[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Rules and Regulations]
[Pages 13067-13069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04698]


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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.

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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