82 FR 13067 - Schedules of Controlled Substances: Placement of Brivaracetam Into Schedule V
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 45 (March 9, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 45 (March 9, 2017)
| Page Range | 13067-13069 | |
| FR Document | 2017-04698 |
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)] [Rules and Regulations] [Pages 13067-13069] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04698] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-435] Schedules of Controlled Substances: Placement of Brivaracetam Into Schedule V AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule adopts without change an interim final rule with request for comments published in the Federal Register on May 12, 2016. The Drug Enforcement Administration is placing the substance brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact) (including its salts) into schedule V of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015. DATES: The effective date of this final rulemaking is March 9, 2017. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, 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. 21 U.S.C. 801-971. 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. 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 all scheduled substances is published at 21 CFR part 1308. The Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89) was signed into law on November 25, 2015. This law amended the CSA and states that in cases where the DEA receives notification from HHS that the Secretary has approved an application under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA), the DEA is required to issue an interim final rule, with opportunity for public comment and to request a hearing, controlling the drug not later than 90 days after receiving such notification from HHS and subsequently to issue a final rule. 21 U.S.C. 811(j). When controlling a drug pursuant to section 811(j), the DEA must apply the scheduling criteria of subsections 811(b), (c), and (d) and section 812(b). 21 U.S.C. 811(j)(3). Background Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) [[Page 13068]] (also referred to as BRV; UCB-34714; Briviact) is a new molecular entity with central nervous system (CNS) depressant properties. BRV is known to be a high affinity ligand for the synaptic vesicle protein, SV2A, which is found on excitatory synapses in the brain. On November 22, 2014, UCB Inc. (Sponsor) submitted three New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the tablet, oral, and intravenous formulations of BRV. The FDA accepted the NDA filings for BRV on January 21, 2015. On March 28, 2016 the DEA received notification that the HHS/FDA approved BRV, under section 505(c) of the FDCA, as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy. On May 12, 2016, the DEA published an interim final rule [81 FR 29487] to make BRV (including its salts) a schedule V controlled substance(s). Interested persons were provided a 30 day comment period in which to file written comments on this rulemaking in accordance with 21 CFR 1308.43(g). In addition, interested persons, defined at 21 CFR 1300.01 as those ``adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),'' were provided an opportunity to file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44. The deadline for submitting comments or requests for hearing/waiver of hearing was June 13, 2016. In response to the interim final rule, the DEA did not receive any comments. In addition, the DEA did not receive any requests for hearing or waiver of hearing pursuant to 21 CFR 1308.44. Based on the rationale set forth in the interim final rule, the DEA adopts the interim final rule, without change. Requirements for Handling Brivaracetam BRV is subject to the CSA's schedule V regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule V substances, including the following: 1. Registration. Any person who handles (manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) BRV, or who desires to handle BRV, 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. Any person who currently handles BRV, and is not registered with the DEA, must submit an application for registration and may not continue to handle BRV, unless the DEA has approved that application for registration, pursuant to 21 U.S.C. 822, 823, 957, and 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 V registration must surrender all quantities of currently held BRV, or may transfer all quantities of currently held BRV to a person registered with the DEA in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws. 3. Security. BRV is subject to schedule III-V security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, and 871(b), and in accordance with 21 CFR 1301.71-1301.93. 4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of BRV must comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302. 