Unknown. Guidance
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/register/2016/10/05/2016-24067·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2016-10-05.xml --- 81 193 Wednesday, October 5, 2016 Contents Agriculture Agriculture Department See Food Safety and Inspection Service See Forest Service See Rural Housing Service Army Army Department NOTICES Meetings: Advisory Committee on Arlington National Cemetery, 69051-69052 2016-24046 Advisory Committee on Arlington National Cemetery, Honor Subcommittee and the Remember and Explore Subcommittee, 69050-69051 2016-24053 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Public List of Companies Offering Existing Customers Free Access to a Credit Score, 69046-69047 2016-24014 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program:
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, etc.; Correction, 68947-68963 2016-24042 Coast Guard Coast Guard RULES Special Local Regulations: Arkansas River, Little Rock, AR, 68934-68936 2016-24071 Commerce Commerce Department See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration NOTICES Performance Review Board Membership, 69038-69039 2016-24049 Consumer Product Consumer Product Safety Commission NOTICES Settlement Agreements:
Best Buy Co., Inc., 69047-69050 2016-24075 Defense Department Defense Department See Army Department NOTICES Committee Establishment: Advisory Panel on Streamlining and Codifying Acquisition Regulations, 69052 2016-24045 Meetings: Defense Business Board, 69052-69053 2016-24072 Drug Drug Enforcement Administration NOTICES Established Aggregate Production Quotas for Schedule I and II Controlled Substances: Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2017, 69079-69083 2016-23988 Education Department Education Department NOTICES Privacy Act;
System of Records, 69053-69054 2016-24141 Employee Benefits Employee Benefits Security Administration NOTICES Meetings: Advisory Council on Employee Welfare and Pension Benefit Plans, 69087 2016-24102 Energy Department Energy Department See Energy Efficiency and Renewable Energy Office See Federal Energy Regulatory Commission NOTICES Meetings: Biological and Environmental Research Advisory Committee, 69054 2016-24058 Environmental Management Site-Specific Advisory Board, Northern New Mexico, 69054-69055 2016-24057 Energy Efficiency Energy Efficiency and Renewable Energy Office PROPOSED RULES Energy Conservation Standards:
General Service Lamps; Meeting, 69009-69010 2016-24063 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Georgia; Volatile Organic Compounds, 68936-68938 2016-23970 Pesticide Tolerances: Acrylic acid-butyl acrylate-styrene copolymer; Exemption, 68944-68946 2016-24083 Tolfenpyrad; Emergency Exemption, 68938-68944 2016-24093 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations:
Georgia; Volatile Organic Compounds, 69019 2016-23971 NOTICES Applications: Pesticide Experimental Use Permits, 69059-69060 2016-24101 Meetings: Pesticide Program Dialogue Committee, 69058 2016-24104 Pesticide Product Registrations: Applications for New Uses; Correction, 69060 2016-24103 Receipt of Information under the Toxic Substances Control Act, 69059 2016-24112 Federal Aviation Federal Aviation Administration NOTICES Meetings: RTCA SC-224 Standards for Airport Security Access Control Systems Plenary, 69183-69184 2016-24011 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 69060-69061 2016-24069 Federal Deposit Federal Deposit Insurance Corporation NOTICES Meetings: Advisory Committee on Economic Inclusion, 69061-69062 2016-24039 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 69055-69058 2016-24106 2016-24107 2016-24108 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Chisholm View Wind Project II, LLC, 69057 2016-24110 Nippon Dynawave Packaging Co., 69055 2016-24109 Federal Motor Federal Motor Carrier Safety Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Commercial Driver's License Skills Testing Delays, 69184-69185 2016-24177 Future Enhancements to the Safety Measurement System, 69185-69189 2016-24114 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 69062 2016-24055 Fish Fish and Wildlife Service RULES Endangered and Threatened Species: Endangered Species Status for the Miami Tiger Beetle (Cicindelidia floridana), 68985-69007 2016-23945 Kentucky Arrow Darter, 69312-69363 2016-23539 Threatened Species Status for Kentucky Arrow Darter with 4(d) Rule, 68963-68985 2016-23545 Food and Drug Food and Drug Administration NOTICES Guidance:
Product-Specific Bioequivalence Recommendations, 69064-69066 2016-24050 Meetings: Pharmacy Compounding Advisory Committee, 69062-69063 2016-24085 Requests for Nominations: Voting Members, Patient Engagement Advisory Committee, 69063-69064 2016-24100 Food Safety Food Safety and Inspection Service RULES Documentation Needed to Substantiate Animal Raising Claims for Label Submission, 68933-68934 2016-24067 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 69036 2016-23990 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 69190-69200 2016-24043 Foreign Trade Foreign-Trade Zones Board NOTICES Applications for Subzone Status:
Romark Global Pharma, LLC, Foreign-Trade Zone 7, Mayaguez, PR, 69039 2016-24098 Approvals of Subzone Status: Tesla Motors, Inc. Palo Alto and Fremont, CA, 69039-69040 2016-24094 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Nez Perce-Clearwater National Forests Travel Planning Project, 69036-69037 2016-24047 Meetings: Black Hills National Forest Advisory Board, 69037 2016-24096 Geological Geological Survey NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 69074-69076 2016-24064 Government Ethics Government Ethics Office PROPOSED RULES Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture, 69204-69238 2016-22958 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration Homeland Homeland Security Department See Coast Guard See U.S.
