80 FR 65635 - Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Vicks® VapoInhaler®
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 207 (October 27, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 207 (October 27, 2015)
| Page Range | 65635-65637 | |
| FR Document | 2015-27266 |
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)] [Rules and Regulations] [Pages 65635-65637] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27266] ----------------------------------------------------------------------- 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: Interim final rule. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration (DEA) 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 Proctor & Gamble Company. This over-the-counter, non-narcotic drug product is excluded from provisions of the Controlled Substances Act. DATES: This interim final rule is effective on October 27, 2015. Interested persons may file written comments on this rule pursuant to 21 CFR 1308.21(c). Electronic comments must be submitted, and written comments must be postmarked, on or before December 28, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons are defined as those ``adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).'' 21 CFR 1300.01(b). ADDRESSES: To ensure proper handling of comments, please reference ``Docket No. DEA-367'' on all electronic and written correspondence, including any attachments. The DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Paper comments that duplicate electronic submissions are not necessary. Should you, however, wish to submit written comments, in lieu of electronic comments, they should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received in response to this docket are considered part of the public record and will be made available for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment. Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential. An electronic copy of this document and supplemental information to this interim final rule is available at http://www.regulations.gov for easy reference. Legal Authority The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the ``Controlled Substances Act'' and the ``Controlled Substances Import and Export Act,'' respectively, and are collectively referred to as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while 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 [[Page 65636]] protect the public health and safety. 21 U.S.C. 801. 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. 21 U.S.C. 812(a). The CSA states that the Attorney General shall by regulation exclude any non-narcotic 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 non-narcotic 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 On February 9, 2012, pursuant to the application process of 21 CFR 1308.21, the DEA received correspondence from The Proctor & 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] InhalerTM product which is currently excluded under 21 CFR 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 their Vicks[supreg] InhalerTM and indicated it had acquired Richardson-Vicks, Inc. (including its subsidiary, the Vick Chemical Company). The company also stated that the product name has been modified from Vicks[supreg] InhalerTM 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. P&G also 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 has 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 finds 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 finds and concludes that this product continues to meet the criteria for exclusion from the CSA pursuant to 21 U.S.C. 811(g)(1). 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. Administrative Procedure Act An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), including notice of proposed rulemaking and the pre-promulgation opportunity for public comment, if it is determined to be impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). The DEA finds for good cause that it is unnecessary to seek public comment prior to amending the table of Excluded Nonnarcotic Products to update the listing for this product, as the amendments are primarily technical in nature and would not result in any substantive change. The product was previously exempted under a different company name, which is no longer accurate due to acquisition of Vick Chemical Company by The Proctor & Gamble Company. Additionally, the product name has been modified and was reassigned a corresponding NDC number, and the nomenclature for the active ingredient has changed. Lastly, while the amount of the schedule II ingredient l-desoxyephedrine (levmetamfetamine) in this product has been reduced by half the original quantity, the changes in the formulation will not affect the effectiveness of the product or the public's ability to benefit from the use of the product. There is also no further formulation change which would affect other aspects of the drug delivery system. The APA requires the publication of a substantive rule to be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, this requirement need not apply for ``a substantive rule which grants or recognizes an exemption or relieves a restriction'' or ``as otherwise provided by the agency for good cause found and published with the rule.'' 5 U.S.C. 553(d)(1). This rule continues the exclusion of a nonnarcotic drug product from the provisions of the CSA. Given that these amendments to the table of Excluded Nonnarcotic Products are primarily technical in nature and thereby would not warrant any further delay, the DEA finds that there is good cause to make this rule effective immediately upon publication. 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. This product is a modified version of a product that is currently exempted under the DEA's regulations. 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. 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 [[Page 65637]] 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 the provisions of the UMRA. Paperwork Reduction Act of 1995 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. However, pursuant to the CRA, the DEA has submitted a copy of this interim final rule to both Houses of Congress and to the Comptroller General. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR part 1308 is amended as follows: 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. In Sec. 1308.22, remove the product listed in the table for the company, ``Vicks Chemical Co'' and Trade name, ``Vicks Inhaler,'' and add to the table, in alphabetical order, the product listed below: Sec. 1308.22 Excluded substances. * * * * * Excluded Nonnarcotic Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Company Trade name NDC code Form Controlled substance (mg or mg/ml) -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * Proctor & Gamble Co., The.............. Vicks VapoInhaler......... 37000-686-01 IN Levmetamfetamine (l- 50.00 Desoxyephedrine). * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: October 20, 2015. Louis J. Milione, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. 2015-27266 Filed 10-26-15; 8:45 am] BILLING CODE 4410-09-P
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EXCLUDED NONNARCOTIC PRODUCTS
Company Trade name NDC code Form Controlled substance (mg or mg/ml)
* * * * * * *
Aphena Pharma Solu- Nasal Decongestant In- ........................ IN .... Levmetamfetamine (l-Desoxyephedrine) ............. 50.00
tions—New York, LLC. haler/Vapor Inhaler.
