Unknown. Final order

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--- schema: federal-register doc_type: fedreg source_file: FR-2016-04-14.xml --- 81 72 Thursday, April 14, 2016 Contents Agricultural Research Agricultural Research Service NOTICES Intent to Grant Exclusive Licenses: Chengdu Rong Cheng Jiu Tian Biotechnology Co., Ltd., 22048 2016-08634 Agriculture Agriculture Department See Agricultural Research Service Antitrust Division Antitrust Division NOTICES Changes under the National Cooperative Research and Production Act: Cable Television Laboratories, Inc., 22119 2016-08582 Cooperative Research Group on Advanced Combustion Catalyst and Aftertreatment Technologies, 22119 2016-08571 Cooperative Research Group on Chede-VII, 22121 2016-08580 Medical Technology Enterprise Consortium, 22119-22120 2016-08574 National Armaments Consortium, 22121 2016-08577 National Spectrum Consortium, 22120-22121 2016-08584 Pistoia Alliance, Inc., 22119 2016-08579 Chemical Chemical Safety and Hazard Investigation Board NOTICES Meetings;

Sunshine Act, 22048 2016-08676 Children Children and Families Administration NOTICES Single-Source Grant Awards: Pennsylvania Coalition Against Domestic Violence in Harrisburg, PA, 22091-22092 2016-08534 Single-Source Program Expansion Supplement Grants: American Bar Association Fund for Justice and Education, Washington, DC, 22091 2016-08545 University of Denver (Colorado Seminary), in Denver, CO, for the Capacity Building Center for Tribes, 22090-22091 2016-08544 Yakima Valley Farm Workers Clinic, Toppenish, WA, and the Confederated Salish and Kootenai Tribes, Pablo, MT, 22090 2016-08588 Zero to Three in Washington, DC, for the Quality Improvement Center for Research-Based Infant-Toddler Court Teams, 22091 2016-08521 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 22163-22165 2016-08586 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22060-22061 2016-08663 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22063-22067 2016-08542 2016-08549 2016-08562 2016-08567 2016-08614 Arms Sales, 22061-22063 2016-08585 Charter Renewals: Federal Advisory Committees, 22066 2016-08590 Exclusive Licenses:

SW Complete, Inc., 22067 2016-08593 Drug Drug Enforcement Administration RULES Schedules of Controlled Substances: Placement of AH-7921 into Schedule I, 22023-22025 2016-08566 NOTICES Decisions and Orders: Rezik A. Saqer, M.D., 22122-22128 2016-08572 Manufacturers of Controlled Substances; Applications: Patheon API Manufacturing, Inc., 22122 2016-08569 Manufacturers of Controlled Substances; Registrations: Stepan Co., 22121-22122 2016-08576 Education Department Education Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Parent Information and School Choice Evaluation, 22067-22068 2016-08536 Energy Department Energy Department See Federal Energy Regulatory Commission See Western Area Power Administration Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; South Coast; Moderate Area Plan for the 2006 PM2.5 NAAQS, 22025-22032 2016-08039 Findings of Failure to Submit State Implementation Plans Required for Attainment of the 1-Hour Primary Sulfur Dioxide National Ambient Air Quality Standard;

Correction, 22025 2016-08509 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Registration of Fuels and Fuel Additives — Health-Effects Research Requirements for Manufacturers, 22080-22081 2016-08628 Proposed CERCLA Ability to Pay Settlement: Yosemite Slough Site, San Francisco, CA, 22080 2016-08627 Proposed Consent Decree, Clean Air Act Citizen Suit, 22079-22080 2016-08626 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives:

Airbus Airplanes, 22033-22037 2016-08367 Bombardier Inc. Airplanes, 22037-22039 2016-08533 NOTICES Meetings: Research, Engineering and Development Advisory Committee; Correction, 22155 2016-08392 Federal Communications Federal Communications Commission NOTICES Meetings: Federal Advisory Committee Act; Technological Advisory Council, 22081-22082 2016-08529 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22163-22165 2016-08586 Meetings;

Sunshine Act, 22082 2016-08718 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 22068-22069, 22072-22075 2016-08595 2016-08599 2016-08600 2016-08601 2016-08602 2016-08608 2016-08609 Filings: Gregory and Beverly Swecker v. Midland Power Cooperative, et al., 22071 2016-08603 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Copper Mountain Solar 4, LLC, 22071-22072 2016-08598 Mesquite Solar 2, LLC, 22072 2016-08596 Mesquite Solar 3, LLC, 22072-22073 2016-08597 Petitions for Declaratory Orders:

Medallion Pipeline Co., LLC, 22069-22070 2016-08605 Staff Attendance, 22070-22071 2016-08604 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22163-22165 2016-08586 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 22082 2016-08610 Federal Trade Federal Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22088-22089 2016-08657 Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Telemarketing Sales, 22082-22088 2016-08655 Federal Transit Federal Transit Administration NOTICES Funding Opportunities: Transit-Oriented Development Planning Pilot Program, 22155-22160 2016-08538 Limitations on Claims Against Proposed Public Transportation Projects, 22160-22161 2016-08537 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: Threatened Species Status for Platanthera integrilabia (White Fringeless Orchid), 22041-22042 2016-08615 Food and Drug Food and Drug Administration NOTICES Environmental Assessments;

Availability, etc.: Investigational Use of Oxitec OX513A Mosquitoes, 22092-22093 2016-08678 Health and Human Health and Human Services Department See Children and Families Administration See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Transportation Security Administration Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Affirmatively Furthering Fair Housing Assessment Tool for Public Housing;

Correction, 22105 2016-08565 Debt Resolution Program, 22101-22102 2016-08531 Ginnie Mae Mortgage-Backed Securities Guide 5500.3, Revision 1, Forms and Electronic Data Submissions, 22095-22097 2016-08623 Housing Counseling Program, 22103-22104 2016-08540 HUD-Administered Small Cities Program Performance Assessment Report, 22103 2016-08563 Manufactured Home Construction and Safety Standards Program, 22104-22105 2016-08541 Revitalization Area Designation and Management, 22105-22106 2016-08528 Single Family Premium Collection Subsystem-Upfront, 22102 2016-08527 Funding Awards:

Indian Community Development Block Grant Program Fiscal Year 2015, 22097-22101 2016-08564 Indian Affairs Indian Affairs Bureau PROPOSED RULES Intents to Establish Negotiated Rulemaking Committees, 22039-22040 2016-08629 Interior Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See Office of Natural Resources Revenue Internal Revenue Internal Revenue Service NOTICES Meetings: Taxpayer Advocacy Panel Notices and Correspondence Project Committee, 22165-22166 2016-08668 Taxpayer Advocacy Panel Special Projects Committee, 22166 2016-08619 Taxpayer Advocacy Panel Tax Forms and Publications Project Committee, 22165 2016-08667 Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee, 22165 2016-08666 Taxpayer Advocacy Panel Taxpayer Communications Project Committee, 22166 2016-08665 Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee, 22166 2016-08670 Requests for Nominations:

Taxpayer Advocacy Panel, 22166-22167 2016-08618 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Honey from the People's Republic of China; Rescission, 22049-22050 2016-08631 Pressure Sensitive Plastic Tape from Italy, 22048-22049 2016-08630 International Trade Com International Trade Commission NOTICES Complaints: Certain Electrical Conductor Composite Cores and Components Thereof, 22117-22118 2016-08594 Complaints;

Solicitation of Comments Relating to the Public Interest, 22118-22119 2016-08624 Investigations; Determinations, Modifications, and Rulings, etc.: Carbon and Alloy Steel Cut-to-Length Plate from Austria, Belgium, Brazil, China, France, Germany, Italy, Japan, Korea, South Africa, Taiwan, and Turkey, 22116-22117 2016-08543 Justice Department Justice Department See Antitrust Division See Drug Enforcement Administration NASA National Aeronautics and Space Administration NOTICES Partially Exclusive Licenses, 22128 2016-08546 2016-08547 National Institute National Institutes of Health NOTICES Meetings:

National Institute on Drug Abuse, 22093 2016-08523 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Summer Flounder Fishery; Quota Transfer, 22032 2016-08616 PROPOSED RULES Atlantic Highly Migratory Species: Archival Tag Management Measures, 22044-22047 2016-08535 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Shrimp Fishery of the Gulf of Mexico; Amendment 17A, 22042-22044 2016-08607 NOTICES Meetings:

Endangered Species Act, 22058-22059 2016-08561 Takes of Marine Mammals Incidental to Specified Activities: Russian River Estuary Management Activities, 22050-22058 2016-08587 National Telecommunications National Telecommunications and Information Administration NOTICES Requests for Nominations: First Responder Network Authority Board Members, 22059-22060 2016-08664 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Guidance: Neutron-Absorbing Materials in Spent Fuel Pools, 22129-22130 2016-08621 License Renewal Applications:

Entergy Operations, Inc.; Waterford Steam Electric Station, Unit 3, 22128-22129 2016-08660 Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, 22129 2016-08589 Natural Resources Office of Natural Resources Revenue NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Solid Minerals and Geothermal Collections, 22106-22116 2016-08661 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Applications for Special Permits:

Hazardous Materials, 22161-22162 2016-08174 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Periodic Reporting, 22040-22041 2016-08591 NOTICES New Postal Products, 22130-22131 2016-08613 2016-08612 Postal Service Postal Service NOTICES Mail Classification Schedule Changes: Priority Mail International Flat Rate Envelopes and Priority Mail International Small Flat Rate Boxes, 22131-22132 2016-08583 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances:

