the PowerShares Actively Managed Exchange-Traded Fund Trust (the “Trust”),
The Shares are offered by the Trust, a statutory trust organized under the laws of the State of Delaware and registered with the Commission as an open-end management investment company.
In this proposed rule change, the Exchange proposes to reflect changes to the investment strategy that the Adviser utilizes in seeking to achieve the Fund's investment objective, as described below.
The Prior Release stated that, according to the Registration Statement, the Fund is an actively managed exchange-traded fund that will seek to achieve positive total returns in rising or falling markets that are not directly correlated to broad equity or fixed income market returns. According to the Registration Statement, the Fund seeks to achieve its investment objective by using a quantitative, rules-based investment strategy designed to provide returns that correspond to the performance of the S&P 500 Dynamic VEQTOR Index (the “Benchmark”). The Registration Statement also stated that the allocation among the Fund's investments generally will approximate the allocation among the components of the Benchmark.
The Adviser now represents that, rather than employing a quantitative, rules-based strategy designed to provide returns that correspond to the performance of the Benchmark, the Fund will use a quantitative, rules-based strategy that is designed to outperform the Benchmark rather than match it.
The Adviser will continue to invest the Fund in the same instruments as are contained in the Benchmark, as discussed in the Prior Release. However, the Adviser now represents that the Fund will use portfolio management strategies in seeking to achieve its investment objective that allocate the Fund's assets in a manner that may not correspond to the Benchmark. The Adviser also now represents that, going forward, the Fund will seek to outperform the Benchmark rather than match it.
The Exchange notes that the Prior Release stated that, according to the Registration Statement, the Fund may invest a portion of its assets in high-quality money market instruments, cash, and cash equivalents to provide liquidity, to collateralize its futures contracts investments, or to track the Benchmark during times when the Benchmark moves its entire allocation to cash. The Exchange also proposes to change this representation to state that the Fund may invest a portion of its assets in high-quality money market instruments, cash, and cash equivalents to provide liquidity, to collateralize its futures contracts investments, or during periods of heightened volatility when the Adviser believes that it is in the best interest of the Fund to do so. Because the Fund, going forward, would seek to outperform rather than match the Benchmark, the Fund would no longer utilize high quality money market instruments, cash and cash equivalents for the purpose of tracking the Benchmark.
The Adviser represents that there is no change to the Fund's investment objective. The Fund will continue to invest in the securities and financial instruments identified in the Prior
Except for the changes noted above, all other facts presented and representations made in the Prior Release are unchanged.
The Fund will continue to comply with all initial and continued listing requirements under NYSE Arca Equities Rule 8.600.
All terms referenced but not defined herein are defined in the Prior Release.
The basis under the Act for this proposed rule change is the requirement under Section 6(b)(5)
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices. The proposed changes to the representations contained in the Prior Release are limited in scope. The Adviser is changing the representation in the Prior Release that the Fund will employ a quantitative, rules-based strategy designed to provide returns that correspond to the performance of the Benchmark, to a representation that the Fund will use a quantitative, rules-based strategy that is designed to outperform the Benchmark rather than seek returns comparable to it.
The Adviser represents that there is no change to the Fund's investment objective or to the securities and financial instruments identified in the Prior Release that the Fund utilizes in seeking to achieve its investment objective. The Fund's use of such securities and financial instruments will remain subject to the applicable allocation limitations identified in the Prior Release. The Fund will continue to comply with all initial and continued listing requirements under NYSE Arca Equities Rule 8.600.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that the Adviser represents that there is no change to the Fund's investment objective. The Adviser represents that the allocation of the Fund's portfolio will remain consistent with the allocation limitations discussed in the Prior Release, and that the Fund may invest in the same instruments as are contained in the Benchmark, as discussed in the Prior Release. However, the Adviser now represents that the Fund will use portfolio management strategies in seeking to achieve its investment objective that allocate the Fund's assets in a manner that may not correspond to the Benchmark. The Adviser also now represents that, going forward, the Fund will seek to outperform the Benchmark rather than match it.
As noted above, the Prior Release stated that, according to the Registration Statement, the Fund may invest a portion of its assets in high-quality money market instruments, cash, and cash equivalents to provide liquidity, to collateralize its futures contracts investments, or to track the Benchmark during times when the Benchmark moves its entire allocation to cash. The Exchange also proposes to change this representation to state that the Fund may invest a portion of its assets in high-quality money market instruments, cash, and cash equivalents to provide liquidity, to collateralize its futures contracts investments, or during periods of heightened volatility when the Adviser believes that it is in the best interest of the Fund to do so.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that the Fund will continue to comply with all initial and continued listing requirements under NYSE Arca Equities Rule 8.600. The proposed rule change will permit the Fund to operate in a manner similar to other issues of Managed Fund Shares that seek to outperform an index and will permit continued listing on the Exchange of the Fund after it begins to utilize the quantitative, rules-based strategy designed to outperform the Benchmark, which will enhance competition among issues of Managed Fund Shares currently trading on the Exchange. Except for the changes noted above, all other representations made in the Prior Release are unchanged.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed change will permit the Fund to operate in a manner similar to other issues of Managed Fund Shares that seek to outperform an index and will permit continued listing on the Exchange of the Fund after it begins to utilize the quantitative, rules-based strategy designed to outperform the Benchmark, which will enhance competition among issues of Managed Fund Shares.
No written comments were solicited or received with respect to the proposed rule change.
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, if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Chicago Board Options Exchange, Incorporated (the “Exchange” or “CBOE”) proposes to amend the Options Regulatory Fee. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to increase the Options Regulatory Fee (“ORF”) from $.0064 to $.0081 per contract in order to help ensure that revenue collected from the ORF, in combination with other regulatory fees and fines, meets the Exchange's total regulatory costs. The proposed fee change would be operative on February 1, 2016.
The ORF is assessed by the Exchange to each Trading Permit Holder for all options transactions executed or cleared by the Trading Permit Holder that are cleared by The Options Clearing Corporation (“OCC”) in the customer range (
The ORF is designed to recover a material portion of the costs to the Exchange of the supervision and regulation of Trading Permit Holder customer options business, including performing routine surveillances, investigations, examinations, financial monitoring, as well as policy, rulemaking, interpretive and enforcement activities. The Exchange believes that revenue generated from the ORF, when combined with all of the Exchange's other regulatory fees and fines, will cover a material portion, but not all, of the Exchange's regulatory costs. The Exchange notes that its regulatory responsibilities with respect to Trading Permit Holder compliance
The Exchange will continue to monitor the amount of revenue collected from the ORF to ensure that it, in combination with its other regulatory fees and fines, does not exceed the Exchange's total regulatory costs. The Exchange monitors its regulatory costs and revenues at a minimum on a semi-annual basis. If the Exchange determines regulatory revenues exceed or are insufficient to cover a material portion of its regulatory costs, the Exchange will adjust the ORF by submitting a fee change filing to the Commission. The Exchange notifies Trading Permit Holders of adjustments to the ORF via regulatory circular. The Exchange endeavors to provide Trading Permit Holders with such notice at least 30 calendar days prior to the effective date of the change.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed fee change is reasonable because it would help ensure that revenue collected from the ORF, in combination with other regulatory fees and fines, does not exceed the Exchange's total regulatory costs. Moreover, the Exchange believes the ORF ensures fairness by assessing higher fees to those Trading Permit Holders that require more Exchange regulatory services based on the amount of customer options business they conduct. Regulating customer trading activity is much more labor intensive and requires greater expenditure of human and technical resources than regulating non-customer trading activity, which tends to be more automated and less labor-intensive. As a result, the costs associated with administering the customer component of the Exchange's overall regulatory program are materially higher than the costs associated with administering the non-customer component (
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, because it applies to all Trading Permit Holders. The proposed ORF is comparable to fees charged by other options exchanges for the same or similar service. The Exchange believes any burden on competition imposed by the proposed rule change is outweighed by the need to help the Exchange adequately fund its regulatory activities to ensure compliance with the Exchange Act.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) 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)
The Exchange proposes to modify the NYSE Amex Options Fee Schedule (“Fee Schedule”). The Exchange proposes to implement the fee change effective February 1, 2016. The proposed change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The purpose of this filing is to implement a monthly credit available to Specialists to promote trading in Binary Return Derivatives (“ByRDs”),
To encourage trading of ByRDs, the Exchange proposes to offer an incentive to Specialists appointed to trade ByRDs.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed monthly credit is reasonable, equitable and not unfairly discriminatory for the following reasons. First, the proposed credit would generate additional order flow to the Exchange by creating incentives to quote and trade ByRDs options, which would benefit all market participants even those not eligible to receive the credit. The Exchange believes it is appropriate to offer the credit to Specialists (and not to other types of Market Makers) as the Specialists are subject to heightened continuous quoting obligations, which exceed those imposed on other Market Makers.
In addition, the Exchange has evaluated the market conditions, including the technology needs of Specialists appointed to options on ByRDs and believes the proposed monthly credit of $335 is reasonable, equitable and not unfairly discriminatory.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
To the extent that there is an additional competitive burden on market participants that are not eligible for the credit (
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
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. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
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)
The Exchange proposes to amend the NYSE MKT Company Guide (the “Company Guide”) to create a new Section 146 under which a certain category of newly listed issuers would be entitled to receive complimentary products and services from the Exchange. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of,
The Exchange proposes to amend the Company Guide to create a new Section 146 under which a certain category of newly listed issuers would be entitled to receive complimentary products and services from the Exchange. The Exchange proposes to offer such complimentary products and services for a period of 24 calendar months from the date of initial listing to (i) any U.S. company that lists common stock on the Exchange for the first time and any non-U.S. company that lists an equity security
Historically, the Exchange has served as an alternative listing venue to the New York Stock Exchange (the “NYSE”) for small capitalization companies unable to meet the NYSE's heightened initial listing standards. In this respect, the Exchange regularly competes with the Nasdaq Capital Market tier of the Nasdaq Stock Market and, in some cases, with the Nasdaq Global Market tier of the Nasdaq Stock Market. Like the Exchange, Nasdaq Capital Market and Nasdaq Global Market each have initial listing standards that can more readily accommodate small capitalization companies than the NYSE. The Exchange hopes in the future to compete for new listings to a greater degree with the Nasdaq Global Market. One way that the exchanges compete with each other is to offer companies services that aid their transition to being public or listed on a new exchange. For example, the Nasdaq Global Market currently offers newly listed companies the following services for a period of 24 calendar months following their listing: whistleblower hotline, investor relations Web site, press releases, interactive webcasting and market analytic tools.
To enable it to compete for listings with the Nasdaq Global Market, the Exchange proposes to offer Eligible New Listings Web-hosting products and services (with a commercial value of approximately $16,000 annually), web-casting services (with a commercial value of approximately $6,500 annually), whistleblower hotline services (with a commercial value of approximately $4,000 annually), news distribution products and services (with a commercial value of approximately $20,000 annually) and corporate governance tools (with a commercial value of approximately $15,000 annually) for a period of 24 calendar months from the date of initial listing on the Exchange.
The Exchange believes that each of the services it proposes to offer to Eligible New Listings on the Exchange may be valuable to companies that are listing publicly for the first time or transferring their listing to the Exchange. Web-hosting products and services assist Eligible New Listings in engaging with their shareholders by providing them with a Web site that contains business content that can be viewed by investors. Similarly, web-casting services are an important tool utilized by listed companies to communicate with shareholders in connection with their quarterly earnings release process. A whistleblower hotline assists Eligible New Listings in complying with, among other things, the requirements of the Sarbanes-Oxley Act, Foreign Corrupt Practices Act and UK Bribery Act. News distribution products and services assist Eligible New Listings in complying with Exchange disclosure requirements. Lastly, corporate governance tools will help educate the board of directors of each Eligible New Listing about corporate governance best practices.
The Exchange proposes to codify in the new Section 146 of the Company Guide that all companies listed on the Exchange are entitled to certain complimentary products and services via the Exchange's Market Access Center. The Market Access Center is a market information analytics platform that is a combination of technology-enabled market intelligence insight and a team of highly skilled market professionals. The platform was created to provide issuers with better market insight and information across all exchanges and trading venues. The Market Access Center includes products and services that were (i) developed by the Exchange using proprietary data and/or intellectual property or (ii) built by a third-party expressly for the Exchange's listed companies. Within this platform all issuers have access to tools and information related to market intelligence, education, investor outreach, media visibility, corporate governance, and advocacy initiatives. For example, the Market Access Center offers daily trading summaries; a trading alert system highlighting user-defined trading or market events; a Web site featuring timely content for Exchange-listed senior executives featuring trading information, market data, and institutional ownership. All issuers listed on the Exchange have access to the Exchange's Market Access Center on the same basis. The products and services currently available through the Exchange's Market Access Center have a commercial value of approximately $50,000.
The specific tools and services offered by the products discussed herein will be developed by the Exchange or by third-party vendors. NYSE Governance Services
The Exchange believes that companies listing on the Exchange for the first time often require a period of time after listing to complete the contracting and training process with vendors providing the complimentary products and services. Therefore, many companies are not able to begin using the suite of products offered to them immediately on the date of listing. To address this issue, the Exchange proposes to specify in Section 146 that if an Eligible New Listing begins using a particular service within 30 days after the date of listing, the complimentary period begins on such date of first use. In all other instances, the complimentary period will begin on the listing date.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that it is reasonable to offer complimentary products and services to attract new listings and respond to competitive pressures. The Exchange faces competition in the market for listing services and it competes, in part, by improving the quality of the services that it offers to listed companies. By offering products and services on a complimentary basis and ensuring that it is offering the services most valued by its listed issuers, the Exchange will improve the quality of the services that listed companies receive.
The Exchange believes it is appropriate to offer a package of complimentary products and services to Eligible New Listings because such services will ease the transition of companies that are becoming public for the first time or transferring their listing to a new exchange. Further, Nasdaq offers a comparable suite of complimentary products and services to new listings and transfers and the proposed rule change will enable the Exchange to more effectively compete for listings.
Allowing companies up to 30 days after their listing to start using the complimentary products and services is a reflection of the Exchange's experience that it can take companies a period of time to review and complete necessary contracts and training for services following their listing. Allowing this modest 30 day period, if the company needs it, helps ensure that the company will have the benefit of the full period permitted under the rule to actually use the services, thus giving companies the full intended benefit.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change enables the Exchange to compete for listings by offering Eligible New Listings a package of complimentary products and services that assist their transition to being publicly listed for the first time or transferring their listing to the Exchange. All similarly situated companies are eligible for the same package of services. Further, the Exchange notes that the Nasdaq Global Market already offers a similar suite of complimentary products and services to companies initially listing or transferring their listing from the New York Stock Exchange to its market. Therefore, the proposed creation of Section 146 of the Company Guide will increase competition by enabling the Exchange to more effectively compete for listings.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be 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 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 ISE proposes to amend the Schedule of Fees to rename its Payment for Order Flow program. The text of the proposed rule change is available on the Exchange's Web site (
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 administers a payment for order flow (“PFOF”) program that helps Market Makers
The Exchange assesses an administrative fee of 0.45% on the total amount of the funds collected each month.
The Exchange believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On October 16, 2015, New York Stock Exchange LLC (“NYSE” or the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to delete Rule 410B, which sets forth certain regulatory reporting requirements for member or member organizations effecting off-Exchange transactions in Exchange listed securities that are not reported to the Consolidated Tape, and to make conforming amendments to Rule 476A to delete a reference to Rule 410B. The Exchange represents that Rule 410B is no longer necessary in light of changes in trade reporting and regulatory requirements that have been put in place since the Exchange adopted Rule 410B.
On July 30, 2007, the National Association of Securities Dealers, Inc. (“NASD”), NYSE, and NYSE Regulation, Inc. (“NYSE Regulation”) consolidated their member firm
In 2008, the Exchange, NASD, NYSE MKT LLC (“NYSE MKT”), and NYSE Regulation also entered into a plan to allocate to FINRA regulatory responsibility, over exchange members that are also FINRA members, for surveillance, investigation, and enforcement of insider trading with respect to NYSE- and MKT-listed stocks, among others, irrespective of where the relevant trading occurred (the “Insider Trading Plan”).
In 1998, FINRA (then the NASD) established the Order Audit Trail System (OATS), as an integrated audit trail of order, quote, and trade information for OTC equity securities and equity securities listed and traded on The Nasdaq Stock Market, Inc. (“Nasdaq”).
According to the Exchange, Rule 410B also predates the establishment of a FINRA Trade Reporting Facility (“TRF”). FINRA Rule 6110 requires FINRA members to report transactions in NMS stocks
The Exchange proposes to delete Rule 410B in its entirety. The Exchange represents that, since 2010, surveillance and enforcement responsibilities across markets have been consolidated at FINRA, which conducts cross-market surveillances on the Exchange's behalf utilizing various data sources, including extensive trade and other information that FINRA collects pursuant to its rules. This trade information includes reports of off-exchange transactions.
The Exchange represents that all of its member organizations, with only nine exceptions, are members of FINRA and, as such, must report all off-exchange transactions to FINRA, including transactions away from the Exchange that are not reported to the Consolidated Tape. The Exchange further represents that this information is essentially duplicative of the Rule 410B reports the Exchange currently supplies to FINRA. The Exchange notes that one exception would be transactions in dually listed securities executed on and reported to a foreign securities exchange, which are not required to be reported because such trades are executed “on or through an exchange.”
The Exchange does not believe that eliminating the Rule 410B reporting requirement for the small number of NYSE-only members
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act
Based on the Exchange's representations, the Commission believes that eliminating the Rule 410B reporting requirement will not reduce the amount of publicly available information about securities transactions and that it is not likely to hamper the ability of the Exchange to conduct regulatory oversight of its members. The Commission notes that Rule 410B does not currently provide for real-time, publicly disseminated reporting of transactions, but instead requires non-public, electronic reporting of trade data to the Exchange on a next-day basis for regulatory purposes only. The Commission further notes that the Exchange represents that its members would remain subject to federal and Exchange books-and-records requirements
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form N-8F (17 CFR 274.218) is the form prescribed for use by registered investment companies in certain circumstances to request orders of the Commission declaring that the registration of that investment company cease to be in effect. The form requests information about: (i) The investment company's identity, (ii) the investment company's distributions, (iii) the investment company's assets and liabilities, (iv) the events leading to the request to deregister, and (v) the conclusion of the investment company's business. The information is needed by the Commission to determine whether an order of deregistration is appropriate.
The Form takes approximately 5.2 hours on average to complete. It is estimated that approximately 150 investment companies file Form N-8F annually, so the total annual burden for the form is estimated to be approximately 780 hours. The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act and is not derived from a comprehensive or even a representative survey or study.
The collection of information on Form N-8F is not mandatory. The information provided on Form N-8F is not kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently-valid OMB control number.
The public may view the background documentation for this information collection at the following Web site,
On December 7, 2015, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange currently conducts Trading Halt Auctions under Exchange Rule 7.35(f).
According to the Exchange, on August 24, 2015, it applied price collar thresholds to Trading Halt Auctions that were 5% for securities with a consolidated last sale price of $25.00 or less, 2% for securities with a consolidated last sale price greater than $25.00 but less than or equal to $50.00, and 1% for securities with a consolidated last sale price greater than $50.00.
Proposed new Rule 1.1(s)(B) would provide that, when the Trading Halt Auction Price is established by Rule 7.35(f)(4)(A), the Limit Orders eligible for determining the Indicative Match Price would be limited by specified price collar thresholds away from the last consolidated sale price before the Trading Halt Auction.
In the proposal, the Exchange represents that it will be conducting an analysis to identify what changes, if any, would be appropriate to balance the need to allow for natural price movement in a Trading Halt Auction, while at the same time avoiding significant price deviations that would not be in line with the fair value of securities listed on the Exchange, which are all Exchange Traded Products.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
As noted above, the Commission received three comment letters on the proposed rule change.
The Commission believes that the proposed rule change, which would widen the Exchange's price collar thresholds for Trading Halt Auctions, is appropriate as an interim measure to protect investors and the public interest.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On November 25, 2015, NASDAQ OMX PHLX LLC (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change as well as the report of pilot data submitted by the Exchange in support of its proposal. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Department of State.
Notice.
The U.S. Department of State's Bureau of Political-Military Affairs' Defense Trade Advisory Group (DTAG) is accepting membership applications. The Bureau of Political-Military Affairs is interested in applications from subject matter experts from the United States defense industry, relevant trade and labor associations, academic, and foundation personnel.
The DTAG was established as an advisory committee under the authority of 22 U.S.C. 2651a and 2656 and the Federal Advisory Committee Act, 5 U.S.C. App. (“FACA”). The purpose of the DTAG is to provide the Bureau of Political-Military Affairs with a formal channel for regular consultation and coordination with U.S. private sector defense exporters and defense trade organizations on issues involving U.S. laws, policies, and regulations for munitions exports. The DTAG advises the Bureau on its support for and regulation of defense trade to help ensure that impediments to legitimate exports are reduced while the foreign policy and national security interests of the United States continue to be protected and advanced in accordance with the Arms Export Control Act (AECA), as amended. Major topics addressed by the DTAG include (a) policy issues on commercial defense trade and technology transfer; (b) regulatory and licensing procedures applicable to defense articles, services, and technical data; (c) technical issues involving the U.S. Munitions List (USML); and (d) questions relating to actions designed to carry out the AECA and International Traffic in Arms Regulations (ITAR).
Members are appointed by the Assistant Secretary of State for Political-Military Affairs on the basis of individual substantive and technical expertise and qualifications, and must be representatives of United States defense industry, relevant trade and labor associations, academic, and foundation personnel. In accordance with the DTAG Charter, all DTAG members must be U.S. citizens, and DTAG members will represent the views of their organizations. All DTAG members shall be aware of the Department of State's mandate that arms transfers must further U.S. national security and foreign policy interests. DTAG members also shall be versed in the complexity of commercial defense trade and industrial competitiveness, and all members must be able to advise the Bureau on these matters. While members are expected to use their expertise and provide candid advice, national security and foreign policy interests of the United States, as well as the interests of the entities they represent, shall be the bases for all policy and technical recommendations.
DTAG members' responsibilities include:
• Service for a consecutive two-year term which may be renewed or terminated at the discretion of the Assistant Secretary of State for Political-Military Affairs (membership shall automatically terminate for members who fail to attend two consecutive DTAG plenary meetings).
• Making recommendations in accordance with the DTAG Charter and the FACA.
• Making policy and technical recommendations within the scope of the U.S. commercial export control regime as mandated in the AECA, the ITAR, and appropriate directives.
Please note that DTAG members may not be reimbursed for travel, per diem, and other expenses incurred in connection with their duties as DTAG members. How to apply: Applications in response to this notice must contain the following information: (1) Name of applicant; (2) affirmation of U.S. citizenship; (3) organizational affiliation and title, as appropriate; (4) mailing address; (5) work telephone number; (6) email address; (7) résumé; and (8) summary of qualifications for DTAG membership.
This information may be provided via two methods:
• Emailed to the following address:
• Send in hardcopy to the following address: Mr. Glenn Smith, PM/DDTC, SA-1, 12th Floor, Directorate of Defense Trade Controls, Bureau of Political
All applications must be postmarked by March 7, 2016.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to March 4, 2016.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Sumitra Siram, Sumitra Siram, Program Officer, Department of State, Bureau of Population, Refugees and Migration, Office of Admissions, 2025 E Street NW., Washington, DC 20522 who may be reached on 202-453-9250 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Form DS-234 is being added to this collection to elicit information used to determine the eligibility of Iraqis and Afghan nationals applying for special immigrant visas.
The SIV Biodata information form (DS-234) is submitted electronically by the applicant to the National Visa Center, which will forward the forms to the Refugee Processing Center of the Bureau of Population, Refugees and Migration.
The Advisory Committee on International Economic Policy (ACIEP) will meet from 2 until 5 p.m., on Wednesday, February 17, in Washington, DC at the State Department, 320 21st Street NW. in conference room 4477. The meeting will be hosted by the Assistant Secretary of State for Economic and Business Affairs, Charles H. Rivkin and Committee Chair Paul R. Charron. The ACIEP serves the U.S. government in a solely advisory capacity, and provides advice concerning topics in international economic policy. It is expected that the ACIEP subcommittees will provide updates on their work.
This meeting is open to public participation, though seating is limited. Entry to the building is controlled. To obtain pre-clearance for entry, members of the public planning to attend should no later than Friday, February 12, provide their full name and professional affiliation to Alan Krill by email:
This announcement might appear in the
For additional information, contact Alan Krill, Office of Economic Policy Analysis and Public Diplomacy, Bureau of Economic and Business Affairs, at (202) 647-0812, or
Federal Highway Administration (FHWA), DOT.
Notice of Limitation on Claims for Judicial Review of Actions by the California Department of Transportation (Caltrans), pursuant to 23 U.S.C. 327.
The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans, that are final within the meaning of 23 U.S.C. 139(
By this notice, the FHWA, on behalf of Caltrans, is advising the public of final agency actions subject to 23 U.S.C. 139(
For Caltrans: Sue Bauer, Branch Chief, Caltrans Office of Environmental Management, M-1, California Department of Transportation, 703 B Street, Marysville, CA 95901, Office Hours: 8:00 a.m.-5:00 p.m., Pacific Standard Time, Telephone (530) 741-7113, Email:
Effective July 1, 2007, the Federal Highway Administration (FHWA) assigned, and the California Department of Transportation (Caltrans) assumed, environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that the Caltrans has taken final agency actions subject to 23 U.S.C. 139(
The City of Rancho Cordova, in cooperation with the California Department of Transportation, proposes to widen and construct improvements to White Rock Road from Sunrise Boulevard to Grant Line Road. Improvements to the existing six-lane portion of White Rock Road from Sunrise Boulevard to Luyung Drive include restriping and additional pavement for the addition of a second westbound through lane on the east leg of the Fitzgerald Road/Sunrise Park Drive intersection with White Rock Road. White Rock Road will be reconstructed and widened from two lanes to four lanes from Luyung Drive to Grant Line Road. The Federal ID number for the roadway widening project is STPLCM 5482 (013).
The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Final Environmental Assessment (FEA)/Finding of No Significant Impact (FONSI) for the project, approved on January 26, 2016, and in other documents in the FHWA project records. The FEA, FONSI and other project records are available by contacting Caltrans at the addresses provided above. The Caltrans FEA, FONSI and other project records can be viewed and downloaded from the project Web site at
This notice applies to all 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:
23 U.S.C. 139(
Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review of actions by the California Department of Transportation (Caltrans), pursuant to 23 U.S.C. 327.
The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans that are final within the meaning of 23 U.S.C. 139(
By this notice, the FHWA, on behalf of Caltrans, is advising the public of final agency actions subject to 23 U.S.C. 139(
For Caltrans: David Nagy, Chief, Environmental Branch B, California Department of Transportation—District 11, 4050 Taylor Street, San Diego, CA 92110, 8 a.m. to 5 p.m., 619-688-0224,
Effective July 1, 2007, the Federal Highway Administration (FHWA) assigned, and the California Department of Transportation (Caltrans) assumed, environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that the Caltrans, have taken final agency actions subject to 23 U.S.C. 139(
1. Council on Environmental Quality regulations;
2. National Environmental Policy Act (NEPA);
3. Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU);
4. Department of Transportation Act of 1966;
5. Federal Aid Highway Act of 1970;
6. Clean Air Act Amendments of 1990;
7. Noise Control Act of 1970;
8. 23 CFR part 772 FHWA Noise Standards, Policies and Procedures;
9. Department of Transportation Act of 1966, Section 4(f);
10. Clean Water Act of 1977 and 1987;
11. Endangered Species Act of 1973;
12. Migratory Bird Treaty Act;
13. Uniform Relocation Assistance and Real Property Acquisition Act of 1970;
14. National Historic Preservation Act of 1966, as amended;
15. Historic Sites Act of 1935;
16. Executive Order 11990, Protection of Wetlands
17. Executive Order 13112, Invasive Species; and,
18. Executive Order 11988, Floodplain Management.
23 U.S.C. 139(
In accordance with part 211 of title 49 of the Code of Federal Regulations (CFR), this document provides the public notice that by a document dated September 22, 2015, Amtrak has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 238—Passenger Equipment Safety Standards. FRA assigned the petition Docket Number FRA-2016-0003.
Amtrak seeks a temporary waiver of compliance from the requirements of 49 CFR 238.125—
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by March 21, 2016 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with part 235 of Title 49 of the Code of Federal Regulations (CFR) and Title 49 U.S.C. 20502(a), this
UP seeks approval of the discontinuance of Hold Signal Y077 at Milepost (MP) 77.50 and the removal of the coded track in Yard Lead 202 on the Geneva Subdivision in the State of Illinois.
The reason given for the proposed discontinuance is to allow and facilitate yard switching operations on the affected trackage, which are necessary to maintain fluid operation.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by March 21, 2016 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
In accordance with part 235 of title 49 Code of Federal Regulations (CFR) and 49 U.S.C. 20502(a), this document provides the public notice that by a document dated October 22, 2015, Union Pacific Railroad (UP) petitioned the Federal Railroad Administration (FRA) seeking approval for the discontinuance or modification of a signal system. FRA assigned the petition Docket Number FRA-2016-0004.
UP seeks approval to modify Control Point (CP) B002 on the Omaha Subdivision in the State of Iowa by dividing it into two CP's, CP B902 and CP B002. The reason given for the proposed modification is to accommodate a U.S. Department of Transportation (DOT) project to widen Interstate 29, as well as to facilitate yard operations and expedite train movements in the area. The modification will involve the relocation of most signals and some changes in signal aspects currently in service.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by March 21, 2016 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Federal Transit Administration (FTA), DOT.
Notice; request for comments on updates to the USOA and changes to the NTD reporting requirements.
The Federal Transit Administration is updating the Uniform System of Accounts (USOA). The proposed updates are prompted by the outdated nature of the 1995 USOA. FTA is seeking public comment on these proposed changes before releasing the updated USOA and implementing the associated changes to 49 U.S.C. 5335, National Transit Database.
Comments must be received by April 4, 2016. Any comments filed after this deadline will be considered to the extent practicable.
Please submit your comments by only one of the following methods, identifying your submission by Docket Number FTA-2016-0009
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Margaret Schilling, National Transit Database Program Manager, Office of Budget and Policy, (202) 366-2054, or email:
The National Transit Database (NTD) is the Federal Transit Administration's (FTA) primary database for statistics on the transit industry. Congress established the NTD to “help meet the needs of . . . the public for information on which to base public transportation service planning . . .” (49 U.S.C 5335). Currently, 821 transit providers in urbanized areas report to the NTD through its online reporting system. Each year, performance data from these submissions are used to apportion over $7 billion of FTA funds for Urbanized Area Formula (section 5307) grants, Rural Area Formula (section 5311) grants, Tribal Transit Formula grants, Bus and Bus Facilities Formula (section 5339) grants, and State of Good Repair (section 5337) grants. The data is made available on the NTD Web site at
This notice proposes changes to the USOA that impact NTD reporting requirements. FTA proposes that changes A-J below take effect starting with the FY17 data reporting cycle. Change K below, the revised APC certification policy, would take effect when changes are proposed in the
Additionally, this notice proposes the following changes to the NTD reporting requirements that are not directly addressed in the updated USOA:
Finally, FTA seeks comments on the decision to not require a separate non-add item for police force expenses.
Currently, the NTD category “Passenger Fares” includes both directly paid fares collected via standard methods such as a farebox or purchase of monthly passes and less direct fares—for example, where a university pays the transit agency to provide fare-free service to students. This combination of revenue sources has been confusing to some reporters.