* * * * * * *
Dated: October 20, 2015. attachments. The DEA encourages that publicly available, you must include the
Louis J. Milione, all comments be submitted phrase ‘‘CONFIDENTIAL BUSINESS
Deputy Assistant Administrator, Office of electronically through the Federal INFORMATION’’ in the first paragraph
Diversion Control. eRulemaking Portal which provides the of your comment. You must also
[FR Doc. 2015–27264 Filed 10–26–15; 8:45 am] ability to type short comments directly prominently identify the confidential
BILLING CODE 4410–09–P into the comment field on the Web page business information to be redacted
or attach a file for lengthier comments. within the comment.
Please go to http://www.regulations.gov Comments containing personal
DEPARTMENT OF JUSTICE and follow the online instructions at identifying information or confidential
that site for submitting comments. Paper business information identified as
Drug Enforcement Administration comments that duplicate electronic directed above will be made publicly
submissions are not necessary. Should available in redacted form. If a comment
21 CFR Part 1308 you, however, wish to submit written has so much confidential business
comments, in lieu of electronic information that it cannot be effectively
[Docket No. DEA–367]
comments, they should be sent via redacted, all or part of that comment
RIN 1117–AB39 regular or express mail to: Drug may not be made publicly available.
Enforcement Administration, Attention: Comments posted to http://
Schedules of Controlled Substances: DEA Federal Register Representative/ www.regulations.gov may include any
Table of Excluded Nonnarcotic ODL, 8701 Morrissette Drive, personal identifying information (such
Products: Vicks® VapoInhaler® Springfield, Virginia 22152. as name, address, and phone number)
FOR FURTHER INFORMATION CONTACT: John included in the text of your electronic
AGENCY: Drug Enforcement
Administration, Department of Justice. R. Scherbenske, Office of Diversion submission that is not identified as
Control, Drug Enforcement directed above as confidential.
ACTION: Interim final rule. Administration; Mailing Address: 8701
An electronic copy of this document
SUMMARY: The Drug Enforcement Morrissette Drive, Springfield, Virginia
and supplemental information to this
Administration (DEA) is amending the 22152; Telephone: (202) 598–6812.
interim final rule is available at http://
table of Excluded Nonnarcotic Products SUPPLEMENTARY INFORMATION: www.regulations.gov for easy reference.
to update the listing for Vicks® Posting of Public Comments
VapoInhaler®, containing 50 mg Legal Authority
levmetamfetamine in a nasal Please note that all comments
received in response to this docket are The Drug Enforcement
decongestant inhaler, marketed by The Administration (DEA) implements and
Proctor & Gamble Company. This over- considered part of the public record and
will be made available for public enforces titles II and III of the
the-counter, non-narcotic drug product Comprehensive Drug Abuse Prevention
is excluded from provisions of the inspection online at http://
www.regulations.gov. Such information and Control Act of 1970, as amended. 21
Controlled Substances Act. U.S.C. 801–971. Titles II and III are
includes personal identifying
DATES: This interim final rule is information (such as your name, referred to as the ‘‘Controlled
effective on October 27, 2015. Interested address, etc.) voluntarily submitted by Substances Act’’ and the ‘‘Controlled
persons may file written comments on the commenter. Substances Import and Export Act,’’
this rule pursuant to 21 CFR 1308.21(c). The Freedom of Information Act respectively, and are collectively
Electronic comments must be (FOIA) applies to all comments referred to as the ‘‘Controlled
submitted, and written comments must received. If you want to submit personal Substances Act’’ or the ‘‘CSA’’ for the
be postmarked, on or before December identifying information (such as your purpose of this action. The DEA
28, 2015. Commenters should be aware name, address, etc.) as part of your publishes the implementing regulations
that the electronic Federal Docket comment, but do not want it to be made for these statutes in title 21 of the Code
Management System will not accept publicly available, you must include the of Federal Regulations (CFR), chapter II.
