81_FR_6476 81 FR 6451 - Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Vicks® VapoInhaler®

81 FR 6451 - Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Vicks® VapoInhaler®

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 25 (February 8, 2016)

Page Range6451-6453
FR Document2016-02403

This final rule adopts the interim final rule, with a correction to spelling of the manufacturer's name 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 listing for Vicks[supreg] VapoInhaler[supreg], containing 50 mg levmetamfetamine in a nasal decongestant inhaler, marketed by The Procter & Gamble Company. This over-the-counter, non-narcotic drug product is excluded from provisions of the Controlled Substances Act.

Federal Register, Volume 81 Issue 25 (Monday, February 8, 2016)
[Federal Register Volume 81, Number 25 (Monday, February 8, 2016)]
[Rules and Regulations]
[Pages 6451-6453]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02403]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-367]
RIN 1117-AB39


Schedules of Controlled Substances: Table of Excluded Nonnarcotic 
Products: Vicks[supreg] VapoInhaler[supreg]

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule adopts the interim final rule, with a 
correction to spelling of the manufacturer's name 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 listing for Vicks[supreg] VapoInhaler[supreg], containing 
50 mg levmetamfetamine in a nasal decongestant inhaler, marketed by The 
Procter & Gamble Company. This over-the-counter, non-narcotic drug 
product is excluded from 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, with a change to the spelling of the 
manufacturer's name, the interim final rule, ``Schedules of Controlled 
Substances: Table of Excluded Nonnarcotic Products: Vicks[supreg] 
VapoInhaler[supreg] '' that was published in the Federal Register on 
October 27, 2015. 80 FR 65635. The correct spelling of the 
manufacturer's name is ``The Procter & Gamble Company.'' The

[[Page 6452]]

interim final rule contained a typographical error in which ``Procter'' 
was inadvertently spelled as ``Proctor.''
    On February 9, 2012, pursuant to the application process of Sec.  
1308.21, the DEA received correspondence from The Procter & Gamble 
Company (``P&G'') notifying the DEA that it had reduced the quantity of 
l-desoxyephedrine (levmetamfetamine) from 113 mg to 50 mg in their 
Vicks[supreg] Inhaler\TM\ product which is currently excluded under 
Sec.  1308.22. Levmetamfetamine is controlled in schedule II as an 
isomer of methamphetamine. 21 CFR 1308.12(d)(2). P&G requested that the 
DEA update the current exclusion for its Vicks[supreg] Inhaler\TM\ and 
indicated it had acquired Richardson-Vicks, Inc. (including its 
subsidiary, the Vick Chemical Company). The company stated that the 
product name has been modified from Vicks[supreg] Inhaler\TM\ to 
Vicks[supreg] VapoInhaler[supreg] and that the change included a 
corresponding National Drug Code (NDC) number reassignment by the U.S. 
Food and Drug Administration. Furthermore, P&G stated that the 
nomenclature for the active ingredient/controlled substance had been 
changed from l-desoxyephedrine to levmetamfetamine. P&G indicated that 
nothing in the formulation change affects other aspects of the drug 
delivery system.
    Based on the application and other information received, including 
the quantitative composition of the substance and labeling and 
packaging information, 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 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 product continues to meet the 
criteria for exclusion from the CSA pursuant to 21 U.S.C. 811(g)(1).
    The interim final rule provided an opportunity for interested 
persons to 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 which was a request from P&G for a correction 
to the spelling of their name. As noted above, the spelling has been 
corrected in this final 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 over-the-counter 
without a prescription under the FD&C Act. 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 Regulatory Flexibility Act, 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

    As stated in the interim final rule, 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

    As stated in the interim final rule, 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.

[[Page 6453]]

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.

    Accordingly, for the reasons stated above, the interim final rule 
that was published in the Federal Register on October 27, 2015 (80 FR 
65635), is adopted as final with the following change:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.


0
2. Amend Sec.  1308.22, in the table, by removing the company name, 
``Proctor & Gamble Co., The'' and adding in its place ``Procter & 
Gamble Co., The''.