Customs and Border Protection Housing Housing and Urban Development Department PROPOSED RULES Application of Fair Housing Act's Discriminatory Effects Standard to Insurance, 69012-69019 2016-23858 NOTICES Certain Operating Cost Adjustment Factors for 2017, 69073-69074 2016-24070 Industry Industry and Security Bureau NOTICES Meetings: Information Systems Technical Advisory Committee, 69040-69041 2016-24136 Materials Processing Equipment Technical Advisory Committee, 69040 2016-24139 Sensors and Instrumentation Technical Advisory Committee, 69040 2016-24099 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Land Management Bureau See National Park Service NOTICES Meetings:
Exxon Valdez Oil Spill Public Advisory Committee, 69076 2016-24143 Internal Revenue Internal Revenue Service RULES Disguised Sales, 69291-69300 2016-23387 Liabilities Recognized as Recourse Partnership Liabilities Under Section 752, 69282-69291 2016-23388 Real Estate Investment Trust Real Property; Correction, 68934 2016-23991 PROPOSED RULES Liabilities Recognized as Recourse Partnership Liabilities Under Section 752, 69301-69309 2016-23390 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
Certain Frozen Warmwater Shrimp from India, 69041 2016-24122 Membership of the Performance Review Board, 69041-69042 2016-24044 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Aluminum Extrusions from China, 69078-69079 2016-24059 Investigations; Determinations, Modifications, and Rulings, etc.: Hot-Rolled Flat-Rolled Carbon-Quality Steel Products from Russia, 69079 2016-23994 Justice Department Justice Department See Drug Enforcement Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: National Use-of-Force Data Collection, 69084-69087 2016-24173 Proposed Consent Decrees under the Clean Air Act, 69083-69084 2016-24020 2016-24021 2016-24111 Labor Department Labor Department See Employee Benefits Security Administration See Workers Compensation Programs Office Land Land Management Bureau PROPOSED RULES Public Lands in Colorado, 69019-69023 2016-21934 NOTICES Meetings: Coeur d'Alene District Resource Advisory Council, ID;
Cancellation, 69076 2016-24097 Las Cruces District Resource Advisory Council, NM, 69076-69077 2016-24092 Maritime Maritime Administration NOTICES Meetings: U.S. Maritime Transportation System National Advisory Committee, 69189-69190 2016-23989 National Institute National Institute of Standards and Technology NOTICES U.S. Technical Participation in the 15th Conference of the International Organization of Legal Metrology, 69042-69043 2016-24076 National Institute National Institutes of Health NOTICES Meetings:
Center For Scientific Review, 69067-69069 2016-24022 2016-24023 Eunice Kennedy Shriver National Institute Of Child Health and Human Development, 69067 2016-24027 National Heart, Lung, And Blood Institute, 69068 2016-24024 National Institute Of Allergy And Infectious Diseases, 69067 2016-24025 2016-24026 National Institute on Minority Health and Health Disparities, 69069-69070 2016-24028 Proposed Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers, 69066-69067 2016-24030 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: 2016 Commercial Accountability Measure and Closure for South Atlantic Vermilion Snapper, 69008 2016-24105 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Educational Partnership Program, etc., 69044-69045 2016-24048 Meetings: Fisheries of the South Atlantic Southeast Data, Assessment, and Review Stock Identification Work Group Post-Meeting Webinar for Atlantic Blueline Tilefish, 69043-69044 2016-24051 Stock Status Determination for Atlantic Dusky Sharks, 69043 2016-24077 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:
After School Place-Based Science Technology Engineering and Mathematics Learning Partnership Evaluation Survey, 69077-69078 2016-24037 National Telecommunications National Telecommunications and Information Administration NOTICES Incentives, Benefits, Costs, and Challenges to Internet Protocol v6 Implementation, 69045-69046 2016-24033 Nuclear Regulatory Nuclear Regulatory Commission PROPOSED RULES Processing Fitness-for-Duty Drug and Alcohol Cases, 69010-69011 2016-24073 NOTICES Guidance:
General Use of Locks in the Protection and Control of Facilities, Radioactive Materials, Classified Information, Classified Matter, and Safeguards Information, 69088-69089 2016-23992 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 69089-69090 2016-24017 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Defense and National Security: Unified Command Plan; Transfer of Responsibilities (Memorandum of September 30, 2016), 69365-69367 2016-24308 Rural Housing Service Rural Housing Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 69037-69038 2016-24013 Securities Securities and Exchange Commission PROPOSED RULES Securities Transaction Settlement Cycle, 69240-69280 2016-23890 NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Bats EDGX Exchange, Inc., 69172-69181 2016-24010 Boston Stock Exchange Clearing Corp., 69159-69165 2016-24004 International Securities Exchange, LLC, 69102-69109 2016-24007 ISE Gemini, LLC, 69165-69172 2016-24003 ISE Mercury, LLC, 69127-69133 2016-24002 Miami International Securities Exchange, LLC, 69090-69092 2016-23997 NASDAQ BX, Inc., 69152-69159 2016-24008 NASDAQ PHLX, LLC, 69133-69140 2016-24000 NASDAQ Stock Market, LLC, 69109-69122, 69140-69152 2016-23999 2016-24001 2016-24086 National Stock Exchange, Inc., 69123-69126 2016-24009 New York Stock Exchange, LLC;
NYSE MKT LLC; NYSE Arca, Inc., 69092-69093 2016-24016 Options Clearing Corp., 69100-69102 2016-24005 Stock Clearing Corporation of Philadelphia, 69093-69100 2016-24006 Temporary Exemptions, 69122 2016-23998 Small Business Small Business Administration PROPOSED RULES Small Business Investment Companies—Early Stage; Meetings, 69012 2016-24031 NOTICES Conflicts of Interest; Exemption Applications: Avante Mezzanine Partners SBIC II, LP, 69181 2016-24035 Interest Rates, 69182 2016-24034 State Department State Department NOTICES Meetings:
President's Emergency Plan for AIDS Relief Scientific Advisory Board, 69182 2016-24095 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 69070-69071 2016-24012 Surface Transportation Surface Transportation Board PROPOSED RULES Offers of Financial Assistance, 69023-69035 2016-24056 Susquehanna Susquehanna River Basin Commission NOTICES Public Hearings, 69182-69183 2016-24032 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Maritime Administration Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service NOTICES Senior Executive Service Legal Division Performance Review Board, 69200 2016-23993 Customs U.S.
Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: NAFTA Regulations and Certificate of Origin, 69071-69072 2016-24018 United States-Caribbean Basin Trade Partnership Act, 69072-69073 2016-24019 Veteran Affairs Veterans Affairs Department NOTICES Meetings: Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, 69200-69201 2016-24074 Workers' Workers Compensation Programs Office NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 69087-69088 2016-24123 Separate Parts In This Issue Part II Government Ethics Office, 69204-69238 2016-22958 Part III Securities and Exchange Commission, 69240-69280 2016-23890 Part IV Treasury Department, Internal Revenue Service, 69282-69309 2016-23387 2016-23388 2016-23390 Part V Interior Department, Fish and Wildlife Service, 69312-69363 2016-23539 Part VI Presidential Documents, 69365-69367 2016-24308 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 81 193 Wednesday, October 5, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 317, 381, and 412 [Docket No. FSIS-2016-0021] Food Safety and Inspection Service Labeling Guideline on Documentation Needed To Substantiate Animal Raising Claims for Label Submission AGENCY:
Food Safety and Inspection Service, USDA. ACTION: Guidance. SUMMARY: The Food Safety and Inspection Service
(FSIS)is announcing the availability of an updated version of the Agency's compliance guideline on documentation needed to support animal-raising claims on product labels that must be submitted for Agency approval before they can be used on product labels. The updated guideline reflects FSIS's current position and procedures for reviewing animal-raising claims and includes explanations of animal-raising claims that FSIS may approve and the types of supporting documentation that the Agency requires to be submitted to support these claims. DATES: Submit comments on or before December 5, 2016. ADDRESSES: A downloadable version of the compliance guideline is available to view and print at *http://www.fsis.usda.gov/wps/wcm/connect/6fe3cd56-6809-4239-b7a2-bccb82a30588/RaisingClaims.pdf?MOD=AJPERES* once copies of the guideline have been published. FSIS invites interested persons to submit comments on this guidance. Comments may be submitted by one of the following methods: *Federal eRulemaking Portal:* This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to *http://www.regulations.gov/.* Follow the on-line instructions at that site for submitting comments. *Mail, including CD-ROMs:* Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163B, Washington, DC 20250-3700. *Hand- or courier-delivered submittals:* Deliver to Patriots Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20250-3700. *Instructions:* All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2016-0021. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to *http://www.regulations.gov.* *Docket:* For access to background documents or to comment received, go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 164-A, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development; Telephone:
(202)205-0495. SUPPLEMENTARY INFORMATION: Background A federally inspected meat or poultry establishment is required to use labels that are in compliance with the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 *et seq.,* 607), the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 *et seq.,* 457), and the implementing regulations. Requirements include all mandatory labeling requirements as prescribed in Title 9 of the Code of Federal Regulations section 317.2 and 381 Subpart N. All labels with special claims, including animal-raising claims, need to be submitted to FSIS prior to being used on the product under 9 CFR 412.1(c)(3). As with all labels with special claims, labels with animal-raising claims must be submitted to the Labeling and Program Delivery Staff, Office of Policy and Program Development in FSIS with specific documentation to support all such claims that appear on that label. Examples of animal-raising claims include, but are not limited to: “Raised Without Antibiotics,” “Organic,” “Grass-Fed,” “Free-Range,” and “Raised without the use of hormones.” For most animal-raising claims, the documentation typically needed to support these claims includes: 1. A detailed written description explaining the controls used for ensuring that the raising claim is valid from birth to harvest or the period of raising being referenced by the claim; 2. A signed and dated document describing how the animals are raised ( *e.g.,* vegetarian-fed, raised without antibiotics, grass-fed), to support that the specific claim made is truthful and not misleading; 3. A written description of the product-tracing and segregation mechanism from time of slaughter or further processing through packaging and wholesale or retail distribution; 4. A written description for the identification, control, and segregation of non-conforming animals or products; and 5. If a third party certifies a claim, a current copy of the certificate. FSIS previously issued a compliance guideline on animal-raising claims in 2002. The changes included in this version of the guideline include definitions for frequently used animal-raising claims, the detailed supporting documentation required for each specific claim that appears on the label, additional information regarding the claim *grass fed,* information required for duplicating raising claims from purchased product, and examples of labels bearing claims. This guideline represents FSIS's current position and procedures for approving animal-raising claims, and although FSIS is requesting comments on this guideline and may update it in response to comments, FSIS encourages establishments that wish to submit request for approvals of animal raising claims on product labels to begin using this guideline. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this **Federal Register** publication on-line through the FSIS Web page located at: *http://www.fsis.usda.gov/federal-register.* FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, **Federal Register** notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: *http://www.fsis.usda.gov/subscribe.* Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password-protect their accounts. USDA Nondiscrimination Statement No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination, any person in the United States under any program or activity conducted by the USDA. To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at: *http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf,* or write a letter signed by you or your authorized representative. Send your completed complaint form or letter to USDA by mail, fax, or email: *Mail:* U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410. *Fax:*
(202)690-7442. *Email: program.intake@usda.gov.* Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at
(202)720-2600 (voice and TDD). Done at Washington, DC on: September 29, 2016. Alfred V. Almanza, Acting Administrator. [FR Doc. 2016-24067 Filed 10-4-16; 8:45 am]
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- 9 CFR 412.1(c)(3)
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