Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2016-02-12.xml --- 81 29 Friday, February 12, 2016 Contents Agriculture Agriculture Department See National Institute of Food and Agriculture See Rural Utilities Service RULES Agriculture Acquisition Regulation, Fire Suppression and Liability, 7478-7480 2016-02745 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: Reporting and Returning of Overpayments, 7654-7684 2016-02789 Civil Rights Civil Rights Commission NOTICES Meetings;

Sunshine Act, 7499-7500 2016-02992 Coast Guard Coast Guard PROPOSED RULES Special Local Regulations: Chesapeake Bay, between Sandy Point and Kent Island, MD, 7481-7483 2016-02814 NOTICES Policy Letters: Guidance for Training of Deck Officers on Vessels Subject to the International Code for Ships Operating in the Polar Waters, 7552-7553 2016-02890 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List;

Additions, 7510 2016-02941 Procurement List; Additions and Deletions, 7508-7510 2016-02940 Proposed Additions to and Deletion from the Procurement List, 7510-7511 2016-02943 Consumer Product Consumer Product Safety Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Requirements Pertaining to Third Party Conformity Assessment Bodies, 7511-7512 2016-02939 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 7512-7513 2016-02861 Defense Department Defense Department NOTICES Arms Sales, 7513-7520, 7522-7530 2016-02842 2016-02862 2016-02865 2016-02891 2016-02905 2016-02918 2016-02938 Arms Sales Notification, 7520-7522 2016-02847 Drug Drug Enforcement Administration NOTICES Manufacturers of Controlled Substances; Applications: Noramco, Inc., Athens, GA, 7587-7588 2016-02863 Energy Department Energy Department See Energy Information Administration See Federal Energy Regulatory Commission NOTICES Meetings:

Electricity Advisory Committee, 7531-7532 2016-02793 State Energy Advisory Board, 7530-7531 2016-02796 Energy Information Energy Information Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 7532-7533 2016-02800 Environmental Protection Environmental Protection Agency RULES Allocations of Cross-State Air Pollution Rule Allowances from New Unit Set-Asides for the 2015 Compliance Year, 7466 2016-02955 Clean Air Act Operating Permit Programs:

West Virginia; Revision, 7463-7465 2016-02831 Pesticide Tolerances: Diflubenzuron, 7466-7472 2016-02816 Requirements of a Tolerance; Exemptions: Benzyl acetate, 7473-7477 2016-02815 Significant New Use Rule on Certain Chemical Substances, 7455-7463 2016-02952 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; San Joaquin Valley Unified Air Pollution Control District, 7489 2016-02845 Idaho; Interstate Transport Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards, 7489-7491 2016-02846 Tennessee;

Removal of I/M Program in Memphis and Revisions to the 1997 8-Hour Ozone Maintenance Plan for Shelby County, TN, 7483-7489 2016-02844 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: EPA's ENERGY STAR Program in the Commercial and Industrial Sectors, 7538-7539 2016-02919 Landfill Methane Outreach Program, 7539-7540 2016-02920 On-Highway Motorcycle Certification and Compliance Program, 7536-7537 2016-02956 Recordkeeping and Reporting Related to RFS2 Voluntary RIN Quality Assurance Program, 7537-7538 2016-02921 Environmental Impact Statements;

Availability, etc., 7538 2016-02937 Federal Communications Federal Communications Commission RULES Broadcast Licensee-Conducted Contests, 7477-7478 2016-02900 PROPOSED RULES Petitions for Reconsideration of Action in a Rulemaking Proceeding, 7491-7492 2016-02899 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7540-7541 2016-02901 2016-02902 List of Reserve-Eligible Nationwide Service Providers in Each Partial Economic Area for the Broadcast Incentive Auction, 7542-7543 2016-03058 Order Declares ACT Telecommunications, Inc.'s International Section 214 Authorization Terminated, 7542 2016-02932 Federal Emergency Federal Emergency Management Agency NOTICES Adjustment of Statewide Per Capita Indicator for Recommending a Cost Share Adjustment, 7558-7559 2016-02908 Changes in Flood Hazard Determinations, 7559-7561 2016-02909 Major Disaster Declarations:

Texas; Amendment No. 3, 7563 2016-02907 Proposed Flood Hazard Determinations, 7557-7558, 7561-7563 2016-02911 2016-02912 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 7534-7535 2016-02922 2016-02923 Complaints: Dominion Energy Marketing, Inc., Dominion Energy Manchester Street, Inc. v. ISO New England, Inc., 7534-7535 2016-02924 Hydroelectric Applications: Idaho Power Company, 7533-7534 2016-02926 Southern California Edison Company, 7535-7536 2016-02925 Federal Motor Federal Motor Carrier Safety Administration NOTICES Hours of Service of Drivers;