    Dated: February 2, 2016.
Louis J. Milione,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2016-02403 Filed 2-5-16; 8:45 am]
BILLING CODE 4410-09-P



                                                                       Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Rules and Regulations                                          6451

                                                  Order 1050.1F, ‘‘Environmental                                That airspace extending upward from the            U.S.C. 801–971. Titles II and III are
                                                  Impacts: Policies and Procedures,’’                        surface within 3.7 miles each side of the             referred to as the ‘‘Controlled
                                                  paragraph 5–6.5.a. This airspace action                    Midwest VOR/DME 215° radial, extending                Substances Act’’ and the ‘‘Controlled
                                                  is not expected to cause any potentially                   from the 4.2-mile radius of Wilmington Air            Substances Import and Export Act,’’
                                                                                                             Park to 7 miles southwest of the airport, and
                                                  significant environmental impacts, and                     within 3.7 miles each side of the Midwest
                                                                                                                                                                   respectively, and they are collectively
                                                  no extraordinary circumstances exist                       VOR/DME 041° radial extending from the                referred to as the ‘‘Controlled
                                                  that warrant preparation of an                             4.2-mile radius of the airport to 7 miles             Substances Act’’ or the ‘‘CSA’’ for the
                                                  environmental assessment.                                  northeast of the airport, excluding that              purpose of this action. The DEA
                                                                                                             portion of airspace within a 1-mile radius of         publishes the implementing regulations
                                                  Lists of Subjects in 14 CFR Part 71                        Hollister Field Airport.                              for these statutes in title 21 of the Code
                                                   Airspace, Incorporation by reference,                       Issued in Fort Worth, Texas, on January 29,         of Federal Regulations (CFR), chapter II.
                                                  Navigation (air).                                          2016.                                                    The CSA and its implementing
                                                                                                             Robert W. Beck,                                       regulations are designed to prevent,
                                                  Adoption of the Amendment                                                                                        detect, and eliminate the diversion of
                                                                                                             Manager, Operations Support Group, ATO
                                                    In consideration of the foregoing, the                   Central Service Center.
                                                                                                                                                                   controlled substances and listed
                                                  Federal Aviation Administration                                                                                  chemicals into the illicit market while
                                                                                                             [FR Doc. 2016–02284 Filed 2–5–16; 8:45 am]
                                                  amends 14 CFR part 71 as follows:                                                                                ensuring an adequate supply is available
                                                                                                             BILLING CODE 4910–13–P
                                                                                                                                                                   for the legitimate medical, scientific,
                                                  PART 71—DESIGNATION OF CLASS A,                                                                                  research, and industrial needs of the
                                                  B, C, D, AND E AIRSPACE AREAS; AIR                                                                               United States. Controlled substances
                                                  TRAFFIC SERVICE ROUTES; AND                                DEPARTMENT OF JUSTICE                                 have the potential for abuse and
                                                  REPORTING POINTS                                                                                                 dependence and are controlled to
                                                                                                             Drug Enforcement Administration                       protect the public health and safety.
                                                  ■ 1. The authority citation for part 71                                                                             Under the CSA, each controlled
                                                                                                             21 CFR Part 1308                                      substance is classified into one of five
                                                  continues to read as follows:
                                                                                                             [Docket No. DEA–367]                                  schedules based upon its potential for
                                                    Authority: 49 U.S.C. 106(f), 106(g); 40103,                                                                    abuse, its currently accepted medical
                                                  40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,               RIN 1117–AB39
                                                  1959–1963 Comp., p. 389.
                                                                                                                                                                   use in treatment in the United States,
                                                                                                                                                                   and the degree of dependence the drug
                                                                                                             Schedules of Controlled Substances:                   or other substance may cause. 21 U.S.C.
                                                  § 71.1       [Amended]
                                                                                                             Table of Excluded Nonnarcotic                         812. The initial schedules of controlled
                                                  ■ 2. The incorporation by reference in                     Products: Vicks® VapoInhaler®                         substances established by Congress are
                                                  14 CFR 71.1 of FAA Order 7400.9Z,                                                                                found at 21 U.S.C. 812(c) and the
                                                  Airspace Designations and Reporting                        AGENCY:  Drug Enforcement
                                                                                                             Administration, Department of Justice.                current list of all scheduled substances
