80 FR 65632 - Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhaler/Vapor Inhaler
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 | 65632-65635 | |
| FR Document | 2015-27264 |
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)] [Rules and Regulations] [Pages 65632-65635] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27264] ======================================================================= ----------------------------------------------------------------------- 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: Interim final rule. ----------------------------------------------------------------------- SUMMARY: 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 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-409'' 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 [[Page 65633]] 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 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. 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 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 On December 10, 2013, pursuant to the application process of 21 CFR 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 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 \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 finds and concludes 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. --------------------------------------------------------------------------- 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 [[Page 65634]] 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 amendment is technical in nature and would not result in any substantive change. The DEA is merely changing the name of the company associated with the Nasal Decongestant Inhaler/Vapor Inhaler as the result of the acquisition of Classic Pharmaceuticals LLC by Aphena Pharma. The manufacturing process (i.e., facility) and the formulation for the drug product Nasal Decongestant Inhaler/Vapor Inhaler have not changed as a result of this acquisition. 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 this amendment to the table of Excluded Nonnarcotic Products is 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 was previously exempted under a different company name. 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 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. 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 to read 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 company name ``Classic Pharmaceuticals LLC'', and add to the table, in alphabetical order, the company name listed below to read as follows: Sec. 1308.22 Excluded substances. * * * * * [[Page 65635]] Excluded Nonnarcotic Products ---------------------------------------------------------------------------------------------------------------- Company Trade name NDC code Form Controlled substance (mg or mg/ml) ---------------------------------------------------------------------------------------------------------------- * * * * * * * Aphena Pharma Solutions--New Nasal ............... IN..... Levmetamfetamine (l- 50.00 York, LLC. Decongestant Desoxyephedrine). Inhaler/Vapor Inhaler. * * * * * * * ---------------------------------------------------------------------------------------------------------------- Dated: October 20, 2015. Louis J. Milione, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. 2015-27264 Filed 10-26-15; 8:45 am] BILLING CODE 4410-09-P
![65632 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations
(D) A summary of the user developing a disease in the future. On section, shall be limited to the
comprehension study must be provided its own, this test is also not intended to manufacturer, the manufacturer’s
and include the following: tell you anything about the health of subsidiaries, and laboratories regulated
(1) Results regarding reports that are your fetus, or your newborn child’s risk under the Clinical Laboratory
provided for each gene/variant/ethnicity of developing a particular disease later Improvement Amendments.
tested. on in life.’’ Dated: October 20, 2015.
(2) Statistical methods used to analyze (v) For over-the-counter tests, the
Leslie Kux,
all data sets. following warnings that read:
(3) Completion rate, non-responder (A) ‘‘This test is not a substitute for Associate Commissioner for Policy.
rate, and reasons for non-response/data visits to a healthcare provider. It is [FR Doc. 2015–27197 Filed 10–26–15; 8:45 am]
exclusion, as well as a summary table of recommended that you consult with a BILLING CODE 4164–01–P
comprehension rates regarding healthcare provider if you have any
comprehension concepts (purpose of questions or concerns about your
test, test results, test limitations, results.’’ DEPARTMENT OF JUSTICE
ethnicity relevance for the test results, (B) ‘‘The test does not diagnose any
etc.) for each study report. health conditions. Results should be Drug Enforcement Administration
(4) Your 21 CFR 809.10 compliant used along with other clinical
labeling and any test report generated information for any medical purposes.’’ 21 CFR Part 1308
must include the following warning and (C) ‘‘The laboratory may not be able [Docket No. DEA–409]
limitation statements, as applicable: to process your sample. The probability
(i) A warning that reads ‘‘The test is that the laboratory cannot process your RIN 1117–ZA30
intended only for autosomal recessive saliva sample can be up to [actual
carrier screening in adults of probability percentage].’’ Schedules of Controlled Substances:
reproductive age.’’ (D) ‘‘Your ethnicity may affect how Table of Excluded Nonnarcotic
(ii) A statement accurately disclosing your genetic health results are Products: Nasal Decongestant Inhaler/
the genetic coverage of the test in lay interpreted.’’ Vapor Inhaler
terms, including, as applicable, (vi) For a positive result in an over- AGENCY: Drug Enforcement
information on variants not queried by the-counter test when the positive Administration, Department of Justice.
the test, and the proportion of incident predictive value for a specific
ACTION: Interim final rule.