5. Inventory. Every DEA registrant who possesses any quantity of BRV must take an inventory of BRV on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Any person who becomes registered with the DEA must take an initial inventory of all stocks of controlled substances (including BRV) 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 a new inventory of all stocks of controlled substances (including BRV) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 6. Records and Reports. Every DEA registrant must maintain records and submit reports for BRV, or products containing BRV, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317. 7. Prescriptions. All prescriptions for BRV or products containing BRV must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C. 8. Importation and Exportation. All importation and exportation of BRV must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312. 9. Liability. Any activity involving BRV not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Analyses Administrative Procedure Act This final rule, without change, affirms the amendment made by the interim final rule that is already in effect. Section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553) generally requires notice and comment for rulemakings. However, Public Law 114-89 was signed into law, amending 21 U.S.C. 811. This amendment provides that in cases where a new drug is (1) approved by the Department of Health and Human Services (HHS) and (2) HHS recommends control in CSA schedule II-V, the DEA shall issue an interim final rule scheduling the drug within 90 days. This action was taken May 12, 2016. Additionally, the law specifies that the rulemaking shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause. Executive Orders 12866, Regulatory Planning and Review, and 13563, Improving Regulation and Regulatory Review In accordance with Public Law 114-89, this scheduling action is subject to formal rulemaking procedures performed ``on the record after opportunity for a hearing,'' which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563. Executive Order 12988, Civil Justice Reform This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction. Executive Order 13132, Federalism This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial [[Page 13069]] 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. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This rule does not have tribal implications warranting the application of Executive Order 13175. It 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. As noted in the above discussion regarding applicability of the Administrative Procedure Act, the DEA was not required to publish a general notice of proposed rulemaking prior to this final rule. Consequently, the RFA does not apply. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in 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 for inflation) in any one year.'' Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995. 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. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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 rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this final rule 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, Reporting and recordkeeping requirements. PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 Accordingly, the interim final rule amending 21 CFR part 1308, which published on May 12, 2016 (81 FR 29487), is adopted as a final rule without change. Dated: February 22, 2017. Chuck Rosenberg, Acting Administrator. [FR Doc. 2017-04698 Filed 3-8-17; 8:45 am] BILLING CODE 4410-09-P
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§ 71.1 [Amended] Airspace Designations and Reporting Paragraph 2007 Canadian Area Navigation
Points, dated August 3, 2016, and Routes.
■ 2. The incorporation by reference in effective September 15, 2016, is * * * * *
14 CFR 71.1 of FAA Order 7400.11A, amended as follows:
Q–917 Sault Ste Marie, MI (SSM) to WOZEE, NY [Amended]
Sault Ste VOR/DME (Lat. 46°24′43.60″ N., long. 084°18′53.54″ W.)
Marie, MI
(SSM)
ULUTO, WP (Lat. 46°18′16.00″ N., long. 084°05′41.00″ W.)
Canada
VIGLO, Can- WP (Lat. 45°23′48.00″ N., long. 082°25′11.00″ W.)
ada
DUTEL, Can- WP (Lat. 44°39′59.00″ N., long. 081°17′47.00″ W.)
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PEPLA, Can- WP (Lat. 43°47′50.98″ N., long. 080°00′53.56″ W.)
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HOZIR, NY WP (Lat. 43°06′03.59″ N., long. 079°02′05.27″ W.)
WOZEE, NY WP (Lat. 42°56′01.65″ N., long. 078°44′19.64″ W.)
Excluding the airspace within Canada.
* * * * * * *
Q–923 HOCKE, MI to DUTEL, Canada [Amended]
HOCKE, MI WP (Lat. 43°15′43.38″ N., long. 082°42′38.27″ W.)
KARIT, MI WP (Lat. 43°43′23.00″ N., long. 082°08′40.00″ W.)
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Excluding the airspace within Canada.
* * * * * * *
Issued in Washington, DC, on March 1, was signed into law on November 25, and dependence and are controlled to
2017. 2015. protect the public health and safety.
Rodger A. Dean Jr.,
DATES: The effective date of this final Under the CSA, controlled substances
Manager, Airspace Policy Group. are classified into one of five schedules
rulemaking is March 9, 2017.