In order to address these issues and clarify reporting requirements, FTA proposes the separation of Passenger Fares into two categories: “Passenger-Paid Fares” and “Organization-Paid Fares.” Traditional fare revenue would be captured as “Passenger-Paid Fares”, while other “farelike” revenue would be “Organization-Paid Fares.” This proposed update provides additional insight into the sources of revenues and helps the reporters identify peers with similar operating models.
Currently the NTD includes employees' paid absences,
In order to resolve this discrepancy, FTA proposes the creation of a new category “Paid Absences.” This category would be further divided between operators and non-operators, to align with the way salaries and wages are reported in NTD. FTA considered simply moving paid absences from “Fringe Benefits” to “Salaries and Wages,” but did not propose this change because it would produce a discontinuity in the data over time.
Currently the NTD captures “Casualty and Liability Costs” expenses under three functions: Vehicle Maintenance, Non-Vehicle Maintenance, and General Administration. However, these expenses are reported under these functions inconsistently across reporters. Some reporters divide the expenses among the three functions according to the type of expense, while others report all “Casualty and Liability Costs” under General Administration.
Due to the intricacy and variety of expenses classified as “Casualty and Liability Costs,” it may be impractical to provide classifications for all possible “Casualty and Liability Costs” by function. Therefore, FTA proposes that reporters consolidate all “Casualty and Liability Costs” under the General Administration function. While this would produce a one-time discontinuity in the data for some reporters, it would improve comparability of data across reporters in the future and reduce reporting burden.
The current F-60 Statement of Finances form was instituted with the purpose of providing a transit agency's financial status at a glance. However the required fields in the current form do not provide a comprehensive insight into the agency's financial status. Its limited nature makes it only marginally useful for this purpose while creating confusion for reporters in determining what information to report.
FTA proposes expanding the form to resemble an agency's published balance sheet at the summary level. FTA initially considered requiring agencies to upload their published balanced sheets to NTD but decided against this because it would not provide uniform categories with which to facilitate fair peer comparisons and calculation of financial metrics. FTA proposes the following categories:
○ Current Assets
The existing USOA did not provide guidance on how agencies should report transaction in which an entity does not receive equal return for what it provides. For example, if one agency constructs a new fixed rail line and transfers ownership to another agency, this transaction is called a “Voluntary Non-Exchange Transaction.”
FTA proposes the addition of revenue and expense fields for “Voluntary Non-Exchange Transactions” on the F-10 Sources of Funds: Non-Added Revenue and F-40 Operating Expenses Summary and Reconciling Items forms. The reporter providing the asset or service would record the value of the asset as a reconciling item expense, while the receiving reporter would record its value as non-added revenue, which means it would not be included in the reporter's revenue total alongside cash revenues like fares, local funds, and federal grants. This would provide explanation for the sudden decrease/increase in assets.
Currently, the USOA includes funds received from selling or disposing capital assets in directly generated funds. In most cases this activity is not considered a revenue, since the agency is simply converting an asset from one form to another (
All State funding comes either from the General Fund or the Transportation Fund. Currently, the NTD requires transit agencies to report the Transportation Fund at the original dedicated sources of funds level such as fuel taxes, income taxes, and vehicle registration fees. However, it has proved impractical for reporters to separate their Transportation Funds into these categories, since the proportion of the Transportation Funds provided by each funding source changes from year to year, and in many cases, occurs before the funding ever reaches the transit agency.
FTA proposes to consolidate all Dedicated Funds and Other Funds under the State section on the F-10 Sources of Funds form into a single category called “State Transportation Funds.” Rather than gathering inaccurate or inconsistent data, NTD will simply collect whether state funding comes from the General Fund or the Transportation Fund.
At present, the B-30 Contractual Relationship form requires agencies to perform counterintuitive calculations and report data in fields with names that are difficult to understand. As a result, agencies may report inaccurate and inconsistent data into the NTD and data users have difficulty interpreting NTD data.
FTA proposes to have three different versions of this form, customized based on whether the fare revenues are retained by the contractor or by the reporter, and whether the purchased transportation mode is Vanpool. The customized forms will reduce confusion regarding the calculation that must be performed to report data into the form.
In the new scheme, there would be separate versions of the form for the case where the contractor retains the fare revenue, and the case where the agency retains the fare revenue. The reporter would complete fields called “Purchased Transportation Fare Revenue,” “Direct Payment,” “Capital Leasing,” “Other Operating Expenses Incurred by the Buyer,” and “Other Reconciling Item Expenses Incurred by the Buyer.”
In addition, FTA proposes that Vanpool mode should have its own version of the B-30 form. This will reflect the ways Vanpool contracts usually differ from other purchased transportation contracts. Vanpool reporters would complete fields called “Passenger Fees,” “Passenger Out-of-Pocket Expenses,” “Agency Subsidy,” “Capital Leasing,” “Other Operating Expenses Incurred by the Buyer,” and “Other Reconciling Item Expenses Incurred by the Buyer.”
On the F-30 Operating Expenses form, NTD collects data on salaries and wages for operators and non-operators separately. However, on the R-10 Employees form, NTD currently collects data on hours worked and employee counts for these categories combined.
FTA proposes that NTD collect data on hours worked and employee counts for operators and non-operators separately. This would allow calculation of separate wage rates and hours per employee for these two categories, which would be useful data to any user interested in labor costs. The data should be readily available in most agencies' payroll systems and thus a marginal increase in burden.
Currently FTA requires NTD reporters to undergo a one-time auditor's review at the commencement of reporting. The agency must file an Independent Auditor's Statement for Financial Data. The purpose of this review is to ensure that the reporter is equipped to report to the NTD according to FTA's requirements, using accrual accounting and the USOA. There is currently little guidance on when, if ever, an agency must obtain a new Auditor's Statement. In addition, Reduced Reporters (Small Systems) are not required to perform this review.
FTA proposes that Reduced Reporters be required to undergo this review, and further, that all NTD reporters be required to undergo a new review once every ten years. This would provide additional confidence that all reporters are conforming to FTA's reporting requirements. Due to the limited nature and infrequency of this review, this new requirement should not be overly burdensome to reporters.
The NTD requires the reporting of ridership data, both unlinked passenger trips (UPT) and passenger miles traveled (PMT), by mode and type of service. These two data items are important measures of service consumed and are used by many analysts to assess the effectiveness of transit services. PMT is also used in the annual formula allocation of federal transit funds for the Urbanized Area Formula Program (§ 5307) and the Bus and Bus Facilities Grants (§ 5339).
Some transit agencies use automatic passenger counters (APCs) for collecting UPT and PMT. This requires prior FTA approval. If a transit agency fails to obtain FTA approval in advance, the NTD will not accept the reported APC-derived data.
In the current certification process FTA requires agencies to submit the following plans:
• An APC benchmarking plan for the first year and,
• AN APC maintenance plan for subsequent years.
The APC benchmarking plan must include a validation of the APC measuring process for UPT and PMT data against a separate manual sample covering a full year. The maintenance plan includes an annual checkup to insure that the APC system continues to function correctly.
We propose to revise the certification requirements for new APC systems and for maintenance testing of all APC systems. FTA believes that APC technologies have advanced to the point where they produce better data than sampling with manual counts and, as such, we no longer need the extensive comparisons we have required in the past. The goal of the new certification procedures proposed here is to insure that APC data collection systems are implemented correctly while reducing the time and effort required for reporters to demonstrate this.
We propose to revise the benchmarking test by eliminating the full year comparison of manual and APC counts on randomly-selected trips and replacing it with a more comprehensive comparison of a much smaller number of trips. Reporters with fewer than 30 APC-equipped vehicles would need to evaluate fifteen trips. Reporters with more than 30 APC-equipped vehicles would need to evaluate a number of trips equivalent to half their number of APC-equipped vehicles, up to a maximum of 50 trips. The trips selected for evaluation must meet the following requirements:
• The trips must include some of the reporter's heaviest passenger loads,
• The trips must be distributed over as much of the agency's fleet of APC-equipped vehicles as possible, and
• Manual and APC data sets must be collected for each trip.
Trips do not have to be selected randomly. They can be spread over any convenient period of time. They no longer need to be distributed over an entire year.
Manual counts can be made using data collection staff or on-board cameras. To insure accurate counts we recommend using a data collector at each door on heavily-loaded trips. APC data should be processed to correct for anomalies as it would be in the reporter's normal data collection process. The objective is to compare manually-collected data with processed APC data and demonstrate that they are equivalent or that any differences are justifiable.
Reporters would be required to analyze the manual and APC data on a side-by-side basis to identify and explain inconsistencies. APC and manual counts of passengers getting on and off at each stop should be compared for each trip. FTA may ask to see this data as part of our certification review. A report on the results of the analysis must be submitted to FTA with the certification request. This report would include:
• Description of the APC system(s) used,
• Description of the benchmarking procedure,
• Description of trips that were eliminated due to APC data that failed diagnostic tests,
• Comparison of distances between stops used by the two methods,
• Passenger count comparison (% difference),
• Passenger miles comparison (% difference), and
• Calculation of
FTA would certify APC systems where the passenger count comparison, passenger mile comparison, and unbalanced error over all benchmark trips are each less than five percent (5%). Reporters that file a reduced report (formerly called a small systems waiver) do not need to meet the standards for passenger miles or unbalanced error.
We propose to eliminate the maintenance plan requirement and replace it with a repetition of the benchmarking test in every fiscal year that is evenly divisible by three. APC systems already approved for NTD reporting would need to be retested in the next fiscal year that is evenly divisible by three.
Transit agencies that collect this ridership data on all (>98 percent) of their vehicle trips may correct for missing trips using average values. However, if the vehicle trips with missing data exceed two percent (2%) of all trips, agencies would need to have a qualified statistician approve the correction (or expansion) method. This is consistent with our treatment of manual counting methods and does not represent a change in policy. Thus an agency that does not have a fleet that is fully-equipped with APCs could use APC data in any NTD-approved sampling plan.
Additionally, FTA considered requiring transit systems to report their police force expense as a separate non-add item in the F-30 Operating Expenses form in addition to reporting it in the appropriate operating expense object classes (
FTA thanks our stakeholders in advance for providing comment on the above proposed changes to the NTD reporting requirement.
Bureau of Transportation Statistics (BTS), Office of the Assistant Secretary for Research and Technology (OST-R), DOT.
Notice and request for comments.
In accordance with the requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, this notice announces the intention of the BTS to request the Office of Management and Budget's (OMB's) approval for an information collection related to the nation's ferry operations. The information collected will be used to produce a descriptive database of existing ferry operations. A summary report of survey findings will also be published by BTS on the BTS Web page.
Comments must be submitted on or before April 4, 2016.
You may submit comments identified by DOT Docket ID Number DOT-OST-2016-0007 to the U.S. Department of Transportation (DOT), Dockets Management System (DMS). You may submit your comments by mail or in person to the Docket Clerk, Docket No., U.S. Department of Transportation, 1200 New Jersey Ave. SE., West Building, Room W12-140, Washington, DC 20590. Comments should identify the docket number as indicated above.
Paper comments should be submitted in duplicate. The DMS is open for examination and copying, at the above address, from 9 a.m. to 5 p.m., Monday through Friday, except federal holidays. If you wish to receive confirmation of receipt of your written comments, please include a self-addressed, stamped postcard with the following statement: “Comments on Docket DOT-OST-2016-0007.”
The Docket Clerk will date stamp the postcard prior to returning it to you via the U.S. mail. Please note that due to delays in the delivery of U.S. mail to Federal offices in Washington, DC, we recommend that persons consider an alternative method (the Internet, fax, or professional delivery service) to submit comments to the docket and ensure their timely receipt at U.S. DOT. You may fax your comments to the DMS at (202) 493-2251. Comments can also be viewed and/or submitted via the Federal Rulemaking Portal:
Please note that anyone is able to electronically search all comments received into our docket management system 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
Janine L. Bonner, (202) 366-2468, NCFO Project Manager, BTS, OST-R, Department of Transportation, 1200 New Jersey Ave. SE., Room E34-411, Washington, DC 20590. Office hours are from 8:00 a.m. to 5:30 p.m., E.T., Monday through Friday, except Federal holidays.
BTS conducted the first Census of Ferry Operators in 2006. The Census was conducted again in 2008, 2010, 2014, and will be again in spring 2016. These information collections were originally approved by OMB under Control Number 2139-0009. The recently enacted FAST Act legislation [Fixing America's Surface Transportation Act (Pub. L. 114-94, sec. 1112)] continues the BTS mandate to conduct the NCFO on a biennial basis, and extended the requirement that the Federal Highway Administration (FHWA) use the NCFO data to set the specific formula for allocating federal ferry funds based on a percentage of the number of passenger boardings, vehicle boardings, and route miles served. The overall length of the revised questionnaire for the 2018 NCFO will remain consistent with that of previous years. The survey will be administered to the entire population of ferry operators (estimate 260 or less). The survey will request the respondents to provide information such as: the points served; the type of ownership; the number of passengers and vehicles carried in the past 12 months; vessel descriptions (including type of fuel), federal, state and local funding sources, and intermodal connectivity. All data collected in 2018 will be added to the existing NCFO database.
The Transportation Equity Act for the 21st Century, (Pub. L. 105-178), section 1207(c), The Safe, Accountable, Flexible Efficient Transportation Equity Act-A Legacy for Users (SAFETEA-LU) Pub. L. 109-59, Moving Ahead for Progress in the 21st Century Act (MAP-21) Pub. L. 112-141, 49 CFR 1.46, and Fixing America's Surface Transportation Act (Pub. L. 114-94, sec. 1112).
Departmental Offices, U.S. Department of the Treasury.
Notice of open meeting.
This notice announces that the Department of the Treasury's Advisory Committee on Risk-Sharing Mechanisms (“Committee”) will convene a meeting on Tuesday, February 16, 2016, in Room 4121, 1500 Pennsylvania Avenue NW., Washington, DC 20220, from 1-4:30 p.m. Eastern Time. The meeting is open to the public, and the site is accessible to individuals with disabilities.
The meeting will be held on Tuesday, February 16, 2016, from 1-4:30 p.m. Eastern Time.
The Advisory Committee on Risk-Sharing Mechanisms meeting will be held in Room 4121, Department of the Treasury, 1500 Pennsylvania Avenue NW., Washington, DC 20220. The meeting will be open to the public. Because the meeting will be held in a secured facility, members of the public who plan to attend the meeting must either:
1. Register online. Attendees may visit
(
2. Contact the Federal Insurance Office (FIO), at (202) 622-5892, by 5 p.m. Eastern Time on Thursday, February 11, 2016, and provide registration information.
Requests for reasonable accommodations under Section 504 of the Rehabilitation Act should be directed to Marcia Wilson, Office of Civil Rights and Diversity, Department of the Treasury at (202) 622-8177, or
Brett D. Hewitt, Policy Advisor, FIO, Room 1410, Department of the Treasury, 1500 Pennsylvania Avenue NW., Washington, DC 20220, at (202) 622-5892 (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 Relay Service at (800) 877-8339.
Notice of this meeting is provided in accordance with the Federal Advisory Committee Act, 5 U.S.C. App. II 10(a)(2), through implementing regulations at 41 CFR 102-3.150.
• Send electronic comments to
• Send paper statements in triplicate to the Advisory Committee on Risk-Sharing Mechanisms, Room 1410, Department of the Treasury, 1500
In general, the Department of the Treasury will post all statements on its Web site
Notification of Citizens Coinage Advisory Committee February 16, 2016, public meeting
Pursuant to United States Code, Title 31, section 5135(b)(8)(C), the United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for February 16, 2016.
In accordance with 31 U.S.C. 5135, the CCAC:
Advises the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals.
Advises the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made.
Makes recommendations with respect to the mintage level for any commemorative coin recommended.
William Norton, United States Mint Liaison to the CCAC; 801 9th Street NW; Washington, DC 20220; or call 202-354-7200.
Any member of the public interested in submitting matters for the CCAC's consideration is invited to submit them by fax to the following number: 202-756-6525.
31 U.S.C. 5135(b)(8)(C).
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This proposed rule addresses changes to the Shared Savings Program that would modify the program's benchmark rebasing methodology to encourage ACOs' continued investment in care coordination and quality improvement, and identifies publicly available data to support modeling and analysis of these proposed changes. In addition, it would streamline the methodology used to adjust an ACO's historical benchmark for changes in its ACO participant composition, offer an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program, and establish policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 28, 2016.
In commenting, please refer to file code CMS-1644-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Elizabeth November, (410) 786-8084. Email address:
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
Section 1899 of the Social Security Act (the Act) established the Medicare Shared Savings Program, which promotes accountability for a patient population, fosters coordination of items and services under Medicare Parts A and B, and encourages investment in infrastructure and redesigned care processes for high quality and efficient health care service delivery. This
This proposed rule is designed to improve program function and transparency. To achieve these goals, we propose to make the following modifications to the current program:
• Modifying the methodology for rebasing and updating ACO historical benchmarks when an ACO renews its participation agreement for a second or subsequent agreement period to incorporate regional expenditures, thereby making the ACO's cost target more independent of its historical expenditures and more reflective of FFS spending in its region.
• Modifying the methodology for risk adjustment to account for the health status of the ACO's assigned population in relation to FFS beneficiaries in the ACO's regional service area, and to apply this approach in determining the regional adjustment that is applied to the ACO's rebased historical benchmark.
• Revising the methodology for adjusting ACO benchmarks to account for changes in ACO participant (TIN) composition.
• Adding a participation agreement renewal option to encourage ACOs to enter performance-based risk arrangements earlier in their participation in the Shared Savings Program.
• Defining circumstances under which we would reopen payment determinations to make corrections after the financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
As a result of this proposed rule, the median estimate of the financial impact of the Shared Savings Program for CYs 2017 through 2019 would be net federal savings of $120 million greater than what would have been saved if no changes were made. Although this is the best estimate of the financial impact of the Shared Savings Program during CYs 2017 through 2019, a relatively wide range of possible outcomes exists. While approximately two-thirds of the stochastic trials resulted in an increase in net program savings, the 10th and 90th percentiles of the estimated distribution show a net increase in costs of $230 million to net savings of $490 million, respectively.
Overall, our analysis projects that improvements in the accuracy of benchmark calculations, including through the introduction of a regional adjustment to the ACO's rebased historical benchmark, are expected to result in increased overall participation in the program. The proposed changes are also expected to improve the incentive for ACOs to invest in effective care management efforts, increase the attractiveness of participation under performance-based risk in Track 2 or 3 for certain ACOs with lower beneficiary expenditures, and result in overall greater gains in savings on FFS benefit claims costs than the associated increase in expected shared savings payments to ACOs. We intend to monitor emerging results for ACO effects on claims costs, changing participation (including risk for cost due to selective changes in participation), and unforeseen biased benchmark adjustments due to diagnosis coding intensity shifts. Such monitoring will inform future rulemaking, such as if the Secretary determines that a lower weight should be used in calculating the regional adjustment amount for ACOs' third and subsequent agreement periods.
On March 23, 2010, the Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted, followed by enactment of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30, 2010, which amended certain provisions of Public Law 111-148. Collectively known as the Affordable Care Act, these public laws include a number of provisions designed to improve the quality of Medicare services, support innovation and the establishment of new payment models, better align Medicare payments with provider costs, strengthen Medicare program integrity, and put Medicare on a firmer financial footing.
Section 3022 of the Affordable Care Act amended Title XVIII of the Act (42 U.S.C. 1395
We published the final rule entitled “Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” (November 2011 final rule), which appeared in the November 2, 2011
As of January 1, 2016, over 400 ACOs were participating in the Shared Savings Program. This includes 147 ACOs with 2012 and 2013 agreement start dates that entered into a new 3-year agreement effective January 1, 2016, to continue their participation in the program. We continue to see strong interest in the program, for instance, as indicated by the 100 ACOs that entered the program for a first agreement period beginning January 1, 2016. See Fact Sheet: CMS Welcomes New Medicare Shared Savings Program (Shared Savings Program) Participants, (January 11, 2016) available online at
As evidenced by the high degree of interest in participation in the Shared Savings Program, we believe that the policies adopted in the November 2011 final rule are generally well-accepted. However, we identified several policy areas that should be revisited in light of the additional experience we gained during the first two years of program implementation. Therefore, we published a subsequent final rule entitled “Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” (June 2015 final rule), which appeared in the June 9, 2015
The purpose of this proposed rule is to propose revisions to some key policies of the Shared Savings Program adopted in the November 2011 final rule (76 FR 67802) and modified by the June 2015 final rule (80 FR 32692) including: (1) Proposing regulatory changes to the benchmarking methodology that will apply when resetting and updating the benchmark for an ACO's second or subsequent agreement period; (2) proposing a change to the methodology for adjusting an ACO's historical benchmark for changes to the ACO's certified ACO Participant List; (3) proposing a regulatory change to facilitate ACOs' transition to performance-based risk models; and (4) proposing a policy on administrative finality to address the circumstances under which payment determinations would be reopened to correct financial reconciliation calculations. We seek stakeholders' input regarding these proposed policies, which we believe are important to the continued success of the Shared Savings Program.
Section 1899(d)(1)(B)(ii) of the Act addresses how ACO benchmarks are to be established and updated. This provision specifies that the Secretary shall estimate a benchmark for each agreement period for each ACO using the most recent available 3 years of per beneficiary expenditures for Parts A and B services for Medicare FFS beneficiaries assigned to the ACO. Such benchmark shall be adjusted for beneficiary characteristics and such other factors as the Secretary determines appropriate and updated by the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare FFS program, as estimated by the Secretary. Such benchmark shall be reset at the start of each agreement period. In addition to the statutory benchmarking methodology established in section 1899(d) of the Act, section 1899(i)(3) of the Act grants the Secretary the authority to use other payment models, including payment models that would use alternative benchmarking methodologies, if the Secretary determines that doing so would improve the quality and efficiency of items and services furnished under this title and the alternative methodology would result in program expenditures equal to or lower than those that would result under the statutory payment model.
In the November 2011 final rule, establishing the Shared Savings Program, we adopted policies for establishing, updating and resetting ACO benchmarks at § 425.602. Under this methodology, we use national FFS spending and trends as part of establishing, updating and resetting ACO-specific benchmarks. Specifically,
Under section 1899(d)(1)(B)(ii) of the Act and § 425.602(c) of the Shared Savings Program regulations, an ACO's benchmark must be reset at the start of each new agreement period. In the June 2015 final rule, we established a policy for resetting ACO benchmarks that accounts for factors relevant to ACOs that have participated in the program for at least one agreement period. This policy is intended to help ensure that the Shared Savings Program remains attractive to ACOs and continues to encourage ACOs to participate in additional agreement periods and to continue to improve their performance, particularly those ACOs that have achieved shared savings. Specifically, we revised § 425.602(c) to specify that in resetting the historical benchmark for ACOs in their second or subsequent agreement period we: (1) Weight each benchmark year equally; and (2) make an adjustment to reflect the average per capita amount of savings earned by the ACO in its prior agreement period, reflecting the ACO's financial and quality performance, during that prior agreement period. The additional per capita amount is applied as an adjustment to the ACO's rebased historical benchmark for a number of assigned beneficiaries (expressed as person years) not to exceed the average number of assigned beneficiaries (expressed as person years) under the ACO's prior agreement period. If an ACO was not determined to have generated net savings in its prior agreement period, we do not make any adjustment to the ACO's rebased historical benchmark. We use performance data from each of the ACO's performance years under its prior agreement period in resetting the ACO's benchmark for its second or subsequent agreement period.
We adjust the ACO's historical benchmark for changes during the performance period in the health status and demographic factors of the ACO's assigned beneficiaries (§ 425.604(a), § 425.606(a), § 425.610(a)), as described in section II.A.3. of this proposed rule. Consistent with section 1899(d)(1)(B)(ii) of the Act, we update the ACO's benchmark annually, based on the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original FFS program, as described further in section II.A.2.d. of this proposed rule. Additionally, as described further in section II.B. of this proposed rule, we also adjust ACO historical benchmarks annually based on changes to the ACO's certified ACO Participant List.
In the December 2014 proposed rule, we sought comment on three approaches to account for regional FFS expenditures in ACO benchmarks: (1) Use of regional FFS expenditures, instead of national FFS expenditures, to trend forward the most recent 3 years of per beneficiary expenditures for Parts A and B services in order to establish the historical benchmark for each ACO and to update the benchmark during the agreement period; (2) adjusting the ACO's benchmark from its prior agreement period to reflect trends in FFS costs in the ACO's region, effectively holding a portion of the ACO's reset benchmark constant relative to its region; and (3) transitioning ACOs from benchmarks based on their historical costs toward benchmarks based only on regional FFS costs. Under this approach, an ACO's benchmark would gradually become more independent of the ACO's historical expenditures and gradually more reflective of FFS trends in its region. We also sought comment on a number of technical issues specific to these alternatives, including: How to define an ACO's region, and specifically, the ACO's regional reference population; how to account for changes in ACO participants from year-to-year and across agreement periods; and considerations related to risk adjusting benchmarks based on regional factors. We also discussed and sought comment on how broadly or narrowly to apply these alternative benchmarking approaches to the program's financial tracks, and the timing for implementing any changes.
Many commenters indicated their support for revising the program's benchmarking methodology to reflect regional cost variation. (See June 2015 final rule (80 FR 32791 through 32796) for a discussion of comments received on and considerations for use of regional factors in establishing, updating and resetting benchmarks.) Of the options to incorporate regional FFS costs in ACO benchmarks, the approach that would transition ACOs to regionally based benchmarks over time seemed to garner the greatest support from commenters. Commenters suggested CMS consider a variety of additional methodologies for revising the program's benchmarks, sometimes offering opposing alternatives. For example, some commenters supported blended approaches, whereby benchmarks would reflect a combination of the ACO's historical costs and regional, national or a combination of regional/national costs. MedPAC offered a vision for both the near and long term evolution of the program's benchmarking methodology. (See letter from Glenn M. Hackbarth, J.D., Chairman, Medicare Payment Advisory Commission to Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services, regarding File code CMS-1461-P (February 2, 2015) (available through
Many commenters pointed to the importance of the details of the chosen methodology, for example, the definition of the ACO's region. Some commenters indicated there were insufficient details in the December 2014 proposed rule on the alternative benchmarking approaches or cited their lack of data to analyze the alternatives discussed in order to make an informed and effective recommendation about the options. These commenters indicated the need for CMS to perform additional modeling and analytic work on the alternatives discussed in the December 2014 proposed rule, and to share the results of this analysis and put forward detailed proposals on revisions to the benchmarking methodology through additional notice and comment rulemaking. More generally, other commenters requested that CMS provide detailed documentation regarding program calculations and greater access to the underlying data.
In response, we acknowledged the importance of quickly moving to a benchmark rebasing approach that accounts for regional FFS costs and trends in addition to the ACO's historical costs and trends. In the June 2015 final rule, we committed to engaging in additional rulemaking to propose modifications to the Shared Savings Program's methodology for resetting ACO benchmarks. We signaled our anticipated policy direction by outlining an approach to rebasing that would account for regional expenditures and identified additional issues we would need to address in implementing this approach. We discussed a rebasing approach based on a blend of: (1) A regionally trended component, reflecting ACO historical costs for the 3 years preceding its first agreement period that starts in 2017 or a subsequent year, adjusted by a regional trend factor based on changes in regional expenditures for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible) for the most recent year prior to the start of the ACO's new agreement period, and adjusted for changes in the health status and demographic factors of the ACO's assigned beneficiary population in each benchmark year relative to its region; and (2) a rebased component calculated using the current rebasing methodology (based on historical costs from the 3 most recent years prior to the start of the ACO's new agreement period), including equally weighting the benchmark years but excluding the addition of a portion of savings generated over the same 3 most recent years.
In the June 2015 final rule (80 FR 32796), we specified that the forthcoming proposed rule would provide a detailed discussion of key methodological issues, including: Weight of the two benchmark components, risk adjustment, defining an ACO's region, and accounting for changes in ACO participant composition. We indicated that in developing the proposed rule we would take into account broader considerations for the program, including: Whether to change the methodology for updating the benchmark; whether to make adjustments to account for ACOs whose costs are relatively high or low in relation to FFS trends in their region or the nation; and how to safeguard against ACOs that may increase their spending to lock in higher benchmarks for future agreement periods.
In the June 2015 final rule we explained that the revised rebasing approach would require tradeoffs among several criteria:
• Strong incentives for ACOs to improve efficiency and to continue participation in the program over the long term.
• Benchmarks which are sufficiently high to encourage ACOs to continue to meet the three-part aim, while also safeguarding the Medicare Trust Funds against the possibility that ACOs' reset benchmarks become overly inflated to the point where ACOs need to do little to maintain or change their care practices to generate savings.
• Generating benchmarks that reflect ACOs' actual costs in order to avoid potential selective participation by (and excessive shared payments to) ACOs with high benchmarks.
In further considering modifications to the benchmarking methodology for this proposed rule, we added the following set of guiding principles:
•
•
•
•
• Maintain program momentum and market stability by providing sufficient notice of methodological changes and phase-in of these changes.
The June 2015 final rule indicated that in defining an ACO's region we would consider using Metropolitan Statistical Areas (MSAs) and non-MSA portions of a state, Combined Statistical Areas (CSAs), or another definition of regionally-based statistical areas, or the ACO's county-level service area.
For purposes of this proposed rule, we consider an ACO's region to be synonymous with its service area from which it derives its assigned beneficiaries. Further, as discussed in this section of the proposed rule, issues related to the definition of an ACO's regional service area include: (1) The selection of the geographic unit of
We considered the geographic unit of measure to use in defining an ACO's regional service area for the purpose of determining the corresponding regional FFS expenditures to be used in calculations based on regional spending in the modified approach to establishing, adjusting and updating the ACO's rebased historical benchmark, discussed in this proposed rule. These regional FFS expenditures will be used in determining a regional adjustment to an ACO's rebased historical benchmark and in calculating growth rates of regional spending used in establishing and updating the ACO's rebased historical benchmark, which are described later in this proposed rule. We considered the stability of the definition of the geographic unit of measure, specifically: Whether it is a legal or statistical area defined according to uniform national criteria by the U.S. government (for example, by the U.S. Bureau of the Census); whether the area has boundaries that do not change frequently; and CMS' use of the area in other Medicare operations. Core Based Statistical Areas (CBSAs), MSAs, and CSAs are delineated by OMB and are the result of the application of published standards to Census Bureau data. Other options for defining regional service areas, for example, Hospital Referral Regions as defined by the Dartmouth Institute, may have certain advantages in terms of linking markets together by utilization patterns as opposed to, for example, commuting patterns used by the Census Bureau to define CSAs. However, such definitions are not governmentally maintained, may change over time, and are not otherwise directly utilized for FFS Medicare payment. Of the options considered, definitions of counties, states and territories are the most stable.
We also considered whether the geographic unit is used in other CMS operations. MSAs and rest of state areas are used by CMS for the hospital wage index. Geographic practice cost indices (GPCIs) used to adjust payments for physicians' services are based on 89 Medicare localities, which are either state-wide or combination MSA and rest-of-state areas. There is precedent in the Medicare program for using county-level data to set cost targets for value based purchasing initiatives. CMS used counties to define the service areas of Physician Group Practice (PGP) demonstration sites (a predecessor of CMS' ACO initiatives) and used Parts A and B spending by county as part of setting benchmarks for these organizations. CMS also uses county-level FFS expenditure data, in combination with other adjustments, to establish the benchmarks used for setting local Medicare Advantage (MA) rates. However, under the MA program, special payment areas apply to ESRD enrollees. ESRD payments are determined using State capitation rates for enrollees in dialysis and transplant status (See Medicare Managed Care Manual, Chapter 8—Payments To Medicare Advantage Organizations, available at
We believe county-level data offer a number of advantages over the other options (CBSA, MSA, CSA, State/territory). Counties tend to be stable regional units compared to some alternatives, as the definition of county borders tends not to change. Further, the agency has experience with identifying populations of beneficiaries by county of residence and calculating county-level rates based on their costs. In terms of determining regional costs, smaller areas (such as counties) better capture regional variation in Medicare expenditures, and allow for more customized regional definitions for each ACO, but risk being dominated by expenditures from a single ACO or group of ACOs, which could potentially reduce ACO benchmarks in clustered markets. We can guard against the potential bias from this effect by using a sufficiently large county-based population, as discussed in section II.A.2.b.3. of this proposed rule.