                                                  Points, dated August 6, 2015, effective                                                                          is published at 21 CFR part 1308.
                                                  September 15, 2015, is amended as                          ACTION: Final rule.
                                                                                                                                                                      The CSA states that the Attorney
                                                  follows:                                                                                                         General shall by regulation exclude any
                                                                                                             SUMMARY:    This final rule adopts the
                                                                                                             interim final rule, with a correction to              nonnarcotic drug which contains a
                                                  Paragraph 6002 Class E Airspace
                                                                                                             spelling of the manufacturer’s name that              controlled substance from the
                                                  Designated as Surface Areas.
                                                                                                             was published in the Federal Register                 application of the CSA, if such drug
                                                  *        *      *       *      *                                                                                 may, under the Federal Food, Drug, and
                                                                                                             on October 27, 2015. The Drug
                                                  AGL OH E2 Wilmington, OH (Amended)                         Enforcement Administration is                         Cosmetic Act (FD&C Act), 21 U.S.C. 301
                                                  Wilmington, Wilmington Air Park, OH                        amending the table of Excluded                        et seq., be lawfully sold over-the-
                                                     (Lat. 39°25′41″ N., long. 083°47′32″ W.)                Nonnarcotic Products to update the                    counter without a prescription. 21
                                                  Wilmington, Hollister Field Airport, OH                    listing for Vicks® VapoInhaler®,                      U.S.C. 811(g)(1). Such exclusions apply
                                                     (Lat. 39°26′15″ N., long. 083°42′30″ W.)                containing 50 mg levmetamfetamine in                  only to specific nonnarcotic drugs
                                                     Within a 4.2-mile radius of Wilmington Air              a nasal decongestant inhaler, marketed                following suitable application to the
                                                  Park, and within 3.7 miles each side of the                by The Procter & Gamble Company.                      DEA in accordance with 21 CFR
                                                  Midwest VOR/DME 215° radial extending                      This over-the-counter, non-narcotic                   1308.21. The current table of Excluded
                                                  from the 4.2-mile radius of Wilmington Air                                                                       Nonnarcotic Products is found in 21
                                                  Park to 7 miles southwest of the airport, and
                                                                                                             drug product is excluded from
                                                                                                             provisions of the Controlled Substances               CFR 1308.22. The authority to exclude
                                                  within 3.7 miles each side of the Midwest                                                                        such substances has been delegated to
                                                  VOR/DME 041° radial extending from the                     Act.
                                                  4.2-mile radius of the airport to 7 miles
                                                                                                                                                                   the Administrator of the DEA, 28 CFR
                                                                                                             DATES: This final rule is effective on
                                                  northeast of the airport, excluding that                                                                         0.100, and redelegated to the Deputy
                                                                                                             February 8, 2016.
                                                  portion of airspace within a 1-mile radius of                                                                    Assistant Administrator of the Office of
                                                                                                             FOR FURTHER INFORMATION CONTACT:                      Diversion Control, section 7 of 28 CFR
                                                  Hollister Field Airport.
                                                                                                             Barbara J. Boockholdt, Office of                      part 0, appendix to subpart R.
                                                  *        *      *       *      *                           Diversion Control, Drug Enforcement
                                                  Paragraph 6004 Class E Airspace Areas                      Administration; Mailing Address: 8701                 Background
                                                  Designated as an Extension to a Class D or                 Morrissette Drive, Springfield, Virginia                This final rule adopts, with a change
                                                  Class E Surface Area.                                      22152; Telephone: (202) 598–6812.                     to the spelling of the manufacturer’s
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                  *        *      *       *      *                           SUPPLEMENTARY INFORMATION:                            name, the interim final rule, ‘‘Schedules
                                                  AGL OH E4 Wilmington, OH (Amended)                                                                               of Controlled Substances: Table of
                                                                                                             Legal Authority                                       Excluded Nonnarcotic Products: Vicks®
                                                  Wilmington, Wilmington Air Park, OH
                                                   (Lat. 39°25′41″ N., long. 083°47′32″ W.)                    The Drug Enforcement                                VapoInhaler® ’’ that was published in
                                                  Wilmington, Hollister Field Airport, OH                    Administration (DEA) implements and                   the Federal Register on October 27,
                                                   (Lat. 39°26′15″ N., long. 083°42′30″ W.)                  enforces titles II and III of the                     2015. 80 FR 65635. The correct spelling
                                                  Midwest VOR/DME                                            Comprehensive Drug Abuse Prevention                   of the manufacturer’s name is ‘‘The
                                                   (Lat. 39°25′47″ N., long. 083°48′04″ W.)                  and Control Act of 1970, as amended. 21               Procter & Gamble Company.’’ The