[FR Doc. 2017–04568 Filed 3–8–17; 8:45 am] based upon their potential for abuse,
FOR FURTHER INFORMATION CONTACT: their currently accepted medical use in
BILLING CODE 4910–13–P
Michael J. Lewis, Diversion Control treatment in the United States, and the
Division, Drug Enforcement degree of dependence the substance
Administration; Mailing Address: 8701 may cause. 21 U.S.C. 812. The initial
DEPARTMENT OF JUSTICE Morrissette Drive, Springfield, Virginia schedules of controlled substances
22152; Telephone: (202) 598–6812. established by Congress are found at 21
Drug Enforcement Administration SUPPLEMENTARY INFORMATION: U.S.C. 812(c), and the current list of all
Legal Authority scheduled substances is published at 21
21 CFR Part 1308 CFR part 1308.
The Drug Enforcement The Improving Regulatory
[Docket No. DEA–435] Administration (DEA) implements and Transparency for New Medical
enforces titles II and III of the Therapies Act (Pub. L. 114–89) was
Schedules of Controlled Substances:
Comprehensive Drug Abuse Prevention signed into law on November 25, 2015.
Placement of Brivaracetam Into
and Control Act of 1970, as amended. 21 This law amended the CSA and states
Schedule V
U.S.C. 801–971. Titles II and III are that in cases where the DEA receives
AGENCY: Drug Enforcement referred to as the ‘‘Controlled notification from HHS that the Secretary
Administration, Department of Justice. Substances Act’’ and the ‘‘Controlled has approved an application under
ACTION: Final rule. Substances Import and Export Act,’’ section 505(c) of the Federal Food, Drug,
respectively, and are collectively and Cosmetic Act (FDCA), the DEA is
SUMMARY: This final rule adopts without referred to as the ‘‘Controlled required to issue an interim final rule,
change an interim final rule with Substances Act’’ or the ‘‘CSA’’ for the with opportunity for public comment
request for comments published in the purpose of this action. The DEA and to request a hearing, controlling the
Federal Register on May 12, 2016. The publishes the implementing regulations drug not later than 90 days after
Drug Enforcement Administration is for these statutes in title 21 of the Code receiving such notification from HHS
placing the substance brivaracetam of Federal Regulations (CFR), chapter II. and subsequently to issue a final rule.
((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin- The CSA and its implementing 21 U.S.C. 811(j). When controlling a
1-yl] butanamide) (also referred to as regulations are designed to prevent, drug pursuant to section 811(j), the DEA
jstallworth on DSK7TPTVN1PROD with RULES
BRV; UCB–34714; Briviact) (including detect, and eliminate the diversion of must apply the scheduling criteria of
its salts) into schedule V of the controlled substances and listed subsections 811(b), (c), and (d) and
Controlled Substances Act. This chemicals into the illicit market while section 812(b). 21 U.S.C. 811(j)(3).
scheduling action is pursuant to the providing for the legitimate medical,
Controlled Substances Act, as revised by scientific, research, and industrial needs Background
the Improving Regulatory Transparency of the United States. Controlled Brivaracetam ((2S)-2-[(4R)-2-oxo-4-
for New Medical Therapies Act which substances have the potential for abuse propylpyrrolidin-1-yl] butanamide)
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![13068 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Rules and Regulations
(also referred to as BRV; UCB–34714; conduct such activities pursuant to 21 952, 953, 957, and 958, and in
Briviact) is a new molecular entity with U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR part 1312.
central nervous system (CNS) accordance with 21 CFR parts 1301 and 9. Liability. Any activity involving
depressant properties. BRV is known to 1312. Any person who currently BRV not authorized by, or in violation
be a high affinity ligand for the synaptic handles BRV, and is not registered with of, the CSA or its implementing
vesicle protein, SV2A, which is found the DEA, must submit an application for regulations, is unlawful, and may
on excitatory synapses in the brain. On registration and may not continue to subject the person to administrative,
November 22, 2014, UCB Inc. (Sponsor) handle BRV, unless the DEA has civil, and/or criminal sanctions.