Therefore, we considered developing county FFS rates based on Parts A and B spending by county. We considered the fact that some commenters responding to the December 2014 proposed rule urged CMS to more closely align the Shared Savings Program with MA when adopting a benchmarking approach that accounts for regional costs. For instance, MedPAC's longer term vision for the program's benchmarking methodology included achieving equity among ACOs in a geographic market and rewarding efficiency across payment models, including FFS Medicare, the Shared Savings Program, and MA. Use of county-level FFS data in calculating expenditures for an ACO's regional service area would permit ACOs to be viewed as being on the spectrum between traditional FFS Medicare and MA, a concept some commenters and stakeholders have urged CMS to articulate. Use of county FFS expenditure data, which are publicly available, would allow for increased transparency in ACO benchmark calculations and would ease ACOs' and stakeholders' access to data for use in modeling and predictive analyses. We would make adjustments to county FFS expenditure data to assure parity between the calculation of these expenditures and calculations of ACO benchmark and performance year expenditures as currently specified under the Shared Savings Program regulations by excluding indirect medical education (IME) payments, disproportionate share hospital (DSH) payments and uncompensated care payments, and by including beneficiary-identifiable payments under a demonstration, pilot or time limited program as discussed in section II.A.2.e. of this proposed rule.
Additionally, consistent with the approach used in MA, we believe the use of state-wide values for the ESRD population is appropriate given the small numbers of ESRD beneficiaries residing in many U.S. counties. Use of values for ESRD beneficiaries at the county level, based on very small numbers, would likely lead to greater instability of county-level expenditures for the ESRD population than for the other larger populations (disabled, aged/dual eligible and aged/non-dual eligible beneficiaries) considered in the program. This concern is particularly acute for ACOs operating in rural areas that tend to be more sparsely populated. We believe use of statewide values, for all ESRD beneficiaries residing in any county within the state, will be more statistically stable.
We propose to determine an ACO's regional service area by the counties of residence of the ACO's assigned beneficiary population. Furthermore, we propose to define regional costs as county FFS expenditures as determined according to the discussion later in this
The population that is the basis for calculating regional FFS costs must be sufficiently large to produce statistically stable mean expenditure estimates (avoiding biases that result from small numbers), and must be representative of the demographic mix, health status and cost trends of the beneficiary population within the ACO's regional service area. Therefore, we considered whether the calculation of regional FFS costs for an ACO's regional service area should include or exclude the costs for the ACO's assigned beneficiary population. While including these ACO-assigned beneficiaries results in a larger reference population for calculating regional costs, some stakeholders have expressed concern that doing so will capture the impact of the ACO's efforts to coordinate care and reduce expenditures for the FFS population it treats and result in relatively lower regional expenditures being used for setting its benchmark.
The following points informed our consideration of this issue:
• Most individual ACO assigned beneficiary populations only make up a small fraction of the FFS beneficiaries in an ACO's regional service area. For example, we found that the rate at which an ACO's assigned population comprised its regional FFS population
• In cases where an ACO's assigned population makes up a large portion of the population of its region, removal of the ACO's assigned beneficiaries from the regional FFS population would limit the comparison population and may bias results.
• Removing an ACO's assigned population would add both complexity and volatility to calculations particularly in circumstances where it results in small numbers of beneficiaries remaining in the regional FFS population.
• Including beneficiaries who are not eligible to be assigned to an ACO in the regional FFS population could bias calculations of regional expenditures. For example, including Medicare FFS beneficiaries who have not utilized services (“non-utilizers”) in these calculations would result in relatively lower per capita expenditures for the regional FFS population.
Based on this analysis, we concluded that attempting to identify regional FFS expenditures for only non-ACO beneficiaries (or customizing the calculation of regional FFS expenditures for each ACO by excluding its own beneficiaries) would add significant complexity and create potential bias. Furthermore, excluding the ACO's assigned beneficiaries from the population used to determine regional FFS expenditures may also produce biased results where an ACO tends to serve beneficiaries of a particular Medicare enrollment type, demographic or socio-economic status (for example, ACOs serving largely dual-eligible populations) and when an ACO tends to dominate (serve a large proportion of FFS beneficiaries) in a region. In order to address the latter situation, we considered expanding the scope of an ACO's region (for example, by including adjoining counties) to allow the ACO's regional service area to include a greater mix of beneficiaries who are not assigned to the ACO. However, we believe that this approach may be challenging to apply consistently and accurately given the potential for variation of populations across and within regional areas, and a potentially cumbersome policy to maintain as ACOs continue to develop across the country. In addition, this type of policy would require that we establish a threshold to determine whether an ACO is sufficiently dominant in its region to warrant an expansion of its regional service area. We are concerned that application of such a threshold may encourage ACO decision making based on the ACO's relationship to the threshold (for instance decisions related to an ACO's structure or operations, particularly with respect to its composition of ACO participants and the beneficiaries it serves), either to remain below or exceed the threshold to yield a more favorable benchmark.
Several elements of Shared Savings Program financial calculations are based on expenditures for all Medicare FFS beneficiaries as opposed to the expenditures only for the ACO's assigned beneficiary population, as discussed further in section II.A.2.e. of this proposed rule. For example, we use all FFS beneficiaries in calculating the following: The growth rates used to trend forward expenditures during the benchmark period; the projected absolute amount of growth in national per capita expenditures for Parts A and B services used to update the benchmark; the completion factors applied to benchmark and performance year expenditures; and the truncation thresholds set at the 99th percentile of national Medicare FFS expenditures. To maintain consistency across program calculations, we considered using all FFS beneficiaries in determining expenditures for the ACO's regional service area. However, we believe that continuing to include expenditures for all FFS beneficiaries would introduce bias into the calculations of the ACO's regional service area expenditures. For one, the overall FFS population will include beneficiaries who are not eligible for assignment to ACOs. In current calculations, we believe this bias is mitigated to some extent by the large size of the national Medicare FFS population. Regional FFS expenditures, calculated based on relatively smaller populations, may be more susceptible to the influence of this bias. For example, in counties where the health status of the overall beneficiary population leads more beneficiaries to be non-utilizers of services a bias in the direction of relatively lower regional expenditures may be more pronounced. On the other hand, a bias in the direction of relatively higher regional expenditures may be more pronounced in counties where there are established patterns of accessing primary care services through specialists who are not the basis for assignment. (We note that recent changes in the assignment algorithm have narrowed the use of services
To address this concern, we considered limiting the beneficiary population included for purposes of calculating expenditures for an ACO's regional service area to Medicare FFS beneficiaries who could be considered for assignment to ACOs. As described in greater detail in section II.A.2.e. of this proposed rule, we identify the pool of beneficiaries who are eligible to be assigned to an ACO as those beneficiaries that have received at least one primary care service from a physician in the ACO who is a primary care physician or who has as primary specialty designation included in § 425.402(c) that is utilized in the assignment methodology. We will then use this population of eligible beneficiaries to determine the beneficiaries who will be assigned to an ACO based on the two-step assignment process under § 425.402(b). We considered applying a similar logic to identifying the population of FFS beneficiaries that should be considered in determining expenditures for an ACO's regional service area. That is: If a beneficiary gets at least one primary care service from any Medicare-enrolled physician who is a primary care physician or who has one of the primary specialty designations that are used for purposes of assignment under the Shared Savings Program, the beneficiary would be included in the calculation of expenditures for the ACO's regional service area. We refer to this population as “assignable beneficiaries.”
We also considered how to weight the ACO's regional costs in cases where an ACO's assigned population spans multiple counties. ACOs often serve beneficiaries in multiple counties within a state or across several states, with some ACOs being an aggregation of providers located in different parts of the country. We currently provide ACOs with a quarterly report showing the distribution of the ACO's assigned beneficiary residence by county where the ACO's service area is defined as counties with at least 1 percent of assigned beneficiaries. Based on assignment data from Quarter 1 2015 for all active ACOs in the Shared Savings Program, ACOs served beneficiaries residing in between 2 and 32 counties, with a median of 8 counties served. Given the geographic spread of some ACOs' assigned populations, we believe it will be important to weight an ACO's regional expenditures relative to the proportion of its assigned beneficiaries in each county. Absent this weighting, we could overstate or understate the influence of the expenditures for a county where relatively few or many of an ACO's assigned beneficiaries reside.
Taking these considerations into account, we propose using all assignable beneficiaries, including ACO-assigned beneficiaries, in determining expenditures for the ACO's regional service area in order to ensure sufficiently stable regional mean expenditures. We propose to define the ACO's regional service area to include any county where one or more assigned beneficiaries reside. We also propose to include the expenditures for all assignable FFS beneficiaries residing in those counties in calculating county FFS expenditures by enrollment type that will be used in the ACO's regional cost calculations (discussed in detail in sections II.A.2.c. and II.A.2.d. of this proposed rule). Further, we propose to weight county-level FFS expenditures by the ACO's proportion of assigned beneficiaries in the county, determined by the number of the ACO's assigned beneficiaries residing in the county in relation to the ACO's total number of assigned beneficiaries. These proposals are reflected in the proposed addition of new definitions for “assignable beneficiary” and “ACO's regional service area” to § 425.20, and in the proposed new regulation at § 425.603.
We believe this proposed approach will result in the most accurate and predictable regional expenditure factor for each ACO. However, we would monitor for cases where an ACO tends to serve a large proportion of FFS beneficiaries in its region, and consider the effect of these circumstances on ACO benchmarks. If warranted, we would explore developing adjustments to the definition of an ACO's regional service area to account for this circumstance in future rulemaking. We also seek comment on alternatives to proposed use of assignable beneficiaries in establishing the expenditures for an ACO's regional service area, including use of all Medicare FFS beneficiaries in determining these expenditures.
We considered how to calculate county FFS expenditures for use in factors based on regional FFS expenditures described in this proposed rule. Consistent with proposals described in other sections of this proposed rule, we are proposing the following approach to calculating county FFS expenditures:
• Determine county FFS expenditures based on the expenditures of the assignable population of beneficiaries in each county, where assignable beneficiaries are identified for the 12-month period corresponding to the applicable calendar year (see sections II.A.2.b.3. and II.A.2.e. of this proposed rule). We will make separate expenditure calculations according to the following populations of beneficiaries (identified by Medicare enrollment type): ESRD, disabled, aged/dual-eligible, aged/non-dual eligible.
• Calculate assignable beneficiary expenditures using the payment amounts included in Part A and B FFS claims with dates of service in the 12-month calendar year for the relevant benchmark or performance year, allowing for a 3-month claims run out and applying a completion factor (see section II.A.2.e.2. of this proposed rule). The completion factor will be calculated based on national FFS assignable beneficiary expenditures (see section II.A.2.e. of this proposed rule).
++ These calculations will exclude IME, DSH, and uncompensated care payments (see section II.A.2.e.2. of this proposed rule).
++ These calculations will take into consideration individually beneficiary identifiable payments made under a demonstration, pilot or time limited program (see section II.A.2.e.2. of this proposed rule).
• Truncate a beneficiary's total annual Parts A and B FFS per capita expenditures at the 99th percentile of national Medicare FFS assignable beneficiary expenditures as determined for the relevant year, in order to minimize variation from catastrophically large claims (see section II.A.2.e. of this proposed rule). We would determine truncation thresholds separately for each of the four Medicare enrollment types (ESRD, disabled, aged/dual eligible, aged/non-dual eligible).
• Adjust county FFS expenditures for severity and case mix of assignable beneficiaries in the county using prospective CMS—Hierarchical Condition Category (HCC) risk scores (see section II.A.2.e.2. of this proposed rule). We would determine average risk scores separately for each of the four Medicare enrollment types (ESRD, disabled, aged/dual eligible, aged/non-dual eligible).
Consistent with the discussion in section II.A.2.b.2. of this proposed rule, we propose to compute state-level per capita expenditures and average risk scores for the ESRD population in each state and to apply those state-level values to all counties in a state. We believe this approach addresses issues associated with small numbers of ESRD beneficiaries in certain counties that can lead to statistical instability in expenditures for this complex population.
We anticipate making county level data used in Shared Savings Program calculations publicly available annually. For example, a publicly available data file would indicate for each county: Average per capita FFS assignable beneficiary expenditures and average risk scores for all assignable beneficiaries by Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible). In addition, as described in the regulatory impact analysis section of this proposed rule, we are making publicly available a data file with county-level expenditure and risk score data to support modeling of the proposed changes to the benchmark rebasing methodology.
We propose to include this approach for determining county FFS expenditures in a new regulation at § 425.603. We seek comment on these proposals as well as any additional factors we would need to consider in calculating risk adjusted county FFS expenditures.
The discussion of benchmark alternatives in the recent rulemaking underscores the array of options for incorporating regional expenditures in ACO benchmarks (see the December 2014 proposed rule at 79 FR 72839 through 72843; see the June 2015 final rule at 80 FR 32791 through 32796). While we agree with commenters on the benefits of incorporating regional expenditures in rebased benchmarks, we are interested in moving to an alternative rebasing approach that builds on the program's existing benchmarking methodology established under the authority of section 1899(d)(1)(B)(ii) of the Act and codified in the Shared Savings Program regulations at § 425.602. Over 400 ACOs have voluntarily entered the Shared Savings Program under the financial models (Track 1 and Track 2) established in the November 2011 final rule and as modified by the June 2015 final rule (adding a choice of Track 3 for agreement periods beginning January 1, 2016). Further, 147 ACOs with 2012 and 2013 agreement start dates elected to continue their participation in the program for a second 3-year agreement effective January 1, 2016 to which the current methodology for resetting the ACO's benchmark applies (including the rebasing modifications finalized with the June 2015 final rule). The value proposition of the program's financial models, which is largely determined by the methodology used to establish ACO benchmarks, is an important consideration for organizations deciding whether to engage (or continue to engage) in this new approach to the delivery of health care. Therefore, in considering how to incorporate regional expenditures into the benchmarking methodology, we believe that building from the existing benchmarking methodology will help maintain the stability of the program and ultimately result in revised policies that are more easily understood by ACOs and program stakeholders, and more readily implemented by CMS.
Principally, we considered using the Secretary's discretion under section 1899(d)(1)(B)(ii) of the Act to adjust the historical benchmark by “such other factors as the Secretary determines appropriate” in order to incorporate regional FFS expenditures into the rebased historical benchmark. In this proposed rule we discuss two approaches to calculating an adjustment to an ACO's rebased historical benchmark to account for regional FFS expenditures for the ACO's regional service area, and describe how the adjustment would be applied to the rebased historical benchmark.
We believe the plain language of section 1899(d)(1)(B)(ii) of the Act demonstrates Congress' intent that the benchmark established for a Shared Savings Program ACO would reflect the ACO's historical expenditures in the 3 most recent years prior to the start of the ACO's agreement period. Congress also recognized that this historical benchmark should be adjusted “for beneficiary characteristics and such other factors as the Secretary determines appropriate.” Therefore, to the extent an ACO's rebased benchmark continues to be based on the ACO's historical expenditures in the 3 years preceding the start of the new agreement period, we believe adjusting those historical expenditures to account for regional FFS expenditures for the ACO's regional service area falls within the Secretary's discretion to make adjustments to the historical benchmark for “other factors” under section 1899(d)(1)(B)(ii) of the Act.
Currently, CMS makes several adjustments to an ACO's historical benchmark under the Secretary's discretion under section 1899(d)(1)(B)(ii) of the Act, including to: (1) Adjust benchmark year expenditures to exclude IME and DSH payments (§ 425.602(a)(1)(i)); (2) adjust the historical benchmark for the addition and removal of ACO participants (§ 425.602(a)(8)); (3) adjust the rebased historical benchmark to account for the average per capita amount of savings generated during the ACO's previous agreement period (§ 425.602(c)(2)(ii)); and (4) adjust the historical benchmark for changes in demographics and health status of the ACO's performance year assigned beneficiary population (§§ 425.604(a)(1) through (3), 425.606(a)(1) through (3), 425.610(a)(1) through (3)). For the reasons discussed in the June 2015 final rule, we believe it is appropriate to further adjust ACO historical benchmarks to reflect regional FFS expenditures (see 80 FR 32791 through 32796). Further, in relation to use of regional FFS expenditures in developing the ACO's rebased benchmark, for the reasons discussed in section II.A.2.c.2. of this proposed rule we believe it appropriate to forgo making an additional adjustment to account for savings generated by the ACO in its prior agreement period (see 80 FR 32796).
Table 2 summarizes the proposals discussed in this section of the proposed rule, including the percentage (weight) to be used in calculating the amount of the adjustment for regional FFS expenditures to be applied to the ACO's rebased historical benchmark, using regional (instead of national) trend factors in establishing an ACO's rebased historical benchmark, using regional (instead of national) FFS expenditures to update the ACO's benchmark for each performance year, and the timing of the applicability of the proposed new rebasing methodology.
Our proposal for adjusting an ACO's rebased historical benchmark to reflect regional FFS expenditures for the ACO's regional service area expands on the approaches initially outlined in the June 2015 final rule (see 80 FR 32795 through 32796). The discussion elsewhere in this proposed rule describes two options for calculating the regional FFS adjustment, as well as the calculation of the ACO's rebased historical benchmark. The first option would be to
Under both options, we would calculate the ACO's rebased historical benchmark using the current rebasing methodology established in the June 2015 final rule under which an ACO's rebased benchmark is calculated based on the 3 years prior to the start of its current agreement period. Consistent with the current policy we would equally weight the 3 benchmark years. However, in trending forward benchmark year (BY) 1 and BY2 expenditures to BY3 dollars, we would use regional growth rates (instead of national growth rates) for Parts A and B FFS expenditures, as discussed in section II.A.2.d. of this proposed rule.
Furthermore, in calculating the ACO's rebased historical benchmark, we would not apply the current adjustment to account for savings generated by the ACO under its prior agreement period. We have observed that for ACOs generating savings, an alternative rebasing methodology that accounts for regional FFS expenditures would generally leave a similar or slightly greater share of measured savings in an ACO's rebased benchmark for its ensuing agreement period. By contrast, for ACOs generating losses, an alternative rebasing methodology that accounts for regional FFS expenditures would tend to carry forward a significant portion of measured losses into their rebased benchmarks and push benchmarks lower than the current rebasing policy. Therefore, in transitioning to a benchmark rebasing methodology that incorporates an adjustment for regional FFS expenditures, we believe it is important to forgo the current adjustment to account for shared savings generated by the ACO under its prior agreement period. (For further information, see section IV.E. of this proposed rule.)
We considered two options for calculating regional expenditures as an input into an adjustment that we would apply to the ACO's rebased historical benchmark. First, we considered calculating a regionally-trended amount developed using the ACO's historical benchmark from an earlier agreement period adjusted by a regional trend factor based on changes in regional expenditures for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible) for the most recent year prior to the start of the ACO's current agreement period and for changes in health status and demographic factors of the assigned patient population. The calculation of the regionally-trended amount would generally involve the following steps:
• Use the ACO's historical benchmark from a prior agreement period, adjusted to account for ACO Participant List changes. We would use an expenditure ratio to adjust the benchmark for changes in ACO participant (TIN) composition, as described in section II.B. of this proposed rule.
• Risk adjust to reflect changes in the health status of the ACO's assigned beneficiaries from that prior agreement period to the most recent year prior to the start of the new agreement period.
• Trend the historical benchmark to the most recent year prior to the start of the new agreement period based on risk adjusted county FFS expenditures for the ACO's regional service area. As discussed in section II.A.2.b. of this proposed rule, we would determine regional FFS expenditures for an ACO's regional service area, using an approach that weights county expenditures according to the proportion of the ACO's assigned beneficiaries residing in each county.
• Use weighting to reflect changes in the proportion of each of the four Medicare enrollment types from the prior agreement period to the most recent year prior to the start of the new agreement period. Specifically, we would weight the regionally-trended expenditures by the proportions of the ACO's assigned beneficiaries in each Medicare enrollment type for benchmark year 3 of the ACO's new agreement period.
In the June 2015 final rule (80 FR 32796), we also indicated that we were considering an alternative approach based on regional average spending to transition ACOs to benchmarks based on regional FFS costs. Under this approach, we would calculate a regional FFS adjustment to the ACO's rebased historical benchmark using regional average expenditures. Calculation of regional average expenditures would generally involve the following key steps:
• Calculate risk adjusted regional per capita FFS expenditures using county level Parts A and B expenditures for the ACO's regional service area for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible); weighted based on the proportion of ACO assigned beneficiaries residing in each county for the most recent benchmark year. We describe the risk adjustment approach that would be used in these calculations to adjust for differences in health status between an ACO and its regional service area in section II.A.3. of this proposed rule.
• Weight the resulting regional expenditures by the proportion of assigned beneficiaries for the most recent benchmark year for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible).
In comparing the features of the two options, the regionally-trended amount and regional average expenditures, we believe using regional average expenditures offers a preferred approach. While we believe both options would avoid penalizing ACOs that improve their spending relative to that of their region, the approach of using regional average expenditures would not depend on older historical data in calculations as would be required under the alternative involving calculation of a regionally-trended amount. In general, from an operational standpoint, using a regional average as part of calculating regional FFS expenditures for an ACO's regional service area is anticipated to be easier for ACOs and stakeholders to understand as well as for CMS to implement in comparison to the alternative considered, and would more closely align with the MA rate-setting methodology.
We also considered how the adjustment based on regional FFS expenditures should be applied to the ACO's rebased historical benchmark. Our preferred approach is to use the following steps to adjust the ACO's rebased historical benchmark:
• Calculations of the ACO's rebased historical benchmark and regional average expenditures, as described previously in this section of the proposed rule, would result in average per capita values of expenditures for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible).
• For each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible) we would determine the difference between the per capita regional average amount and the average per capita amount of the ACO's rebased historical benchmark. These values may be positive or negative. For example, for a particular Medicare enrollment type, if the value of the ACO's rebased historical benchmark is greater than the regional average amount, the difference between these values will be expressed as a negative number.
• Multiply the resulting difference, for each Medicare enrollment type by a percentage determined for the relevant
• Add the adjustment to the ACO's rebased historical benchmark, adding the adjustment amount for the Medicare enrollment type to the truncated, trended and risk adjusted average per capita value of ACO's rebased historical benchmark for the same Medicare enrollment type.
• Multiply the adjusted value of the ACO's rebased historical benchmark for each Medicare enrollment type by the proportion of the ACO's assigned beneficiary population for that Medicare enrollment type, based on the ACO's assigned beneficiary population for benchmark year 3 of the rebased historical benchmark.
• Sum expenditures across the four Medicare enrollment types to determine the ACO's adjusted rebased historical benchmark.
Therefore, we are proposing to calculate the ACO's rebased benchmark using historical expenditures for the beneficiaries assigned to the ACO in the 3 years prior to the start of its current agreement period, applying equal weights to the benchmark years, but not accounting for shared savings generated by the ACO in its prior agreement period. We propose to adjust the ACO's rebased historical benchmark to reflect risk adjusted regional average expenditures, based on county FFS expenditures determined for the ACO's regional service area. We propose to revise section § 425.602 in order to limit the scope of the provision to establishing, adjusting, and updating the benchmark for an ACO's first agreement period. We propose to specify in a new regulation at § 425.603 how the benchmark would be reset for a subsequent agreement period, including the proposed methodology for adjusting an ACO's rebased historical benchmark to reflect FFS expenditures in the ACO's regional service area in the ACO's second or subsequent agreement period starting on or after January 1, 2017. Further, we propose to make conforming and clarifying revisions to the provisions of § 425.602, including to: Revise the title of the section; remove paragraph (c) from § 425.602 and incorporate this paragraph in the new regulation at § 425.603; and to add a paragraph that describes the adjustments made to the ACO's historical benchmark during an ACO's first agreement period to account for changes in severity and case mix for newly and continuously assigned beneficiaries as presently specified under § 425.604, § 425.606, and § 425.610. We also propose to make a clarifying change to § 425.20, to specify that the acronym “BY” stands for benchmark year.
We seek comment on our proposals and on the alternative approach of using a regionally-trended amount developed from the ACO's historical benchmark for a prior agreement period instead of regional average expenditures to adjust the ACO's rebased historical benchmark. We are particularly interested in comments on the design of the approaches for calculating the regional adjustment to the ACO's rebased historical benchmark described in this section of the proposed rule, as well as any concerns about implementing the proposed regional adjustment.
As discussed in the June 2015 final rule, we considered applying a weight of 70 percent on the regionally-trended component of the rebased benchmark. We explained our initial belief that this weight would serve the goal of providing strong incentives for ACOs to achieve savings and to continue to participate in the Shared Savings Program (see 80 FR 32796). In developing the policies for this proposed rule, we considered both the potential positive and negative consequences of quickly transitioning to use of a greater weight in calculating the regional adjustment to ACOs' rebased historical benchmarks.
We believe placing a greater weight on regional expenditures in adjusting an ACO's historical benchmark will encourage existing low spending ACOs in higher spending and/or higher growth regions to enter and continue their participation in the Shared Savings Program. Stakeholders have expressed concerns that the original rebasing methodology promulgated in the November 2011 final rule, in which an ACO's benchmark is rebased using the ACO's historical expenditures for the most recent 3 years corresponding to its prior agreement period, absent additional adjustment, penalizes an ACO for past achievement of savings by reducing its benchmark for the following agreement period (see 80 FR 32786). In the June 2015 final rule, we expressed our view that the benchmarking methodology should be revised to help ensure that an ACO that has previously achieved success in the program will be rebased under a methodology that encourages its continued participation in the program (see 80 FR 32788). Further, we have noted the importance of quickly moving to a benchmark rebasing approach that accounts for regional FFS expenditures and trends in addition to the ACO's historical expenditures and trends (see 80 FR 32795 through 32796).
We are also concerned that existing low spending ACOs operating in regions with relatively higher spending and/or higher growth in expenditures may be positioned to generate savings under the proposed methodology because of the regional adjustment to their rebased historical expenditures rather than as a result of actual gains in efficiency, creating an opportunity for arbitrage. In particular, we are concerned about the potential for ACOs to alter their healthcare provider and beneficiary compositions or take other such actions in order to achieve more favorable performance relative to their region without actually changing their efficiency. We anticipate these effects to be more pronounced, the larger the percentage that is applied to the difference between the regional average expenditures for the ACO's regional service area and the ACO's rebased historical expenditures when calculating the regional adjustment. However, we believe there is uncertainty around the magnitude of these possible negative consequences of adjusting the ACO's rebased benchmark based on regional expenditures in the ACO's regional service area which have yet to be observed. We believe these concerns are likely to be outweighed by the benefits of encouraging more efficient care through a benchmark rebasing methodology that encourages continued participation by ACOs that are efficient relative to their regional service area by placing greater weight on regional expenditures when resetting the ACO's benchmark over subsequent agreement periods. The use of a higher percentage in calculating the regional adjustment would create strong incentives for higher spending ACOs to be more efficient relative to their regional service areas while also improving the quality of care provided to their beneficiaries. Furthermore, this approach will also ensure that ACOs' rebased benchmarks continue to reflect in part their historical spending.
To balance these concerns, we considered a phased approach to transitioning to greater weights in calculating the adjustment amount, expressed as a percentage of the difference between regional average
• Maintain the current methodology for establishing the benchmark for an ACO's first agreement period in the Shared Savings Program based on the historical expenditures for beneficiaries assigned to the ACO with no adjustment for expenditures in the ACO's regional service area in order to provide continued stability to the program and the momentum for attracting new organizations. As over 400 ACOs have voluntarily entered the program under this methodology we believe the current methodology is an important part of facilitating entry into the program by organizations located throughout the nation that have differing degrees of experience with accountable care models and have varying provider compositions.
• Increase the percentage used in calculating the regional adjustment amount, applied to the ACO's rebased historical benchmark (determined as specified in this proposed rule), over subsequent agreement periods. For ACOs entering their second agreement period, in calculating the regional adjustment we would take 35 percent of the difference between the ACO's regional service area expenditures and the ACO's rebased historical benchmark expenditures. For ACOs entering their third or subsequent agreement period, the percentage used in this calculation would be set at 70 percent unless the Secretary determines a lower weight should be applied, as specified through future rulemaking.
In making a determination of whether a lower weight should be used in calculating the adjustment, the Secretary would assess what effects the regional adjustment (and other modifications to the program made under this rule) are having on the Shared Savings Program, considering factors such as but not limited to: The effects on net program costs; the extent of participation in the Shared Savings Program; and the efficiency and quality of care received by beneficiaries. As part of this determination, the Secretary may also take into account other factors, such as the effect of implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) on the Shared Savings Program by incentivizing physicians and certain other practitioners to participate more broadly in alternative payment models.
Such a determination could potentially occur in advance of the first application of this higher percentage. For example, the determination could be made in advance of the agreement period beginning January 1, 2020, which is the start of the third agreement period for ACOs that entered the program in January 2014 and the first group of ACOs to which the revised rebasing methodology discussed in this proposed rule would apply. Any necessary modifications to program policies as a result of the Secretary's determination, such as reducing the long-term weight used in calculating the regional adjustment below 70 percent or making other program changes (for example, refinements to the risk adjustment methodology as described in section II.A.2.e.3. of this proposed rule) would be proposed in future rulemaking, such as through the calendar year (CY) 2020 Physician Fee Schedule rule. Subsequently, we would periodically assess the effects of the regional adjustment over time and address any needed modifications to program policies in future rulemaking.
• As discussed in section II.A.2.f. of this proposed rule, for ACOs that started in the program in 2012 and 2013 and started their second agreement period on January 1, 2016, we would apply this phased approach when rebasing for their third and fourth agreement periods.
We believe this phased approach to moving to a higher percentage in calculating the adjustment for regional expenditures would give ACOs sufficient notice of the transition to benchmarks that reflect regional expenditures. Further, we believe this approach to phasing in the use of a greater percentage to calculate the regional adjustment provides a smoother transition for ACOs to benchmarks reflective of regional FFS expenditures, giving ACOs more time to prepare for this change and therefore ultimately maintaining the stability of ACOs, the Shared Savings Program and the markets where ACOs operate.
Alternatively, we considered using a percentage set at 50 percent in calculating the regional adjustment amount for ACOs entering their third and subsequent agreement periods (under the phased approach previously described in this section of the proposed rule). We also considered taking a more gradual approach to transitioning to the use of a higher percentage in calculating the adjustment. For instance, in the ACO's second agreement period the percentage used in calculating the regional adjustment would be set at 35 percent; in the ACO's third agreement period the percentage would be set at 50 percent; and in the ACO's fourth and subsequent agreement periods, the percentage would be set at 70 percent unless the Secretary determines a lower weight should be applied, as specified through future rulemaking. However, we prefer an approach which more quickly transitions to the use of a higher percentage in calculating the adjustment, as previously described, over the course of two rebasing periods (for example, the ACO's second and third agreement periods). We believe this faster transition to use of a higher percentage in calculating the adjustment would more quickly create incentives to drive the most meaningful change for ACOs under the Shared Savings Program, including ensuring the program more immediately encourages continued participation by ACOs that are efficient relative to their regional service area.