National Equal Pay Day (Proc. 9422), 22169-22172 2016-08848 Reagan-Udall Reagan-Udall Foundation For The Food And Drug Administration NOTICES Meetings: Reagan-Udall Foundation for the Food and Drug Administration, 22132 2016-08656 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22133, 22143, 22150-22151 2016-08550 2016-08551 2016-08552 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 22143-22148 2016-08554 BOX Options Exchange, LLC, 22133-22136, 22151-22154 2016-08555 2016-08559 Chicago Board Options Exchange, Inc., 22138-22140, 22148-22150 2016-08557 2016-08560 Financial Industry Regulatory Authority, Inc., 22136-22138 2016-08553 ISE Mercury, LLC, 22140-22143 2016-08556 NYSE Arca, Inc., 22136 2016-08558 Small Business Small Business Administration NOTICES Disaster Declarations:

Florida, 22154-22155 2016-08653 2016-08662 Transportation Department Transportation Department See Federal Aviation Administration See Federal Transit Administration See Pipeline and Hazardous Materials Safety Administration Security Transportation Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Baseline Assessment for Security Enhancement Program, 22093-22095 2016-08568 Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service Western Western Area Power Administration NOTICES Environmental Impact Statements;

Availability, etc.: Southline Transmission Line Project, 22076-22078 2016-08620 Separate Parts In This Issue Part II Presidential Documents, 22169-22172 2016-08848 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 72 Thursday, April 14, 2016 Rules and Regulations DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No.

DEA-432] Schedules of Controlled Substances: Placement of AH-7921 Into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final order. SUMMARY: With the issuance of this final order, the Administrator of the Drug Enforcement Administration places the substance AH-7921 (Systematic IUPAC Name: 3,4-dichloro- *N* -[(1dimethylamino)cyclohexylmethyl]benzamide), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, into schedule I of the Controlled Substances Act.

This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its obligations under the Single Convention on Narcotic Drugs, 1961. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, AH-7921.

DATES: Effective May 16, 2016. FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone:

(202)598-6812. SUPPLEMENTARY INFORMATION: Legal Authority The Drug Enforcement Administration

(DEA)implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Under the CSA, controlled substances are classified into one of five schedules based upon their potential for abuse, their currently accepted medical use in treatment in the United States, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of scheduled substances is published at 21 CFR part 1308. Section 201(d)(1) of the CSA (21 U.S.C. 811(d)(1)) states that, if control of a substance is required “by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings and procedures required by section 201(a) and