submitted three New Drug Applications approved that application for Regulatory Analyses
(NDAs) to the U.S. Food and Drug registration, pursuant to 21 U.S.C. 822,
Administration (FDA) for the tablet, 823, 957, and 958, and in accordance Administrative Procedure Act
oral, and intravenous formulations of with 21 CFR parts 1301 and 1312. This final rule, without change,
BRV. The FDA accepted the NDA filings 2. Disposal of stocks. Any person who affirms the amendment made by the
for BRV on January 21, 2015. does not desire or is not able to obtain interim final rule that is already in
On March 28, 2016 the DEA received a schedule V registration must surrender effect. Section 553 of the Administrative
notification that the HHS/FDA approved all quantities of currently held BRV, or Procedure Act (APA) (5 U.S.C. 553)
BRV, under section 505(c) of the FDCA, may transfer all quantities of currently generally requires notice and comment
as an add-on treatment to other held BRV to a person registered with the for rulemakings. However, Public Law
medications to treat partial onset DEA in accordance with 21 CFR part 114–89 was signed into law, amending
seizures in patients age 16 years and 1317, in addition to all other applicable 21 U.S.C. 811. This amendment
older with epilepsy. federal, state, local, and tribal laws. provides that in cases where a new drug
On May 12, 2016, the DEA published 3. Security. BRV is subject to schedule is (1) approved by the Department of
an interim final rule [81 FR 29487] to III–V security requirements and must be Health and Human Services (HHS) and
make BRV (including its salts) a handled and stored pursuant to 21 (2) HHS recommends control in CSA
schedule V controlled substance(s). U.S.C. 821, 823, and 871(b), and in schedule II–V, the DEA shall issue an
Interested persons were provided a 30 accordance with 21 CFR 1301.71– interim final rule scheduling the drug
day comment period in which to file within 90 days. This action was taken
1301.93.
written comments on this rulemaking in May 12, 2016. Additionally, the law
4. Labeling and Packaging. All labels,
accordance with 21 CFR 1308.43(g). In specifies that the rulemaking shall
labeling, and packaging for commercial
addition, interested persons, defined at become immediately effective as an
containers of BRV must comply with 21
21 CFR 1300.01 as those ‘‘adversely interim final rule without requiring the
U.S.C. 825 and 958(e), and be in
affected or aggrieved by any rule or DEA to demonstrate good cause.
accordance with 21 CFR part 1302.
proposed rule issuable pursuant to
5. Inventory. Every DEA registrant Executive Orders 12866, Regulatory
section 201 of the Act (21 U.S.C. 811),’’
who possesses any quantity of BRV Planning and Review, and 13563,
were provided an opportunity to file a
must take an inventory of BRV on hand, Improving Regulation and Regulatory
request for hearing or waiver of hearing
pursuant to 21 U.S.C. 827 and 958, and Review
pursuant to 21 CFR 1308.44. The
in accordance with 21 CFR 1304.03,
deadline for submitting comments or In accordance with Public Law 114–
1304.04, and 1304.11.
requests for hearing/waiver of hearing 89, this scheduling action is subject to
was June 13, 2016. Any person who becomes registered
with the DEA must take an initial formal rulemaking procedures
In response to the interim final rule, performed ‘‘on the record after
the DEA did not receive any comments. inventory of all stocks of controlled
opportunity for a hearing,’’ which are
In addition, the DEA did not receive any substances (including BRV) on hand on
conducted pursuant to the provisions of
requests for hearing or waiver of hearing the date the registrant first engages in
5 U.S.C. 556 and 557. The CSA sets
pursuant to 21 CFR 1308.44. Based on the handling of controlled substances,
forth the procedures and criteria for
the rationale set forth in the interim pursuant to 21 U.S.C. 827 and 958, and
scheduling a drug or other substance.
final rule, the DEA adopts the interim in accordance with 21 CFR 1304.03,
Such actions are exempt from review by
final rule, without change. 1304.04, and 1304.11.
the Office of Management and Budget
After the initial inventory, every DEA
Requirements for Handling (OMB) pursuant to section 3(d)(1) of
registrant must take a new inventory of
Brivaracetam Executive Order 12866 and the
all stocks of controlled substances
principles reaffirmed in Executive Order
BRV is subject to the CSA’s schedule (including BRV) on hand every two
13563.