                                             VerDate Sep<11>2014      16:19 Feb 05, 2016   Jkt 238001   PO 00000   Frm 00041   Fmt 4700   Sfmt 4700   E:\FR\FM\08FER1.SGM   08FER1


                                                  6452              Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Rules and Regulations

                                                  interim final rule contained a                          detailed in the application for                       have a significant economic impact on
                                                  typographical error in which ‘‘Procter’’                exclusion), which is lawfully sold over-              a substantial number of small entities.
                                                  was inadvertently spelled as ‘‘Proctor.’’               the-counter without a prescription
                                                     On February 9, 2012, pursuant to the                                                                       Executive Order 12988
                                                                                                          under the FD&C Act. The extraction or
                                                  application process of § 1308.21, the                   removal of the active ingredient                         This regulation meets the applicable
                                                  DEA received correspondence from The                    (levmetamfetamine) from the inhaler                   standards set forth in sections 3(a) and
                                                  Procter & Gamble Company (‘‘P&G’’)                      shall negate this exclusion and result in             3(b)(2) of Executive Order 12988, ‘‘Civil
                                                  notifying the DEA that it had reduced                   the possession of a schedule II                       Justice Reform,’’ to eliminate drafting
                                                  the quantity of l-desoxyephedrine                       controlled substance.                                 errors and ambiguity, minimize
                                                  (levmetamfetamine) from 113 mg to 50                                                                          litigation, provide a clear legal standard
                                                  mg in their Vicks® InhalerTM product                    Regulatory Analyses
                                                                                                                                                                for affected conduct, and promote
                                                  which is currently excluded under                       Executive Orders 12866 and 13563                      simplification and burden reduction.
                                                  § 1308.22. Levmetamfetamine is
                                                                                                             This regulation has been developed in              Executive Order 13132
                                                  controlled in schedule II as an isomer of
                                                  methamphetamine. 21 CFR                                 accordance with the Executive Orders
                                                  1308.12(d)(2). P&G requested that the                   12866, ‘‘Regulatory Planning and                        This rulemaking does not have
                                                  DEA update the current exclusion for its                Review,’’ section 1(b) and Executive                  federalism implications warranting the
                                                  Vicks® InhalerTM and indicated it had                   Order 13563, ‘‘Improving Regulation                   application of Executive Order 13132.
                                                  acquired Richardson-Vicks, Inc.                         and Regulatory Review.’’ The DEA has                  The rule does not have substantial
                                                  (including its subsidiary, the Vick                     determined that this rule is not ‘‘a                  direct effects on the States, on the
                                                  Chemical Company). The company                          significant regulatory action,’’ and                  relationship between the Federal
                                                  stated that the product name has been                   accordingly this rule has not been                    Government and the States, or the
                                                  modified from Vicks® InhalerTM to                       reviewed by the Office of Management                  distribution of power and
                                                  Vicks® VapoInhaler® and that the                        and Budget. As discussed above, this                  responsibilities among the various
                                                  change included a corresponding                         product was previously exempted under                 levels of government.
                                                  National Drug Code (NDC) number                         a different company name. As discussed
                                                                                                          in the interim final rule, this action will           Executive Order 13175
                                                  reassignment by the U.S. Food and Drug
                                                  Administration. Furthermore, P&G                        not have an annual effect on the                        This rule does not have tribal
                                                  stated that the nomenclature for the                    economy of $100 million or more or                    implications warranting the application
                                                  active ingredient/controlled substance                  adversely affect in a material way the                of Executive Order 13175. This rule
                                                  had been changed from l-                                economy, a sector of the economy,                     does not have substantial direct effects
                                                  desoxyephedrine to levmetamfetamine.                    productivity, competition, jobs, the                  on one or more Indian tribes, on the
                                                  P&G indicated that nothing in the                       environment, public health or safety, or              relationship between the Federal
                                                  formulation change affects other aspects                State, local, or tribal governments or                Government and Indian tribes, or on the