comments after 11:59 p.m. Eastern Time phrase ‘‘PERSONAL IDENTIFYING The CSA and its implementing
on the last day of the comment period. INFORMATION’’ in the first paragraph regulations are designed to prevent,
Interested persons are defined as those of your comment. You must also place detect, and eliminate the diversion of
‘‘adversely affected or aggrieved by any all of the personal identifying controlled substances and listed
rule or proposed rule issuable pursuant information you do not want made chemicals into the illicit market while
tkelley on DSK3SPTVN1PROD with RULES
to section 201 of the Act (21 U.S.C. publicly available in the first paragraph ensuring an adequate supply is available
811).’’ 21 CFR 1300.01(b). of your comment and identify what for the legitimate medical, scientific,
ADDRESSES: To ensure proper handling information you want redacted. research, and industrial needs of the
of comments, please reference ‘‘Docket If you want to submit confidential United States. Controlled substances
No. DEA–367’’ on all electronic and business information as part of your have the potential for abuse and
written correspondence, including any comment, but do not want it to be made dependence and are controlled to
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![65636 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations
protect the public health and safety. 21 nothing in the formulation change will not affect the effectiveness of the
U.S.C. 801. affects other aspects of the drug delivery product or the public’s ability to benefit
Under the CSA, each controlled system. from the use of the product. There is
substance is classified into one of five Based on the application and other also no further formulation change
schedules based upon its potential for information received, including the which would affect other aspects of the
abuse, its currently accepted medical quantitative composition of the drug delivery system.
use in treatment in the United States, substance and labeling and packaging The APA requires the publication of
and the degree of dependence the drug information, the DEA has determined a substantive rule to be made not less
or other substance may cause. 21 U.S.C. that this product may, under the FD&C than 30 days before its effective date. 5
812. The initial schedules of controlled Act, be lawfully sold over-the-counter U.S.C. 553(d). However, this
substances established by Congress are without a prescription. 21 U.S.C. requirement need not apply for ‘‘a
found at 21 U.S.C. 812(c), and the 811(g)(1). In addition, the Deputy substantive rule which grants or
current list of all scheduled substances Assistant Administrator of the Office of recognizes an exemption or relieves a
is published at 21 CFR part 1308. 21 Diversion Control finds that the active restriction’’ or ‘‘as otherwise provided
U.S.C. 812(a). ingredient in this drug product by the agency for good cause found and
The CSA states that the Attorney (levmetamfetamine) is a schedule II published with the rule.’’ 5 U.S.C.
General shall by regulation exclude any controlled substance and is not a 553(d)(1). This rule continues the
non-narcotic drug which contains a narcotic drug as defined by 21 U.S.C. exclusion of a nonnarcotic drug product
controlled substance from the 802(17). The Deputy Assistant from the provisions of the CSA. Given
application of the CSA, if such drug Administrator of the Office of Diversion that these amendments to the table of
may, under the Federal Food, Drug, and Control therefore finds and concludes Excluded Nonnarcotic Products are
Cosmetic Act (FD&C Act), [21 U.S.C. that this product continues to meet the primarily technical in nature and
301 et seq.] be lawfully sold over-the- criteria for exclusion from the CSA thereby would not warrant any further
counter without a prescription. 21 pursuant to 21 U.S.C. 811(g)(1). delay, the DEA finds that there is good
U.S.C. 811(g)(1). Such exclusions apply This exclusion only applies to the cause to make this rule effective
only to specific non-narcotic drugs finished drug product in the form of an immediately upon publication.