Exemption Applications: Farruggio's Express, 7626-7627 2016-02896 Federal Railroad Federal Railroad Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7628-7629 2016-02892 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 7543 2016-02906 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants: Initiation of 5-Year Status Reviews of 76 species in Hawaii, Oregon, Washington, Montana, and Idaho, 7571-7573 2016-02895 Endangered Species Permits, 7573-7582 2016-02723 Food and Drug Food and Drug Administration RULES Anesthesiology Devices:

Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure, 7446-7452 2016-02876 Medical Devices: General and Plastic Surgery Devices; Classification of the Scalp Cooling System to Reduce the Likelihood of Chemotherapy-Induced Alopecia, 7452-7454 2016-02878 Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972, 7445-7446 2016-02884 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Guidance for Industry on Formal Meetings with Sponsors and Applicants for Prescription Drug User Fee Act Products, 7549 2016-02889 Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration, 7547 2016-02880 Manufactured Food Regulatory Program Standards, 7544-7546 2016-02888 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 7548 2016-02881 Request for Samples and Protocols, 7546 2016-02882 Government-Owned Inventions;

Availability for Licensing: Influenza virus neuramindase, 7547-7548 2016-02887 Guidance: Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices, 7543-7544 2016-02879 Meetings: Annual Computational Science Symposium; Public Conference, 7548-7549 2016-02877 Gastrointestinal Drugs Advisory Committee, 7546-7547 2016-02857 Foreign Trade Foreign-Trade Zones Board NOTICES Proposed Production Activities: Thoma-Sea Marine Constructors, L.L.C., Foreign-Trade Zone 279—Terrebonne Parish, LA, 7500 2016-02993 Geological Geological Survey NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 7582-7583 2016-02867 Charter Renewals: National Geospatial Advisory Committee, 7583 2016-02893 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S. Citizenship and Immigration Services See U.S. Customs and Border Protection NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Infrastructure Protection Gateway Facility Surveys, 7563-7564 2016-02871 Housing Housing and Urban Development Department NOTICES Federal Property Suitable as Facilities to Assist the Homeless, 7632-7651 2016-02584 Guidance: Community Development Block Grant Disaster Recovery, 7567-7569 2016-02913 Mortgage and Loan Insurance Programs under the National Housing Act: Debenture Interest Rates, 7569-7571 2016-02870 Indian Affairs Indian Affairs Bureau NOTICES Indian Gaming;

Extension of Tribal-State Class III Gaming Compact; Crow Creek Sioux Tribe and the State of South Dakota, 7583-7584 2016-02917 Information Information Security Oversight Office NOTICES Meetings: National Industrial Security Program Policy Advisory Committee, 7594-7595 2016-02934 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Indian Affairs Bureau International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Magnesia Carbon Bricks from Mexico and the People's Republic of China, 7502 2016-02994 Citric Acid and Certain Citrate Salts from Canada, 7500-7502 2016-02996 Drawn Stainless Steel Sinks from the People's Republic of China; Changed Circumstances Review, 7504-7506 2016-02997 Light-Walled Rectangular Pipe and Tube from Turkey, 7503-7504 2016-02995 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Corrosion-Resistant Steel Products from China, India, Italy, Korea, and Taiwan, 7585-7587 2016-02914 Investigations; Determinations, Modifications, and Rulings, etc.: Stainless Steel Products, Certain Processes for Manufacturing or Relating to Same, and Certain Products Containing Same, 7584-7585 2016-02869 Stainless Steel Wire Rod from Italy, Japan, Korea, Spain, and Taiwan, 7587 2016-02897 Meetings; Sunshine Act, 7587 2016-03096 Justice Department Justice Department See Drug Enforcement Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: ATF Distribution Center Survey, ATF F 1370.4, 7590 2016-02935 Contraband Cigarette Trafficking Act Delivery Sale Information Form—Schedule B, 7591-7592 2016-02819 FFL Out of Business Records Request, ATF F 5300.3A, 7588 2016-02910 Manufacturers of Ammunition, Records and Supporting Data of Ammunition Manufactured and Disposed Of, 7588-7589 2016-02936 Reporting and Recordkeeping for Digital Certificates, 7592 2016-02817 Tobacco Inventory Report, 7590-7591 2016-02818 Voluntary Magazine Questionnaire For Agencies/Entities Who Store Explosive Materials, 7589-7590 2016-02898 Labor Department Labor Department See Workers Compensation Programs Office NASA National Aeronautics and Space Administration NOTICES Meetings:

Aerospace Safety Advisory Panel, 7593 2016-02886 NASA International Space Station Advisory Committee, 7593-7594 2016-02885 Science Committee, 7594 2016-02868 National Archives National Archives and Records Administration See Information Security Oversight Office National Highway National Highway Traffic Safety Administration PROPOSED RULES Petition for Rulemaking; Denials: Federal Motor Vehicle Safety Standards, 7492-7493 2016-02763 National Institute Food National Institute of Food and Agriculture NOTICES Interagency Special Report: 2nd State of the Carbon Cycle Report, 7497-7499 2016-02927 National Institute National Institute of Standards and Technology NOTICES Views on the Framework for Improving Critical Infrastructure Cybersecurity, 7506 2016-02860 National Institute National Institutes of Health NOTICES Meetings:

National Institute of General Medical Sciences, 7549-7550, 7552 2016-02851 2016-02852 2016-02853 2016-02850 National Institute on Drug Abuse, 7550-7552 2016-02848 2016-02849 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Pacific Island Fisheries: Hawaii Bottomfish and Seamount Groundfish; Revised Essential Fish Habitat and Habitat Areas of Particular Concern, 7494-7496 2016-02843 Trade Monitoring Procedures for Fishery Products; International Trade in Seafood:

Permit Requirements for Importers and Exporters Public Meetings; Correction, 7493 2016-03053 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7507 2016-02904 Meetings: Pacific Fishery Management Council, 7507-7508 2016-02933 National Science National Science Foundation NOTICES Permits Issued under the Antarctic Conservation Act of 1978, 7595 2016-02835 Pension Benefit Pension Benefit Guaranty Corporation RULES Benefits Payable in Terminated Single-Employer Plans;

Interest Assumptions for Paying Benefits, 7454-7455 2016-02810 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 7595-7596 2016-02854 2016-02855 2016-02856 Presidential Documents Presidential Documents EXECUTIVE ORDERS Committees; Establishment, Renewal, Termination, etc.: Enhancing National Cybersecurity, Commission on; Establishment (EO 13718), 7441-7444 2016-03038 Privacy Council, Federal; Establishment (EO 13719), 7685-7689 2016-03141 ADMINISTRATIVE ORDERS Balanced Budget and Emergency Deficit Control Act;

Sequestration Order for FY 2017 (Order of February 9, 2016), 7691-7693 2016-03170 Rural Utilities Rural Utilities Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7499 2016-02949 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7596-7597, 7616-7618 2016-02832 2016-02833 Applications: State Farm Associates' Funds Trust, et al., 7619-7620 2016-02834 Self-Regulatory Organizations;

Proposed Rule Changes: BATS Exchange, Inc., 7599-7609 2016-02838 Chicago Board Options Exchange, Inc., 7609-7613 2016-02841 ICE Clear Credit LLC, 7613-7616 2016-02839 NASDAQ PHLX LLC, 7618-7619 2016-02836 The NASDAQ Stock Market LLC, 7597-7599, 7620-7623 2016-02837 2016-02840 Small Business Small Business Administration NOTICES Conflicts of Interest Exemption Requests: C3 Capital Partners III, LP, 7624 2016-02872 Disaster Declarations: Arkansas, 7624-7625 2016-02929 2016-02931 Florida, 7623 2016-02873 2016-02874 Michigan, 7623-7624 2016-02928 Oklahoma;

Amendment 1, 7624 2016-02930 State Department State Department RULES Visas: Documentation of Nonimmigrants under the Immigration and Nationality Act, as Amended, 7454 2016-02962 Surface Transportation Surface Transportation Board NOTICES Trackage Rights Exemptions: Wisconsin Central Ltd. from Lines of Union Pacific Railroad Co. and Illinois Central Railroad Co., 7625-7626 2016-02903 Transportation Department Transportation Department See Federal Motor Carrier Safety Administration See Federal Railroad Administration See National Highway Traffic Safety Administration U.S.

Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: H-2 Petitioner's Employment Related or Fee Related Notification, 7564-7565 2016-02363 Immigrant Petition for Alien Worker, Form I-140; Extension, 7565-7566 2016-02915 Petition for CNMI-Only Nonimmigrant Transitional Worker, 7566-7567 2016-02942 Customs U.S. Customs and Border Protection NOTICES Commercial Gaugers and Laboratories; Approvals:

Amspec Services, LLC, 7553-7556 2016-02954 2016-02960 Saybolt LP, 7556 2016-02961 Commercial Gaugers and Laboratories; Approvals: and Accreditations: Inspectorate America Corp., Aston, PA, 7554-7555 2016-02951 Veteran Affairs Veterans Affairs Department NOTICES West Los Angeles VA Medical Center; Draft Master Plan, 7630 2016-02883 Workers' Workers Compensation Programs Office NOTICES Charter Amendments: Advisory Board on Toxic Substances and Worker Health, 7592-7593 2016-02859 Separate Parts In This Issue Part II Housing and Urban Development Department, 7632-7651 2016-02584 Part III Health and Human Services Department, Centers for Medicare & Medicaid Services, 7654-7684 2016-02789 Part IV Presidential Documents, 7685-7689 2016-03141 Part V Presidential Documents, 7691-7693 2016-03170 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 LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 81 29 Friday, February 12, 2016 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 601 [Docket No. FDA-2015-N-2103] Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972 AGENCY:

Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products.