(b)(21 U.S.C. 811(a) and (b)) and section 202(b) (21 U.S.C. 812(b)) of the Act.” 21 U.S.C. 811(d)(1), 21 CFR 1308.46. If a substance is added to one of the schedules of the Single Convention on Narcotic Drugs, 1961, then, in accordance with article 3, paragraph 7 of the Convention, as a signatory Member State, the United States is obligated to control that substance under its national drug control legislation, the CSA. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100. Background On May 8, 2015, the Secretary-General of the United Nations advised the Secretary of State of the United States, that during the 58th session of the Commission on Narcotic Drugs, AH-7921 was added to schedule I of the Single Convention on Narcotic Drugs, 1961. This letter was prompted by a decision at the 58th session of the Commission on Narcotic Drugs in March 2015 to schedule AH-7921 under schedule I of the Single Convention on Narcotic Drugs. As a signatory Member State to the Single Convention on Narcotic Drugs, the United States is obligated to control AH-7921 under its national drug control legislation, the CSA, in the schedule deemed most appropriate to carry out its international obligations. 21 U.S.C. 811(d)(1). AH-7921 AH-7921 is an *N* -substituted cyclohexylmethyl benzamide developed in 1962 by Allen and Hanbury's, Ltd., a pharmaceutical company in the United Kingdom. AH-7921 is a µ-opioid receptor agonist with analgesic activity similar to that of morphine. The DEA is not aware of any commercial or medical uses for this substance. In animals, withdrawal symptoms are observed following repeated administration of AH-7921. Currently, clinical studies evaluating the safety and pharmacological effects of AH-7921 in humans have not been reported in the scientific literature. Usage of AH-7921 for eliciting euphoria and relaxation has been documented. There have been several reports of overdoses and deaths from AH-7921 reported worldwide including at least one published case report of a death resulting from AH-7921 in the United States. Given the increasing abuse of opioid prescription drugs ( *e.g.,* oxycodone, hydrocodone and fentanyl) and increased use of heroin in the United States, there are legitimate concerns about an increased potential of abuse of AH-7921. DEA is not aware of any claims or any medical or scientific literature suggesting that AH-7921 has a currently accepted medical use in treatment in the United States. Accordingly, DEA has not requested that HHS conduct a scientific and medical evaluation of the substance's medical utility. Furthermore, DEA is not required under 21 U.S.C. 811(d)(1) to make any findings required by 21 U.S.C. 811(a) or 812(b), and is not required to follow the procedures prescribed by 21 U.S.C. 811(a) and (b). Therefore, consistent with the framework of 21 U.S.C. 811(d), DEA concludes that AH-7921 has no currently accepted medical use in treatment in the United States and is most appropriately placed in schedule I of the CSA. Conclusion In order to meet the obligations of the Single Convention on Narcotic Drugs, 1961 and because AH-7921 has no currently accepted medical use in treatment in the United States, the Administrator of the Drug Enforcement Administration has determined that this substance should be placed in schedule I of the Controlled Substances Act. Requirements for Handling Upon the effective date of this final order, AH-7921 is subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, engagement in research, and conduct of instructional activities with, and possession of schedule I controlled substances including the following: 1. *Registration.* Any person who handles (manufactures, distributes, imports, exports, engages in research or conducts instructional activities with, or possesses), or who desires to handle, AH-7921 must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312, as of May 16, 2016. Any person who currently handles AH-7921, and is not registered with the DEA, must submit an application for registration and may not continue to handle AH-7921 as of May 16, 2016, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. 2. *Disposal of stocks.* Any person who does not desire or is not able to obtain a schedule I registration must surrender all quantities of currently held AH-7921, or may transfer all quantities of currently held AH-7921 to a person registered with the DEA on or before May 16, 2016 in accordance with all applicable federal, state, local, and tribal laws. As of May 16, 2016, controlled substances must be disposed of in accordance with 21 CFR part 1317, in additional to all other applicable federal, state, local, and tribal laws. 3. *Security.* AH-7921 is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of May 16, 2016. 4. *Labeling and packaging.* All labels, labeling, and packaging for commercial containers of AH-7921 must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302 as of May 16, 2016. 5. *Quota.* A quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 is required in order to manufacture AH-7921 as of May 16, 2016. 6. *Inventory.* Every DEA registrant who possesses any quantity of AH-7921 on the effective date of this order must take an inventory of all stocks of this substance on hand as of May 16, 2016, pursuant to 21 U.S.C. 827 and 958, and in accordance with §§ 1304.03, 1304.04, and 1304.11. Any person who becomes registered with the DEA after May 16, 2016 must take an initial inventory of all stocks of controlled substances (including AH-7921) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including AH-7921) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with §§ 1304.03, 1304.04, and 1304.11. 7. *Records and Reports.* Every DEA registrant would be required to maintain records and submit reports with respect to AH-7921 pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304 and 1312. 8. *Order Forms.* All DEA registrants who distribute AH-7921 must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of May 16, 2016. 9. *Importation and Exportation.* All importation and exportation of AH-7921 must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of May 16, 2016. 10. *Liability.* Any activity involving AH-7921 not authorized by, or in violation of the CSA, occurring as of May 16, 2016, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Analyses Administrative Procedure Act The CSA provides for an expedited scheduling action where control is required by the United States obligations under international treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is required pursuant to such international treaty, convention, or protocol, the Attorney General must issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings or procedures otherwise required for scheduling actions. *Id.* To the extent that 21 U.S.C. 811(d)(1) directs that if control is required by the United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, scheduling actions shall be issued by order (as compared to scheduling pursuant to 21 U.S.C. 811(a) by rule), the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this scheduling action. In the alternative, even if this action does constitute “rule making” under 5 U.S.C. 551(5), this action is exempt from the notice and comment requirements of 5 U.S.C. 553 pursuant to 21 U.S.C. 553(a)(1) as an action involving a foreign affairs function of the United States given that this action is being done in accordance with 21 U.S.C. 811(d)(1)'s requirement that such action be taken to comply with the United States obligations under the specified international agreements. Executive Order 12866 This action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB). *Executive Order 13132* This action does not have federalism implications warranting the application of Executive Order 13132. This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Executive Order 13175 This action does not have tribal implications warranting the application of Executive Order 13175. The action does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Regulatory Flexibility Act The Regulatory Flexibility Act

(RFA)(5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA or any other law. As explained above, the CSA exempts this final order from notice and comment. Consequently, the RFA does not apply to this action. Paperwork Reduction Act of 1995 This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. 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. Congressional Review Act This action is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). However, the DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. For the reasons set out above, the DEA amends 21 CFR part 1308 as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 2. Amend § 1308.11 by redesignating paragraphs (b)(3) through

(55)as (b)(4) through

(56)and adding a new (b)(3)to read as follows: § 1308.11 Schedule I.

(b)* * *

(3)AH-7921 (3,4-dichloro- *N* -[(1-dimethylamino) cyclohexylmethyl]benzamide 9551 Dated: April 8, 2016 Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-08566 Filed 4-13-16; 8:45 am]

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