We also considered an approach that would be similar to the approach to phasing in regional costs described previously, except that we would begin to incorporate some information on an ACO's regional costs during an ACO's initial agreement period, for agreement periods beginning on or after January 1, 2017. In particular, rather than using national trends in FFS expenditures to trend benchmark year expenditures when establishing the benchmark and to update the benchmark annually during the agreement period, we considered using regional FFS expenditures for both of these purposes for an ACO's first agreement period, similar to the approach we are proposing to use for subsequent agreement periods. We describe and seek comment on related considerations in sections II.A.2.d.2. and II.A.2.d.3. of this proposed rule. Under this alternative, the modified first agreement period benchmarking methodology would apply prospectively
Therefore, we are proposing a phased approach to moving to a higher weight in calculating the regional adjustment, ultimately reaching 70 percent, subject to assessment by the Secretary as discussed previously. We propose to incorporate the following proposed policies regarding the weight to be applied in determining the regional adjustment in a new regulation at § 425.603:
• Calculate the regional adjustment in the ACO's second agreement period by applying a weight of 35 percent to the difference between regional average expenditures for the ACO's regional service area and the ACO's rebased historical benchmark expenditures.
• In the ACO's third and subsequent agreement periods, the percentage used in this calculation would be set at 70 percent unless the Secretary determines a lower weight should be applied as specified through future rulemaking.
We seek comment on our proposed approach to phase in the weight used in calculating the regional adjustment. We are particularly interested in understanding commenters' thoughts and suggestions about the percentage that should be used in calculating the adjustment for regional FFS expenditures. We also seek comment on the alternatives we considered including: (1) Limiting the weight used in the calculation of the adjustment to 50 percent (instead of 70 percent) in the ACO's third and subsequent agreement period; (2) a more gradual transition to use of a higher percentage in calculating the adjustment (such as 35 percent in the second agreement period, 50 percent in the third agreement period, and 70 percent in the fourth and subsequent agreement period); and (3) a phase-in approach that uses regional (instead of national) FFS expenditures to trend benchmark year expenditures when establishing and updating the benchmark during an ACO's first agreement period (for agreement periods beginning on or after January 1, 2017). We also seek comment on alternative approaches to address our concerns about selective program participation and arbitrage opportunities that would facilitate our use of a higher percentage in calculating the amount of the adjustment.
In the initial rulemaking to establish the Shared Savings Program, we identified the need to trend forward the expenditures in each of the 3 years making up the historical benchmark. As explained in earlier rulemaking, because the statute requires the use of the most recent 3 years of per-beneficiary expenditures for Parts A and B services for FFS beneficiaries assigned to the ACO to estimate the benchmark for each ACO, the per capita expenditures for each year must be trended forward to current year dollars before they are averaged using the applicable weights to obtain the benchmark (see 76 FR 19609). In the November 2011 final rule, we finalized an approach under § 425.602(a)(5) for trending forward benchmark expenditures based on national FFS Medicare growth rates for each of the following populations of beneficiaries: ESRD, disabled, aged/dual eligible, aged/non-dual eligible (76 FR 67924 through 67925). We also explained that making separate calculations for specific groups of beneficiaries—specifically the aged/dual eligible, aged/non-dual eligible, disabled, and ESRD populations—accounts for variation in costs of these groups of beneficiaries, resulting in more accurate calculations (76 FR 67924). We considered using national, State or local growth factors to trend forward historical benchmark expenditures (76 FR 19609 through 19610, 76 FR 67924 through 67925). However, we concluded that using the national growth rate for Parts A and B FFS expenditures as a trend factor for establishing the historical benchmark offered a number of advantages over the alternatives considered, including the following:
• More consistent with the statutory methodology for updating an ACO's benchmark (see 76 FR 19610 and 76 FR 67924).
• Applies a single growth factor to all ACOs, regardless of their size or geographic area; allowing us to move toward establishing a national standard to calculate and measure ACO financial performance (see 76 FR 19610 and 76 FR 67925).
• Appropriately balanced concerns that benchmark trending should encourage participation among providers that are already efficient or operating in low cost regions without unduly rewarding ACOs in high-cost areas (see 76 FR 67925).
We discussed this last point in detail, considering the likely incentives for developing organizations to participate in the program that would result from a policy of using national growth rates to trend forward benchmark expenditures. We explained that the anticipated net effect of using the same trending factor for all ACOs would be to provide a relatively higher expenditure benchmark for low growth/low spending ACOs and a relatively lower benchmark for high growth/high spending ACOs. ACOs in high cost, high growth areas would therefore have an incentive to reduce their rate of growth more to bring their costs more in line with the national average; while ACOs in low cost, low growth areas would have an incentive to continue to maintain or improve their overall lower spending levels (see 76 FR 67925). We also explained that use of the national growth rate could also disproportionately encourage the development of ACOs in areas with historical growth rates below the national average (see 76 FR 19610). These ACOs would benefit from having a relatively higher benchmark, which would increase the chances for shared savings. On the other hand, ACOs in areas with historically higher growth rates above the national average would have a relatively lower benchmark, and might be discouraged from participating in the program (see 76 FR 19610).
In contrast, as we explained in the initial rulemaking to establish the Shared Savings Program, trending expenditures based on State or local area growth rates in Medicare Parts A and B expenditures may more accurately reflect the experience in an ACO's area and mitigate differential incentives for participation based on location (see 76 FR 19610). We considered, but did not finalize, an option to trend the benchmark by the lower of the national projected growth rate or the State or the local growth rate (see 76 FR 19610 and 76 FR 67925). This option balanced providing a more accurate reflection of local experience with not rewarding historical growth higher than the national average. We believed this method would instill stronger saving incentives for ACOs in both high growth and low growth areas (see 76 FR 19610).
Section 1899(d)(1)(B)(ii) of the Act states that the benchmark shall be updated by the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare FFS program, as estimated by the Secretary. Further, the Secretary's authority under section 1899(i)(3) of the Act, for implementing other payment models, allows for alternatives to using national expenditures for updating the benchmark, as long as the Secretary determines the approach improves the quality and efficiency of items and services furnished under Medicare and does not to result in additional program expenditures.
In the initial rulemaking, we considered using the flat dollar amount equivalent to the absolute amount of growth in the national FFS expenditures to update the benchmark during an agreement period as specified under section 1899(d)(1)(B)(ii) of the Act. We also considered using our authority under section 1899(i)(3) of the Act to update the benchmark by the lower of the national projected absolute amount of growth in national per capita expenditures and the local/state projected absolute amount of growth in per capita expenditures (see 76 FR 19610 through 19611).
We explained our belief that use of a national update factor was the most appropriate option in light of the following considerations:
• Congress demonstrated an interest in mitigating some of the regional differences in Medicare spending among ACOs by requiring the use of the flat dollar amount equivalent to the absolute amount of growth in national FFS expenditures to update the benchmark during the agreement period (76 FR 19610).
• ACOs in both high spending, high growth and low spending, low growth areas would have appropriate incentives to participate in the program (76 FR 19611).
In contrast, updating the benchmark by the lower of the national projected absolute amount of growth in national per capita expenditures and the local/state projected absolute amount of growth in per capita expenditures could instill strong saving incentives for ACOs in low-growth areas, as well as for ACOs in high-growth areas. Incorporating more localized growth factors reflects the expenditure and growth patterns within the geographic area served by ACO participants, potentially providing a more accurate estimate of the updated benchmark based on the area from which the ACO derives its patient population (76 FR 19610).
Ultimately, we finalized our policy under § 425.602(b) to update the historical benchmark annually for each year of the agreement period based on the flat dollar equivalent of the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare FFS program. Further, consistent with the final policies for calculating the historical benchmark (among other aspects of the Shared Savings Program's financial models) the calculations for updating the benchmark are made for each of the following populations of beneficiaries: ESRD, disabled, aged/dual eligible, aged/non-dual eligible (76 FR 67926 through 67927).
In the December 2014 proposed rule, we sought comment on a benchmark rebasing alternative that would use regional FFS expenditures, instead of national FFS expenditures, to develop the historical benchmark trend factors and to update the benchmark during the agreement period (79 FR 72839). We sought comment on using this approach in combination with other alternatives for incorporating regional expenditures into ACO benchmarks, including transitioning ACOs from benchmarks based on their historical expenditures toward benchmarks based on regional FFS expenditures over the course of several agreement periods (79 FR 72841 through 72843). Some commenters were supportive of using a combination of approaches to incorporate regional expenditures into benchmarks. On the issue of which FFS expenditures should be the basis for trending the historical benchmark and updating the benchmark, some commenters expressed support for maintaining the current approach of using only national FFS expenditures, while others suggested using only regional FFS expenditures, or a combination of factors based on regional and national FFS expenditures (see 80 FR 32794).
More specifically, some commenters encouraged CMS to reflect location-specific changes in Medicare payment rates in the benchmarks by using regional factors (based on regional FFS costs) in establishing and updating ACO-specific benchmarks. Other commenters supporting this approach explained that regional expenditures more accurately reflect the health status of populations (for risk adjustment), differences between rural and urban areas or market/regional differences more generally, and differences in beneficiaries' socioeconomic status. A commenter who supported use of regional costs in updating benchmarks indicated this would better address the effects of churn in the ACO's assigned population, which the commenter explained leads the ACO's population to become less reflective of its historical population and more reflective of its regional population. On the other hand, some commenters encouraged CMS to continue using factors based on national FFS costs to trend and update benchmarks. For example, a commenter expressed concern that using regional FFS expenditures instead of national FFS expenditures in establishing and updating the benchmark may further disadvantage existing low-cost ACOs. Others supported allowing ACOs a choice of either regional and national trends, applying the higher of regional or national trends, or applying regional trends to ACOs in existing high-cost regions and national trends to ACOs in existing low-cost regions. Several commenters offered conflicting views on whether moving to use of regional FFS costs in establishing historical and updated benchmarks would advantage or disadvantage existing low cost providers (80 FR 32792).
In the June 2015 final rule (80 FR 32796), we indicated that we needed to consider further what additional adjustments should be made to the benchmarking methodology when moving to a rebasing approach that accounts for regional FFS trends. These considerations included whether to incorporate regional FFS expenditures in updating an ACO's historical benchmark each performance year or to maintain the current policy under which we update an ACO's benchmark based on the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original FFS program. For instance, the update factor could be
In considering how to compute an ACO's rebased historical benchmark, we considered replacing the national trend factor that is currently used in trending an ACO's BY1 and BY2 expenditures forward to BY3 with a regional trend factor based on regional FFS expenditures corresponding to the ACO's regional service area. To align with the proposed calculation of the regional FFS expenditures for an ACO's regional service area, we considered the following approach for calculating regional FFS trend factors:
• For each benchmark year, calculate risk adjusted county FFS expenditures for the ACO's regional service area, as described under sections II.A.2.b and II.A.2.e.2 of this proposed rule. As described in section II.A.2.b.4 of this proposed rule, county FFS expenditures would be determined using total county-level FFS Parts A and B expenditures for assignable beneficiaries, excluding IME, DSH, and uncompensated care payments, but including beneficiary identifiable payments made under a demonstration, pilot or time limited program; regional expenditures would be calculated for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible);
• For each benchmark year, compute a weighted average of risk adjusted county-level FFS expenditures with weights based on the ACO's regional service area, that is the proportion of an ACO's assigned beneficiaries residing in each county within the ACO's regional service area. Calculations would be done by Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible) based on the ACO's benchmark year assigned population.
• Compute the average growth rates from BY1 to BY3, and from BY2 to BY3, using the weighted average risk-adjusted county level FFS expenditures for the respective benchmark years, for each Medicare enrollment type.
We would apply these regional trend factors to the ACO's historical benchmark expenditures, which are also adjusted based on the CMS-HCC model, to account for the severity and case mix of the ACO's assigned beneficiaries in each benchmark year.
Using regional trend factors, instead of national trend factors to trend forward expenditures in the benchmark period, would further incorporate regional FFS spending and population dynamics specific to the ACO's regional service area in the ACO's rebased benchmark. We believe there are number of relevant considerations for moving to use of regional trend factors, including the following:
• Regional trend factors would more accurately reflect the cost experience in an ACO's regional service area compared to use of national trend factors.
• Regional trend factors would reflect the health status of the FFS population that makes up the ACO's regional service area, the region's geographic composition (such as rural versus urban areas), and socio-economic differences that may be regionally related.
• Regional trend factors could better capture location-specific changes in Medicare payments (for example, the area wage index) compared to use of national trend factors.
We also considered how use of regional trend factors in resetting ACO benchmarks could affect participation by relatively high- and low-growth ACOs operating in regions with high and low growth in Medicare FFS expenditures. We anticipate using regional trend factors would result in relatively higher benchmarks for ACOs that are low growth in relation to their region compared to benchmarks for ACOs that are high growth relative to their region. Therefore, use of regional FFS trends could disproportionately encourage the development of and continued participation by ACOs with rates of growth below that of their region. These ACOs would benefit from having a relatively higher benchmark, which would increase their chances for shared savings. On the other hand, ACOs with historically higher rates of growth above the regional average would have a relatively lower benchmark and may be discouraged from participating if they are not confident of their ability to bring their costs in line with costs in their region.
In using regional growth rates specific to an ACO's regional service area and composition (by Medicare enrollment type) we expect to see significant variation in the growth rates between health care markets in different regions of the country and even between ACOs operating in the same markets. This approach would be a departure from the current methodology that applies a single set of national growth factors calculated for each benchmark year by Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible). However, ACOs familiar with the composition of their assigned population and cost trends in their regional service area may find they can more readily anticipate what these trend factors may be. Additionally, stakeholders may find it helpful to observe differences in county FFS expenditures using the data files made publicly available in conjunction with this proposed rule, as described in detail in the regulatory impact analysis section.
Accordingly, we are proposing to replace the national trend factors used for trending an ACO's BY1 and BY2 expenditures to BY3 in calculating an ACO's rebased historical benchmark with regional trend factors derived from a weighted average of risk adjusted FFS expenditures in the counties where the ACO's assigned beneficiaries reside. Further, we propose to calculate and apply these trend factors for each of the following populations of beneficiaries: ESRD, disabled, aged/dual eligible, aged/non-dual eligible. We propose to incorporate this proposal in a new regulation at § 425.603. We seek comment on this proposed change.
We also considered whether it would be sufficient to incorporate regional FFS expenditures into rebased benchmarks by applying regional trend factors (instead of national trend factors) in establishing the rebased benchmark under the existing rebasing methodology. Therefore, we specifically seek comment on the use of regional trend factors for trending forward an ACO's BY1 and BY2 expenditures to BY3 in establishing and resetting historical benchmarks under the current approach to resetting ACO benchmarks in § 425.602(c) as an alternative to adopting the proposed approach to adjusting rebased benchmarks to reflect FFS expenditures in the ACO's regional service area, as discussed in section II.A.2.c of this proposed rule. Further, we considered and seek comment on an alternative under which we would apply regional trend factors for trending forward BY1 and BY2 expenditures to BY3 in establishing the benchmark for an ACO's first agreement period under § 425.602(a), allowing this policy to be applied consistently program-wide beginning with an ACO's first agreement period.
Section 1899(d)(1)(B)(ii) of the Act states the benchmark shall be updated
We considered using an update factor based on the regional FFS expenditures for the ACO's regional service area to update an ACO's rebased historical benchmark during the ACO's second or subsequent agreement period. This approach would align with our proposal to use regional FFS expenditures in developing the trend factors for the rebased historical benchmark (to trend BY1 and BY2 expenditures to BY3) and our proposal to adjust the ACO's rebased historical benchmark to reflect regional FFS expenditures. Updating the benchmark based on regional FFS expenditures annually, during the course of the agreement period, would result in a benchmark used to determine shared savings and losses for a performance year that reflects trends in regional FFS growth for the ACO's regional service area for the corresponding year. As with use of regional trend factors instead of national trend factors (discussed in section II.A.2.d.2. of this proposed rule), we believe calculating the update factor using regional FFS expenditures would better capture the cost experience in the ACO's region, the health status and socio-economic dynamics of the regional population, and location-specific Medicare payments, when compared to using national FFS expenditures. Adopting this approach would require our use of authority under section 1899(i)(3) of the Act as it is a departure from the methodology for annually updating the benchmark specified under section 1899(d)(1)(B)(ii) of the Act.
We considered using the following approach to calculate the regional update amount for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible):
• For each calendar year corresponding to a performance year, calculate risk adjusted county FFS expenditures for the ACO's regional service area, as described under sections II.A.2.b. and II.A.2.e.2. of this proposed rule. As described in section II.A.2.b.4. of this proposed rule, county FFS expenditures would be determined using total county-level FFS Parts A and B expenditures for assignable beneficiaries, excluding IME, DSH, and uncompensated care payments, but including beneficiary identifiable payments made under a demonstration, pilot or time limited program, truncated and risk adjusted for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible). The ACO's regional service area would be defined based on the ACO's assigned beneficiary population used to perform financial reconciliation for the relevant performance year.
• Compute a weighted average of risk adjusted county-level FFS expenditures with weights based on the proportion of an ACO's assigned beneficiaries residing in each county of the ACO's regional service area. Calculations would be done by Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible) based on the ACO's assigned population used to perform financial reconciliation for the relevant performance year. This would result in an update factor for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible).
We considered whether to calculate a flat dollar equivalent of the projected absolute amount of growth in regional per capita expenditures for Parts A and B FFS services, or whether to calculate the percentage change in growth in regional FFS expenditures for the ACO's regional service area. We discussed issues related to use of a growth rate or a flat dollar amount in the initial rulemaking to establish the Shared Savings Program, including our view that a growth rate would more accurately reflect each ACO's historical experience, but could also perpetuate current regional differences in medical expenditures (see 76 FR 19609 through 19610 and 76 FR 67924). For the reasons discussed in the earlier rulemaking, we believe that using growth rates to determine the annual update would more effectively capture changes in the ACO's regional service area expenditures and changes in the health status of the ACO's population in comparison to the health status of the population of the ACO's regional service area over time. Using a growth rate to update ACOs' benchmarks would also result in proportionately larger updates for higher spending ACOs in the region and lower updates for lower spending ACOs in the region and would strike a balance with the flat-dollar average regional expenditures used to adjust the ACOs historical benchmark.
We also considered how to apply the update to the ACO's rebased historical benchmark adjusted for expenditures in the ACO's regional service area. To maintain the overall structure of the program's current methodology, and to align with the other proposed revisions to the methodology used to calculate an ACO's rebased historical benchmark described in this proposed rule, the update would be applied after all adjustments are made to the ACO's rebased benchmark. For example, for an ACO in its second or subsequent agreement period, the sequence for adjustments and the application of the update would be as follows:
• Calculate the ACO's rebased historical benchmark using historical expenditures for the beneficiaries assigned to the ACO in the 3 years prior to the start of its current agreement period, using trend factors based on regional FFS expenditures to trend the ACO's BY1 and BY2 expenditures to BY3, and applying equal weights to the benchmark years (as described in sections II.A.2.c. and II.A.2.d.2. of this proposed rule).
• Adjust the ACO's rebased historical benchmark to reflect risk adjusted regional average expenditures based on county FFS expenditures determined for the ACO's regional service area, as described in section II.A.2.c. of this proposed rule.
• As needed, adjust the ACO's rebased historical benchmark to account for changes in ACO participants for the performance year, as described in section II.B. of this proposed rule.
• Adjust the ACO's rebased historical benchmark according to the health status and demographic factors of the ACO's performance year assigned beneficiary population. We would continue to apply the current newly and continuously assigned risk adjustment methodology, described in detail in section II.A.3. of this proposed rule.
• Update the adjusted rebased historical benchmark using the growth rates in risk adjusted FFS expenditures for the ACO's regional service area for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible).
The use of an update factor based on regional FFS spending offers different incentives compared to an update factor reflecting only growth in national FFS spending. For instance, accounting for national FFS spending in an ACO's benchmark update, similar to the current methodology for updating ACO benchmarks, would continue to incorporate a national standard in the calculation and measurement of ACO financial performance. This approach would provide a relatively higher expenditure benchmark for low spending ACOs in low growth areas and
However, we anticipate there being significant variation in annual benchmark updates for individual ACOs, reflecting the cost experience in each ACO's individualized regional service area along with changes in the health status of the population of patients served by the ACO as well as changes in the types of Medicare entitlement status in the ACO's assigned beneficiary population. The update factors are used to account for change in FFS growth. The degree of year-to-year change in expenditures will likely vary in both existing low- and high-growth regions and could also vary significantly from expectations. In particular, we note our early experience in the program, where the 2012 national FFS growth factors (as used for interim reconciliation for the 2012 starters) showed an overall decrease in expenditures totaling −0.5 percent, and decreases in expenditures for three of four Medicare eligibility types (ESRD, aged/dual eligible, aged/non-dual eligible). Only disabled beneficiaries experienced a growth in expenditures in this timeframe. The resulting negative updates (and corresponding decreases in benchmark values) were surprising to many stakeholders who presumed that the updates would result in benchmark increases.
As discussed previously in this section, it would be necessary to use the discretionary authority in section 1899(i)(3) of the Act to adopt a policy under which we would calculate the benchmark update using regional FFS expenditures. Section 1899(i)(3) of the Act authorizes the Secretary to use other payment models in place of the payment model outlined in section 1899(d) of the Act as long as the Secretary determines these other payment models will improve the quality and efficiency of items and services furnished to Medicare beneficiaries, without additional program expenditures. We believe that updating an ACO's rebased historical benchmark based on regional FFS spending, rather than national FFS spending (as is done currently) would have positive effects for the Shared Savings Program and Medicare beneficiaries. As described in the regulatory impact analysis of this proposed rule, the proposed changes to the payment model used in the Shared Savings Program, including updating the ACO's rebased historical benchmark based on regional FFS spending, are anticipated to increase overall participation in the program, improve incentives for ACOs to invest in effective care management efforts, and increase the accuracy of benchmarks in capturing the experience in an ACO's regional service area compared to the use of national FFS expenditures. Therefore, we believe these changes would result in improved quality of care furnished to Medicare beneficiaries, and greater efficiency of items and services furnished to these beneficiaries, as more ACOs enter and remain in the Shared Savings Program and continue to work to meet the program's three-part aim of better care for individuals, better health for populations and lower growth in expenditures.
We note that section 1899(i)(3)(B) of the Act provides that the requirement that the other payment model not result in additional program expenditures “shall apply . . . in a similar manner as [subparagraph (b) of paragraph (2) of section 1899(i)] applies to the payment model under [section 1899(i)(2)].” Section 1899(i)(2) of the Act provides discretion for the Secretary to use a partial capitation model rather than the payment model described in section 1899(d) of the Act. Section 1899(i)(2)(B) of the Act provides that—
Section 1899(i)(3)(B) of the Act also specifies that the other payment model must not result in additional program expenditures. Section IV.E. of this proposed rule discusses our analysis of this requirement, and our initial assessment of the costs associated with a payment model that includes changes to the manner in which we update the benchmark during an ACO's agreement period. We compared all current policies and proposed policies to policies that could be implemented under section 1899(d)(1)(B)(ii) of the Act, and assessed that for the period spanning 2017 through 2019 there would be net federal savings. Therefore, we believe that the proposed alternative payment model under section 1899(i)(3) of the Act, which includes using regional FFS expenditures to update an ACO's rebased historical benchmark and using FFS expenditures of assignable beneficiaries to calculate the national benchmark update for ACOs in their first agreement period and for ACOs that started a second agreement period on January 1, 2016, as discussed in section II.A.2.d.3. of this proposed rule, as well as current policies established using the authority of section 1899(i)(3) of the Act, meets the requirements under section 1899(i)(3)(B) of the Act. We anticipate that the costs of this alternative payment model will be periodically reassessed as part of the impact analysis for subsequent rulemaking regarding the payment models used under the Shared Savings Program. However, in the event we do not undertake additional rulemaking, we intend to periodically reassess whether a payment model established under authority of section 1899(i)(3) of the Act continues to improve the quality and efficiency of items and services furnished to Medicare beneficiaries, without resulting in additional program expenditures. If we determine the payment model no longer satisfies the requirements of section 1899(i)(3) of the Act, for example if the alternative payment model results in net program costs, we would undertake additional notice and comment rulemaking to make adjustments to our payment methodology to assure continued compliance with the statutory requirements.
To summarize, we are proposing to include a provision in the proposed new regulation at § 425.603 to specify that for ACOs in their second or subsequent agreement period whose rebased historical benchmark incorporates an adjustment to reflect regional expenditures, the annual update to the benchmark will be calculated as a growth rate that reflects risk adjusted growth in regional per beneficiary FFS spending for the ACO's regional service area. Further, we propose to calculate and apply separate update factors based on risk adjusted regional FFS expenditures for each of the following populations of beneficiaries: ESRD, disabled, aged/dual eligible, and aged/non-dual eligible. We seek comment on this proposal. We also seek comment on the alternatives considered, including calculating the update factor as the flat dollar equivalent of the projected absolute amount of growth in regional per capita expenditures for Parts A and B FFS services for the ACO's regional service area.
We want to clarify that the current methodology for calculating the annual update will continue to apply in updating an ACO's historical benchmark during its first agreement period, as well as in updating the rebased historical benchmark for the second agreement period for ACOs that started in the program in 2012 or 2013, and entered their second agreement period on January 1, 2016. That is, for these ACOs, we would continue to update the historical benchmark annually for each year of the agreement period based on the flat dollar equivalent of the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare FFS program. We believe the continued application of an update based on national FFS spending is consistent with the methodology used to establish the benchmarks for these ACOs, particularly the use of trend factors based on national FFS spending to trend an ACO's BY1 and BY2 expenditures to BY3. However, as discussed earlier in this section of this proposed rule, we are seeking comment on the use of trend factors based on regional FFS expenditures, instead of national FFS expenditures, in establishing the benchmark for an ACO's first agreement period (see section II.A.2.d.2. of this proposed rule). Likewise, we considered and seek comment on using regional FFS expenditures, instead of national FFS expenditures, to update an ACO's historical benchmark beginning with its first agreement period.
In the November 2011 final rule, we established a methodology for determining ACO benchmark and performance year expenditures for Medicare FFS beneficiaries assigned to the ACO. Under that methodology, we take into account payments made from the Medicare Trust Funds for Parts A and B services for assigned Medicare FFS beneficiaries, including individually beneficiary identifiable payments made under a demonstration, pilot or time limited program, when computing average per capita Medicare expenditures under the ACO. We exclude IME payments and DSH and uncompensated care payments from both benchmark and performance year expenditures. This adjustment to benchmark expenditures falls under the Secretary's discretion established by section 1899(d)(1)(B)(ii) of the Act to adjust the benchmark for beneficiary characteristics and such other factors as the Secretary determines appropriate. However, section 1899(d)(1)(B)(i) of the Act only provides authority to adjust expenditures in the performance period for beneficiary characteristics and does not provide authority to adjust for “other factors.” Therefore, to remove IME and DSH payments from performance year expenditures, we used our authority under section 1899(i)(3) of the Act, which authorizes use of other payment models, in order to make this adjustment (see 76 FR 67920 through 67922). We allow for a 3-month run out of claims data and apply a claims completion factor (percentage), to more accurately determine an ACO's benchmark and performance year expenditures (76 FR 67837 through 67838). To minimize variation from catastrophically large claims we truncate an assigned beneficiary's total annual Parts A and B FFS per capita expenditures at the 99th percentile of national Medicare FFS expenditures as determined for each benchmark year and performance year (76 FR 67914 through 67916).
We perform many of these calculations separately for each of the following populations of beneficiaries: ESRD, disabled, aged/dual eligible, and aged/non-dual eligible. For example, we calculate benchmark and performance year expenditures, determine truncation thresholds, and risk adjust ACO expenditures separately for each of these four Medicare enrollment types. As part of this methodology, we account for circumstances where a beneficiary is enrolled in a Medicare enrollment type for only a fraction of a year, through a process that results in a calculation of “person years” for a given year. We calculate the number of months that each beneficiary is enrolled in Medicare in each Medicare enrollment type, and divide by 12. When we sum the fraction of the year enrolled in Medicare for all the beneficiaries in each Medicare enrollment type, the result is total person years for the beneficiaries assigned to the ACO.
We apply these policies consistently across the program, as specified in the provisions for establishing, updating and resetting the benchmark under § 425.602, and for determining performance year expenditures under § 425.604 for Track 1 ACOs and under § 425.606 for Track 2 ACOs. Further, in developing Track 3, we determined that it would be appropriate to calculate expenditures consistently program-wide (see 80 FR 32776 through 32777). Accordingly, the provisions in § 425.602 governing establishing, updating, and resetting the benchmark also apply to ACOs under Track 3, and we adopted the same approach for determining performance year expenditures as is used in Track 1 and Track 2 in § 425.610 for Track 3 ACOs.
As part of our proposal to adjust the historical benchmark to reflect regional FFS expenditures, we believe it is important to calculate FFS expenditures for an ACO's region in a manner consistent with the methodology used to calculate an ACO's benchmark and performance year expenditures. Consistent application of program methodology in calculating FFS expenditures will result in more predictable and stable calculations across the program over time, for example as ACOs transition from a benchmarking methodology that incorporates factors based on national FFS expenditures to one that incorporates factors based on regional FFS expenditures. In addition, use of an alternative approach to calculating regional FFS expenditures could introduce bias because different types of payments could be included in or excluded from these expenditures, as compared to historical benchmark expenditures and performance year expenditures.
To increase predictability and stability, and avoid this bias, we believe we should follow the same approach in calculating regional FFS expenditures as is used in calculating benchmark and performance year expenditures, for
In the initial rulemaking establishing the Shared Savings Program, we finalized an approach to determining which payments are included in expenditures used in program calculations. Consistent with section 1899(d)(1) of the Act, we take into account payments made from the Medicare Trust Funds for Parts A and B services for assigned Medicare FFS beneficiaries, including individual beneficiary identifiable payments made under a demonstration, pilot or time limited program when computing average per capita Medicare expenditures under the ACO (see 76 FR 67919 through 67920). We also believe that the calculation of Parts A and B county FFS expenditures used as the basis for calculating the ACO's regional service area expenditures should include individually beneficiary identifiable payments made under a demonstration, pilot or time limited program. Unless these payments are included in the calculation of regional FFS expenditures, these expenditures will be understated compared to ACO benchmark and performance year expenditures. In the November 2011 final rule, we also finalized an approach whereby we exclude IME and DSH payments from program calculations, so as not to create an incentive for ACOs to avoid referrals to hospitals that receive IME and/or DSH payments in an effort to demonstrate savings (see 76 FR 67920 through 67922). Similarly, we believe IME payments and DSH and uncompensated care payments should be excluded from regional FFS expenditures. Absent this adjustment, regional expenditures will overstate payments to providers receiving IME payments and/or DSH and uncompensated care payments, as compared to benchmark and performance year expenditures.
In prior rulemaking for the Shared Savings Program we established policies for truncating an assigned beneficiary's total annual Parts A and B FFS per capita expenditures at the 99th percentile of national Medicare FFS expenditures when calculating benchmark and performance year expenditures (see 76 FR 67915 through 67916; see also 80 FR 32776 through 32777). This truncation minimizes variation from catastrophically large claims. To prevent overstatement of the regional FFS expenditures that will be used to adjust an ACO's rebased historical benchmark, we believe it is necessary to apply the same approach to truncating beneficiary expenditures when calculating county FFS expenditures that are used as the basis for determining expenditures for an ACO's regional service area.