disease that is not related to the gene(s) population is less than 50 percent and
tested. For example, where applicable, more than 5 percent, a warning that SUMMARY: The Drug Enforcement
the statement would have to include a reads ‘‘The positive result you obtained Administration is amending the table of
warning that the test does not or may may falsely identify you as a carrier. Excluded Nonnarcotic Products to
not detect all genetic variants related to Consider genetic counseling and update the company name for the drug
the genetic disease, and that the absence followup testing.’’ product Nasal Decongestant Inhaler/
of a variant tested does not rule out the (vii) For a positive result in an over- Vapor Inhaler (containing 50 milligrams
presence of other genetic variants that the-counter test when the positive levmetamfetamine) to Aphena Pharma
may be disease-related. Or, where predictive value for a specific Solutions—New York, LLC. This over-
applicable, the statement would have to population is less than 5 percent, a the-counter, nonnarcotic drug product is
include a warning that the basis for the warning that reads ‘‘The positive result excluded from the provisions of the
disease for which the genetic carrier you obtained is very likely to be Controlled Substances Act.
status is being tested is unknown or incorrect due to the rarity of this
DATES: This interim final rule is
believed to be non-heritable in a variant. Consider genetic counseling
effective on October 27, 2015. Interested
substantial number of people who have and followup testing.’’
(5) The testing done to comply with persons may file written comments on
the disease, and that a negative test
paragraph (b)(3) of this section must this rule pursuant to 21 CFR 1308.21(c).
result cannot rule out the possibility
show the device meets or exceeds each Electronic comments must be
that any offspring may be affected with
of the following performance submitted, and written comments must
the disease. The statement would have
specifications: be postmarked, on or before December
to include any other warnings needed to
(i) The accuracy must be shown to be 28, 2015. Commenters should be aware
accurately convey to consumers the
equal to or greater than 99 percent for that the electronic Federal Docket
degree to which the test is informative
both PPA and NPA. Variants that have Management System will not accept
for carrier status.
(iii) For prescription use tests, the a point estimate for PPA or NPA of less comments after 11:59 p.m. Eastern Time
following warnings that read: than 99 percent (incorrect test results as on the last day of the comment period.
(A) ‘‘The results of this test are compared to bidirectional sequencing or Interested persons are defined as those
intended to be interpreted by a board- other methods identified as appropriate ‘‘adversely affected or aggrieved by any
certified clinical molecular geneticist or by FDA) must not be incorporated into rule or proposed rule issuable pursuant
equivalent and should be used in test claims and reports. to section 201 of the Act (21 U.S.C.
conjunction with other available (ii) Precision (reproducibility) 811).’’ 21 CFR 1300.01(b).
laboratory and clinical information.’’ performance must meet or exceed 99 ADDRESSES: To ensure proper handling
(B) ‘‘This device is not intended for percent for both positive and negative of comments, please reference ‘‘Docket
disease diagnosis, prenatal testing of results. No. DEA–409’’ on all electronic and
fetuses, risk assessment, prognosis or (iii) The user comprehension study written correspondence, including any
tkelley on DSK3SPTVN1PROD with RULES
pre-symptomatic testing, susceptibility must obtain values of 90 percent or attachments. The DEA encourages that
testing, or newborn screening.’’ greater user comprehension for each all comments be submitted
(iv) For over-the-counter tests, a comprehension concept. electronically through the Federal
statement that reads ‘‘This test is not (6) The distribution of this device, eRulemaking Portal which provides the
intended to diagnose a disease, or tell excluding the collection device ability to type short comments directly
you anything about your risk for described in paragraph (b)(2) of this into the comment field on the Web page
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![Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 65633
or attach a file for lengthier comments. www.regulations.gov may include any CFR 1308.22. The authority to exclude
Please go to http://www.regulations.gov personal identifying information (such such substances has been delegated to
and follow the online instructions at as name, address, and phone number) the Administrator of the DEA, 28 CFR
that site for submitting comments. Paper included in the text of your electronic 0.100, and redelegated to the Deputy
comments that duplicate electronic submission that is not identified as Assistant Administrator of the Office of
submissions are not necessary. Should directed above as confidential. Diversion Control, section 7 of 28 CFR
you, however, wish to submit written An electronic copy of this document part 0, appendix to subpart R.
comments, in lieu of electronic and supplemental information to this
interim final rule is available at http:// Background
comments, they should be sent via
regular or express mail to: Drug www.regulations.gov for easy reference. On December 10, 2013, pursuant to
Enforcement Administration, Attention: the application process of 21 CFR
Legal Authority
DEA Federal Register Representative/ 1308.21, the DEA received
ODL, 8701 Morrissette Drive, The Drug Enforcement correspondence from Aphena Pharma
Springfield, Virginia 22152. Administration (DEA) implements and Solutions—New York, LLC (Aphena
enforces titles II and III of the Pharma) stating that it had acquired
FOR FURTHER INFORMATION CONTACT: John
Comprehensive Drug Abuse Prevention Classic Pharmaceuticals LLC and
R. Scherbenske, Office of Diversion and Control Act of 1970, as amended. 21
Control, Drug Enforcement requesting that the current exclusion for
U.S.C. 801–971. Titles II and III are the drug product Nasal Decongestant
Administration; Mailing Address: 8701 referred to as the ‘‘Controlled
Morrissette Drive, Springfield, Virginia Inhaler/Vapor Inhaler be transferred to
Substances Act’’ and the ‘‘Controlled Aphena Pharma. Aphena Pharma also
22152; Telephone: (202) 598–6812. Substances Import and Export Act,’’ stated that the manufacturing process
SUPPLEMENTARY INFORMATION: respectively, and they are collectively (i.e., facility) and the formulation for the
Posting of Public Comments referred to as the ‘‘Controlled drug product Nasal Decongestant
Substances Act’’ or the ‘‘CSA’’ for the Inhaler/Vapor Inhaler had not changed.