V regulatory controls and years, pursuant to 21 U.S.C. 827 and
administrative, civil, and criminal 958, and in accordance with 21 CFR Executive Order 12988, Civil Justice
sanctions applicable to the manufacture, 1304.03, 1304.04, and 1304.11. Reform
distribution, reverse distribution, 6. Records and Reports. Every DEA This regulation meets the applicable
dispensing, importing, exporting, registrant must maintain records and standards set forth in sections 3(a) and
research, and conduct of instructional submit reports for BRV, or products 3(b)(2) of Executive Order 12988 to
activities and chemical analysis with, containing BRV, pursuant to 21 U.S.C. eliminate drafting errors and ambiguity,
and possession involving schedule V 827 and 958(e), and in accordance with minimize litigation, provide a clear legal
substances, including the following: 21 CFR parts 1304, 1312, and 1317. standard for affected conduct, and
1. Registration. Any person who 7. Prescriptions. All prescriptions for promote simplification and burden
jstallworth on DSK7TPTVN1PROD with RULES
handles (manufactures, distributes, BRV or products containing BRV must reduction.
reverse distributes, dispenses, imports, comply with 21 U.S.C. 829, and be
exports, engages in research, or issued in accordance with 21 CFR parts Executive Order 13132, Federalism
conducts instructional activities or 1306 and 1311, subpart C. This rulemaking does not have
chemical analysis with, or possesses) 8. Importation and Exportation. All federalism implications warranting the
BRV, or who desires to handle BRV, importation and exportation of BRV application of Executive Order 13132.
must be registered with the DEA to must be in compliance with 21 U.S.C. The rule does not have substantial
VerDate Sep<11>2014 14:49 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\09MRR1.SGM 09MRR1](https://thefederalregister.org/doc/82_FR_13112/page/2.svg)
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direct effects on the States, on the economy of $100,000,000 or more; a approval of a non-substantive change to
relationship between the national major increase in costs or prices for the rule as originally proposed. The
government and the States, or on the consumers, individual industries, Commission will publish a document in
distribution of power and Federal, State, or local government the Federal Register announcing the
responsibilities among the various agencies, or geographic regions; or effective date.
levels of government. significant adverse effects on FOR FURTHER INFORMATION CONTACT:
competition, employment, investment, Peter Doyle, Chief, Media Bureau,
Executive Order 13175, Consultation
productivity, innovation, or on the Audio Division, (202) 418–2700 or
and Coordination With Indian Tribal
ability of U.S.-based companies to Peter.Doyle@fcc.gov; Thomas Nessinger,
Governments
compete with foreign based companies Senior Counsel, Media Bureau, Audio
This rule does not have tribal in domestic and export markets. Division, (202) 418–2700 or
implications warranting the application However, pursuant to the CRA, the DEA Thomas.Nessinger@fcc.gov.
of Executive Order 13175. It does not has submitted a copy of this final rule For additional information concerning
have substantial direct effects on one or to both Houses of Congress and to the the Paperwork Reduction Act
more Indian tribes, on the relationship Comptroller General. information collection requirements
between the Federal government and contained in this document, contact
Indian tribes, or on the distribution of List of Subjects in 21 CFR Part 1308
Cathy Williams at 202–418–2918, or via
power and responsibilities between the Administrative practice and the Internet at Cathy.Williams@fcc.gov.
Federal government and Indian tribes. procedure, Drug traffic control,
SUPPLEMENTARY INFORMATION: This is a
Reporting and recordkeeping
Regulatory Flexibility Act summary of the Commission’s Second
requirements.
The Regulatory Flexibility Act (RFA) Report and Order (Second R&O), FCC
(5 U.S.C. 601–612) applies to rules that PART 1308—SCHEDULES OF 17–14, adopted February 23, 2017, and
are subject to notice and comment CONTROLLED SUBSTANCES released February 24, 2017. The full text
under section 553(b) of the APA. As of this document is available for public
noted in the above discussion regarding ■ Accordingly, the interim final rule inspection and copying during regular
applicability of the Administrative amending 21 CFR part 1308, which business hours in the FCC Reference
Procedure Act, the DEA was not published on May 12, 2016 (81 FR Center, 445 Twelfth Street SW., Room
required to publish a general notice of 29487), is adopted as a final rule CY–A257, Portals II, Washington, DC
proposed rulemaking prior to this final without change. 20554. To request materials in
rule. Consequently, the RFA does not Dated: February 22, 2017.