We also risk adjust benchmark expenditures in the Shared Savings Program, to take into account the severity of health status and case mix of assigned beneficiaries, as described in greater detail in section II.A.3.a. of this proposed rule. For example, we use the prospective CMS-HCC model for adjusting benchmark expenditures in establishing the ACO's historical benchmark (see 76 FR 67916 through 67919, and § 425.602(a)(3)). Similarly, we would risk adjust county FFS expenditures for severity and case mix of assignable beneficiaries using the prospective CMS-HCC model.
In financial calculations under the Shared Savings Program, we make separate expenditure calculations for each of the following populations of beneficiaries: ESRD, disabled, aged/dual eligible, and aged/non-dual eligible (see §§ 425.602, 425.604, 425.606, and 425.610). For instance, we use this approach in calculating and truncating benchmark and performance year expenditures, trending historical benchmark expenditures and updating the historical benchmark, and in risk adjusting expenditures. Consistent with this approach, we believe it is important to calculate expenditures for each county used to determine the expenditures for an ACO's regional service area separately for each of these populations of beneficiaries. As described previously in the background for this section of this proposed rule, we use beneficiary person years in calculating expenditures for each Medicare enrollment type. Consistent with this approach, we would also calculate beneficiary person years when determining county FFS expenditures for each Medicare enrollment type.
Taking these considerations into account, we propose to take the following steps in calculating county FFS expenditures used to determine expenditures for an ACO's regional service area:
• Calculate the payment amounts included in Parts A and B FFS claims using a 3-month claims run out with a completion factor. Exclude IME, DSH, and uncompensated care payments. Include individually beneficiary identifiable payments made under a demonstration, pilot or time-limited program.
• Truncate a beneficiary's total annual Parts A and B FFS per capita expenditures at the 99th percentile of
• Adjust expenditures for severity and case mix using prospective CMS-HCC risk scores.
• Make separate expenditure calculations for each of the following populations of beneficiaries, stated as beneficiary person years: ESRD, disabled, aged/dual eligible, and aged/non-dual eligible.
Several elements of the existing Shared Savings Program financial calculations are based on expenditures for all Medicare FFS beneficiaries regardless of whether they are eligible to be assigned to an ACO, including: The growth rates used to trend forward expenditures during the benchmark period; the projected absolute amount of growth in national per capita expenditures for Parts A and B services used to update the benchmark; the completion factors applied to benchmark and performance year expenditures; and the truncation thresholds set at the 99th percentile of national Medicare FFS expenditures. In calculating these factors based on national FFS expenditures, we take into account Parts A and B expenditures for all Medicare FFS beneficiaries, and exclude IME payments and DSH and uncompensated care payments to align with our methodology for calculating benchmark and performance year expenditures.
Generally, beneficiaries eligible for assignment to Shared Savings Program ACOs are a subset of the larger population of Medicare FFS beneficiaries. In identifying the pool of beneficiaries who can be assigned to an ACO, as a “pre-step” to the two-step assignment process under § 425.402, we determine if a beneficiary received at least one primary care service from a physician within the ACO whose services are used in assignment:
• For performance year 2016 and subsequent performance years, the beneficiary must have received a primary care service, as defined under § 425.20, with a date of service during the 12-month assignment window, as defined under § 425.20.
• The service must have been furnished by a primary care physician as defined under § 425.20 or by a physician with one of the primary specialty designations included in § 425.402(c). Therefore, beneficiaries who have not received any primary care service, or who have only received primary care services from physicians with a primary specialty code not specified in § 425.402(c) (see 80 FR 32753 through 32754, Table 5-Physician Specialty Codes Excluded From Assignment Step 2), or from non-physician practitioners are excluded from assignment to an ACO.
This pre-step is designed to satisfy the statutory requirement under section 1899(c) of the Act that beneficiaries be assigned to an ACO based on their use of primary care services furnished by physicians (80 FR 32756; § 425.402(a), § 425.402(b)(1)). We use the beneficiary population resulting from the pre-step, referred to as “assignable beneficiaries,” to determine the beneficiaries who will be assigned to an ACO based on the two-step assignment process under § 425.402.
Including beneficiaries ineligible for assignment in calculating factors that are based on the expenditures of the broader FFS population can bias those calculations. There may be differences in the health status and health care cost experience of Medicare beneficiaries excluded from the pre-step compared to those who are eligible for assignment, based on their health conditions and the providers from whom they receive care. Thus, including the expenditures for non-assignable beneficiaries, such as non-utilizers of health care services, can result in lower overall per capita expenditures. These biases may have a more pronounced effect in calculations of regional FFS expenditures, which are based on relatively smaller populations of beneficiaries, as compared to calculations based on the national FFS population. As a result, we are concerned that using expenditures for all Medicare FFS beneficiaries, as opposed to a narrower population of FFS beneficiaries, in calculating certain program elements may introduce a degree of bias in these calculations, particularly for elements based on regional FFS expenditures (as discussed in section II.A.2.b. of this proposed rule).
Therefore, we believe it is timely to reconsider the population that should be used in program calculations for both national and regional FFS populations. Our preferred approach would be to apply a similar logic as is used to identify the population of FFS beneficiaries eligible for assignment as part of the assignment pre-step under § 425.402(b)(1). We would limit the Medicare FFS population used in these program calculations to “assignable” Medicare beneficiaries who meet the following requirements: (1) Received at least one primary care service, as defined under § 425.20, with a date of service during the 12-month assignment window; and (2) this primary care service was provided by a primary care physician, as defined under § 425.20, or by a physician with one of the primary specialty designations included in § 425.402(c).
One factor related to calculating expenditures for assignable beneficiaries is the assignment window used to identify this population, with options including: The 12-month period used to assign beneficiaries to Track 1 and 2 ACOs based on a calendar year, and an off-set 12-month period used to assign beneficiaries prospectively to an ACO in Track 3. (See definition of assignment window under § 425.20 and related discussion in the June 2015 final rule at 80 FR 32699.) We believe it is important to calculate regional and national FFS expenditures consistently across the three tracks of the program, so as not to advantage or disadvantage an organization simply on this basis. This consistency would help to ensure a level playing field in markets where multiple ACOs are present, and would also simplify program operations. Accordingly, we are proposing to calculate county FFS expenditures and average risk scores, as well as factors based on national FFS expenditures, using the assignable beneficiary population identified using the assignment window for the 12-month calendar year corresponding to the benchmark or performance year. This is the same assignment window that is currently used to assign beneficiaries under Track 1 and Track 2. We plan to monitor for observable differences in the health status (for example, as identified by HCC risk scores) and expenditures of the assignable beneficiaries identified using the 12-month calendar year assignment window, as compared to assignable beneficiaries identified using an assignment window that is the off-set 12-month period prior to the benchmark or performance year (for example October through September preceding
This proposed rule primarily focuses on modifying the methodology for resetting the ACO's historical benchmark for an ACO's second or subsequent agreement period beginning on or after January 1, 2017. As we have indicated elsewhere in this proposed rule (see section II.A.2.d.3. of this proposed rule), while we are proposing to modify the annual update to the ACO's rebased historical benchmark to reflect a regional update, we are not proposing to extend this modification to the benchmark update for ACOs in their first agreement period or for ACOs that started their second agreement period January 1, 2016. We will continue to apply an update based on national FFS expenditures to these ACOs. However, to the extent that we are proposing to change our methodology in order to use only assignable beneficiaries instead of all Medicare FFS beneficiaries in calculating the benchmark update based on national FFS expenditures, we believe we would need to use the authority under section 1899(i)(3) of the Act to adopt other payment models to implement this proposed change.
Section 1899(d)(1)(B)(ii) of the Act states the benchmark shall be updated by the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare FFS program, as estimated by the Secretary. The plain language of section 1899(d)(1)(B)(ii) of the Act demonstrates Congress' intent that the benchmark update be calculated based on growth in expenditures for the national FFS population, as opposed to a subset of this population. Therefore, in order to allow us to use only assignable beneficiaries in determining the amount of growth in per capita expenditures for Parts A and B services for purposes of determining the benchmark update for ACOs in their first agreement period and those ACOs that started a second agreement period on January 1, 2016, it is necessary to rely upon our authority under section 1899(i)(3) of the Act. Section 1899(i)(3) of the Act authorizes the Secretary to use other payment models in place of the payment model outlined in section 1899(d) of the Act as long as the Secretary determines these other payment models will improve the quality and efficiency of items and services furnished to Medicare beneficiaries, without additional program expenditures.
For the reasons explained in section II.A.2.d.3 of this proposed rule, we believe using our authority under section 1899(i)(3) of the Act to adopt a payment model that includes calculating the benchmark update for ACOs in their first agreement period and for ACOs that started a second agreement period on January 1, 2016, using national FFS expenditures for assignable beneficiaries, rather than for all FFS beneficiaries, would improve the quality and efficiency of items and services furnished to Medicare beneficiaries. We believe this approach would increase the accuracy of benchmarks, by determining the national update using a population that more closely resembles the population that could be assigned to ACOs. Further, we believe using assignable beneficiaries across program calculations based on national and regional FFS expenditures will result in factors that are generally more comparable. As a result, these calculations will be more predictable and stable across the program over time, for example as ACOs transition from a benchmarking methodology that incorporates national FFS expenditures to one that incorporates factors based on regional FFS expenditures. Ultimately, we believe this policy could increase overall participation in the program, thereby resulting in more organizations working to meet the program's three-part aim of better care for individuals, better health for populations and lower growth in expenditures.
As explained in section II.A.2.d.3. of this proposed rule, section 1899(i)(3)(B) of the Act also specifies that the other payment model must not result in additional program expenditures. Section IV.E. of this proposed rule discusses our analysis of this requirement, and our initial assessment that for the period spanning 2017 through 2019 there would be net federal savings associated with a payment model under section 1899(i)(3) that includes the proposed changes to the manner in which we update the benchmark during an ACO's agreement period.
Taking these considerations into account, we believe applying a payment methodology that includes calculating the benchmark update consistently based on assignable FFS beneficiaries, instead of all FFS beneficiaries, would meet the requirements under section 1899(i)(3) of the Act that the payment model would improve the quality and efficiency of items and services furnished to Medicare beneficiaries, without additional program expenditures. However, as discussed in section II.A.2.d.3. of this proposed rule, we intend to revisit this determination periodically. If we determine the payment model no longer satisfies the requirements of section 1899(i)(3) of the Act, for example if the model results in net program costs, we would undertake additional notice and comment rulemaking to make adjustments to the model to assure continued compliance with the statutory requirements. After considering these issues, we are proposing to use the authority under section 1899(i)(3) of the Act to revise the regulation at § 425.602(b)(1) to specify that the annual update to the benchmark will be based on the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare FFS program for assignable beneficiaries. We further propose to specify in this provision of the regulations that we will identify assignable beneficiaries for the purpose of calculating the update based on national FFS expenditures using the 12-month calendar year corresponding to the year for which the update is being calculated. We seek comment on these proposals.
We also propose to make conforming changes to the regulations to specify that assignable Medicare FFS beneficiaries, identified based on the 12-month period corresponding to the calendar year for which the calculations are being made, will be used to perform the following calculations: (1) Truncation thresholds for limiting the impact of catastrophically large claims on ACO expenditures under § 425.602(a)(4), § 425.604(a)(4), § 425.606(a)(4), § 425.610(a)(4); and (2) growth rates used to trend forward expenditures during the benchmark period under § 425.602(a)(5). We will provide additional information through subregulatory guidance regarding the process for using assignable beneficiaries to perform these calculations, as well as calculation of the claims completion factor applied under § 425.602(a)(1), § 425.604(a)(5), § 425.606(a)(5), § 425.610(a)(5).
In addition, we propose to specify in a new provision of the Shared Savings Program regulations at § 425.603 that would govern the methodology for resetting, adjusting, and updating an ACO's benchmark for a second or subsequent agreement period that county FFS expenditures will be based on assignable Medicare FFS beneficiaries determined using the 12-
We propose that regulatory changes regarding use of assignable beneficiaries in calculations based on national FFS expenditures would apply for the 2017 performance year and all subsequent performance years. Under this proposal, these changes would apply to ACOs that are in the middle of an agreement period, specifically ACOs that started their first agreement period in 2015 or 2016 and ACOs that started their second agreement period on January 1, 2016. We would adjust the benchmarks for these ACOs at the start of the first performance year in which these proposed changes apply so that the benchmark for the ACO reflects the use of the same methodology that would apply in expenditure calculations for the corresponding performance year.
We seek comment on these proposals. We also seek comment on whether expenditures for all Medicare FFS beneficiaries should be used to calculate these elements for ACOs in their first agreement period or a second agreement period that started on January 1, 2016, while expenditures for assignable Medicare FFS beneficiaries are used to calculate these elements for the ACO's second and subsequent agreement period in combination with the use of the assignable beneficiary population to determine expenditures for the ACO's regional service area.
In the June 2015 final rule we indicated that the revised rebasing methodology would “apply to ACOs beginning new agreement periods in 2017 or later. ACOs beginning a new agreement period in 2016 would convert to the revised methodology at the start of their third agreement period in 2019” (80 FR 32795). This description did not differentiate between ACOs that started their first agreement period under the Shared Savings Program on January 1, 2016, and ACOs that started in the program in 2012 and 2013 (2012 and 2013 starters) that entered their second agreement period on January 1, 2016.
We considered the following approach, under which the revised rebasing methodology could be applied to new agreement periods beginning on or after January 1, 2017, in a manner that allows for a phase-in to a greater percentage in calculating the regional adjustment (as described in section II.A.2.c.3. of this proposed rule) for all ACOs:
• All ACOs would have the benchmark for their first agreement period set and updated under the methodology under § 425.602(a) and (b).
• The 2014, 2015, 2016 starters and subsequent cohorts entering their second agreement periods on or after January 1, 2017, would be rebased under the proposed new methodology for adjusting an ACO's rebased historical benchmark to reflect expenditures in the ACO's regional service area, and the ACO's rebased benchmark would be updated during the agreement period by growth in regional FFS expenditures. In calculating the regional adjustment to the rebased historical benchmark for an ACO's second agreement period, the percentage applied to the difference between the ACO's regional service area expenditures and ACO's rebased historical benchmark expenditures would be set at 35 percent. In an ACO's third or subsequent agreement period this percentage would be set at 70 percent unless the Secretary determines a lower weight should be applied, as specified through future rulemaking.
• With respect to the 2012 and 2013 starters, who have renewed their agreements for 2016, we would apply the current rebasing methodology, under which we equally weight the benchmark years and account for savings generated during the ACO's prior agreement period, in rebasing their historical benchmark for their second agreement period (beginning in 2016). We would apply the methodology currently specified under § 425.602(b) for updating the benchmark annually for each year of their second agreement period. We would apply the proposed new rebasing policies, including the phase in of the percentage used in calculating the regional adjustment, to these ACOs for the first time in calculating their rebased historical benchmark for their third agreement period (beginning in 2019), as if the ACOs were entering their second agreement period. Accordingly, the 2012 and 2013 starters would have the same transition to the use of a higher percentage in calculating the regional adjustment as all other ACOs.
This approach to phasing in the application of the new methodology for adjusting an ACO's rebased historical benchmark to reflect regional FFS expenditures would give ACOs and other stakeholders greater opportunity to prepare for, understand the effects of and adjust to the application of benchmarks that incorporate regional expenditures.
We are proposing to make these changes applicable to ACOs starting a second or subsequent agreement period on or after January 1, 2017. Therefore, they would initially apply in resetting benchmarks for the second agreement period for all ACOs other than 2012 and 2013 starters (who entered their second agreement period on January 1, 2016). Further we are proposing that 2012 and 2013 starters would have the same transition to regional adjustments to their rebased historical benchmarks as all other ACOs: In calculating the regional adjustment to the ACO's rebased historical benchmark for its third agreement period (in 2019), the percentage applied to the difference between the ACO's regional service area expenditures and ACO's rebased historical benchmark expenditures would be set at 35 percent; in its fourth or subsequent agreement period this percentage would be set at 70 percent unless the Secretary determines a lower weight should be applied, as specified through future rulemaking. We request comment on this proposed approach to phasing in the application of the revised rebasing and updating methodology.
In earlier rulemaking for the Shared Savings Program, we identified several risk adjustment considerations related to use of regional expenditures in resetting ACO benchmarks. In the June 2015 final rule, we specified that the subsequent proposed rule on benchmark rebasing would address the following issues related to risk adjustment: (i) How to refine the program's risk adjustment methodology to account for differences in the mix of beneficiaries assigned to the ACO and in the ACO's region; and (ii) how we might guard against excessive payments as ACOs improve documentation and coding of beneficiary conditions, such as by adjusting ACOs' risk scores for coding intensity or imposing limits on the extent to which an ACO's risk score can rise relative to its region (80 FR 32796). In the December 2014 proposed rule, we acknowledged considerations around the need for normalization of the ACO's assigned beneficiary risk scores among other considerations for additional risk adjustment in developing a rebasing methodology to account for regional expenditures (79 FR 72842).
The Shared Savings Program benchmarking methodology uses the CMS-HCC prospective risk score methodology used by the MA program to adjust expenditures for changes in health status of the population assigned to the ACO. Currently we use CMS-HCC risk scores for an ACO's assigned beneficiary population in risk adjusting the ACO's historical benchmark at the start of its first agreement period, adjusted historical benchmark (based on annual participant list changes during the agreement period) and in rebasing the ACO's benchmark for its second or subsequent agreement period (§ 425.602(a)(3)). Each performance year, we adjust the historical benchmark for changes during the performance period in the health status and demographic factors of assigned beneficiaries (§ 425.604(a), § 425.606(a), § 425.610(a)). We use CMS-HCC prospective risk scores to adjust the benchmark to take into account changes in severity and case mix for newly-assigned beneficiaries and demographic factors to adjust for changes for beneficiaries continuously assigned to the ACO. However, if the continuously assigned population shows a decline in its CMS-HCC prospective risk scores, we adjust the benchmark to reflect the lower risk score for this population. The risk adjustment methodology applied in determining the updated benchmark each performance year limits the impact of changes in health status, including limiting the impact of ACO coding initiatives undertaken during the agreement period.
We anticipate that using CMS-HCC risk scores for an ACO's assigned beneficiary population in resetting the ACO's benchmark has the potential to benefit ACOs that have systematically engaged in coding initiatives during their prior agreement period. This effect would have been limited in the corresponding performance years due to the application of our current approach to risk adjusting during the agreement period according to the ACO's newly and continuously assigned beneficiary populations. Although initial financial performance results (for the performance years ending December 31, 2013 and 2014) do not show strong evidence that concerns about systematic coding practices by ACOs have materialized, complete data are not yet available to analyze the effect of coding initiatives in the initial rebasing of ACO benchmarks, as initial program entrants (ACOs with 2012 and 2013 agreement
We received various suggestions for risk adjustment approaches, including through comments submitted in response to Shared Savings Program proposed rules (see 76 FR 67917 through 67919; 80 FR 32793). For instance, some commenters responding to the December 2014 proposed rule raised the need to revise the program's risk adjustment methodology when moving to an alternative benchmarking methodology that incorporates regional costs. Commenters suggested, for instance: Using a regional HCC growth rate or accounting for regional variation in updating the HCC formulas; using a concurrent risk adjustment methodology, and doing so in combination with a demographically adjusted regional FFS cost baseline; creating a risk adjustment factor by comparing the HCC coding between the ACO's assigned beneficiaries and the regional comparison population; following the MA methodology for risk adjustment; and readjusting the risk determination of a population after removing beneficiaries determined ineligible for assignment. Some commenters suggested that CMS not be overly restrictive in applying regional normalization and coding intensity adjustments. Others suggested CMS specifically account for other factors in regional adjustments such as changes in access to care for low-cost populations, and the socio-economic risk profile of beneficiaries. One commenter requested that risk adjustment be based on the ACO's historical performance and not the market's historical performance.
In addition, although the December 2014 proposed rule did not explicitly request comment on the program's existing risk adjustment methodology, many commenters took the opportunity to criticize this aspect of the calculation of ACO benchmarks. Almost all commenters addressing the program's existing risk adjustment methodology suggested that it inadequately captures the risk and cost associated with assigned beneficiaries. Of the alternatives to the current risk adjustment methodology presented by commenters, many urged CMS to incorporate the full change in HCC risk scores across each performance year (upward and downward adjustment). Some suggested use of regionally-based risk factors. Others suggested that CMS' concerns about upcoding could be addressed through vigilant monitoring or placing a cap on upward risk adjustment growth (for example, relative to a national or regional growth rate). Some urged CMS to continue researching alternative risk adjustment models and consider additional changes to increase the accuracy of the risk adjustment methodology (see 80 FR 32793).
To balance CMS' concerns regarding ACO coding practices with the recommendations of commenters, we considered an approach whereby we would perform risk adjustment to account for the health status of the ACO's assigned population in relation to FFS beneficiaries in the ACO's regional service area when determining the regional adjustment to the ACO's rebased historical benchmark described in section II.A.2.c. of this proposed rule. Additionally, we considered rigorously monitoring for the impact of coding initiatives on ACO benchmarks and modifying the risk adjustment methodology used in resetting ACO benchmarks as warranted through future rulemaking.
We propose to adjust for differences in health status between an ACO and its regional service area in a given year, in determining the regional adjustment to the ACO's rebased historical benchmark. For example, we would compute for each Medicare enrollment type a measure of risk-adjusted regional expenditures that would account for differences in HCC risk scores of the ACO's assigned beneficiaries and the average HCC risk scores in the ACO's regional service area. We believe this approach would account for differences in health status between the ACO's assigned population and the broader FFS population in the ACO's regional service area. It would also capture differences in coding intensity efforts applied to the ACO's assigned population and the FFS population in the ACO's regional service area. We propose to include this risk adjustment approach in the revised benchmark rebasing methodology under a new provision of the Shared Savings Program regulations at § 425.603.
While we anticipate the proposed approach would serve as a partial coding intensity adjustment, it may not fully adjust for differential coding intensity by the ACO relative to its region. In other words, this would not adjust for intensive coding practices of the ACO that are above and beyond the coding practices occurring generally in the ACO's region. For this reason, we plan to rigorously monitor for the impact of coding initiatives on ACO benchmarks and, if warranted, would undertake further rulemaking to modify the risk adjustment methodology to further limit ACOs from generating higher benchmarks simply through systematic coding practices. The combined approach of adjusting for an ACO's risk relative to its region while engaging in further rigorous monitoring is also in alignment with certain comments received in response to the December 2014 proposed rule, including comments recommending that CMS compare an ACO's HCC coding with that of a regional comparison population and avoid being overly restrictive in applying coding intensity adjustments (see 80 FR 32793).
We believe the combined approach of proposing to adjust for an ACO's risk relative to that of its region in determining the regional adjustment to the ACO's rebased historical benchmark, while engaging in further rigorous monitoring, is reasonable given the lack of strong evidence to date that ACOs are engaging in more intensive coding practices and given a number of factors that we believe would mitigate the potential impact of coding intensity on ACO financial calculations, including the following:
• The program's current policy for performance year reconciliation under which the ACO's benchmark is risk adjusted using HCC scores for the newly assigned population, but any upward adjustment for the continuously assigned population is limited to demographics, appears to mitigate the impact of ACO coding initiatives.
• CMS is fully transitioning in 2016 to a new HCC model that markedly reduces the model's sensitivity to subjectively coded severity levels for key chronic conditions.
• ACOs are less susceptible to coding practices, for instance, compared to MA plans, for several reasons including the following: (1) ACOs can be comprised of entities with little influence over the coding practices at other facilities or settings (a point made by commenters responding to the December 2014 proposed rule (see 80 FR 32793)); and (2) unlike MA plans, ACOs cannot submit supplemental diagnosis codes.
• Routine changes in the assignment of beneficiaries to the ACO would tend to reduce the potential disparity in coding intensity between the ACO and its region. As a result of normal changes in beneficiary assignment from year to year, beneficiaries whose risk scores were subject to ACO coding initiatives in one year may no longer be assigned to the ACO in the next year. These changes in the ACO's assigned
• Many ACOs tend to be clustered in similar regions, meaning coding intensity efforts in such regions would also be felt by the region's wider population as a whole, further reducing the potential impact of coding intensity for ACOs relative to their region. Similarly, ACOs serve a wider population than just their assigned beneficiaries which leads to spillover of any coding shifts to the wider region; when many ACOs are clumped together geographically these spillover effects can be further amplified.
However, we considered several alternatives that might be employed in the future to limit the impacts of intensive coding while still accounting for changes in health status within an ACO's assigned beneficiary population.
One alternative we considered would be to apply the methodology currently used to adjust the ACO's benchmark annually to account for the health status and demographic factors of the ACO's performance year assigned beneficiaries (according to newly and continuously assigned populations) when rebasing the ACO's historical benchmark. Under this approach, newly assigned beneficiaries would always receive full HCC risk adjustment, whereas continuously assigned beneficiaries would receive either HCC or demographic risk adjustment, depending on whether average HCC risk scores were rising or falling. We believe this approach would more significantly limit ACOs from generating higher benchmarks simply through systematic coding practices, compared to the current risk adjustment methodology that accounts for the CMS-HCC scores of all assigned beneficiaries in rebasing, or the approaches proposed in this section. An advantage of this alternative is that it is already part of the current benchmarking methodology and is familiar to ACOs and stakeholders, and would be relatively easy for CMS to implement.
We have also considered ultimately moving to a coding intensity adjustment similar to the methodology used in the MA program which relies on an analysis of populations of beneficiaries who remained in MA for two consecutive reference years, and whose diagnoses all came from MA, referred to as stayers. For a full description of the MA approach see “Advance Notice of Methodological Changes for Calendar Year (CY) 2010 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies,” February 20, 2009, available online at
We seek comment on the proposals to risk adjust to account for the health status of the ACO's assigned population in relation to FFS beneficiaries in the ACO's regional service area as part of the methodology for adjusting the ACO's rebased historical benchmark to reflect regional FFS expenditures, and to specify this approach under a new provision of the Shared Savings Program regulations at § 425.603. If this approach is finalized, we would rigorously monitor for the impact of coding initiatives on ACO benchmarks and make necessary refinements to the program's risk adjustment methodology through future rulemaking if program results show adverse impacts due to increased coding intensity. We also seek comment on alternatives considered that might be employed in the future to limit the impacts of intensive coding while still accounting for changes in health status within an ACO's assigned beneficiary population, including: (1) Apply the methodology currently used to adjust the ACO's benchmark annually to account for the health status and demographic factors of the ACO's performance year assigned beneficiaries (according to newly and continuously assigned populations) when rebasing the ACO's historical benchmark; or (2) develop a coding intensity adjustment by looking at risk score changes over time for beneficiaries assigned to the ACO for at least two consecutive prospective risk adjustment data years (similar to the population referred to as stayers under the MA methodology) relative to the greater FFS population.
We note that these proposed changes would not apply in calculating the benchmarks for ACOs in their first agreement period, or in establishing and updating the rebased historical benchmark for the second agreement period for ACOs that started in the program in 2012 and 2013 and started a new agreement period on January 1, 2016. Rather, we will continue to use CMS-HCC risk scores for the ACO's assigned beneficiary population in risk adjusting the ACO's historical benchmark at the start of the agreement period.
Further, for all ACOs, we will continue to use the current methodology to adjust the ACO's benchmark annually to account for the health status and demographic factors of the ACO's performance year assigned beneficiaries (according to the newly and continuously assigned populations).
In the initial rulemaking establishing the Shared Savings Program, we acknowledged that the addition or removal of ACO participants or ACO providers/suppliers (identified by TINs and NPIs, respectively) during the term of an ACO's participation agreement could affect a number of different aspects of the ACO's participation in the Shared Savings Program. In the November 2011 final rule, we included the regulation at § 425.214(a)(3), which specified that the ACO's benchmark, risk scores, and preliminary prospective assignment may be adjusted to reflect changes in ACO participants or ACO providers/suppliers at CMS' discretion. Following the issuance of the November 2011 final rule, we issued subregulatory guidance further describing how the agency would use this discretion to make adjustments to reflect changes in ACO participants. See “Changes in ACO participants and ACO providers/suppliers during the Agreement Period” available online at
After acceptance into the program and upon execution of the participation agreement with CMS, the ACO must certify
CMS will adjust the ACO's historical benchmark at the start of a performance year if the ACO Participant List that the ACO certified at the start of that performance year differs from the one it certified at the start of the prior performance year. We will use the updated certified ACO Participant List to assign beneficiaries to the ACO in the benchmark period (the 3 years prior to the start of the ACO's agreement period) in order to determine the ACO's adjusted historical benchmark. As a result of changes to the ACO's certified ACO Participant List, we may adjust the historical benchmark upward or downward. We'll use the new certified list of ACO participants and the adjusted benchmark for the new performance year's assignment, quality measurement and sampling, reports for the new performance year, and financial reconciliation. We will provide ACOs with the adjusted Historical Benchmark Report.
In the June 2015 final rule we amended the Shared Savings Program regulations to incorporate portions of the subregulatory guidance (80 FR 32707 through 32712) at § 425.118(b)(3)(i). This provision specifies that CMS annually adjusts an ACO's assignment, historical benchmark, the quality reporting sample, and the obligation of the ACO to report on behalf of eligible professionals that bill under the TIN of an ACO participant for certain CMS quality initiatives to reflect the addition or deletion of entities from the list of ACO participants that is submitted to CMS before the start of a performance year in accordance with § 425.118(a). Further, § 425.118(b)(3)(ii) specifies that absent unusual circumstances, CMS does not make adjustments during the performance year to the ACO's assignment, historical benchmark, performance year financial calculations, the quality reporting sample, or the obligation of the ACO to report on behalf of eligible professionals that bill under the TIN of an ACO participant for certain CMS quality initiatives to reflect the addition or deletion of entities from the ACO Participant List that become effective during the performance year. CMS has sole discretion to determine whether unusual circumstances exist that would warrant such adjustments. Because we added a new provision at § 425.118 that addresses the adjustments that CMS will make to reflect changes in an ACO's list of ACO participants, we removed the reference to CMS' discretion to adjust the benchmark under § 425.214(a)(3). The June 2015 final rule also codified the subregulatory policies allowing for consideration of claims billed under merged and acquired Medicare-enrolled TINs for purposes of beneficiary assignment and establishing the ACO's benchmark (§§ 425.204(g), 425.118(a)(2)).
During the program's initial performance years, we experienced a high volume of change requests from ACOs, both adding and removing ACO participants. With each new performance year an ACO has the opportunity to request the addition of new ACO participants and to make other changes to its ACO Participant List resulting in a new certified ACO Participant List as required under § 425.118(a). Prospective additions must be vetted through CMS' screening process which reviews the TINs for program integrity concerns, Medicare enrollment requirements, and participation in other Medicare shared savings initiatives. ACOs may delete ACO participants from their ACO Participant List at any time during the performance year and are required to notify CMS within 30 days after the termination of an ACO participant agreement (§ 425.118(b)(2)).
When we adjust historical benchmarks during the agreement period to account for changes in beneficiary assignment arising from ACO Participant List changes, the benchmark period (the 3 years prior to the start of the ACO's agreement period) remains the same. For instance, if an ACO with an agreement start date of January 1, 2013, added ACO participants for its second performance year (2014), then the adjustments made to the historical benchmark to reflect the ACO's certified ACO Participant List for performance year two would have been based on the same 3 benchmark years (2010, 2011, and 2012) originally used to calculate the historical benchmark for the ACO based on the ACO Participant List it certified when it entered the program at the start of its first performance year. As a result of this methodology, if an ACO certifies revisions to its ACO Participant List for its second and third performance years, it is necessary for us to adjust the historical benchmark to reflect the changes made to the ACO Participant List for the second performance year, and to make further adjustments to reflect the changes made for the third performance year.