following suitable application to the inhaler (in the exact formulation
DEA in accordance with 21 CFR detailed in the application for Regulatory Analyses
1308.21. The current table of Excluded exclusion), which is lawfully sold under Executive Orders 12866 and 13563
Nonnarcotic Products is found in 21 the FD&C Act over-the-counter without
CFR 1308.22. The authority to exclude a prescription. The extraction or This regulation has been developed in
such substances has been delegated to removal of the active ingredient accordance with the Executive Orders
the Administrator of the DEA, 28 CFR (levmetamfetamine) from the inhaler 12866, ‘‘Regulatory Planning and
0.100, and redelegated to the Deputy shall negate this exclusion and result in Review,’’ section 1(b) and Executive
Assistant Administrator of the Office of the possession of a schedule II Order 13563, ‘‘Improving Regulation
Diversion Control, section 7 of 28 CFR controlled substance. and Regulatory Review.’’ The DEA has
part 0, appendix to subpart R. determined that this rule is not a
Administrative Procedure Act significant regulatory action, and
Background An agency may find good cause to accordingly this rule has not been
On February 9, 2012, pursuant to the exempt a rule from certain provisions of reviewed by the Office of Management
application process of 21 CFR 1308.21, the Administrative Procedure Act and Budget. This product is a modified
the DEA received correspondence from (APA), including notice of proposed version of a product that is currently
The Proctor & Gamble Company rulemaking and the pre-promulgation exempted under the DEA’s regulations.
(‘‘P&G’’) notifying the DEA that it had opportunity for public comment, if it is This action will not have an annual
reduced the quantity of l- determined to be impracticable, effect on the economy of $100 million
desoxyephedrine (levmetamfetamine) unnecessary, or contrary to the public or more or adversely affect in a material
from 113 mg to 50 mg in their Vicks® interest. 5 U.S.C. 553(b)(B). The DEA way the economy, a sector of the
InhalerTM product which is currently finds for good cause that it is economy, productivity, competition,
excluded under 21 CFR 1308.22. unnecessary to seek public comment jobs, the environment, public health or
Levmetamfetamine is controlled in prior to amending the table of Excluded safety, or State, local or tribal
schedule II as an isomer of Nonnarcotic Products to update the governments or communities; create a
methamphetamine. 21 CFR listing for this product, as the serious inconsistency or otherwise
1308.12(d)(2). P&G requested that the amendments are primarily technical in interfere with an action taken or
DEA update the current exclusion for nature and would not result in any planned by another agency; materially
their Vicks® InhalerTM and indicated it substantive change. The product was alter the budgetary impact of
had acquired Richardson-Vicks, Inc. previously exempted under a different entitlements, grants, user fees, or loan
(including its subsidiary, the Vick company name, which is no longer programs or the rights and obligations of
Chemical Company). The company also accurate due to acquisition of Vick recipients thereof; or raise novel legal or
stated that the product name has been Chemical Company by The Proctor & policy issues arising out of legal
modified from Vicks® InhalerTM to Gamble Company. Additionally, the mandates, the President’s priorities, or
Vicks® VapoInhaler® and that the product name has been modified and the principles set forth in Executive
change included a corresponding was reassigned a corresponding NDC Order 12866.
National Drug Code (NDC) number number, and the nomenclature for the
tkelley on DSK3SPTVN1PROD with RULES
reassignment by the U.S. Food and Drug active ingredient has changed. Lastly, Executive Order 12988
Administration. P&G also stated that the while the amount of the schedule II This regulation meets the applicable
nomenclature for the active ingredient/ ingredient l-desoxyephedrine standards set forth in sections 3(a) and
controlled substance had been changed (levmetamfetamine) in this product has 3(b)(2) of Executive Order 12988, ‘‘Civil
from l-desoxyephedrine to been reduced by half the original Justice Reform,’’ to eliminate drafting
levmetamfetamine. P&G indicated that quantity, the changes in the formulation errors and ambiguity, minimize
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![Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 65637
litigation, provide a clear legal standard aggregate, or by the private sector, of productivity, innovation, or on the
for affected conduct, and promote $100,000,000 or more (adjusted for ability of United States-based
simplification and burden reduction. inflation) in any one year * * * .’’ companies to compete with foreign-
Therefore, neither a Small Government based companies in domestic and
Executive Order 13132
Agency Plan nor any other action is export markets. However, pursuant to
This rulemaking does not have required under the provisions of the the CRA, the DEA has submitted a copy
federalism implications warranting the UMRA. of this interim final rule to both Houses
application of Executive Order 13132. of Congress and to the Comptroller
The rule does not have substantial Paperwork Reduction Act of 1995
General.
direct effects on the States, on the This rule does not impose a new
relationship between the Federal collection of information requirement List of Subjects in 21 CFR Part 1308
Government and the States, or the under the Paperwork Reduction Act, 44 Administrative practice and
distribution of power and U.S.C. 3501–3521. This action would procedure, Drug traffic control,
responsibilities among the various not impose recordkeeping or reporting Reporting and recordkeeping
levels of government. requirements on State or local requirements.