accessible formats for people with
apply. disabilities (Braille, large print,
Chuck Rosenberg,
electronic files, audio format), send an
Unfunded Mandates Reform Act of 1995 Acting Administrator. email to fcc504@fcc.gov or call the
[FR Doc. 2017–04698 Filed 3–8–17; 8:45 am] Consumer and Governmental Affairs
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995, BILLING CODE 4410–09–P Bureau at 202–418–0530 (voice), 202–
2 U.S.C. 1501 et seq., the DEA has 418–0432 (TTY).
determined and certifies that this action Paperwork Reduction Act of 1995
would not result in any Federal FEDERAL COMMUNICATIONS
COMMISSION Analysis
mandate that may result ‘‘in the
expenditure by State, local, and tribal This Second R&O adopts new or
governments, in the aggregate, or by the 47 CFR Part 74 revised information collection
private sector, of $100,000,000 or more [MB Docket No. 13–249; FCC 17–14] requirements, subject to the Paperwork
(adjusted for inflation) in any one year.’’ Reduction Act of 1995 (PRA) (Pub. L.
Therefore, neither a Small Government Revitalization of the AM Radio Service 104–13, 109 Stat 163 (1995) (codified in
Agency Plan nor any other action is 44 U.S.C. 3501–3520)). The Office of
AGENCY: Federal Communications Management and Budget (OMB)
required under UMRA of 1995. Commission. preapproved the information collection
Paperwork Reduction Act of 1995 ACTION: Final rule. requirements, as set forth in the Further
This action does not impose a new Notice of Proposed Rulemaking
SUMMARY: This document amends the (FNPRM) in this proceeding, 81 FR
collection of information requirement
Commission’s rule setting forth the 2818, January 19, 2016, as follows: FCC
under the Paperwork Reduction Act of
allowable location of an FM translator Form 345, under OMB control number
1995. 44 U.S.C. 3501–3521. This action
station rebroadcasting the signal of an 3060–0075, on March 17, 2016; and FCC
would not impose recordkeeping or
AM broadcast station. It changes the Form 349, under OMB control number
reporting requirements on State or local
rule so that an AM broadcaster has a 3060–0405, on March 21, 2016. The
governments, individuals, businesses, or
greater area in which an FM translator Commission will receive OMB’s final
organizations. An agency may not
rebroadcasting the AM signal may be approval for the information collection
conduct or sponsor, and a person is not
located, giving AM broadcasters greater requirements by submitting a non-
required to respond to, a collection of
flexibility in reaching their listeners. substantive change submission to OMB
information unless it displays a
The change is necessary to for review under section 3507(d) of the
currently valid OMB control number.
accommodate AM radio stations located PRA (44 U.S.C. 3507(d)).
far from their communities of license, or
jstallworth on DSK7TPTVN1PROD with RULES
Congressional Review Act In addition, we note that pursuant to
This rule is not a major rule as those with highly directional signal the Small Business Paperwork Relief
defined by section 804 of the Small patterns. Act of 2002, Public Law 107–198, see 44
Business Regulatory Enforcement DATES: This rule is effective April 10, U.S.C. 3506(c)(4), we previously sought
Fairness Act of 1996 (Congressional 2017. The effective date is delayed specific comment on how the
Review Act (CRA)). This rule will not indefinitely pending Office of Commission might ‘‘further reduce the
result in: An annual effect on the Management and Budget (OMB) information collection burden for small
VerDate Sep<11>2014 14:49 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\09MRR1.SGM 09MRR1](https://thefederalregister.org/doc/82_FR_13112/page/3.svg)
Document Created: 2017-03-09 04:59:04
Document Modified: 2017-03-09 04:59:04
| 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 | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | The effective date of this final rulemaking is March 9, 2017. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 82 FR 13067 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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