81 FR 6453 - Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhaler/Vapor Inhaler
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 25 (February 8, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 25 (February 8, 2016)
| Page Range | 6453-6454 | |
| FR Document | 2016-02404 |
[Federal Register Volume 81, Number 25 (Monday, February 8, 2016)] [Rules and Regulations] [Pages 6453-6454] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02404] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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). --------------------------------------------------------------------------- \1\ Levmetamfetamine is controlled in schedule II of the CSA because it is an isomer of methamphetamine. --------------------------------------------------------------------------- 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
![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.
VerDate Sep<11>2014 16:19 Feb 05, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\FR\FM\08FER1.SGM 08FER1](https://thefederalregister.org/doc/81_FR_6478/page/1.svg)
![6454 Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Rules and Regulations
submit written comments on the rule on substantial number of small entities. As organizations. An agency may not
or before December 28, 2015. The DEA discussed above and in the interim final conduct or sponsor, and a person is not
received one comment in response to rule, this product was previously required to respond to, a collection of
the publication of the interim final rule exempted under a different company information unless it displays a
voicing support for the action. The DEA name. The Deputy Assistant currently valid OMB control number.
appreciates the support for the rule. Administrator, in accordance with the
Congressional Review Act
This exclusion only applies to the RFA, has reviewed this regulation and
finished drug product in the form of an by approving it certifies that this This rule is not a major rule as
inhaler (in the exact formulation regulation will not have a significant defined by section 804 of the Small
detailed in the application for economic impact on a substantial Business Regulatory Enforcement
exclusion), which is lawfully sold under number of small entities. Fairness Act of 1996 (Congressional
the FD&C Act over-the-counter without Review Act (CRA)). This rule will not
Executive Order 12988 result in: An annual effect on the
a prescription. The extraction or
removal of the active ingredient This regulation meets the applicable economy of $100,000,000 or more; a
(levmetamfetamine) from the inhaler standards set forth in sections 3(a) and major increase in costs or prices for
shall negate this exclusion and result in 3(b)(2) of Executive Order 12988, ‘‘Civil consumers, individual industries,
the possession of a schedule II Justice Reform,’’ to eliminate drafting Federal, State, or local government
controlled substance. errors and ambiguity, minimize agencies, or geographic regions; or
litigation, provide a clear legal standard significant adverse effects on
Regulatory Analyses for affected conduct, and promote competition, employment, investment,
Executive Orders 12866 and 13563 simplification and burden reduction. productivity, innovation, or on the
This regulation has been developed in Executive Order 13132 ability of United States-based
accordance with the Executive Orders companies to compete with foreign-
This rulemaking does not have based companies in domestic and
12866, ‘‘Regulatory Planning and federalism implications warranting the
Review,’’ section 1(b) and Executive export markets.
application of Executive Order 13132.
Order 13563, ‘‘Improving Regulation The rule does not have substantial List of Subjects in 21 CFR Part 1308
and Regulatory Review.’’ The DEA has direct effects on the States, on the Administrative practice and
determined that this rule is not a relationship between the Federal procedure, Drug traffic control,
significant regulatory action, and Government and the States, or the Reporting and recordkeeping
accordingly this rule has not been distribution of power and requirements.
reviewed by the Office of Management responsibilities among the various
and Budget. As discussed above, this levels of government. PART 1308—SCHEDULES OF
product was previously exempted under CONTROLLED SUBSTANCES
a different company name. As discussed Executive Order 13175
in the interim final rule, this action will This rule does not have tribal Accordingly, for the reasons stated
not have an annual effect on the implications warranting the application above, the interim final rule that was
economy of $100 million or more or of Executive Order 13175. This rule published in the Federal Register on
adversely affect in a material way the does not have substantial direct effects October 27, 2015 (80 FR 65632), is
economy, a sector of the economy, on one or more Indian tribes, on the adopted as a final rule without change.
productivity, competition, jobs, the relationship between the Federal Dated: February 2, 2016.
environment, public health or safety, or Government and Indian tribes, or on the Louis J. Milione,
State, local or tribal governments or distribution of power and Deputy Assistant Administrator, Office of
communities; create a serious responsibilities between the Federal Diversion Control.
inconsistency or otherwise interfere Government and Indian tribes. [FR Doc. 2016–02404 Filed 2–5–16; 8:45 am]
with an action taken or planned by
another agency; materially alter the Unfunded Mandates Reform Act of 1995 BILLING CODE 4410–09–P
budgetary impact of entitlements, The DEA has determined and certifies
grants, user fees, or loan programs or the pursuant to the Unfunded Mandates
rights and obligations of recipients Reform Act of 1995 (UMRA), 2 U.S.C. DEPARTMENT OF TRANSPORTATION
thereof; or raise novel legal or policy 1501 et seq., that this action would not National Highway Traffic Safety
issues arising out of legal mandates, the result in any Federal mandate that may Administration
President’s priorities, or the principles result ‘‘in the expenditure by State,
set forth in Executive Order 12866. local, and tribal governments, in the 49 CFR Part 571
aggregate, or by the private sector, of
Regulatory Flexibility Analysis
$100,000,000 or more (adjusted for [Docket No. NHTSA–2014–0073]
The Regulatory Flexibility Act (RFA) inflation) in any one year * * *.’’
(5 U.S.C. 601–612) applies to rules that RIN 2127–AL27
Therefore, neither a Small Government
are subject to notice and comment. The Agency Plan nor any other action is Federal Motor Vehicle Safety
DEA determined, as explained in the required under provisions of the UMRA. Standards; Lamps, Reflective Devices,
interim final rule, that public notice and
and Associated Equipment
asabaliauskas on DSK5VPTVN1PROD with RULES
comment were impracticable and Paperwork Reduction Act
contrary to the public interest. This rule does not impose a new AGENCY: National Highway Traffic
Consequently, the RFA does not apply. collection of information requirement Safety Administration (NHTSA),
Although the RFA does not apply to this under the Paperwork Reduction Act, 44 Department of Transportation (DOT).
rulemaking, the DEA has reviewed the U.S.C. 3501–3521. This action would ACTION: Final rule.
potential impacts of this final rule and not impose recordkeeping or reporting
determined that it will not have a requirements on State or local SUMMARY: NHTSA is amending the side
significant economic impact on a governments, individuals, businesses, or marker requirements contained in the
VerDate Sep<11>2014 16:19 Feb 05, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\FR\FM\08FER1.SGM 08FER1](https://thefederalregister.org/doc/81_FR_6478/page/2.svg)
Document Created: 2016-02-06 00:24:05
Document Modified: 2016-02-06 00:24:05
| 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 | This final rule is effective on February 8, 2016. | |
| Contact | Barbara J. Boockholdt, Office of | |
| FR Citation | 81 FR 6453 | |
| RIN Number | 1117-ZA30 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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