governments, individuals, businesses, or
Executive Order 13175
organizations. An agency may not For the reasons set out above, 21 CFR
This rule does not have tribal conduct or sponsor, and a person is not part 1308 is amended as follows:
implications warranting the application required to respond to, a collection of
of Executive Order 13175. This rule information unless it displays a PART 1308—SCHEDULES OF
does not have substantial direct effects currently valid OMB control number. CONTROLLED SUBSTANCES
on one or more Indian tribes, on the
relationship between the Federal Congressional Review Act ■ 1. The authority citation for 21 CFR
Government and Indian tribes, or on the This rule is not a major rule as part 1308 continues to read as follows:
distribution of power and defined by section 804 of the Small Authority: 21 U.S.C. 811, 812, 871(b),
responsibilities between the Federal Business Regulatory Enforcement unless otherwise noted.
Government and Indian tribes. Fairness Act of 1996 (Congressional
Review Act (CRA)). This rule will not ■ 2. In § 1308.22, remove the product
Unfunded Mandates Reform Act of 1995 result in: An annual effect on the listed in the table for the company,
The DEA has determined and certifies economy of $100,000,000 or more; a ‘‘Vicks Chemical Co’’ and Trade name,
pursuant to the Unfunded Mandates major increase in costs or prices for ‘‘Vicks Inhaler,’’ and add to the table, in
Reform Act of 1995 (UMRA), 2 U.S.C. consumers, individual industries, alphabetical order, the product listed
1501 et seq., that this action would not Federal, State, or local government below:
result in any Federal mandate that may agencies, or geographic regions; or
result ‘‘in the expenditure by State, significant adverse effects on § 1308.22 Excluded substances.
local, and tribal governments, in the competition, employment, investment, * * * * *
EXCLUDED NONNARCOTIC PRODUCTS
Controlled
Company Trade name NDC code Form (mg or mg/ml)
substance
* * * * * * *
Proctor & Gamble Co., The .................. Vicks VapoInhaler 37000–686–01 IN Levmetamfetamine 50.00
(l-Desoxyephed-
rine).
* * * * * * *
Dated: October 20, 2015. DEPARTMENT OF THE TREASURY accounting, and certain remedial
Louis J. Milione, actions, for purposes of the private
Deputy Assistant Administrator, Office of Internal Revenue Service activity bond restrictions under section
Diversion Control. 141 of the Internal Revenue Code that
[FR Doc. 2015–27266 Filed 10–26–15; 8:45 am]
26 CFR Part 1 apply to tax-exempt bonds issued by
[TD 9741] State and local governments. The final
BILLING CODE 4410–09–P
regulations provide State and local
RIN 1545–BB23; 1545–BC07; 1545–BH48 governmental issuers of tax-exempt
bonds with guidance for applying the
General Allocation and Accounting private activity bond restrictions.
Regulations Under Section 141;
Remedial Actions for Tax-Exempt DATES: Effective Date: These regulations
Bonds are effective on October 27, 2015.
tkelley on DSK3SPTVN1PROD with RULES
Applicability Date: For dates of
AGENCY: Internal Revenue Service (IRS), applicability, see § 1.141–15.
Treasury.
ACTION: Final regulations. FOR FURTHER INFORMATION CONTACT:
Johanna Som de Cerff or Zoran
SUMMARY: This document contains final Stojanovic, (202) 317–6980 (not a toll-
regulations on allocation and free number).
VerDate Sep<11>2014 16:49 Oct 26, 2015 Jkt 238001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\27OCR1.SGM 27OCR1](https://thefederalregister.org/doc/80_FR_65842/page/3.svg)
Document Created: 2015-12-14 15:36:04
Document Modified: 2015-12-14 15:36:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Interim final rule. | |
| Dates | This interim final rule is effective on October 27, 2015. Interested persons may file written comments on this rule pursuant to 21 CFR 1308.21(c). Electronic comments must be submitted, and written comments must be postmarked, on or before December 28, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons are defined as those ``adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).'' 21 CFR 1300.01(b). | |
| Contact | John R. Scherbenske, Office of | |
| FR Citation | 80 FR 65635 | |
| RIN Number | 1117-AB39 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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