Please note that all comments purpose of this action. The DEA
received in response to this docket are Based on the application and other
publishes the implementing regulations information received, the DEA has
considered part of the public record and for these statutes in title 21 of the Code
will be made available for public determined that this product may,
of Federal Regulations (CFR), chapter II. under the FD&C Act, be lawfully sold
inspection online at http:// The CSA and its implementing
www.regulations.gov. Such information over-the-counter without a prescription.
regulations are designed to prevent, 21 U.S.C. 811(g)(1). In addition, the
includes personal identifying detect, and eliminate the diversion of
information (such as your name, Deputy Assistant Administrator of the
controlled substances and listed Office of Diversion Control finds that
address, etc.) voluntarily submitted by chemicals into the illicit market while
the commenter. the active ingredient in this drug
ensuring an adequate supply is available
The Freedom of Information Act product (levmetamfetamine) is a
for the legitimate medical, scientific,
(FOIA) applies to all comments schedule II controlled substance 1 and is
research, and industrial needs of the
received. If you want to submit personal not a narcotic drug as defined by 21
United States. Controlled substances
identifying information (such as your U.S.C. 802(17). The Deputy Assistant
have the potential for abuse and
name, address, etc.) as part of your Administrator of the Office of Diversion
dependence and are controlled to
comment, but do not want it to be made Control therefore finds and concludes
protect the public health and safety. 21
publicly available, you must include the that this drug product continues to meet
U.S.C. 801.
phrase ‘‘PERSONAL IDENTIFYING the criteria for exclusion from the CSA
Under the CSA, each controlled
INFORMATION’’ in the first paragraph pursuant to 21 U.S.C. 811(g)(1).
substance is classified into one of five
of your comment. You must also place This exclusion only applies to the
schedules based upon its potential for
all of the personal identifying finished drug product in the form of an
abuse, its currently accepted medical
information you do not want made inhaler (in the exact formulation
use in treatment in the United States,
publicly available in the first paragraph detailed in the application for
and the degree of dependence the drug
of your comment and identify what exclusion), which is lawfully sold under
or other substance may cause. 21 U.S.C.
information you want redacted. the FD&C Act over-the-counter without
812. The initial schedules of controlled
If you want to submit confidential a prescription. The extraction or
substances established by Congress are
business information as part of your removal of the active ingredient
found at 21 U.S.C. 812(c) and the
comment, but do not want it to be made (levmetamfetamine) from the inhaler
current list of all scheduled substances
publicly available, you must include the shall negate this exclusion and result in
is published at 21 CFR part 1308. 21
phrase ‘‘CONFIDENTIAL BUSINESS the possession of a schedule II
U.S.C. 812(a).
INFORMATION’’ in the first paragraph The CSA states that the Attorney controlled substance.
of your comment. You must also General shall by regulation exclude any Administrative Procedure Act
prominently identify the confidential nonnarcotic drug which contains a
An agency may find good cause to
business information to be redacted controlled substance from the
exempt a rule from certain provisions of
within the comment. application of the CSA, if such drug
the Administrative Procedure Act
Comments containing personal may, under the Federal Food, Drug, and
(APA), including notice of proposed
identifying information or confidential Cosmetic Act (FD&C Act), [21 U.S.C.
rulemaking and the pre-promulgation
business information identified as 301 et seq.] be lawfully sold over-the-
opportunity for public comment, if it is
directed above will be made publicly counter without a prescription. 21
tkelley on DSK3SPTVN1PROD with RULES
determined to be impracticable,
available in redacted form. If a comment U.S.C. 811(g)(1). Such exclusions apply
unnecessary, or contrary to the public
has so much confidential business only to specific nonnarcotic drugs
interest. 5 U.S.C. 553(b)(B). The DEA
information that it cannot be effectively following suitable application to the
redacted, all or part of that comment DEA in accordance with 21 CFR 1 Levmetamfetamine is controlled in schedule II
may not be made publicly available. 1308.21. The current table of Excluded of the CSA because it is an isomer of
Comments posted to http:// Nonnarcotic Products is found in 21 methamphetamine.
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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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Document Created: 2015-12-14 15:36:40
Document Modified: 2015-12-14 15:36:40
| 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 65632 | |
| RIN Number | 1117-ZA30 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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