Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhaler/Vapor Inhaler, 65632-65635 [2015-27264]

Download as PDF tkelley on DSK3SPTVN1PROD with RULES 65632 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations (D) A summary of the user comprehension study must be provided and include the following: (1) Results regarding reports that are provided for each gene/variant/ethnicity tested. (2) Statistical methods used to analyze all data sets. (3) Completion rate, non-responder rate, and reasons for non-response/data exclusion, as well as a summary table of comprehension rates regarding comprehension concepts (purpose of test, test results, test limitations, ethnicity relevance for the test results, etc.) for each study report. (4) Your 21 CFR 809.10 compliant labeling and any test report generated must include the following warning and limitation statements, as applicable: (i) A warning that reads ‘‘The test is intended only for autosomal recessive carrier screening in adults of reproductive age.’’ (ii) A statement accurately disclosing the genetic coverage of the test in lay terms, including, as applicable, information on variants not queried by the test, and the proportion of incident disease that is not related to the gene(s) tested. For example, where applicable, the statement would have to include a warning that the test does not or may not detect all genetic variants related to the genetic disease, and that the absence of a variant tested does not rule out the presence of other genetic variants that may be disease-related. Or, where applicable, the statement would have to include a warning that the basis for the disease for which the genetic carrier status is being tested is unknown or believed to be non-heritable in a substantial number of people who have the disease, and that a negative test result cannot rule out the possibility that any offspring may be affected with the disease. The statement would have to include any other warnings needed to accurately convey to consumers the degree to which the test is informative for carrier status. (iii) For prescription use tests, the following warnings that read: (A) ‘‘The results of this test are intended to be interpreted by a boardcertified clinical molecular geneticist or equivalent and should be used in conjunction with other available laboratory and clinical information.’’ (B) ‘‘This device is not intended for disease diagnosis, prenatal testing of fetuses, risk assessment, prognosis or pre-symptomatic testing, susceptibility testing, or newborn screening.’’ (iv) For over-the-counter tests, a statement that reads ‘‘This test is not intended to diagnose a disease, or tell you anything about your risk for VerDate Sep<11>2014 16:49 Oct 26, 2015 Jkt 238001 developing a disease in the future. On its own, this test is also not intended to tell you anything about the health of your fetus, or your newborn child’s risk of developing a particular disease later on in life.’’ (v) For over-the-counter tests, the following warnings that read: (A) ‘‘This test is not a substitute for visits to a healthcare provider. It is recommended that you consult with a healthcare provider if you have any questions or concerns about your results.’’ (B) ‘‘The test does not diagnose any health conditions. Results should be used along with other clinical information for any medical purposes.’’ (C) ‘‘The laboratory may not be able to process your sample. The probability that the laboratory cannot process your saliva sample can be up to [actual probability percentage].’’ (D) ‘‘Your ethnicity may affect how your genetic health results are interpreted.’’ (vi) For a positive result in an overthe-counter test when the positive predictive value for a specific population is less than 50 percent and more than 5 percent, a warning that reads ‘‘The positive result you obtained may falsely identify you as a carrier. Consider genetic counseling and followup testing.’’ (vii) For a positive result in an overthe-counter test when the positive predictive value for a specific population is less than 5 percent, a warning that reads ‘‘The positive result you obtained is very likely to be incorrect due to the rarity of this variant. Consider genetic counseling and followup testing.’’ (5) The testing done to comply with paragraph (b)(3) of this section must show the device meets or exceeds each of the following performance specifications: (i) The accuracy must be shown to be equal to or greater than 99 percent for both PPA and NPA. Variants that have a point estimate for PPA or NPA of less than 99 percent (incorrect test results as compared to bidirectional sequencing or other methods identified as appropriate by FDA) must not be incorporated into test claims and reports. (ii) Precision (reproducibility) performance must meet or exceed 99 percent for both positive and negative results. (iii) The user comprehension study must obtain values of 90 percent or greater user comprehension for each comprehension concept. (6) The distribution of this device, excluding the collection device described in paragraph (b)(2) of this PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 section, shall be limited to the manufacturer, the manufacturer’s subsidiaries, and laboratories regulated under the Clinical Laboratory Improvement Amendments. Dated: October 20, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27197 Filed 10–26–15; 8:45 am] BILLING CODE 4164–01–P 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 Drug Enforcement Administration, Department of Justice. ACTION: Interim final rule. AGENCY: 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 overthe-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 SUMMARY: E:\FR\FM\27OCR1.SGM 27OCR1 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations or attach a file for lengthier comments. Please go to https://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: tkelley on DSK3SPTVN1PROD with RULES 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 https:// 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 https:// VerDate Sep<11>2014 16:49 Oct 26, 2015 Jkt 238001 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 https:// 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-thecounter 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 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 65633 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). 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 1 Levmetamfetamine is controlled in schedule II of the CSA because it is an isomer of methamphetamine. E:\FR\FM\27OCR1.SGM 27OCR1 65634 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 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 tkelley on DSK3SPTVN1PROD with RULES 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 VerDate Sep<11>2014 16:49 Oct 26, 2015 Jkt 238001 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 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 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 foreignbased 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 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. 2. In § 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: ■ § 1308.22 Excluded substances. * * E:\FR\FM\27OCR1.SGM * 27OCR1 * * 65635 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations EXCLUDED NONNARCOTIC PRODUCTS Company Trade name NDC code * * * Aphena Pharma SoluNasal Decongestant In........................ tions—New York, LLC. haler/Vapor Inhaler. * * [FR Doc. 2015–27264 Filed 10–26–15; 8:45 am] BILLING CODE 4410–09–P 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® VapoInhaler® Drug Enforcement Administration, Department of Justice. ACTION: Interim final rule. AGENCY: The Drug Enforcement Administration (DEA) is amending the table of Excluded Nonnarcotic Products to update the listing for Vicks® VapoInhaler®, containing 50 mg levmetamfetamine in a nasal decongestant inhaler, marketed by The Proctor & Gamble Company. This overthe-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 tkelley on DSK3SPTVN1PROD with RULES SUMMARY: 16:49 Oct 26, 2015 Controlled substance (mg or mg/ml) * IN .... * * Levmetamfetamine (l-Desoxyephedrine) ............. * 50.00 * Dated: October 20, 2015. Louis J. Milione, Deputy Assistant Administrator, Office of Diversion Control. VerDate Sep<11>2014 Form Jkt 238001 * * * * 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 https://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: 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 https:// 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 https:// www.regulations.gov for easy reference. 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 https:// 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 Legal Authority PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 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 E:\FR\FM\27OCR1.SGM 27OCR1

Agencies

[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Rules and Regulations]
[Pages 65632-65635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27264]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

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


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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Interim final rule.

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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 https://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 https://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 https://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 https://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).
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    \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
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