                                                  of the drug delivery system.                            communities; create a serious                         distribution of power and
                                                     Based on the application and other                   inconsistency or otherwise interfere                  responsibilities between the Federal
                                                  information received, including the                     with an action taken or planned by                    Government and Indian tribes.
                                                  quantitative composition of the                         another agency; materially alter the
                                                  substance and labeling and packaging                    budgetary impact of entitlements,                     Unfunded Mandates Reform Act of 1995
                                                  information, the DEA determined that                    grants, user fees, or loan programs or the
                                                                                                          rights and obligations of recipients                    As stated in the interim final rule, the
                                                  this product may, under the FD&C Act,
                                                                                                          thereof; or raise novel legal or policy               DEA has determined and certifies
                                                  be lawfully sold over-the-counter
                                                                                                          issues arising out of legal mandates, the             pursuant to the Unfunded Mandates
                                                  without a prescription. 21 U.S.C.
                                                                                                          President’s priorities, or the principles             Reform Act of 1995 (UMRA), 2 U.S.C.
                                                  811(g)(1). In addition, the Deputy
                                                                                                          set forth in Executive Order 12866.                   1501 et seq., that this action would not
                                                  Assistant Administrator of the Office of
                                                                                                                                                                result in any Federal mandate that may
                                                  Diversion Control found that the active                 Regulatory Flexibility Analysis                       result ‘‘in the expenditure by State,
                                                  ingredient in this drug product
                                                  (levmetamfetamine) is a schedule II                       The Regulatory Flexibility Act (RFA)                local, and tribal governments, in the
                                                  controlled substance and is not a                       (5 U.S.C. 601–612) applies to rules that              aggregate, or by the private sector, of
                                                  narcotic drug as defined by 21 U.S.C.                   are subject to notice and comment. The                $100,000,000 or more (adjusted for
                                                  802(17). The Deputy Assistant                           DEA determined, as explained in the                   inflation) in any one year * * *.’’
                                                  Administrator of the Office of Diversion                interim final rule, that public notice and            Therefore, neither a Small Government
                                                  Control therefore found and concluded                   comment were impracticable and                        Agency Plan nor any other action is
                                                  that this product continues to meet the                 contrary to the public interest.                      required under provisions of the UMRA.
                                                  criteria for exclusion from the CSA                     Consequently, the RFA does not apply.                 Paperwork Reduction Act
                                                  pursuant to 21 U.S.C. 811(g)(1).                        Although the RFA does not apply to this
                                                     The interim final rule provided an                   rulemaking, the DEA has reviewed the                    As stated in the interim final rule, this
                                                  opportunity for interested persons to                   potential impacts of this final rule and              rule does not impose a new collection
                                                  submit written comments on the rule on                  determined that it will not have a                    of information requirement under the
                                                  or before December 28, 2015. The DEA                    significant economic impact on a                      Paperwork Reduction Act, 44 U.S.C.
                                                  received one comment in response to                     substantial number of small entities. As              3501–3521. This action would not
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                  the publication of the interim final rule               discussed above and in the interim final              impose recordkeeping or reporting
                                                  which was a request from P&G for a                      rule, this product was previously                     requirements on State or local
                                                  correction to the spelling of their name.               exempted under a different company                    governments, individuals, businesses, or
                                                  As noted above, the spelling has been                   name. The Deputy Assistant                            organizations. An agency may not
                                                  corrected in this final rule.                           Administrator, in accordance with the                 conduct or sponsor, and a person is not
                                                     This exclusion only applies to the                   Regulatory Flexibility Act, has reviewed              required to respond to, a collection of
                                                  finished drug product in the form of an                 this regulation and by approving it                   information unless it displays a
                                                  inhaler (in the exact formulation                       certifies that this regulation will not               currently valid OMB control number.