Changes in the ACO participant TINs that compose ACOs are also relevant to determining beneficiary assignment across all ACOs participating in the program. A beneficiary is assigned to an ACO if the beneficiary received the plurality of his or her primary care services (measured in allowed charges) from ACO professionals billing under the TINs of ACO participants in the ACO rather than outside the ACO (such as from ACO professionals billing under the TINs of ACO participants in other ACOs or from individual providers or provider organizations that are not participating in an ACO). We perform the assignment process for ACOs simultaneously, regardless of whether they have had an ACO Participant List change. To determine where a beneficiary got the plurality of his or her primary care services, we compare the total allowed charges for each beneficiary for primary care services provided by the ACO (in total for all ACO participants) to the allowed charges for primary care services provided by ACO participants in other ACOs and by non-ACO providers and suppliers. See “Medicare Shared Savings Program: Shared Savings and Losses and Assignment Methodology Specifications” available online at
In summary, in making adjustments to the historical benchmarks for ACOs within an agreement period to account for ACO Participant List changes, the historical benchmark period remains constant, but beneficiary assignment reflects the influence of ACO Participant List changes. Under this methodology, the historical benchmarks for ACOs with ACO Participant List changes from one performance year to the next continue to reflect the ACOs' historical costs in relation to the current composition of the ACO. Changes to an ACO's list of ACO participants will result in changes to the ACO's assigned beneficiary population which can affect the proportion of an ACO's assigned population in each Medicare enrollment type (ESRD, disabled, aged/dual
In accordance with these policies, we adjusted the historical benchmarks for 162 of 220 ACOs (74 percent) with 2012 and 2013 start dates for the 2014 performance year to reflect changes in ACO participants. For the 2015 performance year, we adjusted benchmarks for 245 of 313 ACOs (78 percent) with 2012, 2013 or 2014 start dates to reflect changes in ACO participants. Among the ACOs that made TIN changes effective for performance year 2015, the mean percentage change in historical benchmark value was −0.3 percent and the magnitude of the change for most ACOs was between −2 percent and +2 percent.
While the current methodology ensures that a benchmark that has been adjusted based on changes in the ACO's participant composition accurately reflects benchmark year assignment using the most recent certified ACO Participant List, a primary drawback is that this methodology is operationally burdensome. To adjust benchmarks to account for ACO Participant List changes made by ACOs for each new performance year we must repeat the assignment process for all 3 benchmark years for each starter cohort. For example, in order to adjust benchmarks for 2012, 2013, and 2014 starters making ACO Participant List changes for the 2015 performance year we had to perform the assignment process for 5 different benchmark years: 2009, 2010, 2011, 2012, and 2013. The operational burden associated with the current methodology will increase further as Track 3 ACOs enter the program. Track 3 ACOs have an offset assignment window based on the most recent 12-month period preceding the relevant calendar year for which data are available (for example, the period spanning October-September prior to the start of the benchmark year) whereas the assignment window for Track 1 and 2 ACOs is based on the 12-month calendar year that corresponds to the benchmark year. Therefore, with the first ACOs starting their participation under Track 3 on January 1, 2016, we now have to perform two assignment runs for each benchmark year.
In light of the operational burden of adjusting benchmarks to reflect changes in ACO participants under the current policy, and the considerations associated with our proposal to adopt a benchmark rebasing methodology that requires additional calculations, we considered alternative approaches to streamline calculations of adjusted historical benchmarks. Under these alternatives, we would start with the historical benchmark based on the ACO's certified ACO Participant List for the most recent prior performance year and make adjustments to the benchmark using expenditures from a single reference year—for example, the third benchmark year (BY3) of the current agreement period—for which beneficiary assignment has been performed using both the ACO Participant List for the most recent prior performance year and the new ACO Participant List for the current performance year. This approach would allow us to adjust the benchmark to reflect changes in the ACO participants while reducing the number of benchmark years for which assignment would need to be redetermined based on the new ACO Participant List. Under this approach, where we would adjust the benchmark determined based on the ACO's list of ACO participants for the most recent prior performance year, there would be a cumulative effect of the adjustment in the case where an ACO certifies changes to its ACO Participant List effective for the second and third performance years of the agreement period. However, the number of cumulative adjustments would be limited and, further, we believe that applying adjustments to the benchmark determined based on the certified ACO Participant List for the most recent prior performance year in all cases enhances the simplicity of the approach.
Calculations for the adjustment would be made in relation to three populations of beneficiaries assigned to the ACO in the reference year:
• Stayers: Beneficiaries assigned to an ACO using both the ACO Participant List for the most recent prior performance year and the new ACO Participant List.
• Joiners: Beneficiaries who are assigned to the ACO using the new ACO Participant List but not the ACO Participant List for the most recent prior performance year.
• Leavers: Beneficiaries who are assigned to the ACO using the ACO Participant List for the most recent prior performance year but not the new ACO Participant List.
Calculation of the adjusted historical benchmark would include the following steps for each Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible):
• Calculate a stayer component: Multiply an ACO's historical benchmark by a ratio of average per capita reference year expenditures for stayers to average per capita reference year expenditures for stayers and leavers combined. This ratio may adjust the benchmark upward or downward depending on the relative expenditures and person years of the stayers and leavers.
• Calculate a joiner component: Determine average per capita reference year expenditures for joiners.
• Combine the stayer and joiner components: Obtain the overall adjusted benchmark for each enrollment type by taking a weighted average of the stayer and joiner components where each component's weight is its relative share of the total number of assigned beneficiaries, identified as stayers or joiners (respectively), based on the new Participant List.
• Once the preceding three steps have been completed for each Medicare enrollment type: Calculate a single weighted average per capita adjusted historical benchmark. We will sum the product of the benchmark expenditures for each Medicare enrollment type and the ACO's proportion of assigned beneficiaries for the corresponding Medicare enrollment type. We will determine the proportion of assigned beneficiaries by Medicare enrollment type during the reference year based on the assigned beneficiary population determined using the new ACO Participant List.
• In conjunction with the proposals to adjust an ACO's rebased historical benchmark to account for regional expenditures, we would also redetermine the regional adjustment to account for changes to the ACO's certified ACO Participant List. In addition to the steps described previously, we would redetermine the ACO's regional service area during the reference year based on the residence of the ACO's assigned beneficiaries for the reference year determined using the new ACO Participant List. We would also use this assigned population to determine the ACO's proportion of beneficiaries by Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible) to be used in calculating the regional adjustment. We would redetermine the regional adjustment, using the approach described previously under section II.A.2.c. of this proposed rule. In calculating the regional adjustment, we
We believe that this approach offers the right balance between approximating the accuracy of the current methodology for adjusting historical benchmarks (which requires performing beneficiary assignment for all 3 of an ACO's historical benchmark years with the new ACO Participant List) and operational ease. Initial modeling suggests that benchmarks calculated using this alternative methodology are highly correlated with those calculated using the current methodology.
We also examined a second alternative under which we would calculate the average per capita expenditures for leavers in the reference year and use this value, along with the relative person years for leavers and stayers, to impute average per capita reference year expenditures for stayers from the historical benchmark. The imputed expenditures for stayers would then be combined with average per capita reference year expenditures for joiners to obtain the overall adjusted benchmark. This second alternative, in addition to being more complex to compute and explain, does not consistently improve the accuracy of the calculations compared to the first alternative. For example, initial modeling indicates this approach can produce a phenomenon whereby ACOs with large numbers of high cost leavers (in relation to their stayer and joiner populations) actually retained relatively high benchmarks under this adjustment, which was an unanticipated result. Further, we have concerns about the reliability and predictability of imputed data, on which this approach depends.
We believe that several clarifications to the application of the preferred first alternative methodology are important. First, in the case where an ACO's new ACO Participant List yields zero assigned beneficiaries who are identified as stayers, we would apply the current methodology for adjusting the historical benchmark for ACO Participant List changes. That is, in such cases, we would calculate the ACO's average per capita historical benchmark based on assignment for each of the 3 benchmark years prior to the start of the ACO's agreement period using the new ACO Participant List. Second, the ACO Participant List for the performance year would be used to identify the counties of residence for the ACO's assigned beneficiaries in order to determine the ACO's regional service area for the purpose of calculating the regional benchmark update, as discussed in section II.A.2.d. of this proposed rule.
We considered whether to apply the preferred alternative methodology for adjusting the historical benchmark for ACO Participant List changes for all ACOs beginning with an ACO's first agreement period, or only for ACOs in a second or subsequent agreement period as part of the revised rebasing methodology. We believe that applying a single policy for adjusting historical benchmarks for changes in ACO participants to all ACOs participating in the program would provide operational consistency and stability to the program and its participants.
Therefore, we propose to replace the current approach for calculating adjusted historical benchmarks for ACOs that make ACO Participant List changes with an approach that adjusts an ACO's historical benchmark using a ratio that is based on expenditures for the ACO's beneficiaries assigned using both the ACO Participant List for the new performance year and the ACO Participant List for the most recent prior performance year (stayers) and expenditures for the ACO's beneficiaries assigned using only the ACO Participant List for the ACO's most recent prior performance year (stayers and leavers) for the same reference year. We propose to define the reference year as benchmark year 3 of the ACO's current agreement period. This figure would then be combined with reference year expenditures for beneficiaries assigned using only the ACO Participant List for the new performance year (joiners) to obtain the overall adjusted benchmark. Calculations of the adjustment would be made, and applied to the historical benchmark, for each of the following populations of beneficiaries, according to Medicare enrollment type: ESRD, disabled, aged/dual eligible, and aged/non-dual eligible. We propose to apply this adjustment to the ACO's historical benchmark determined based the ACO's certified ACO Participant List for the most recent prior performance year. We propose to apply this new approach program wide as we believe it will address operational inefficiencies in the calculation of adjusted historical benchmarks under the current approach while still providing an accurate adjustment to reflect changes in ACO participants. We also propose that in the event an ACO's new ACO Participant List results in zero stayers, we would continue to apply the current methodology for adjusting the ACO's historical benchmark for ACO Participant List changes. We propose to incorporate this adjustment to the historical benchmark for ACOs in their first agreement period and those ACOs that started a second agreement period on January 1, 2016, by adding a paragraph to § 425.602. In addition, we propose to specify that the adjustment would apply to the ACO's rebased historical benchmark in a new provision of the Shared Savings Program regulations at § 425.603. We also propose to add definitions for “stayers”, “joiners” and “leavers” to § 425.20.
We seek comment on this proposed approach to adjusting ACO historical benchmarks for changes in ACO participants and any modifications to our proposed approach that may be needed. We welcome comments on alternatives to applying the adjustment to the ACO's historical benchmark determined based on the ACO's certified ACO Participant List for the most recent prior performance year, such as applying the proposed adjustment to the historical benchmark established for the first performance year of the ACO's agreement period. Further, we seek commenters' suggestions on the anticipated interactions between the proposed approach to adjusting ACO historical benchmarks using an expenditure ratio and the rebasing alternatives discussed previously in this proposed rule.
As discussed in the December 2014 proposed rule (79 FR 72815 through 72816), we believe that in order for the Shared Savings Program to be effective and sustainable over the long term, we need to further strengthen our efforts to transition the Shared Savings Program to a two-sided performance-based risk program in which ACOs share in both savings and losses. Although we are encouraged by stakeholder interest in the Shared Savings Program, ACOs have been cautious in choosing to enter performance-based risk arrangements. Only a small number of ACOs have agreed to participate under the program's performance-based risk track (Track 2) established in the November 2011 final rule. Therefore, in the June 2015 final rule, we established a new performance-based risk track at § 425.610, referred to as Track 3, and made other program revisions (see 80 FR 32694 and 32695 for a summary) to encourage ACOs to accept performance-based risk arrangements. We also indicated in the June 2015 final rule (80 FR 32695) that we intended to consider
Currently, for its initial agreement period, an ACO applies to participate in a particular financial model or track of the program as specified under § 425.600(a). If the ACO's application is accepted, the ACO must remain under that financial model for the duration of its 3-year agreement. ACOs entering the program under the one-sided shared savings model (Track 1) that meet eligibility criteria may continue their participation under this model for a second 3-year agreement period as specified under § 425.600(b).
Stakeholders and ACOs have suggested a variety of options to address their concerns about some of the current agreement period related policies. For example, as discussed in the June 2015 final rule (80 FR 32763), some commenters responding to the December 2014 proposed rule supported allowing ACOs initially participating under Track 1 to extend their first agreement period by 1, 2 or 3 years, under certain circumstances, to gain additional experience before starting their second agreement period under a performance-based risk track. Under such an option in which ACOs are allowed to choose voluntarily to have a longer agreement period under Track 1, stakeholders requested that we also maintain an ACO's original historical benchmark as it gains additional experience before moving to performance-based risk. These stakeholders explained that this approach would facilitate ACOs' transition to two-sided performance-based risk arrangements. We did not adopt these suggestions for the reasons discussed in the June 2015 final rule (80 FR 32763). However, based on our experience with the first group of ACOs eligible for renewal for 2016 in which nearly all such ACOs applied to remain in Track 1 for an additional agreement period, we have further considered these issues.
We further considered these stakeholder suggestions and whether it would be appropriate to offer an additional option to encourage ACOs to move more quickly from the one-sided shared savings model to a performance-based risk model when renewing their agreements. To respond to stakeholder concerns and to provide additional support for ACOs that are willing to accept performance-based risk arrangements, we are proposing to add a participation option that would allow eligible Track 1 ACOs to defer by 1 year their entrance into a performance-based risk model (Track 2 or 3) by extending their first agreement period under Track 1 for a fourth performance year. ACOs that would be eligible to elect this proposed new participation option would be those ACOs eligible to renew for a second agreement period under Track 1 but instead are willing to move to a performance-based risk track 2 years earlier, after continuing under Track 1 for 1 additional year. This option would assist ACOs in transitioning to a two-sided risk track when they need only one additional year in Track 1 rather than a full 3-year agreement period in order to prepare to accept performance-based risk. The additional year could allow such ACOs to further develop necessary infrastructure to meet the program's goals, such as further developing their care management services, adopting additional mechanisms for measuring and improving quality performance, finalizing implementation and testing of electronic medical records, and performing data analytics. This option would be available to Track 1 ACOs whose first agreement period is scheduled to end on or after December 31, 2016. Under this proposal, ACOs that elect this new participation option would continue under their first agreement period for a fourth year, deferring benchmark rebasing as well as deferring entrance to a two-sided risk track if they are approved for renewal.
More specifically, we are proposing to provide an additional option for ACOs participating under Track 1 to apply to renew for a second agreement period under a two-sided track (Track 2 or Track 3) under the renewal process specified at § 425.224. If the ACO's renewal request is approved, the ACO would be able to defer entering the new agreement period under a performance-based risk track for 1 year. Further, as a result of this deferral, we would also defer rebasing the ACO's benchmark for 1 year. At the end of this fourth performance year under Track 1, the ACO would transition to the selected performance-based risk track for a 3-year agreement period. Accordingly, we are proposing to amend the participation agreement requirements at § 425.200 to provide that an ACO that defers entering its new agreement period will be able to continue participating under its first agreement for an additional year (for an agreement period that would total 4 years).
An ACO electing this option would still be required to undergo the renewal process specified at § 425.224 prior to the end of its initial agreement (PY 3) and meet all other renewal requirements including the requirement that the ACO demonstrate that it is capable of repaying shared losses as required to enter a performance-based risk track. Because the ACO would be committing under the renewal application to transition to a performance-based risk track following completion of PY 4 under Track 1, the ACO would be required to demonstrate as part of its renewal application that it has established an adequate repayment mechanism as specified at § 425.204(f) to assure CMS of its ability to repay losses for which it may be liable during the new agreement period. We propose to make this option available to Track 1 ACOs whose first agreement period is scheduled to end on or after December 31, 2016. Therefore, if finalized, this option would be available to ACOs with 2014 start dates seeking to renew their participation agreement in order to enter their second agreement period beginning in 2017. Under this proposal, we would update the ACO's benchmark as specified at § 425.602(b) for performance year 4 of the initial participation agreement. However, we would defer resetting the benchmark as specified at proposed § 425.603 until the beginning of the ACO's second agreement period (that is, the ACO's first agreement period under the selected performance-based risk track). The benchmark would be reset under the policies in place for that time period including any regional adjustment, as described in this proposed rule, if finalized. Also, we propose that the quality performance standard that would apply for performance year 4 of the initial participation agreement would be the same as for the ACO's performance year 3, consistent with § 425.502(a)(2). Specifically, we propose that during the fourth performance year of the ACO's first agreement period, the ACO must continue to report all measures and the ACO will be assessed on performance based on the quality performance standard in place for the third performance year of the ACO's first agreement period.
In addition, under this proposal, if a Track 1 ACO finishing its initial agreement period chooses to elect this option during the renewal of its
If such an ACO subsequently decides during the fourth performance year that it no longer wants to transition to the performance-based risk track it selected in its application for a second agreement period, then the currently established close-out procedures and payment consequences of early termination under § 425.221 would apply. For example, if the ACO voluntarily terminates its agreement under § 425.221(a), effective December 31 of its fourth performance year, and completes all required close-out procedures, then as specified by § 425.221(b), the ACO would be eligible to share in any shared savings for its fourth performance year.
However, we believe it would be appropriate under this proposed participation option to provide some incentive for ACOs to honor their commitment to participate early in a performance-based risk track. Therefore, we are proposing that if an ACO that has been approved for an extension of its initial agreement period terminates its participation agreement prior to the start of the first performance year of the second agreement period, then the ACO would be considered to have terminated its participation agreement for the second agreement period under § 425.220. Such an ACO would not be eligible to participate in the Shared Savings Program again until after the date on which the term of that second agreement period would have expired if the ACO had not terminated its participation, consistent with § 425.222.
We would further note that if an ACO that goes on to participate under a two-sided track under this proposed option voluntarily terminates its agreement during its second agreement period, then the currently established close-out procedures and payment consequences of early termination under § 425.221 would apply. If an ACO terminates its agreement under its selected performance-based risk track and subsequently decides to reapply to participate in the Shared Savings Program, then the requirements under § 425.222 for re-application after termination would apply. For example, consistent with our current policy, such an organization would be required to apply to participate under a two-sided model and would have to wait the duration of its remaining agreement period before reapplying.
In developing this proposal to support our policy goal of providing additional flexibility to ACOs that are considering transitioning to two-sided risk, we considered an alternative approach that might achieve the same goal. Specifically, we considered an alternative option that would permit the ACO to transition to a two-sided risk track during a subsequent 3-year agreement period under Track 1, instead of extending the first agreement period for an additional year. Under this alternative approach, we would allow the ACO to remain in Track 1 for the first performance year of the second 3-year agreement period. The ACO would then be required to transition to Track 2 or 3 for the final 2 performance years of the agreement period. An ACO choosing this option would be required to satisfy all the requirements for a performance-based risk track at the time of renewal, including the requirement that the ACO demonstrate that it is capable of repaying shared losses as required to enter a performance-based risk track. Under this approach, we would rebase the ACO's benchmark as provided under proposed § 425.603, effective for the first year of the second 3-year agreement period. Further, we would calculate shared savings for the first year of the second 3-year agreement period under the one-sided model as specified at § 425.604. During the second and third performance years of the second agreement period we would calculate shared savings and shared losses, as applicable, under either Track 2 (as determined at § 425.606) or Track 3 (as determined at § 425.610). We did not elect to propose this alternative option because we believe there could be a stronger incentive for some ACOs to transition to two-sided performance-based risk if we were to defer resetting the ACO's benchmark until the beginning of the ACO's second agreement period. Additionally, the alternative approach could raise concerns about risk selection since an ACO could participate for the first performance year of the second agreement period under this alternative, learn midway through the second performance year that its expenditures for the first performance year were below the negative MSR, and withdraw from the program before being subjected to reconciliation under performance-based risk.
We welcome comments on this proposal and the alternative approach, as well as on other possible alternatives to provide flexibility and encourage ACOs to enter into and honor their participation agreements under performance-based risk tracks, and any related issues.
ACOs enter into agreements with CMS to participate in the Shared Savings Program, under which ACOs that meet quality performance requirements and reduce the Medicare Parts A and B expenditures for their assigned beneficiaries below their benchmark by a specified margin are eligible to share a percentage of savings with the Medicare program. Further, ACOs participating under a two-sided track, whose Medicare Parts A and B expenditures for their assigned beneficiaries exceed their benchmarks by a specified margin, are liable for sharing losses with CMS. After each performance year (PY), CMS calculates whether an ACO has generated shared savings by comparing its actual expenditures for its assigned beneficiaries in the PY with its updated benchmark. Savings are generated if actual Medicare Parts A and B expenditures for assigned beneficiaries are less than the updated benchmark expenditures and shared with the ACO if they exceed the ACO's minimum savings rate, and the ACO meets the minimum quality performance standards and otherwise maintains its eligibility to participate in the Shared Savings Program. For an ACO in a two-sided track, losses are generated if actual Medicare Parts A and B expenditures for assigned beneficiaries are greater than the updated benchmark expenditures and the ACO is liable for shared losses if the losses exceed the ACO's minimum loss rate.
To date, we have announced 2 years of financial performance results for ACOs participating in the Shared Savings Program, in Fall 2014 for 220 ACOs with 2012 and 2013 start dates for PY 1 (concluding December 31, 2013), and in August 2015 for 333 ACOs with 2012, 2013 and 2014 start dates for PY 2014. Several months after the release of PY 1 financial reconciliation results and shared savings payments to eligible ACOs, we discovered that there was an issue with one of the source input data fields used in the final financial reconciliation calculations that we ultimately determined resulted in an estimated 5 percent overstatement of PY 1 shared savings payments to ACOs and an understatement of shared losses. The issue did not result in understated PY
When we calculate total Medicare Parts A and B FFS expenditures for assigned beneficiaries for purposes of establishing ACO benchmarks and determining performance year results, we make an adjustment to remove IME payments and DSH payments, including uncompensated care payments. We identified an issue in the source data for Quarter 4 of CY 2013 that caused some cancellation claims for uncompensated care to be incorrectly signed (plus sign instead of a minus sign) in the national claim data repository used to calculate ACO benchmarks and performance year results. The outcome of the sign error was that the amounts deducted from total CY 2013 expenditure calculations were doubled for claims that were canceled and resubmitted, which ultimately led to ACO total expenditures for PY 1 being understated in the final reconciliation for PY 1 (that is, for the performance year ending December 31, 2013). As a result, the PY 1 shared savings payments were overstated for some ACOs and shared losses were understated for some other ACOs. The impact on individual ACOs varied depending on the extent to which services provided to the ACO's assigned beneficiaries were furnished by providers that receive DSH payments.
The financial reconciliation calculation/methodology and the amount of shared savings an ACO might earn, including all underlying financial calculations, are not appealable. That is, the determination of whether an ACO is eligible for shared savings under section 1899(d), and the amount of such shared savings, as well as the underlying financial calculations are precluded from administrative and judicial review under section 1899(g)(4) of the Act and § 425.800(a)(4). However, under § 425.314(a)(4), if as a result of any inspection, evaluation, or audit, it is determined that the amount of shared savings due to the ACO or the amount of shared losses owed by the ACO has been calculated in error, CMS reserves the right to reopen the initial determination and issue a revised initial determination. (See also the CMS Web site at
Thus far, we have not further specified, either through regulations or program guidance, the actions that we would take under circumstances when we identify an error in a prior payment determination, such as the error that occurred in the calculation of PY 1 shared savings and shared losses. We have considered what actions we believe would be appropriate for addressing issues with the financial reconciliation calculations underlying the initial determination of ACO shared savings and shared losses in situations such as the data source error that occurred for PY 1, or a final agency determination under § 425.804 or § 425.806, if an error were discovered after a request for reconsideration of the initial determination. In considering this issue, we reviewed existing, analogous provisions within the Medicare program (such as § 405.980 and § 405.986 regarding reopening of initial determinations of claims under the original Medicare program, § 405.1885 regarding reopening of intermediary determinations of program reimbursement under the original Medicare program, and § 423.346 regarding reopening of payment determinations under Medicare Part D).
We are concerned that adopting wholesale one of these existing reopening processes, including all of the associated timeframes, may not be appropriate for the Shared Savings Program. For example, many ACOs have indicated that they intend to quickly reinvest some of any future shared savings they might receive to provide additional staff training, hire additional staff and make other infrastructure improvements to further improve the quality of care for Medicare beneficiaries and reduce unnecessary costs. We believe such investments may be critical so that ACOs can innovate further to achieve even greater cost savings. Shared savings payments also can support an ACO's ongoing operational costs, which we previously estimated to be an average of $0.86 million for an ACO participating in the Shared Savings Program (80 FR 32827). For example, shared savings payments support infrastructure (such as IT solutions) and process development, staffing, population management, care coordination, quality reporting and improvement, and patient education (80 FR 32767). We believe that ACOs may be reluctant to make the necessary investments to enable them to further improve the quality of care for Medicare beneficiaries and achieve greater cost savings if they might be required to unexpectedly pay back some or all of their shared savings payments. Further, ACOs could be reluctant to participate in two-sided performance-based risk tracks, if after receiving a payment determination they might subsequently be required to pay additional amounts for shared losses.
We are concerned that the current uncertainty regarding the timeframes and other circumstances in which we would reopen a payment determination to correct financial calculations under the Shared Savings Program could introduce financial uncertainty which could seriously limit an ACO's ability to invest in additional improvements to increase quality and efficiency of care. This uncertainty could also limit an ACO's ability to get a clean opinion from its financial auditors, which could, for example, harm the ACO's ability to obtain necessary capital for additional program improvements. This could be especially challenging for ACOs seeking to enter or continue under a two-sided performance-based risk track since under the requirements at § 425.204(f)(2), such an ACO must, as part of its application for a two-sided performance-based risk track, demonstrate its ability to repay shared losses to the Medicare program, which it may do by placing funds in escrow, obtaining a surety bond, establishing a line of credit (as evidenced by a letter of credit that the Medicare program can draw upon), or establishing a combination of such repayment mechanisms, that will ensure its ability to repay the Medicare program. These arrangements can often require that an ACO and/or its financial supporters make an assessment of the ACO's level of financial risk for possible repayments. Uncertainty over past financial results could significantly affect an ACO's ability to obtain and maintain these arrangements with financial institutions, and thus discourage ACOs from participating in the Shared Savings Program under two-sided performance-based risk tracks. We are particularly concerned that this could discourage ACOs from moving more quickly from the one-sided shared savings track to a performance-based risk track when renewing their agreements.
We considered an approach under which we would always reopen a determination of ACO shared savings or shared losses to correct any issue that might arise with respect to a financial calculation. Under this approach, we would correct for any and all issues (for example, a source data error or computational error), even for relatively minor errors having little impact on ACO financial results, that are identified within four years after the release of final financial reconciliation results. We are concerned that this approach of correcting even very minor errors might result in significant operational burdens
We also considered whether to adopt a policy under which we would never correct for errors after performing the financial calculations and making initial determinations of ACO shared savings and shared losses. By establishing such definitive administrative finality following notification of any applicable performance-based payments or loss recoupments, both ACOs and CMS would be better able to anticipate that such performance-based payments or loss recoupments would not be subject to subsequent revision. Financial calculations and shared savings payments or shared loss recoupments would not be subject to future reopening, and ACOs would be able to plan future transactions, issue financial reports, and plan for contingencies in reliance on the fact that those payment determinations were closed. However, we believe it would be appropriate to reopen financial calculations in certain circumstances, such as in the case of fraud or similar fault as defined at § 405.902, or for errors with a significant impact on the computation of ACOs' shared savings/shared losses. Therefore, we believe it would be appropriate to allow for corrections, under certain circumstances and within a defined timeframe, after financial calculations have been performed and the determination of ACO shared savings and shared losses has been made. In the following section we further discuss the rationale and the details of our proposed finality policy for financial calculations and shared savings payments or shared loss recoupments.
It is longstanding policy in the Medicare program that a determination may be reopened at any time if it was procured by fraud or “similar fault,” (see, for example, § 405.980(b)(3); 74 FR 65296, 65313 (December 9, 2009)). Further, under the Shared Savings Program regulations at § 425.314(a)(4), if as a result of any inspection, evaluation, or audit, it is determined that the amount of shared savings due to the ACO or the amount of shared losses owed by the ACO has been calculated in error, CMS reserves the right to reopen the initial determination and issue a revised initial determination. We believe it would be appropriate to define the circumstances under which we would reopen a payment determination to make corrections after the financial calculations have been performed and ACO shared savings and shared losses determined, absent evidence of fraud or similar fault. In developing the proposals in this section, we considered the following issues: (1) The type of issue/error that we would correct; (2) the timeframes for reopening a payment determination; and (3) whether we should establish a materiality threshold as an indicator of a material effect on shared savings and shared losses that would warrant a correction, and if so, at what level.
First, we are proposing that CMS would have discretion to reopen a payment determination at any time in the case of fraud or “similar fault,” as defined in § 405.902. Second, we are proposing that in certain circumstances we would reopen a payment determination for good cause. For consistency and to decrease program complexity, we believe it would be reasonable and appropriate to base the definition of good cause for purposes of the Shared Savings Program on the definition of good cause used elsewhere in the Medicare FFS program. We propose to follow the same approach to reopening for good cause as applies to the reopening of Parts A and B claims determinations under § 405.986. Specifically, we propose that CMS will have the discretion to reopen a payment determination, within 4 years after the date of notification to the ACO of the initial determination of shared savings or shared losses for the relevant performance year, if there is good cause. We propose that good cause may be established if there is new and material evidence that was not available or known at the time of the payment determination, and which may result in a different conclusion, or if the evidence that was considered in making the payment determination clearly shows on its face that an obvious error was made at the time of the payment determination.
New and material evidence or an obvious error could come to CMS' attention through a variety of means, such as identification by CMS through CMS program integrity reviews or audits, identification through audits conducted by independent federal oversight entities such as the Office of the Inspector General (OIG) or the Government Accountability Office (GAO). CMS program integrity reviews and audits would include reviews and audits conducted by CMS' contractors. We believe it would be appropriate to establish a 4-year time period (that is, 4 years from initial notification of the payment determination) for reopenings for good cause to provide sufficient time to initiate, complete, and evaluate errors through CMS program integrity reviews or audits by oversight entities like OIG or GAO. A timeline for reopenings for good cause that is too short could undermine the ability of CMS to address significant issues raised through such program integrity initiatives or audits. Therefore, we believe that it would be appropriate to establish a 4-year timeframe for reopening Shared Savings Program payment determinations for good cause. In developing the proposed time period for reopenings, we considered alternative approaches in which we would provide for either shorter or longer time periods for reopenings for good cause. We chose not to propose these alternative time periods for good cause. A shorter time period might provide more financial certainty for ACOs but could make it difficult for CMS to make corrections based on program integrity reviews or audits by OIG or GAO. Similarly, a longer time period might make it feasible for CMS to make additional corrections based on program integrity reviews or audits by OIG or GAO, but could provide less financial certainty for ACOs.
