[Federal Register Volume 81, Number 25 (Monday, February 8, 2016)]
[Rules and Regulations]
[Pages 6453-6454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02404]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-409]
RIN 1117-ZA30


Schedules of Controlled Substances: Table of Excluded Nonnarcotic 
Products: Nasal Decongestant Inhaler/Vapor Inhaler

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: This final rule adopts, without change, the interim final rule 
that was published in the Federal Register on October 27, 2015. The 
Drug Enforcement Administration is amending the table of Excluded 
Nonnarcotic Products to update the company name for the drug product 
Nasal Decongestant Inhaler/Vapor Inhaler (containing 50 milligrams 
levmetamfetamine) to Aphena Pharma Solutions--New York, LLC. This over-
the-counter, nonnarcotic drug product is excluded from the provisions 
of the Controlled Substances Act.

DATES: This final rule is effective on February 8, 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. 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 they 
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 ensuring an adequate supply is 
available 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, each controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other 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 CSA states that the Attorney General shall by regulation 
exclude any nonnarcotic drug which contains a controlled substance from 
the application of the CSA, if such drug may, under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 301 et seq., be lawfully 
sold over-the-counter without a prescription. 21 U.S.C. 811(g)(1). Such 
exclusions apply only to specific nonnarcotic drugs following suitable 
application to the DEA in accordance with 21 CFR 1308.21. The current 
table of Excluded Nonnarcotic Products is found in 21 CFR 1308.22. The 
authority to exclude such substances has been delegated to the 
Administrator of the DEA, 28 CFR 0.100, and redelegated to the Deputy 
Assistant Administrator of the Office of Diversion Control, section 7 
of 28 CFR part 0, appendix to subpart R.

Background

    This final rule adopts, without change, the interim final rule, 
``Schedules of Controlled Substances: Table of Excluded Nonnarcotic 
Products: Nasal Decongestant Inhaler/Vapor Inhaler'' that was published 
in the Federal Register on October 27, 2015. 80 FR 65632.
    On December 10, 2013, pursuant to the application process of Sec.  
1308.21, the DEA received correspondence from Aphena Pharma Solutions--
New York, LLC (Aphena Pharma) stating that it had acquired Classic 
Pharmaceuticals LLC and requesting that the current exclusion for the 
drug product Nasal Decongestant Inhaler/Vapor Inhaler be transferred to 
Aphena Pharma. Aphena Pharma also stated that the manufacturing process 
(i.e., facility) and the formulation for the drug product Nasal 
Decongestant Inhaler/Vapor Inhaler had not changed.
    Based on the application and other information received, the DEA 
determined that this product may, under the FD&C Act, be lawfully sold 
over-the-counter without a prescription. 21 U.S.C. 811(g)(1). In 
addition, the Deputy Assistant Administrator of the Office of Diversion 
Control found that the active ingredient in this drug product 
(levmetamfetamine) is a schedule II controlled substance \1\ and is not 
a narcotic drug as defined by 21 U.S.C. 802(17). The Deputy Assistant 
Administrator of the Office of Diversion Control therefore found and 
concluded that this drug product continues to meet the criteria for 
exclusion from the CSA pursuant to 21 U.S.C. 811(g)(1).
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    \1\ Levmetamfetamine is controlled in schedule II of the CSA 
because it is an isomer of methamphetamine.
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    The interim final rule provided an opportunity for interested 
persons to

[[Page 6454]]

submit written comments on the rule on or before December 28, 2015. The 
DEA received one comment in response to the publication of the interim 
final rule voicing support for the action. The DEA appreciates the 
support for the rule.
    This exclusion only applies to the finished drug product in the 
form of an inhaler (in the exact formulation detailed in the 
application for exclusion), which is lawfully sold under the FD&C Act 
over-the-counter without a prescription. The extraction or removal of 
the active ingredient (levmetamfetamine) from the inhaler shall negate 
this exclusion and result in the possession of a schedule II controlled 
substance.

Regulatory Analyses

Executive Orders 12866 and 13563

    This regulation has been developed in accordance with the Executive 
Orders 12866, ``Regulatory Planning and Review,'' section 1(b) and 
Executive Order 13563, ``Improving Regulation and Regulatory Review.'' 
The DEA has determined that this rule is not a significant regulatory 
action, and accordingly this rule has not been reviewed by the Office 
of Management and Budget. As discussed above, this product was 
previously exempted under a different company name. As discussed in the 
interim final rule, this action will not have an annual effect on the 
economy of $100 million or more or adversely affect in a material way 
the economy, a sector of the economy, productivity, competition, jobs, 
the environment, public health or safety, or State, local or tribal 
governments or communities; create a serious inconsistency or otherwise 
interfere with an action taken or planned by another agency; materially 
alter the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or raise 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in Executive Order 
12866.

Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment. The DEA determined, as 
explained in the interim final rule, that public notice and comment 
were impracticable and contrary to the public interest. Consequently, 
the RFA does not apply. Although the RFA does not apply to this 
rulemaking, the DEA has reviewed the potential impacts of this final 
rule and determined that it will not have a significant economic impact 
on a substantial number of small entities. As discussed above and in 
the interim final rule, this product was previously exempted under a 
different company name. The Deputy Assistant Administrator, in 
accordance with the RFA, has reviewed this regulation and by approving 
it certifies that this regulation will not have a significant economic 
impact on a substantial number of small entities.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, ``Civil Justice 
Reform,'' 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

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The rule does not have 
substantial direct effects on the States, on the relationship between 
the Federal Government and the States, or the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. This rule 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.

Unfunded Mandates Reform Act of 1995

    The DEA has determined and certifies pursuant to the Unfunded 
Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., 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 
provisions of the UMRA.

Paperwork Reduction Act

    This rule does not impose a new collection of information 
requirement under the Paperwork Reduction Act, 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 United States-based 
companies to compete with foreign-based companies in domestic and 
export markets.

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

    Accordingly, for the reasons stated above, the interim final rule 
that was published in the Federal Register on October 27, 2015 (80 FR 
65632), is adopted as a final rule without change.

    Dated: February 2, 2016.
Louis J. Milione,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2016-02404 Filed 2-5-16; 8:45 am]
BILLING CODE 4410-09-P