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                                                                    Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Rules and Regulations                                                  6453

                                                  Congressional Review Act                                SUMMARY:   This final rule adopts,                    nonnarcotic drug which contains a
                                                    This rule is not a major rule as                      without change, the interim final rule                controlled substance from the
                                                  defined by section 804 of the Small                     that was published in the Federal                     application of the CSA, if such drug
                                                  Business Regulatory Enforcement                         Register on October 27, 2015. The Drug                may, under the Federal Food, Drug, and
                                                  Fairness Act of 1996 (Congressional                     Enforcement Administration is                         Cosmetic Act (FD&C Act), 21 U.S.C. 301
                                                  Review Act (CRA)). This rule will not                   amending the table of Excluded                        et seq., be lawfully sold over-the-
                                                  result in: An annual effect on the                      Nonnarcotic Products to update the                    counter without a prescription. 21
                                                  economy of $100,000,000 or more; a                      company name for the drug product                     U.S.C. 811(g)(1). Such exclusions apply
                                                  major increase in costs or prices for                   Nasal Decongestant Inhaler/Vapor                      only to specific nonnarcotic drugs
                                                  consumers, individual industries,                       Inhaler (containing 50 milligrams                     following suitable application to the
                                                  Federal, State, or local government                     levmetamfetamine) to Aphena Pharma                    DEA in accordance with 21 CFR
                                                  agencies, or geographic regions; or                     Solutions—New York, LLC. This over-                   1308.21. The current table of Excluded
                                                  significant adverse effects on                          the-counter, nonnarcotic drug product is              Nonnarcotic Products is found in 21
                                                  competition, employment, investment,                    excluded from the provisions of the                   CFR 1308.22. The authority to exclude
                                                  productivity, innovation, or on the                     Controlled Substances Act.                            such substances has been delegated to
                                                  ability of United States-based                          DATES: This final rule is effective on                the Administrator of the DEA, 28 CFR
                                                  companies to compete with foreign-                      February 8, 2016.                                     0.100, and redelegated to the Deputy
                                                  based companies in domestic and                         FOR FURTHER INFORMATION CONTACT:                      Assistant Administrator of the Office of
                                                  export markets.                                         Barbara J. Boockholdt, Office of                      Diversion Control, section 7 of 28 CFR
                                                                                                          Diversion Control, Drug Enforcement                   part 0, appendix to subpart R.
                                                  List of Subjects in 21 CFR Part 1308
                                                                                                          Administration; Mailing Address: 8701                 Background
                                                    Administrative practice and                           Morrissette Drive, Springfield, Virginia
                                                  procedure, Drug traffic control,                                                                                 This final rule adopts, without
                                                                                                          22152; Telephone: (202) 598–6812.
                                                  Reporting and recordkeeping                                                                                   change, the interim final rule,
                                                                                                          SUPPLEMENTARY INFORMATION:                            ‘‘Schedules of Controlled Substances:
                                                  requirements.
                                                    Accordingly, for the reasons stated                   Legal Authority                                       Table of Excluded Nonnarcotic
                                                  above, the interim final rule that was                                                                        Products: Nasal Decongestant Inhaler/
                                                                                                             The Drug Enforcement
                                                  published in the Federal Register on                                                                          Vapor Inhaler’’ that was published in
                                                                                                          Administration (DEA) implements and
                                                  October 27, 2015 (80 FR 65635), is                                                                            the Federal Register on October 27,
                                                                                                          enforces titles II and III of the
                                                  adopted as final with the following                                                                           2015. 80 FR 65632.
                                                                                                          Comprehensive Drug Abuse Prevention                      On December 10, 2013, pursuant to
                                                  change:                                                 and Control Act of 1970, as amended. 21               the application process of § 1308.21, the
                                                                                                          U.S.C. 801–971. Titles II and III are                 DEA received correspondence from
                                                  PART 1308—SCHEDULES OF                                  referred to as the ‘‘Controlled
                                                  CONTROLLED SUBSTANCES                                                                                         Aphena Pharma Solutions—New York,
                                                                                                          Substances Act’’ and the ‘‘Controlled                 LLC (Aphena Pharma) stating that it had
                                                                                                          Substances Import and Export Act,’’                   acquired Classic Pharmaceuticals LLC
                                                  ■ 1. The authority citation for 21 CFR
                                                                                                          respectively, and they are collectively               and requesting that the current
                                                  part 1308 continues to read as follows:
                                                                                                          referred to as the ‘‘Controlled                       exclusion for the drug product Nasal
                                                    Authority: 21 U.S.C. 811, 812, 871(b),                Substances Act’’ or the ‘‘CSA’’ for the
                                                  unless otherwise noted.                                                                                       Decongestant Inhaler/Vapor Inhaler be
                                                                                                          purpose of this action. The DEA                       transferred to Aphena Pharma. Aphena
                                                  ■ 2. Amend § 1308.22, in the table, by                  publishes the implementing regulations                Pharma also stated that the
                                                  removing the company name, ‘‘Proctor                    for these statutes in title 21 of the Code            manufacturing process (i.e., facility) and
                                                  & Gamble Co., The’’ and adding in its                   of Federal Regulations (CFR), chapter II.             the formulation for the drug product
                                                  place ‘‘Procter & Gamble Co., The’’.                       The CSA and its implementing
                                                                                                                                                                Nasal Decongestant Inhaler/Vapor
                                                    Dated: February 2, 2016.                              regulations are designed to prevent,
                                                                                                                                                                Inhaler had not changed.
                                                  Louis J. Milione,                                       detect, and eliminate the diversion of                   Based on the application and other
                                                                                                          controlled substances and listed                      information received, the DEA
                                                  Deputy Assistant Administrator, Office of
                                                  Diversion Control.                                      chemicals into the illicit market while               determined that this product may,
                                                                                                          ensuring an adequate supply is available              under the FD&C Act, be lawfully sold
                                                  [FR Doc. 2016–02403 Filed 2–5–16; 8:45 am]
                                                                                                          for the legitimate medical, scientific,               over-the-counter without a prescription.
                                                  BILLING CODE 4410–09–P
                                                                                                          research, and industrial needs of the                 21 U.S.C. 811(g)(1). In addition, the
                                                                                                          United States. Controlled substances                  Deputy Assistant Administrator of the
                                                  DEPARTMENT OF JUSTICE                                   have the potential for abuse and                      Office of Diversion Control found that
                                                                                                          dependence and are controlled to                      the active ingredient in this drug
                                                  Drug Enforcement Administration                         protect the public health and safety.                 product (levmetamfetamine) is a
                                                                                                             Under the CSA, each controlled
                                                                                                                                                                schedule II controlled substance 1 and is
                                                  21 CFR Part 1308                                        substance is classified into one of five
                                                                                                                                                                not a narcotic drug as defined by 21
                                                                                                          schedules based upon its potential for
                                                  [Docket No. DEA–409]                                                                                          U.S.C. 802(17). The Deputy Assistant
                                                                                                          abuse, its currently accepted medical
                                                                                                                                                                Administrator of the Office of Diversion
                                                  RIN 1117–ZA30                                           use in treatment in the United States,
                                                                                                                                                                Control therefore found and concluded
                                                                                                          and the degree of dependence the drug
                                                                                                                                                                that this drug product continues to meet
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                  Schedules of Controlled Substances:                     or other substance may cause. 21 U.S.C.
                                                  Table of Excluded Nonnarcotic                                                                                 the criteria for exclusion from the CSA
                                                                                                          812. The initial schedules of controlled
                                                  Products: Nasal Decongestant Inhaler/                                                                         pursuant to 21 U.S.C. 811(g)(1).
                                                                                                          substances established by Congress are                   The interim final rule provided an
                                                  Vapor Inhaler                                           found at 21 U.S.C. 812(c) and the                     opportunity for interested persons to
                                                  AGENCY:  Drug Enforcement                               current list of all scheduled substances
                                                  Administration, Department of Justice.                  is published at 21 CFR part 1308.                       1 Levmetamfetamine is controlled in schedule II
                                                                                                             The CSA states that the Attorney                   of the CSA because it is an isomer of
                                                  ACTION: Final rule.
                                                                                                          General shall by regulation exclude any               methamphetamine.



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Document Created: 2016-02-06 00:24:51
Document Modified: 2016-02-06 00:24:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis final rule is effective on February 8, 2016.
ContactBarbara J. Boockholdt, Office of
FR Citation81 FR 6451 
RIN Number1117-AB39
CFR AssociatedAdministrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements

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