We propose that good cause would not be established by changes in substantive law or interpretative policy. A change of legal interpretation or policy by CMS in a regulation, CMS ruling, or CMS general instruction, whether made in response to judicial precedent or otherwise, would not be a basis for reopening a payment determination under this section. Further, we propose CMS has sole
When determining whether to reopen for good cause, we would also consider whether the error is material and thus warrants a correction by reviewing the nature and particular circumstances of the error. Under this proposal, we would not reopen a payment determination to consider, or otherwise consider as part of a reopening, additional claims information submitted following the end of the 3-month claims run out and the use of the completion factor. We would continue to use claims submitted prior to the end of the 3-month claims run out with a completion factor to calculate an ACO's per capita expenditures for each performance year, consistent with §§ 425.604(a)(5), 425.606(a)(5) and 425.610(a)(5). Also, consistent with established policy, under this proposed policy, we would not reopen a determination if an ACO's ACO participants submitted additional claims or submitted corrected claims after the 3-month claims run out period following the end of the performance year. As discussed in the November 2011 final rule (76 FR 67837 through 67838), in establishing this policy we focused on balancing the need for timely payment determinations and the benefits of utilizing the most complete data in calculating both the quality metrics and the shared savings reconciliation. We continue to believe that a 3-month run out of claims data aids in ensuring success for ACOs by allowing prompt shared savings payments to eligible ACOs, enabling them to offset the initial startup and/or ongoing operational costs which would in turn allow the ACOs to remain financially viable and enable them to make additional investments to further improve quality of care and decrease costs, while any decrease in the accuracy as a result of the use of a 3-month run out versus a longer time period is mitigated by the application of a completion factor.
Corrections for errors for good cause could in some circumstances introduce additional program complexities with unanticipated consequences. For example, changes to beneficiary assignment could affect the calculation of shared savings and losses for multiple ACOs. Therefore, in order to provide an opportunity for CMS to consider updated information and make other adjustments to payments determinations across all ACOs, and to minimize program disruptions for ACOs resulting from multiple reopenings, we will, to the extent feasible, make corrections in a unified reopening (as opposed to multiple reopenings) to correct errors for a given performance year. In addition, we will consider other ways to reduce operational burdens for both ACOs and CMS that could result from making payment adjustments. For example, during the 4-year time period from notification of the initial payment determination for reopenings due to good cause, if we determine that a correction needs to be made for a performance year's results, we would seek to potentially adjust shared savings payments to the ACO or shared loss recoupments from the ACO for a subsequent performance year. To illustrate, if an ACO that generated shared savings for the second performance year of its agreement period owed CMS money based on a correction made to the payment determination for the prior performance year, we might be able to deduct the amount owed prior to making the current year shared savings payments (subject to the general requirement, discussed elsewhere, for ACOs to repay monies owed to CMS within 90 days of notification of the obligation).
In addition, we have evaluated how we might consider materiality when determining whether to reopen for good cause in the case of CMS technical errors. We do not intend to propose specific criteria for determining materiality but we would provide additional information for ACOs through subregulatory guidance, as appropriate. For example, in the case of technical errors by CMS such as CMS data source file errors and CMS computational errors, we would consider limiting reopenings of payment determinations under the Shared Savings Program to issues/errors that have a material effect on the net amount of ACO shared savings and shared losses computed for the applicable performance year for all ACOs, and thus warrant a correction due to the magnitude of the error. Establishment of such a threshold for making financial corrections to address errors in the determination of shared savings payments or shared loss recoupments could reduce the likelihood of there being multiple financial reconciliation re-runs for errors that do not significantly affect the financial performance calculations. The general requirement under the Shared Savings Program is that ACOs are required to make payment in full to CMS of all amounts owed within 90 days of their receipt of notification. Numerous off cycle adjustments to address technical errors that do not have a material effect on the total amount of ACO shared savings and shared losses computed for the applicable performance year could be disruptive and administratively burdensome for both ACOs and CMS, and could discourage ACOs from participating in the Shared Savings Program.
Accordingly, in considering when to reopen an error for good cause, we intend to strike a careful balance between important Medicare program integrity concerns that payments be made timely and accurately under the Shared Savings Program with our desire to minimize unnecessary operational burdens for ACOs and CMS, and to support the ACOs' ability to invest in additional improvements to increase quality and efficiency of care. To achieve this careful balance in objectives, for reopenings to address CMS technical errors, we may consider whether the error satisfies a materiality threshold, such as 3 percent of the total amount of net shared savings and shared losses for all ACOs for the applicable performance year. We would expect to provide additional information about how we may consider the materiality of an error in subregulatory guidance, if we finalize
We also initially considered applying a materiality threshold for each ACO rather than applying a materiality threshold to total net shared savings and shared losses for all ACOs. We recognize that in some situations an individual ACO might prefer to have a different materiality threshold, or might prefer that we always correct CMS technical errors that favor the individual ACO. However, we do not believe that applying a materiality threshold, such as 3 percent, to the financial results for each ACO, or applying a lower (or no) materiality threshold for reopenings for CMS technical errors, would achieve the desired level of administrative finality for the Shared Savings Program given that there currently are over 400 ACOs in the program, and correction for CMS technical errors would sometimes favor an individual ACO and sometimes not. We also do not believe it would be appropriate to establish a finality policy to only correct errors that favor the individual ACO. We believe it would be appropriate to limit reopenings to correct CMS technical errors that more widely affect the program rather than reopening determinations for specific issues for each of the hundreds of ACOs participating in the Shared Savings Program absent evidence of fraud or similar fault, or good cause established by evidence of other errors. Otherwise, as noted earlier in this section, a relatively broad scope and extended timeframe for reopening could introduce financial uncertainty that could limit ACOs' ability to invest in additional improvements to increase quality and efficiency of care.
Finally, we note that the current requirements for ACO repayment of shared losses after notification of the initial determination of shared losses would not be affected by any proposals in this section. As described under § 425.606(h)(3) (Track 2) and § 425.610(h)(3) (Track 3), if an ACO has shared losses, the ACO must make payment in full to CMS within 90 days of receipt of notification. These current requirements would continue to apply for repayment by ACOs for shared losses. For example, an ACO would not be able to delay recoupment of any payments required under § 425.606(h)(3) or § 425.610(h)(3) by notifying CMS of a possible error that could merit reopening. Instead, if we determined that a correction should be made, we would subsequently adjust shared savings and shared losses for the applicable performance year based on the correction, and we would add any amount owed to the ACO, as determined through the reopening, prior to making any current year shared savings payments for which the ACO is eligible.
Therefore, after considering these issues, we are proposing to revise § 425.314 to remove (a)(4) and add a new paragraph (e) to specify the circumstances under which we would reopen a payment determination under §§ 425.604(f), 425.606(h), 425.610(h), 425.804, or 425.806. Specifically, we are proposing that, if CMS determines that the amount of shared savings due to the ACO or the amount of shared losses owed by the ACO has been calculated in error, CMS may reopen the earlier payment determination and issue a revised initial determination. We propose that a payment determination may be reopened: (1) At any time in the case of fraud or similar fault, as defined in § 405.902; or (2) not later than 4 years after the date of notification to the ACO of the initial determination of shared savings or shared losses for the relevant performance year, for good cause. We propose that good cause may be established when there is new and material evidence of an error or errors, that was not available or known at the time of the payment determination and may result in a different conclusion, or the evidence that was considered in making the payment determination clearly shows on its face that an obvious error was made at the time of the payment determination. Good cause would not be established by a change of legal interpretation or policy by CMS in a regulation, CMS ruling or CMS general instruction, whether made in response to judicial precedent or otherwise. We have sole discretion to determine whether good cause exists for reopening a payment determination under this section. Also, good cause would not be established by a reconsideration, appeal, or other administrative or judicial review of any determinations precluded under § 425.800.
Under the proposal, the determination of whether an error was made, whether a correction would be appropriate based on these proposed criteria, and the timing and manner of any correction would be made would be within the sole discretion of CMS. If CMS determines that the reopening criteria are met, CMS would recompute the financial results for all ACOs affected by the error or errors. In light of this policy proposal, we would not reopen and revise the PY 1 payment determinations solely affected by the data source error described previously because we so far have not specified, either through regulations or program guidance, the criteria CMS would apply in determining whether to reopen a payment determination. However, we would reopen and revise these PY 1 payment determinations for other errors satisfying the proposed criteria for reopening for good cause or for fraud or similar fault.
We believe this proposal would offer a flexible, balanced approach, providing additional certainty for ACOs as to whether they are eligible for shared savings payments, or required to repay a portion of losses under risk-based tracks, and the amount of any such shared savings or shared losses. ACOs would thus be better able to plan future financial transactions and investments to further improve the quality of beneficiary health care and reduce costs, issue financial reports, and plan for contingencies in reliance on the fact that those payments are closed after the
In addition, we note that nothing in this proposal would limit the scope of the preclusion of administrative and judicial review under § 425.800. However, we propose to amend § 425.800(a)(4), expressly to include a revised initial determination in the list of determinations that are precluded from administrative and judicial review. We invite comments on this proposal, including the proposed criteria for reopening, on alternative approaches for defining the time period for reopenings of payment determinations, on the criteria for establishing good cause, whether the time period for reopenings for good cause should be longer or shorter than 4 years, and on any other criteria that we should consider for the final rule to address issues related to financial reconciliation calculations and the determination of ACO shared savings and shared losses.
As discussed earlier in the overview for this section, the determination of whether an ACO is eligible for shared savings, and the amount of such shared savings, and the limit on the total amount of shared savings as well as the underlying financial calculations are excluded from administrative and judicial review under section 1899(g) of the Social Security Act. Accordingly, in the November 2011 final rule establishing the Shared Savings Program, we adopted the regulation at § 425.800 to preclude administrative and judicial review of the determination of whether an ACO is eligible for shared savings and the amount of shared savings under Track 1 and Track 2 (§ 425.800(a)(4)), and the limit on total amount of shared savings that may be earned under Track 1 and Track 2 (§ 425.800(a)(5)). In the June 2015 final rule, we amended the Shared Savings Program regulations by adding a new provision at § 425.610 to establish a new performance-based risk option (Track 3) that includes prospective beneficiary assignment and a higher sharing rate. However, in the June 2015 final rule we inadvertently did not also update the regulation at § 425.800 to include references to determinations under § 425.610 (Track 3) in the list of determinations under this part for which there is no reconsideration, appeal, or other administrative or judicial review. Therefore, we are proposing a conforming change to amend § 425.800 to add determinations under § 425.610 (Track 3) to the list of determinations under § 425.800 (a)(4) and (a)(5) for which there is no reconsideration, appeal, or other administrative or judicial review.
As stated in section 3022 of the Affordable Care Act, Chapter 35 of title 44, United States Code, shall not apply to the Shared Savings Program. Consequently, the information collection requirements contained in this proposed rule need not be reviewed by the Office of Management and Budget.
This proposed rule is necessary in order to make certain payment and policy changes to the Medicare Shared Savings Program established under section 1899 of the Act. The Shared Savings Program promotes accountability for a patient population, fosters the coordination of items and services under Parts A and B, and encourages investment in infrastructure and redesigned care processes for high quality and efficient service delivery. Proposed changes are focused on calculations for resetting the financial benchmark for an ACO's second or subsequent agreement period, thereby fulfilling a goal communicated in the Shared Savings Program June 2015 final rule (80 FR 32692) to propose a method for taking into account regional expenditures when resetting an ACO's financial benchmark for a second or subsequent agreement period.
We examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA, which to the best of our ability presents the costs and benefits of the rulemaking.
In keeping with our standard practice, the main analysis presented in this RIA compares the expected outcomes if the full set of proposals in this rule were finalized to the expected outcomes under current regulations. We provide our analysis of the expected costs of the proposed payment model under section 1899(i)(3) of the Act to the costs that would be incurred under the statutory payment model under section 1899(d) of the Act in section IV.E. of this proposed rule.
The Shared Savings Program is a voluntary program involving an innovative mix of financial incentives for demonstrating quality of care and efficiency gains within FFS Medicare. As a result, the changes to the Shared Savings Program proposed in this rule
In the June 2015 final rule, we established a policy for rebasing an ACO's financial benchmark for a second or subsequent agreement period by weighting each benchmark year equally and taking into account savings generated by the ACO in the previous agreement period. We also discussed potential future modifications to the rebasing methodology that would account for regional FFS expenditures and remove the policy of adding savings generated by the ACO in the previous agreement period. After further analysis, in this proposed rule, we propose an alternative approach that would adjust the ACO's reset benchmark by a percentage of the difference between the ACO's regional service area average per capita expenditure amount and the ACO's rebased historical benchmark amount (described in section II.A.2.c. of this proposed rule). Under the proposed phased approach to using a higher percentage in calculating the adjustment for regional expenditures (described in section II.A.2.c.3. of this proposed rule): In the ACO's second agreement period the percentage used in calculating the regional adjustment would be set at 35 percent; in the ACO's third agreement period and subsequent agreement periods, the percentage would be set at 70 percent unless the Secretary determines a lower weight should be applied, as specified through future rulemaking. This proposed approach would weaken the link between an ACO's performance in prior agreement periods and its benchmark in subsequent agreement periods. These changes are intended to strengthen the incentives for ACOs to invest in infrastructure and care redesign necessary to improve quality and efficiency and meet the goals of the Shared Savings Program.
Further, a key modification to the benchmark rebasing methodology would be to refine certain calculations that currently rely on national FFS expenditures and corresponding trends so that they would instead be determined according to county FFS trends observed in each ACO's unique assignment-weighted regional service area. Annual average per capita costs would be tabulated for assignable FFS beneficiaries in each county. For each ACO a regional weighted average expenditure would be found by applying ACO assigned-beneficiary weights to the average expenditures tabulated for each county. Changes in an ACO's regional service area average per capita expenditures (and relative risk reflected in associated HCC risk scores) would define a regional trend specific to each ACO's region. This regional trend would be utilized in two specific areas of the existing benchmark methodology to replace the: (1) National expenditure trend in calculations establishing the ACO's rebased historical benchmark; and (2) existing national “flat dollar” growth amount for updating the rebased historical benchmark for each performance year.
By replacing the national average FFS expenditure trend and “flat dollar” update with trends observed for county level FFS assignable beneficiaries in each ACO's unique assignment-weighted regional service area, benchmark calculations would be better structured to account for exogenous trend factors particular to each ACO's region and the pool of potentially-assignable beneficiaries therein (for example, higher trend due to a particularly acute flu season or an unusually large area wage index adjustment or change).
Although the policy would have mixed effects—increasing or decreasing benchmarks for ACOs in various circumstances—an overall increase in program savings would likely result from taking into account service-area trends in benchmark calculations. In some cases lower benchmarks would be produced, preventing shared savings payments to certain ACOs for whom national average trends and updates would have provided higher updated benchmarks. For other ACOs, such a policy would be more sensitive to regional circumstances outside of the ACO's control causing higher trends for the ACO's service area. In such cases, a higher benchmark could improve program cost savings by reducing the likelihood the ACO would choose to drop out of the program because a shared loss would otherwise have been assessed because of exogenous factors unrelated to the ACO's changes in care delivery.
In addition, applying the regional trend as a percentage (rather than “flat dollar”) when updating the benchmark to a performance year basis is anticipated to further reduce program costs by improving the accuracy of updated benchmarks, particularly for ACOs that have historical benchmarks significantly below or above average. The November 2011 final rule discussed the risk that large nominal “flat dollar” growth updates could compound over an agreement period to excessively inflate benchmarks for ACOs with relatively low historical benchmark cost and could lead to predictable bias and resulting cost for selective participation in the program (76 FR 67964). Such risk has not materialized in program experience to date, largely due to the historically low national program trend used to update ACO benchmarks through the first 3 years of the program. However, the per capita trend for the Medicare FFS program is anticipated to be higher in future years associated with the period governed by this proposed rule in contrast to the relatively moderate growth in cost experienced over the first 3 years of the program's implementation.
Program participation and ACO beneficiary assignment are not homogenously distributed geographically. ACOs tend to have service areas overlapping those of other ACOs in the same urban or suburban market(s). Therefore, to the extent that ACOs produce significant reductions in expenditures, a greater proportion of such savings would affect ACO-service-area trends than the average effect felt at the national program level, effectively reducing the average ACO's updated benchmark compared to what the use of a national trend alone would have produced. While such effect has the potential to reduce program costs by reducing net shared savings payments it could be seen as a disadvantage to participating organizations in “ACO-heavy regions” that manage to broadly increase efficiency at the overall regional market level.
Additionally, we anticipate significant program savings would result from the proposal to remove the current policy in which savings generated in the previous agreement period would be taken into account when resetting the benchmark in an ACO's second or subsequent agreement period. This proposed rule would modify the methodology used to rebase ACO benchmarks for agreement periods beginning in 2017 and subsequent years. In other words, the current rebasing methodology would apply to ACOs that entered a second or subsequent agreement period prior to 2017.
Changes to the existing benchmark calculations described previously would therefore benefit program cost savings by producing rebased benchmarks with improved accuracy (for example, reflecting regional trends rather than national average trends and `flat dollar' updates) and of somewhat lower per capita cost on average (due to no longer adding a portion of savings to the baseline and because of oversampling ACO populations in regional trend calculations). However, such savings would be partly offset by increasing shared savings payments to ACOs benefiting from our proposal to adjust the rebased historical benchmark with a portion of the difference between the ACO's regional service area average per capita expenditure amount and the ACO's rebased historical benchmark amount. Such trade-off reflects the intention of our proposal to strengthen the reward for attainment of efficiency in an absolute sense, complementing the existing program's focus on rewarding improvement relative to an ACO's recent baseline.
Making a regional adjustment to the ACO's rebased historical benchmark would strengthen an ACO's incentives to generate and maintain efficient care delivery over the long run by weakening the link between an ACO's prior performance and its future benchmark. This adjustment is expected to marginally increase program participation in agreement periods where risk (Track 2 or 3) is mandatory for an ACO since a significant portion of ACOs will have knowledge that a favorable baseline expenditure comparison to their FFS region will mitigate their risk of being assessed a shared loss in a subsequent agreement period. It is also expected to reduce the frequency with which ACOs in Track 2 or 3 drop out of the program during an agreement period because such ACOs will have somewhat greater certainty regarding the extent to which savings achieved in the prior agreement period would continue to be reflected in a rebased benchmark that incorporates a regional adjustment.
However, more predictable relationships, that is, an ACO's knowledge of its costs relative to FFS expenditures in its region, also creates risk of added cost to the Shared Savings Program by way of—(1) increasing shared savings payments to ACOs exhibiting expenditures significantly below their region at baseline especially in cases where such differences are related to factors exogenous to efficiency in the delivery of care (where shared savings payments could be further inflated by increased selection of Track 3 over Track 2); (2) potentially losing participation from ACOs with expenditures high above their region at baseline—reducing the opportunity to impact beneficiary populations with the greatest potential for improvements in the cost and quality of care;
In addition to the uncertainty with respect to the relationship of the potential offsetting effects noted previously, there remains broader uncertainty as to the number of ACOs that will participate in the program (especially under performance-based risk in Track 2 or Track 3), provider and supplier response to financial incentives offered by the program, interactions with other value based models and programs from CMS and other payers, and the ultimate effectiveness of the changes in care delivery that may result as ACOs work to improve the quality and efficiency of patient care. Certain ACOs that have achieved shared savings in their first agreement period may find that they receive significantly lower benchmarks under the proposed revisions (especially in cases where regional expenditures are much lower than expenditures for the ACO's assigned beneficiary population). Other ACOs may seek to maximize sharing in savings by selecting Track 3 if they have assigned beneficiaries with significantly lower expenditures at baseline relative to their region. These uncertainties continue to complicate efforts to assess the financial impacts of the Shared Savings Program and result in a wide range of potential outcomes regarding the net impact of the changes in this proposed rule on Medicare expenditures.
To best reflect these uncertainties, we continue to utilize a stochastic model that incorporates assumed probability distributions for each of the key variables that will affect the overall financial impact of the Shared Savings Program. A summary of assumptions and assumption ranges utilized in the model includes the following:
• Approximately 100, 100, and 200 ACOs will consider renewing in 2017, 2018, and 2019, respectively.
• ACOs will choose not to renew if—
++ Under the current policy: The ACO's gross loss in the prior performance year was 5 percent or greater; or
++ Under the proposed policies: The ACO's gross loss would be 3 percent or greater in the prior performance year after accounting for the expected effect of the revised rebasing methodology (for example, considering differences between the ACO's spending and that of its region) and adjusting for ACO participant changes which result in baseline cost reduction of 2 percent on average (see discussion elsewhere in this proposed rule).
In either scenario, the thresholds are calibrated to approximate the level of baseline loss an ACO would correlate to an expected shared loss from its rebased benchmark. The magnitude of the loss is roughly equal to the revenue ACO participating physicians may have gained from the 5 percent incentive payment available under MACRA
• Renewing ACO will choose higher risk in Track 3 if—
++ Under the current policies: The ACO's gross savings in prior performance year are 4 percent or greater; or
++ Under the proposed policies: The ACO's prior performance year gross savings adjusted by regional expenditures would be 2 percent or greater.
In either scenario, similar to the renewal assumption, policies included in the proposed rule offer greater certainty that adjusted prior performance will correlate to future performance and therefore the threshold for selecting Track 3 is lower than what is assumed for baseline scenario.
• Marginal gross savings would increase by between 0.0 percent to 1.0 percent for ACOs selecting higher performance-based risk in Track 3 and between 0.0 percent to 0.2 percent for all ACOs due to the adjusted rebasing methodology. These ranges were chosen to encompass a range of relative savings rates observed for performance-based risk accepted by ACOs participating in the Pioneer ACO Model relative to Shared Savings Program ACOs, the vast majority of which have elected to participate under the one-sided shared savings model (Track 1).
• ACOs experiencing a loss during the rebased agreement period are assumed to drop out prior to the second or third performance year if a shared loss from the prior performance year exceeds 2 percent. While Pioneer ACO Model experience would predict a lower tolerance for remaining in the program after a loss, 2 percent was chosen to approximate the incentive payment under MACRA likely to be made available to physicians and certain other practitioners participating in ACOs in Track 2 and Track 3, which was not available to participants in Pioneer ACOs.
• ACOs make adjustments to their ACO Participant Lists that reduce their cost relative to region by approximately 2 percent on average. This assumption is based on empirical analysis of 2015 ACO Participant List change requests and resulting impact on ACO baseline expenditures due to changes in assignment; the magnitude of bias is assumed to be greater for ACOs starting higher than their corresponding regional average expenditures and/or with a relatively small assigned beneficiary population and lower for ACOs starting below regional average expenditures and/or with a relatively large assigned beneficiary population.
• ACOs achieve a mean quality score of 80 percent (based on analysis of Shared Savings Program ACO quality scores in 2013 and 2014).
• ACO savings have a diluted impact on regional expenditures and trends according to ACO assignment saturation of FFS beneficiary population in the market.
Assumptions for ACO baseline costs, including variations in trends for ACOs and their relationship to their respective regions were determined by analyzing existing ACO and corresponding regional expenditures back to 2009, the first benchmark year used for the first wave of ACOs that entered the program in 2012. (Note associated data for the 2012 through 2014 time period is being released in conjunction with this proposed rule to assist commenters in modeling implications of the proposals.) The empirical time series data were randomly extrapolated to form baseline time series data through the end of the rebased agreement period by applying growth rates to ACOs and their regions by randomly sampling empirical growth rates for ACOs (and their respective regions) with similar characteristics in terms of size and relative cost to region.
Using a Monte Carlo simulation approach, the model randomly draws a set of extrapolated ACO baseline trends and specific values for each variable, reflecting the expected covariance among variables, and calculates the program's financial impact based on the specific set of assumptions. We repeated the process for a total of 1,000 random trials, tabulating the resulting individual cost or savings estimates to produce a distribution of potential outcomes that reflects the assumed probability distributions of the incorporated variables.
Table 3 details our estimate of the 3-year net impact of the proposed policy changes on FFS net benefit claims costs, net shared savings payments to ACOs, and the resulting impact on net Federal cost. Projected impacts are detailed for the first 3 cohorts of ACOs that would be renewing agreements under the proposed changes, renewing respectively for agreement periods starting in 2017, 2018, and 2019. During these agreement periods, a 35 percent weight would be placed on the benchmark expenditure adjustment for regional FFS expenditures. In such agreement periods, total savings from the proposed changes to the methodology for calculating and trending expenditures during the benchmark period in order to establish and update the benchmark, as well as anticipated savings from marginally increased program participation and improved incentives for creating efficiency, are expected to be greater than the increase in cost of net shared savings payments due to selective participation in response to adjustments that are predictably significant (either favorable or unfavorable) upon examination of how expenditures for the ACO's historically assigned beneficiary population compare to the ACO's regional service area expenditure level at baseline. For this reason the net Federal impact is projected to be a savings (that is, a negative change in net Federal cost) for the first 3 years for each renewing cohort, and correspondingly a $120 million net Federal savings for the first 3 calendar years of the projection window, 2017 through 2019. Such median impact on net Federal cost results from a projected increase in savings on net benefit claims costs of $370 million partially offset by a $250 million increase in net shared savings payments to ACOs. The last two rows of Table 3 enumerate the range of potential net Federal cost impacts our modeling projected, specifically the 10th percentile of simulation outcomes (a $230 million net Federal increase in cost) and the 90th percentile ($490 million net Federal savings). Overall, approximately two-thirds of trials resulted in combined net Federal savings over 2017 to 2019.
The stochastic model and resulting financial estimates were prepared by the CMS Office of the Actuary (OACT). The median result of $120 million increase in savings in net Federal cost is a reasonable “point estimate” of the impact of the proposed changes to the Shared Savings Program during the period between 2017 through 2019. However, we emphasize the possibility of outcomes differing substantially from the median estimate, as illustrated by the estimate distribution. Accordingly, this RIA presents the costs and benefits of this proposed rule to the best of our ability. To help further develop and potentially improve this analysis, we request comment on the aspects of the rule that may incentivize behavior that could affect participation in the program and potential shared savings payments. As further data emerges and is analyzed, we may improve the precision of future financial impact estimates.
To the extent that the Shared Savings Program will result in net savings or costs to Part B of Medicare, revenues from Part B beneficiary premiums would also be correspondingly lower or higher. In addition, because MA payment rates depend on the level of spending within traditional FFS Medicare, savings or costs arising from the Shared Savings Program would result in corresponding adjustments to MA payment rates. Neither of these secondary impacts has been included in the analysis shown.
For an ACO's third agreement period (that is, second rebased agreement period, for example the 3-year period covering 2020 through 2022 for ACOs renewing for a second agreement period in 2017) we are proposing that the weight on the adjustment to the benchmark for regional FFS expenditures be increased from the 35 percent applicable in the first renewed agreement period to 70 percent. Increasing the weight of the adjustment reduces the strength of the link between an ACO's effect on the cost of care for its assigned beneficiaries and the benchmark calculated for an ensuing agreement period. Weakening this link may increase the incentive for ACOs to make investments in care delivery reforms because resulting potential savings would be more likely to be rewarded over multiple agreement periods rather than being `baked' back into the benchmark at the next rebasing. On the other hand, efficiency gains would need to be significantly greater than those currently achieved by the ACOs participating in the program to result in budget neutrality by sufficiently offsetting increased shared savings payments to ACOs favored by a regional adjustment with 70 percent weight. As discussed in the preamble, we are proposing to set the weight on the regional adjustment at 70 percent for the third and subsequent agreement periods unless the Secretary determines a lower weight should be applied, as specified through future rulemaking. This determination, which could be made in advance of the agreement period beginning January 1, 2020, may be based on an assessment of the effects of the regional adjustment (and other modifications to the program made under this rule) on the Shared Savings Program such as: The effects on net program costs; the extent of participation in the Shared Savings Program; and the efficiency and quality of care received by beneficiaries.
ACOs demonstrate a wide range of differences in expenditures relative to risk adjusted expenditure levels for their region (for the sample of roughly 200 ACOs that started in the program in 2012 or 2013 the percentage by which ACO per capita expenditures exceed or are exceeded by their respective risk-adjusted regional per capita expenditures varies with a standard deviation of approximately 10 percent). Transitioning to a 70 percent weight to calculate the regional adjustment effectively down-weights the savings generated by the changes we are proposing to make to the existing benchmark calculation, since an ACO's benchmark would have increased dependence on the regional FFS expenditures and correspondingly a decreasing dependence on the historical expenditures for the ACO. At the same time, increasing the weight used to
An element of the proposed regional adjustment which becomes apparent when reviewing the accompanying data files and the performance of ACOs in 2013 and 2014 (for those roughly 200 ACOs that started in 2012 and 2013) is that ACOs that are above or below the regional service area expenditure amount used to adjust their rebased benchmark in 1 year tend to have a similar bias in the following year. Placing a 100 percent weight on the regional service area expenditure amount illustrates this. Of the 50 ACOs that were the furthest below their estimated regional service area expenditure level in 2013, all were at least 10 percent below and their average expenditures were roughly 15 percent below the expenditures for the region. In the subsequent year, 2014, none of these ACOs exceeded its regional service area expenditure level, and the average expenditure difference only moved by about 2 percentage points. Similar yet less glaring results occur in those ACOs above their regional service area expenditure level, with the 50 ACOs the furthest above their regional service area expenditure level having costs an average of approximately 10 percent above the regional service area expenditure level in 2013—an average difference for the group that only moved by about 2 percentage points the following year.
Of the approximately 150 ACOs that were more than 0.5 percent below their regional service area expenditure level, only about 10 percent were above their regional service area expenditure level in the following year. Again, ACOs above their regional service area expenditure level follow a similar pattern, though less drastic. Of the ACOs above their regional service area expenditure level by more than 0.5 percent, approximately 25 percent performed below their regional service area expenditure level in the following year. Notwithstanding the potential for behavioral changes, this illustrates that for a significant portion of existing ACOs, there is evidence of a bias when compared to their regional service area expenditure level and that bias is likely to be predictable over time. We have accounted for cost associated with program selection for ACOs favored by such bias and considered attrition in participation by ACOs disfavored by such bias. However for some ACOs of the latter condition, it may take multiple years to sufficiently redesign their care delivery processes in order to generate savings substantial enough to offset high expenditures relative to their region at baseline. We note that this analysis is based on data from the first two years of program operations, and longer term effects may emerge to mitigate bias for certain ACOs with high expenditures at baseline.
Additionally, the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established new incentives to encourage providers to participate in alternative payment models. Paying for value and incentivizing better care coordination and integration is a top priority for us, and we have been implementing policies that encourage a shift towards paying for value instead of volume. MACRA provides additional tools to encourage care integration and value-based payment. Although implementation of MACRA is ongoing and many details are still to be proposed and finalized through rulemaking, the incentives created by MACRA could result in increased market pressure on providers to participate in ACOs. This may lower the risk of selective participation and potentially lead to higher expected net Federal savings.
Emerging data will be monitored in order to provide additional information for updating projections as part of the proposed use of a higher percentage (70 percent) in calculating the regional adjustment amount for ACOs entering a third or subsequent agreement period. For example, if ACOs respond by generating new efficiencies in care beyond those that are anticipated, and/or potential selective participation responses are lower than expected, then a 70 percent weight could potentially be associated with revised expectations regarding net costs or net savings. However, it is also possible that gains in efficiency will fail to materialize and/or selective participation and other behavioral responses will increase cost beyond the level that is currently anticipated, in such scenario we would consider further rulemaking as necessary to protect the Medicare Trust Funds (for example, in order to apply a lower percent weight in calculating the regional adjustment amount). To help further develop and potentially improve this analysis, we request comment on the aspects of the rule that may incentivize behavior that will affect participation in the program and potential shared savings. We specifically request data and methodology suggestions for modeling interactions between ACO payment parameters, anticipated responses to incorporating regional adjustments and trends into the benchmark.
The proposed rule would introduce regional expenditure trends and a regional adjustment to the rebased historical benchmark that would include prospective HCC risk adjustment to ensure trending and the regional adjustment appropriately account for differences in risk between an ACO's assigned beneficiary population and its regional service area assignable beneficiary population. Current program experience supports the hypothesis that the current approach of applying conditional reliance on demographic risk ratios for a continuously-assigned subset of beneficiaries for purposes of adjusting the historical benchmark to a performance year basis provides a reasonable balance between accounting for changes in risk of the population and limiting the risk that coding intensity shifts would artificially inflate ACO benchmarks. The proposal would retain this current policy for adjusting the historical benchmark to a performance year basis.