In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation. DATES: This rule is effective March 14, 2016. ADDRESSES: For access to the docket to read background documents or comments received, go to *http://www.regulations.gov* and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1062, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose of the Final Rule FDA is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972, because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972.

These other statutory and regulatory authorities allow FDA to evaluate and monitor the safety and effectiveness of all biological products and authorize FDA to revoke a license for products because they are not safe and effective, or are misbranded. B. Summary of the Major Provisions of the Final Rule The final rule removes §§ 601.25 and 601.26 (21 CFR 601.25 and 601.26), which prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972.

C. Legal Authority FDA is taking this action under the biological products provisions of the Public Health Service Act (the PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). D. Costs and Benefits Because this final rule would not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal. II. Background A.

History of the Rulemaking In the **Federal Register** of July 2, 2015 (80 FR 38145), FDA proposed to remove regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. As discussed in the preamble to the proposed rule, these regulations were originally issued after the Director of the National Institutes of Health

(NIH)announced in the **Federal Register** on March 15, 1972, that the Division of Biologics Standards, NIH, would review the effectiveness of all licensed biologicals (37 FR 5404). In the **Federal Register** of June 29, 1972 (37 FR 12865), FDA announced the transfer of regulatory authority over biological products from the Division of Biologics Standards, NIH, to FDA. After obtaining regulatory authority over biological products, the Commissioner of FDA proposed procedures for reviewing the safety, effectiveness, and labeling of all biological products licensed at the time of the transfer on July 1, 1972 (37 FR 16679, August 18, 1972). The procedures for review of biological products licensed before July 1, 1972, were codified in 21 CFR 273.245 (38 FR 4319 at 4321, February 13, 1973) and later redesignated to § 601.25 (38 FR 32048, November 20, 1973). The procedures for review of biological products licensed before July 1, 1972, were supplemented by procedures codified in § 601.26 (47 FR 44062, October 5, 1982). B. Current Methods for Ensuring the Safety and Effectiveness of Biological Products Since establishing the procedures under §§ 601.25 and 601.26, FDA developed new regulations to assess and ensure the safety and efficacy of biological products. FDA issued the Current Good Manufacturing Practice

(cGMP)regulations, which contain the minimum cGMP for preparation of drug products, including biological products. The cGMP regulations help FDA ensure that such products meet the requirements for product safety, effectiveness, and labeling. FDA also helps ensure the safety and effectiveness of biological products through application of other regulations, such as the reporting of biological product deviations by licensed manufacturers (see 21 CFR 600.14), postmarketing reporting of adverse experiences (21 CFR 600.80), and labeling regulations (for example, 21 CFR part 201). Biological products that do not meet the requirements under these regulations are subject to license revocation under 21 CFR 601.5, which allows FDA to revoke any biologics license for a product that fails to meet applicable standards and fails to comply with regulations designed to help ensure the safety, purity, and potency of the licensed product, and that the product is not misbranded. In addition, FDA continues to help ensure the safety and effectiveness of licensed biological products through the development and application of additional standards and mechanisms. These mechanisms assist FDA in evaluating and monitoring the safety and effectiveness of biological products. C. Summary of Comments to the Proposed Rule FDA did not receive any comments on the proposed rule. D. General Overview of the Final Rule The final rule removes §§ 601.25 and 601.26 of the regulations, which prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because these regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. III. Legal Authority FDA is issuing this regulation under the biological products provisions of the PHS Act (42 U.S.C. 262 and 264) and the drugs and general administrative provisions of the FD&C Act (sections 201, 301, 501, 502, 503, 505, 510, 701, and 704 (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, and 374)). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent; and to prevent the introduction, transmission, and spread of communicable disease. IV. Economic Analysis of Impacts We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule removes regulations that are obsolete and no longer necessary in light of other current statutory and regulatory authorities, FDA certifies that the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current

(2014)Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in any 1-year expenditure that would meet or exceed this amount. V. Analysis of Environmental Impact We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant adverse effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VI. Paperwork Reduction Act of 1995 This final rule contains no collection of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required. VII. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. List of Subjects in 21 CFR Part 601 Administrative practice and procedure, Biologics, Confidential business information. Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows: PART 601—LICENSING 1. The authority citation for 21 CFR part 601 continues to read as follows: Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note). § 601.25 [Removed] 2. Remove § 601.25. § 601.26 [Removed] 3. Remove § 601.26. Dated: February 5, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-02884 Filed 2-11-16; 8:45 am]

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