However, for the proposed changes involving the use of regional expenditure trends (to trend forward the benchmark years and to update the ACO's rebased historical benchmark) and the adjustment to the rebased benchmark for expenditures in the ACO's regional service area, we are not proposing to interject an additional explicit policy for limiting coding intensity sensitivity at this time (beyond what is described in section II.A.3. of this proposed rule), but would rely on the difference between the average prospective HCC scores for the ACO's assigned beneficiary population and its regional service area assignable beneficiary population. Regional trend calculations for the rebased historical base years are expected to mitigate the risk of sensitivity to potential coding intensity efforts by ACO providers/suppliers for several reasons. The benchmark years for the new agreement period correspond to performance years from a prior agreement period where incentives for coding intensity changes were already actively limited by the continuously assigned demographic alternative calculation. In addition,
If the new benchmark rebasing methodology proposed in this rule is adopted, we intend to carefully monitor emerging program data to assess whether the overall benchmark methodology as revised remains appropriately balanced between sensitivity to real changes in assigned population risk and protection from making shared savings payments due to potential coding intensity shifts. Of particular concern for close monitoring (and potential future rulemaking changes, if necessary) are the unique circumstances related to the use of a prospective beneficiary assignment methodology in Track 3 and the associated benchmark calculations for Track 3 ACOs. Prospective assignment creates an overlap between the claims considered for purposes of determining beneficiary assignment to the ACO and the period in which diagnosis submissions from claims are utilized for calculating a beneficiary's prospective HCC score for the year during which the beneficiary will be assigned to the ACO. A related area for monitoring is whether regional FFS expenditures tabulated at a county level for assignable beneficiaries determined using the assignment methodology used in Track 1 and Track 2 would provide an unbiased comparison to a beneficiary population assigned under the prospective assignment methodology for Track 3. For these reasons, monitoring will consider the potential necessity to undertake rulemaking in order to make adjustments to regional calculations for Track 3 ACOs to avoid biasing the results.
As explained in more detail previously, we believe the proposed changes would provide additional incentive for ACOs to improve care management efforts and maintain program participation. In addition, ACOs with low baseline expenditures relative to their region are more likely to transition to and sustain participation in a risk track (Tracks 2 or 3) in future agreement periods. Consequently, the changes in this rule will also benefit beneficiaries through broader improvements in accountability and care coordination (such as through the use of the waiver of the 3-day stay SNF rule by Track 3 ACOs) than would occur under current regulations.
Additionally, we intend to continue to analyze emerging program data to monitor for any potential unintended effect that the introduction of a regional adjustment to the ACO's rebased historical benchmark could potentially have on the incentive for ACOs to serve vulnerable populations (and for ACOs to maintain existing partnerships with providers and suppliers serving such populations). Further refinements that could be addressed in future rulemaking if monitoring ultimately revealed such problems could include reducing the percentage applied to the adjustment to the benchmark for regional expenditures, introducing additional adjustments (for example, enhancements or complements to the prospective HCC risk model) to control for exogenous factors impacting an ACO's costs relative to its region, or otherwise modifying the benchmark calculation to improve the balance between rewarding attainment and improvement in the efficiency and quality of care delivery for the full spectrum of beneficiaries enrolled in FFS Medicare.
The proposed shift from adding prior agreement period savings to an ACO's rebased baseline (as provided in the June 2015 final rule for ACOs renewing for a second agreement period starting in 2016) to an adjustment reflecting 35 percent of the difference between the ACO's regional service area average per capita expenditure amount and the ACO's rebased historical benchmark amount is anticipated to provide an additional incentive for ACOs to make investments to improve care coordination. At the same time, such change in methodology also shifts the benchmark policy focus from rewarding improvement in trend relative to an ACO's original baseline to an incentive that places more weight on attainment of efficiency—how an ACO compares in absolute expenditures to its region. Certain ACOs that joined the program from a high expenditure baseline relative to their region and that showed savings under the first agreement period benchmark methodology will likely expect lower benchmarks and greater likelihood of shared losses under a methodology that includes a 35 percent weight on the regional expenditure adjustment. Additionally, certain ACOs that joined the program with relatively low expenditures relative to their region may now expect significant shared savings payments even if they failed to generate shared savings in their first agreement period under the existing benchmark methodology.
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most physician practices, hospitals, and other providers are small entities either by virtue of their nonprofit status or by qualifying as a small business under the Small Business Administration's size standards (revenues of less than $7.5 to $38.5 million in any 1 year; NAIC Sector-62 series). States and individuals are not included in the definition of a small entity. For details, see the Small Business Administration's Web site at
Although the Shared Savings Program is a voluntary program and payments for individual items and services will continue to be made on a FFS basis, we acknowledge that the program can affect many small entities and have developed our rules and regulations accordingly in order to minimize costs and administrative burden on such entities as well as to maximize their opportunity to participate. (For example: Networks
Small entities are both allowed and encouraged to participate in the Shared Savings Program, provided the ACO has a minimum of 5,000 assigned beneficiaries, thereby potentially realizing the economic benefits of receiving shared savings resulting from the utilization of enhanced and efficient systems of care and care coordination. Therefore, a solo, small physician practice or other small entity may realize economic benefits as a function of participating in this program and the utilization of enhanced clinical systems integration, which otherwise may not have been possible. We believe the policies included in this proposed rule, such as proposals to facilitate the transition to performance-based risk (see section II.C. of this proposed rule) and to streamline the adjustment to the benchmark for changes in the ACO participant composition (see section II.B. of this proposed rule), may further encourage participation by small entities. For example, smaller entities (among others) that are risk averse but ready to transition to a performance-based risk track may elect the option (if finalized) that would defer by one year their entrance into a two-sided model. Once under a two-sided model, ACOs will have the opportunity for greater reward compared to participation under the one-sided model although they will be at risk for shared losses. Additionally, the proposed approach to adjusting for changes in ACO participant composition could provide greater stability to the benchmark calculations over time, particularly for ACOs with relatively smaller numbers of assigned beneficiaries.
As detailed in this RIA, total median shared savings payments net of shared losses are expected to increase by $250 million over the 2017 to 2019 period as a result of changes that will increase benchmarks for certain ACOs participating in the Shared Savings Program and therefore increase the average small entity's shared savings revenue. However, the impact on any single small entity may depend on its relationship to costs calculated for the counties comprising its regional service area. We seek comment from individual providers, including small entities, regarding the changes proposed with special focus on the impact of the adjustment to the benchmark to reflect regional FFS expenditures, again noting for commenters that county level data are being made available in conjunction with this proposed rule to allow them to analyze such differences in cost for individual ACOs and their regions.
Section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. Although the Shared Savings Program is a voluntary program, this proposed rule will have a significant impact on the operations of a substantial number of small rural hospitals. We have proposed changes to our regulations such that benchmark trend calculations and adjustments for ACOs that include rural hospitals as ACO participants will be made in order to reflect FFS costs and trends in the ACO's regional service area. Overall, we expect the average ACO to receive greater shared savings revenue under the proposed changes ($250 million greater net sharing anticipated over 2017 through 2019). However, the impact on individual ACOs and their participating small rural hospitals may differ from the program average. We seek comment from small rural hospitals on the proposed changes with special focus on the impact of the adjustment to the benchmark to reflect regional FFS expenditures, again noting for commenters that county level data being made available in conjunction with this proposed rule to allow them to analyze such differences in cost for individual ACOs and their regions.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2015, that is approximately $144 million. This proposed rule does not include any mandate that would result in spending by state, local or tribal governments, in the aggregate, or by the private sector in the amount of $144 million in any 1 year. Further, participation in this program is voluntary and is not mandated.
As indicated in the June 2015 final rule (see 80 FR 32795 through 32796), and as discussed previously in section II.A.2.c. of this proposed rule, we also considered an alternative method for establishing benchmarks for subsequent agreement periods that would incorporate regional trends. Under such method we would apply the regional trend to inflate an ACO's historical benchmark from the prior (that is, first) agreement period to represent expenditures expected for the most recent base year preceding the ACO's subsequent agreement period. This approach would therefore be delinked from an ACO's performance over the prior agreement period (except to the extent an ACO's assigned population impacts its wider regional trend)—improving the incentive for ACOs to invest in efforts to improve efficiency. In contrast to the methodology for calculating a regional adjustment proposed in this rule, it would also retain sensitivity to baseline costs demonstrated by beneficiaries assigned to the ACO in the prior agreement period, potentially mitigating concerns regarding certain types of program selection and possibly providing a more incremental transition for ACOs familiar with the existing program benchmark methodology.
Specifically it was estimated that blending an ACO's rebased benchmark with its prior (first) historical benchmark inflated by a regional trend would produce an overall budget neutral change in net program cost for the subsequent agreement period if the blending were accomplished via a 70 percent weight on an ACO's trended prior benchmark and a 30 percent weight on its rebased benchmark. While such blend would reasonably be expected to result in an improvement in program incentives for ACOs to generate new efficiencies in care delivery despite rebasing concerns, other considerations impacted the decision to ultimately propose the different approach detailed in this proposed rule.
Primarily, program experience to date indicates that many ACOs make significant changes to their provider composition over the course of an agreement period. Attempting to lock-in a first historical benchmark that would be trended to form 70 percent of the historical benchmark for future agreement periods would invariably be complicated and in many cases biased by changes in provider composition made years after the ACO's first entry
As previously discussed in this proposed rule, certain proposals rely upon the authority granted in section 1899(i)(3) of the Act to use other payment models that the Secretary determines will improve the quality and efficiency of items and services furnished to Medicare FFS beneficiaries. Section 1899(i)(3)(B) requires that such other payment model must not result in additional program expenditures. Collectively, current and proposed policies falling under authority of section 1899(i)(3) of the Act include: performance-based risk, refining the calculation of national expenditures used to update the historical benchmark to use the assignable subpopulation of total FFS enrollment, updating benchmarks with regional trends as opposed to national average absolute growth in per capita spending, and adjusting performance year expenditures to remove IME, DSH, and uncompensated care payments.
A comparison was constructed between the projected impact of the payment methodology that incorporates all proposed changes and a hypothetical baseline payment methodology that excludes the elements described previously that require section 1899(i)(3) of the Act authority—most importantly performance based risk in Tracks 2 and 3 and updating benchmarks using regional trends. The hypothetical baseline was assumed to include adjustments allowable under section 1899(d)(1)(B)(ii) of the Act including the provision from the June 2015 final rule whereby an ACO's rebased benchmark might include an adjustment reflecting a portion of savings measured during the ACO's prior agreement period and the 35 percent weight used in calculating the regional adjustment to the ACO's rebased historical benchmark proposed in this rule. The stochastic model and associated assumptions described previously in this section were adapted to reflect the agreement period spanning 2017 through 2019 for roughly 100 ACOs expected to renew in 2017. Such analysis estimated approximately $130 million greater average net program savings under the alternative payment model that includes all proposed changes than expected under the hypothetical baseline in total over the 2017 to 2019 agreement period cycle. Furthermore, approximately 78 percent of stochastic trials resulted in greater or equal net program savings. The proposals were projected to result in both greater savings on benefit costs and net payments to ACOs. Participation in performance-based risk under Track 2 and Track 3 is assumed to improve the incentive for ACOs to increase the efficiency of care for beneficiaries (similar to as assumed in the modeling of the impacts, described previously). Such added savings are partly offset by lower participation associated with the requirement to transition to performance-based risk. Correspondingly, net shared savings payments are also expected to be greater under the proposed alternative payment model under section 1899(i)(3) of the Act than under the hypothetical baseline, mainly driven by the higher sharing rates and potentially lower minimum savings requirements in Track 2 and Track 3, but partly offset mainly by lower benchmarks resulting from the removal of the policy adopted in the June 2015 final rule of adding a portion of savings to the rebased benchmark, the use of more-accurate regional benchmark updates, and new shared loss revenue.
Additionally, we also projected a lower net federal savings of approximately $15 million would result from using the hypothetical baseline described previously but forgoing the adjustment to account for a portion of savings generated during the ACO's prior agreement period. We believe the proposed removal of this adjustment for savings generated in the ACO's prior agreement period would enable us to place a greater weight on the amount of the regional adjustment in the future, while not over crediting or penalizing an ACO for its prior performance (discussed in section II.A.2.c. of this proposed rule). This alternative hypothetical baseline (that does not account for savings generated in the ACO's prior agreement period) more closely resembles the future hypothetical baseline that would be used in our analysis of the application of a higher weight in calculating the regional adjustment in subsequent agreement periods (if the policies described in this proposed rule are finalized).
Relative savings projected for the ACOs starting a second agreement period in 2017 participation cycle are reasonably assumed to be proportional for ACOs starting a second agreement period in 2018 and 2019 because the assumptions and parameters would be the same or similar. Accordingly, the requirement under section 1899(i)(3)(B) of the Act that an alternative payment model not result in additional program expenditures is therefore satisfied for the period 2017 through 2019. As discussed in sections II.A.2.d.3. and II.A.2.e.3. of this proposed rule, we will reexamine this projection in the future to ensure that the requirement under section 1899(i)(3)(B) of the Act that an alternative payment model not result in additional program expenditures continues to be satisfied, taking into account, for example, increasing the weight placed on the regional adjustment to an ACO's rebased historical benchmark, which is proposed to increase to 70 percent for an ACO's third and subsequent agreement period (unless the Secretary determines a lower weight should be applied, as specified through future rulemaking). In the event that we conclude that the payment model established under section 1899(i)(3) of the Act no longer meets this requirement, we would undertake additional notice and comment rulemaking to make adjustments to the payment model to assure continued compliance with the statutory requirements.
As required by OMB Circular A-4 under Executive Order 12866, in Table 4, we have prepared an accounting statement showing the change in—(1) net federal monetary transfers; (2) shared savings payments to ACOs net of shared loss payments from ACOs; and (3) the aggregate cost of ACO operations for ACO participants and ACO
We believe several sources of data will facilitate ACOs and other stakeholders in modeling the proposed changes to the benchmark rebasing methodology that include calculations using factors of regional FFS spending. Concurrent with the issuance of this proposed rule, we are making the following new data files available for select calendar years through the Shared Savings Program Web site at
• Files containing average county FFS expenditures, CMS-HCC prospective risk scores and person-years for assignable beneficiaries by Medicare enrollment type (ESRD, disabled, aged/dual eligible, aged/non-dual eligible) for 2012, 2013, and 2014.
• Files containing the total number of assigned beneficiaries for each ACO for each county where at least 1 percent of the ACO's assigned beneficiaries reside for 2012, 2013, and 2014.
A listing of all publicly available Shared Savings Program ACO data and ACO performance data sources maintained by CMS is available through the Shared Savings Program Web site (see the guide titled “Medicare Shared Savings Program Publicly available ACO data and ACO performance data sources maintained by CMS” available online at
Combining data from existing PUFs and the new data files will allow one or more years of comparison between risk-adjusted per capita expenditures for an ACO's assigned beneficiaries and the corresponding risk-adjusted expenditures for the ACO's regional service area, however the specific year or years of available comparison depend on the ACO's start date. For example, it will be possible to use the new data files to estimate the BY2, BY3 and PY1 (respectively CYs 2012, 2013, and 2014) risk standardized regional FFS costs by Medicare enrollment type for ACOs that started January 1, 2014 and then make a piecewise comparison to corresponding ACO assigned population standardized per capita costs by Medicare enrollment type for such years using the existing 2014 PUF data.
While we believe the release of the new data files in conjunction with existing 2014 PUF data will provide a reasonable overall dataset for illustrating relationships that exist between a representative sample of ACOs in terms of their expenditures and trends relative to their risk-adjusted county-weighted FFS regional service area expenditures and trends, we note that precision in such comparison for any single ACO may be limited because the datasets are not exhaustive. For example, as noted previously, assignment data for an ACO are not shown for counties with less than 1 percent of the ACO's overall assigned beneficiary population in the given year, and ACO assignment is not broken out by Medicare enrollment type at the county level.
We note that aside from these data files published and maintained by CMS, there are possibly other sources of data that would inform analyses of the proposed changes to the benchmarking methodology described in this proposed rule. For example, individual ACOs may have access to additional data, specific
The analysis in this section, together with the remainder of this preamble, provides a regulatory impact analysis. As a result of this proposed rule, the median estimate of the financial impact of the Shared Savings Program for CYs 2017 through 2019 would be net federal savings of $120 million greater than what would have been saved if no changes were made. Although this is the best estimate of the financial impact of the Shared Savings Program during CYs 2017 through 2019, a relatively wide range of possible outcomes exists. While approximately two-thirds of the stochastic trials resulted in an increase in net program savings, the 10th and 90th percentiles of the estimated distribution show a net increase in costs of $230 million to net savings of $490 million, respectively.
Overall, our analysis projects that improvements in the accuracy of benchmark calculations, including through the introduction of a regional adjustment to the ACO's rebased historical benchmark, are expected to result in increased overall participation in the program. The proposed changes are also expected to improve the incentive for ACOs to invest in effective care management efforts, increase the attractiveness of participation under performance-based risk in Track 2 or 3 for certain ACOs with lower beneficiary expenditures, and result in overall greater gains in savings on FFS benefit claims costs than the associated increase in expected shared savings payments to ACOs. We intend to monitor emerging results for ACO effects on claims costs, changing participation (including risk for cost due to selective changes in participation), and unforeseen biased benchmark adjustments due to diagnosis coding intensity shifts. Such monitoring will inform future rulemaking such as if the Secretary determines that a lower weight should be used in calculating the regional adjustment amount for ACOs' third and subsequent agreement periods.
In accordance with the provisions of Executive Order 12866, this rule was reviewed by the Office of Management and Budget.
Because of the large number of public comments we normally receive on
Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 425 as set forth below:
Secs. 1102, 1106, 1871, and 1899 of the Social Security Act (42 U.S.C. 1302, 1306, 1395hh, and 1395jjj).
The additions read as follows:
(b) * * *
(3) For 2017 and all subsequent years—
(i) The start date is January 1 of that year; and
(ii) The term of the participation agreement is 3 years, except the term of an ACO's initial agreement period under Track 1 (as described under § 425.604) may be extended, at the ACO's option, for an additional year for a total of 4 performance years if the conditions specified in paragraph (e) of this section are met.
(e)
(i) Is currently participating in its first agreement period under Track 1.
(ii) Has requested renewal of its participation agreement in accordance with § 425.224.
(iii) Has selected a two-sided model (as described under § 425.606 or § 425.610 of this part) in its renewal request.
(iv) Has requested an extension of its current agreement period and a 1-year deferral of the start of its second agreement period in a form and manner specified by CMS.
(v) CMS approves the ACO's renewal, extension, and deferral requests.
(2) An ACO that is approved for renewal, extension, and deferral that terminates its participation agreement before the start of the first performance year of the second agreement period is—
(i) Considered to have terminated its participation agreement for the second agreement period under § 425.220; and
(ii) Not eligible to participate in the Shared Savings Program again until after the date on which the term of that second agreement period would have expired if the ACO had not terminated its participation, consistent with § 425.222.
The additions reads as follows:
(e)
(i) At any time in the case of fraud or similar fault as defined in § 405.902; or
(ii) Not later than 4 years after the date of the notification to the ACO of the initial determination of savings or losses for the relevant performance year under § 425.604(f), § 425.606(h), or § 425.610(h), for good cause.
(2) Good cause may be established when—
(i) There is new and material evidence that was not available or known at the time of the payment determination and may result in a different conclusion; or
(ii) The evidence that was considered in making the payment determination clearly shows on its face that an obvious error was made at the time of the payment determination.
(3) A change of legal interpretation or policy by CMS in a regulation, CMS ruling or CMS general instruction, whether made in response to judicial precedent or otherwise, is not a basis for reopening a payment determination under this section.
(4) CMS has sole discretion to determine whether good cause exists for reopening a payment determination under this section.
The revisions and additions read as follows:
(a) * * *
(4) * * *
(ii) For the 2017 performance year and all subsequent performance years, truncates an assigned beneficiary's total annual Parts A and B fee-for-service per capita expenditures at the 99th percentile of national Medicare fee-for-service expenditures for assignable beneficiaries identified for the 12-month calendar year corresponding to each benchmark year in order to minimize variation from catastrophically large claims.
(5)(i) For performance years before 2017—
(A) Using CMS Office of the Actuary national Medicare expenditure data for each of the years making up the historical benchmark, determines national growth rates and trends expenditures for each benchmark year (BY1 and BY2) to the third benchmark year (BY3) dollars.
(B) To trend forward the benchmark, CMS makes separate calculations for expenditure categories for each of the following populations of beneficiaries:
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(ii) For the 2017 and all subsequent performance years—
(A) Using CMS Office of the Actuary national Medicare expenditure data for each of the years making up the historical benchmark, determines national growth rates for assignable beneficiaries identified for the 12-month calendar year corresponding to each benchmark year, and trends expenditures for each benchmark year (BY1 and BY2) to the third benchmark year (BY3) dollars.
(B) To trend forward the benchmark, CMS makes separate calculations for expenditure categories for each of the following populations of beneficiaries:
(
(
(
(
(8) * * *
(i) For performance years before 2017, the benchmark is adjusted to take into account the expenditures for beneficiaries who would have been assigned to the ACO in any of the 3 most recent years prior to the agreement period using the most recent certified ACO participant list for the relevant performance year.
(ii) For the 2017 performance year and all subsequent performance years, the benchmark is adjusted to account for changes in the certified ACO participant list during the term of the agreement period.
(A) To adjust the benchmark, CMS does the following:
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(B) In the event no stayers are identified to complete the calculation as described in paragraph (a)(8)(ii)(A) of this section, CMS calculates an adjusted historical benchmark for the ACO as described in paragraph (a)(8)(i) of this section.
(9) The historical benchmark is further adjusted at the time of reconciliation for a performance year to account for changes in severity and case mix for newly and continuously assigned beneficiaries using prospective HCC risk scores and demographic
(b) * * *
(1) For performance years before 2017, CMS updates the historical benchmark annually for each year of the agreement period based on the flat dollar equivalent of the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare fee-for-service program.
(i) CMS updates the fixed benchmark by the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare fee-for-service program using data from CMS' Office of the Actuary.
(ii) To update the benchmark, CMS makes expenditure calculations for separate categories for each of the following populations of beneficiaries:
(A) ESRD.
(B) Disabled.
(C) Aged/dual eligible Medicare and Medicaid beneficiaries.
(D) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(2) For the 2017 performance year and all subsequent performance years, CMS updates the historical benchmark annually for each year of the agreement period based on the flat dollar equivalent of the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare fee-for-service program for assignable beneficiaries identified for the 12-month calendar year corresponding to the year for which the update is calculated.
(i) CMS updates the fixed benchmark by the projected absolute amount of growth in national per capita expenditures for Parts A and B services under the original Medicare fee-for-service program for assignable beneficiaries identified for the 12-month calendar year corresponding to the year for which the update is being calculated using data from CMS' Office of the Actuary.
(ii) To update the benchmark, CMS makes expenditure calculations for separate categories for each of the following populations of beneficiaries:
(A) ESRD.
(B) Disabled.
(C) Aged/dual eligible Medicare and Medicaid beneficiaries.
(D) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(a) An ACO's benchmark is reset at the start of each subsequent agreement period.
(b) For ACOs entering into a second agreement period in 2016, CMS establishes, adjusts, and updates the rebased historical benchmark in accordance with § 425.602(a) and (b) with the following modifications:
(1) Rather than weighting each year of the benchmark using the percentages provided at § 425.602(a)(7), each benchmark year is weighted equally.
(2) An additional adjustment is made to account for the average per capita amount of savings generated during the ACO's previous agreement period. The adjustment is limited to the average number of assigned beneficiaries (expressed as person years) under the ACO's first agreement period.
(c) For ACOs entering into a second or subsequent agreement period in 2017 and subsequent years, CMS establishes the rebased historical benchmark by determining the per capita Parts A and B fee-for-service expenditures for beneficiaries who would have been assigned to the ACO in any of the 3 most recent years before the agreement period using the certified ACO participant list submitted before the start of the agreement period as required under § 425.118. CMS does all of the following:
(1) Calculates the payment amounts included in Parts A and B fee-for-service claims using a 3-month claims run out with a completion factor. The calculation—
(i) Excludes IME and DSH payments; and
(ii) Considers individually beneficiary identifiable payments made under a demonstration, pilot or time limited program.
(2) Makes separate expenditure calculations for each of the following populations of beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(3) Adjusts expenditures for changes in severity and case mix using prospective HCC risk scores.
(4) Truncates an assigned beneficiary's total annual Parts A and B fee-for-service per capita expenditures at the 99th percentile of national Medicare fee-for-service expenditures for assignable beneficiaries identified for the 12-month calendar year corresponding to each benchmark year in order to minimize variation from catastrophically large claims.
(5) Trends forward expenditures for each benchmark year (BY1 and BY2) to the third benchmark year (BY3) dollars using regional growth rates based on expenditures for the ACO's regional service area as determined under paragraphs (e) and (f) of this section, making separate expenditure calculations for each of the following populations of beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(6) Restates BY1 and BY2 trended and risk-adjusted expenditures in BY3 proportions of the following populations of beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(7) Weights each benchmark year equally.
(8) The benchmark is adjusted to account for changes in the certified ACO participant list during the term of the agreement period.
(i) To adjust the benchmark, CMS does the following:
(A) Calculates a stayer component using an expenditure ratio of average per capita expenditures for stayers to stayers and leavers combined, using BY3 as a reference year. CMS makes separate expenditure calculations for each of the following populations of beneficiaries:
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(B) Calculates a joiner component using average per capita expenditures for joiners, using BY3 as a reference year. CMS makes separate expenditure calculations for each of the following populations of beneficiaries:
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(ii) In the event no stayers are identified to complete the calculation as described in paragraph (c)(8)(i) of this section, CMS calculates an adjusted historical benchmark for the ACO as described in § 425.602(a)(8)(i).
(iii) CMS redetermines the regional adjustment amount under paragraph (c)(9) of this section, according to the ACO's assigned beneficiaries for BY3 resulting from the most recent certified ACO participant list for the relevant performance year.
(9) Adjusts the historical benchmark based on the ACO's regional service area expenditures, making separate calculations for the following populations of beneficiaries: ESRD, disabled, aged/dual eligible Medicare and Medicaid beneficiaries, and aged/non-dual eligible Medicare and Medicaid beneficiaries. CMS does all of the following:
(i) Calculates an average per capita amount of expenditures for the ACO's regional service area as follows:
(A) Determines the counties included in the ACO's regional service area based on the ACO's BY3 assigned beneficiary population.
(B) Determines the ACO's regional expenditures as specified under paragraphs (e) and (f) of this section for BY3.
(C) Adjusts for differences in severity and case mix between the ACO's assigned beneficiary population and the ACO's regional service area that includes assignable beneficiaries identified for the 12-month calendar year that corresponds to the relevant benchmark year.
(ii) Calculates the adjustment as follows:
(A) Determines the difference between the ACO's regional service area average per capita expenditure amount as specified under paragraph (c)(9)(i) of this section and the average per capita amount of the ACO's rebased historical benchmark determined under paragraphs (c)(1) through (8) of this section, for each of the following populations of beneficiaries:
(
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(B) Applies a percentage, determined as follows:
(
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(10) The historical benchmark is further adjusted at the time of reconciliation for a performance year to account for changes in severity and case mix for newly and continuously assigned beneficiaries using prospective HCC risk scores and demographic factors as described under §§ 425.604(a)(1) through (3), 425.606(a)(1) through (3), and 425.610(a)(1) through (3).
(d) CMS updates the rebased historical benchmark under paragraph (c) of this section, annually for each year of the agreement period by the growth in the ACO's regional service area expenditures by doing all of the following:
(1) Determining the counties included in the ACO's regional service area based on the ACO's assigned beneficiary population used to determine financial reconciliation for the relevant performance year.
(2) Determining growth rates based on expenditures for counties in the ACO's regional service area calculated under paragraphs (e) and (f) of this section, for each performance year.
(3) Updating the benchmark by making separate calculations for each of the following populations of beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(e) For ACOs entering into a second or subsequent agreement period in 2017 and subsequent years, CMS does all of the following to determine risk adjusted county fee-for-service expenditures for use in calculating the ACO's regional fee-for-service expenditures:
(1)(i) Determines average county fee-for-service expenditures based on expenditures for the assignable population of beneficiaries in each county, where assignable beneficiaries are identified for the 12-month calendar year corresponding to the relevant benchmark or performance year.
(ii) Makes separate expenditure calculations for each of the following populations of beneficiaries:
(A) ESRD.
(B) Disabled.
(C) Aged/dual eligible Medicare and Medicaid beneficiaries.
(D) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(iii) The calculation for ESRD beneficiaries is based on the aggregation of expenditures statewide, and applied consistently to each county within a State.
(2) Calculates assignable beneficiary expenditures using the payment amounts included in Part A and B fee-for-service claims with dates of service in the 12-month calendar year for the relevant benchmark or performance year, using a 3-month claims run out with a completion factor. The calculation—
(i) Excludes IME and DSH payments; and
(ii) Considers individually beneficiary identifiable payments made under a demonstration, pilot or time limited program.
(3) Truncates a beneficiary's total annual Parts A and B fee-for-service per capita expenditures at the 99th percentile of national Medicare fee-for-service expenditures for assignable beneficiaries identified for the 12-month calendar year that corresponds to the relevant benchmark or performance year, in order to minimize variation from catastrophically large claims.
(4) Adjusts fee-for-service expenditures for severity and case mix of assignable beneficiaries in the county using prospective CMS-HCC risk scores.
(i) The calculation is made according to the following populations of beneficiaries:
(A) ESRD.
(B) Disabled.
(C) Aged/dual-eligible Medicare and Medicaid beneficiaries.
(D) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(ii) The calculation for ESRD beneficiaries is based on the aggregation of expenditures and prospective CMS-HCC risk scores statewide, and applied consistently to each county within a State.
(f) For ACOs entering into a second or subsequent agreement period in 2017 and subsequent years, CMS does all of
(1) Weights resulting county expenditures by the ACO's proportion of assigned beneficiaries for the relevant benchmark or performance year for each of the following populations of beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
(iii) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
(2) Weights county-level fee-for-service expenditures by the ACO's proportion of assigned beneficiaries in the county, determined by the number of the ACO's assigned beneficiaries residing in the county in relation to the ACO's total number of assigned beneficiaries, to determine regional fee-for-service expenditures for each of the following populations of beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
The addition reads as follows:
(a) * * *
(4) * * *
(ii) For the 2017 and all subsequent performance years to minimize variation from catastrophically large claims, CMS truncates an assigned beneficiary's total annual Parts A and B fee-for-service per capita expenditures at the 99th percentile of national Medicare fee-for-service expenditures for assignable beneficiaries identified for the 12-month calendar year corresponding to the performance year.
The addition reads as follows:
(a) * * *
(4) * * *
(ii) For the 2017 performance years and all subsequent performance years to minimize variation from catastrophically large claims, CMS truncates an assigned beneficiary's total annual Parts A and B fee-for-service per capita expenditures at the 99th percentile of national Medicare fee-for-service expenditures for assignable beneficiaries identified for the 12-month calendar year corresponding to the performance year.
The addition reads as follows:
(a) * * *
(4) * * *
(ii) For the 2017 and all subsequent performance years to minimize variation from catastrophically large claims, CMS truncates an assigned beneficiary's total annual Parts A and B fee-for-service per capita expenditures at the 99th percentile of national Medicare fee-for-service expenditures for assignable beneficiaries identified for the 12-month calendar year corresponding to the performance year.
| 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 |